Impact of a Web-Based Electronic Health Record on Behavioral Health Service Delivery for Children and Adolescents: Randomized Controlled Trial

Background Electronic health records (EHRs) have been widely proposed as a mechanism for improving health care quality. However, rigorous research on the impact of EHR systems on behavioral health service delivery is scant, especially for children and adolescents. Objective The current study evaluated the usability of an EHR developed to support the implementation of the Wraparound care coordination model for children and youth with complex behavioral health needs, and impact of the EHR on service processes, fidelity, and proximal outcomes. Methods Thirty-four Wraparound facilitators working in two programs in two states were randomized to either use the new EHR (19/34, 56%) or to continue to implement Wraparound services as usual (SAU) using paper-based documentation (15/34, 44%). Key functions of the EHR included standard fields such as youth and family information, diagnoses, assessment data, and progress notes. In addition, there was the maintenance of a coordinated plan of care, progress measurement on strategies and services, communication among team members, and reporting on services, expenditures, and outcomes. All children and youth referred to services for eight months (N=211) were eligible for the study. After excluding those who were ineligible (69/211, 33%) and who declined to participate (59/211, 28%), a total of 83/211 (39%) children and youth were enrolled in the study with 49/211 (23%) in the EHR condition and 34/211 (16%) in the SAU condition. Facilitators serving these youth and families and their supervisors completed measures of EHR usability and appropriateness, supervision processes and activities, work satisfaction, and use of and attitudes toward standardized assessments. Data from facilitators were collected by web survey and, where necessary, by phone interviews. Parents and caregivers completed measures via phone interviews. Related to fidelity and quality of behavioral health care, including Wraparound team climate, working alliance with providers, fidelity to the Wraparound model, and satisfaction with services. Results EHR-assigned facilitators from both sites demonstrated the robust use of the system. Facilitators in the EHR group reported spending significantly more time reviewing client progress (P=.03) in supervision, and less time overall sending reminders to youth/families (P=.04). A trend toward less time on administrative tasks (P=.098) in supervision was also found. Facilitators in both groups reported significantly increased use of measurement-based care strategies overall, which may reflect cross-group contamination (given that randomization of staff to the EHR occurred within agencies and supervisors supervised both types of staff). Although not significant at P<.05, there was a trend (P=.10) toward caregivers in the EHR group reporting poorer shared agreement on tasks on the measure of working alliance with providers. No other significant between-group differences were found. Conclusions Results support the proposal that use of EHR systems can promote the use of client progress data and promote efficiency; however, there was little evidence of any impact (positive or negative) on overall service quality, fidelity, or client satisfaction. The field of children’s behavioral health services would benefit from additional research on EHR systems using designs that include larger sample sizes and longer follow-up periods. Trial Registration ClinicalTrials.gov NCT02421874; https://clinicaltrials.gov/ct2/show/NCT02421874 (Archived by WebCite at http://www.webcitation.org/6yyGPJ3NA)

yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly better than intervention in one or more outcomes inconclusive: more research is needed Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
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subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Web-based" 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "behavioral health service delivery" 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Children and Adolescents" Your response is too large. Try shortening some answers. Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "standard elds such as youth and family information, diagnoses, assessment data, and progress notes; as well as maintenance of a coordinated plan of care; progress measurement on strategies and services; communication among team members; and reporting on services, expenditures, and outcomes." subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Thirty-four Wraparound facilitators working in two programs in two states were randomized to either use the new EHR (n=19) or to continue to implement Wraparound services as usual (SAU) using paper-based documentation (n=15). Key functions of the EHR included standard elds such as youth and family information, diagnoses, assessment data, and progress notes; as well as maintenance of a coordinated plan of care; progress measurement on strategies and services; communication among team members; and reporting on services, expenditures, and outcomes. " 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Does your paper address subitem 1b-iii? Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Thirty-four Wraparound facilitators working in two programs in two states were randomized to either use the new EHR (n=19) or continue to implement Wraparound services as usual (SAU) using paper-based documentation (n=15). Assignment was unblended due to facilitators working in the same organizations." Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "EHR-assigned facilitators from both sites demonstrated robust use of the system. Facilitators in the EHR group reported spending signi cantly more time reviewing client progress (P = .03) in supervision, and less time overall sending reminders to youth/families (P = .04). A trend toward less time on administrative tasks (P = .098) in supervision was also found. " 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Results support the proposal that use of EHR systems can promote use of client progress data and promote e ciency; however, there was little evidence of any impact (positive or negative) on overall service quality, delity, or client satisfaction. " Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "In the current study, we examined usability and short-term impacts of an EHR developed to support implementation of care coordination for children and youth with complex behavioral health needs and their families using the Wraparound process [36,37]. This EHR software was found in development studies to have adequate usability under controlled conditions [32]. " Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 1. "What were providers' perceptions of the EHR's feasibility, acceptability, and contextual appropriateness in the "real world" of implementing Wraparound care coordination? 2. Comparing Wraparound facilitators randomly assigned to use the EHR versus paper-based SAU, how did EHR implementation affect relevant work practices and service processes, such as supervision, delity to the Wraparound practice model, collection and use of progress data, teamwork and alliance, and parent satisfaction with care?" 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study employed a blocked randomized control design with Wraparound facilitators (typically Bachelor's or Master's level mental health practitioners)." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No changes were made after trial commencement.

3b-i) Bug xes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Largely N/A -as described in the paper, the system as tested was based on extensive pilot testing (with results previously published); results of current trial have been used subsequently to address bugs and concerns (as described in the Discussion); however, few revisions to the system were conducted during the study itself Your response is too large. Try shortening some answers. 4a) Eligibility criteria for participants subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "To be eligible for the study, children and youth had to be between 5 and 18 years old and experiencing serious emotional and behavioral disturbance (SEBD), de ned as having a mental health diagnosis as designated in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [38] and functional impairment that "substantially interferes with or limits the child from developing social, behavioral, cognitive, communicative or adaptive skills or his activities relating to family, school or community."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Facilitators assigned to the EHR condition were trained and supported to use an online EHR software package " Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, All these details are provided 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. Consent forms are available upon request. Use of the EHR by randomly selected staffpersons was conceived of as being part of organization-wide rollout.
No user staff who were approached declined participation Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study was conducted in two sites. Site 1 was a Wraparound agency located in a diverse, largely rural region of a Southeastern U.S. state. Site 2 was a regional mental health center providing Wraparound and other services in a small, predominantly white city and surrounding region in a Midwestern U.S. state." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes 4b-ii) Report how institutional a liations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No -institutional a liations were not displayed, as it was believed to have likely biased results.

5-i) Mention names, credential, a liations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study was funded by the National Institute of Mental Health (R42-MH95516; PI Bruns). To ensure no con ict of interest biased results, the study team from the University of Washington, which has no nancial interests in the commercialization of the software, designed and conducted the current research as part of a partnership with the small business (FidelityEHR)." Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Facilitators assigned to the EHR condition used an online software system that was developed through a partnership between a university research team and a small behavioral health-focused software developer. " In addition, a previous paper is referenced that provided extensive user testing results from this process: Bruns

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
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subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Development and/or content was essentially "frozen" during the trial. The discussion includes information about the level of development of the software and its potential for impact on the results of the study.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Such information is available on the developer's website and upon request.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The product is an EHR, and as such was mandated for use by the research participants' employer.
Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "For example, the software is organized via tabs that correspond to the sequence of activities that engage the family and build a plan that serves as the focus of coordinated Wraparound teamwork. Examples of information entered and maintained include the family's background and reason for referral, youth and family strengths, a team mission statement, and priority need statements in the family's own words. Each need statement is connected to speci c strategies and one or more outcomes statements on which data must be entered over time. If a strategy is a billable service, the facilitator can enter the service, service provider information, and number of units authorized.
Other functions supported by the EHR system include individualized permission levels that allow for the sharing of information among youth and families, providers, and other team members." Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-ix) Describe use parameters Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Although all efforts on the part of Wraparound care coordinators were completed within the EHR system, documentation by other involved health professionals (e.g., primary or specialty care physicians, child welfare case workers, mental health therapists) did not complete documentation within the records. Evaluation reports, medical records, and other documentation can, however, be uploaded to the record via secure upload. See work published by Bruns and colleagues [32] for more details on the system." Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is largely N/A due to EHR use being initiated by health care providers as part of their ongoing work with clients, but functions that provide prompts and reminders are described: "The EHR also sends system-generated emails that obtain electronic signatures and automated reminders for upcoming meetings. " 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as standalone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "The research team monitored use of the software by EHR-assigned facilitators and reviewed activity logs by facilitator in monthly consultation. The research team also compiled and fed these data back in initial months of the study to ensure the system was being used as intended by EHR group members. The activity monitor recorded each movement the user made within the system (i.e., "Visited Custom Assessment Report Page" or, "Visited Add/Edit User Page") in order to capture how facilitators were utilizing the system. These data were then aggregated into categories (i.e., "Maintaining Service Notes" or, "Updating & Developing the Plan of Care") in order to assess the percentage of time users were spending on each type of function in the EHR." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text N/A Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No trial outcomes were changed after the commencement of the trial.
Your response is too large. Try shortening some answers. 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This was not possible in this small scale pilot trial.
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Your response is too large. Try shortening some answers. 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study employed a blocked randomized control design with Wraparound facilitators (typically Bachelor's or Master's level mental health practitioners). Wraparound facilitators (also care coordinators) were randomly assigned to two conditions, EHR or SAU. A pool of 34 (29 in Site 1 and 5 in Site 2) randomized facilitators were strati ed by the two sites and 5 supervisors (3 in Site 1 and 2 in Site 2) to balance clustering effects. Randomization was conducted by the independent academic partner at the University of Washington." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study employed a blocked randomized control design with Wraparound facilitators (typically Bachelor's or Master's level mental health practitioners). Wraparound facilitators (also care coordinators) were randomly assigned to two conditions, EHR or SAU. A pool of 34 (29 in Site 1 and 5 in Site 2) randomized facilitators were strati ed by the two sites and 5 supervisors (3 in Site 1 and 2 in Site 2) to balance clustering effects. Randomization was conducted by the independent academic partner at the University of Washington." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization was conducted by the independent academic partner at the University of Washington." 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
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subitem not at all important 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "As described above, randomization at the site or supervisor level was not possible, meaning that between-group contamination (e.g., in areas such as supervision style or activities or use of standardized assessment) may have occurred. This may also have compromised the study's ability to detect impacts of the EHR." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The impossibility of use of blinded conditions was explained throughout the paper and discussed as a limitation: "As described above, randomization at the site or supervisor level was not possible, meaning that between-group contamination (e.g., in areas such as supervision style or activities or use of standardized assessment) may have occurred. This may also have compromised the study's ability to detect impacts of the EHR." 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Facilitators in the control group completed research measures as described below, but did not participate in the training or use of the EHR. Rather, SAU-assigned facilitators maintained documentation as usual, involving traditional paper case les. For facilitators in the SAU group, intake paperwork, progress notes, Wraparound plans, meeting minutes, and assessments all continued to be typed and/or hand-written and stored in a paper le and/or Excel les. Supervisors of SAU facilitators continued to review information on family needs, plans, and progress using paper and Excel les in their management and supervision. " Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Equivalence of groups at baseline was assessed using t-tests and chi-square tests. Differences between EHR and SAU in provider work ow, implementation and service processes, and client/facilitator satisfaction were examined using t-tests, and hierarchical linear models were also conducted to account for the nested nature of the data.";"Longitudinal outcomes were tested through two-level growth curve models using HLM 7.0 [61] with observations/time (level 1) nested within facilitators (level 2). The data were also nested by site (level 3) but due to the low ICCs, a dummy variable was created and included in the model." Your response is too large. Try shortening some answers. 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "To account for missing data, which ranged between 20% and 24%, multivariate normal model imputation was used with 100 imputations. Auxiliary variables were included to aid the imputation. These analyses were conducted using Stata Version 13.1." Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study protocol was approved by the institutional review board at the University of Washington. Provider staff (supervisors and facilitators) were consented by the research coordinator in person after an on-site study introduction."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study protocol was approved by the institutional review board at the University of Washington. Provider staff (supervisors and facilitators) were consented by the research coordinator in person after an on-site study introduction." Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons X26-iii) Safety and security procedures Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This item was not directly addressed in the manuscript due to minimal risk of the study procedures (EHR is fully secure and HIPAA compliant and not focused on provision of treatment; evaluation focused on service processes not outcomes).
Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study These numbers are addressed in detail in the text of the manuscript and in the CONSORT diagram provided.
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subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study These numbers are addressed in detail in the text of the manuscript and in the CONSORT diagram provided.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is included in the paper in text and via presentation in Figure 1.
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study was initiated in November 2015 in Site 1 and January 2016 in Site 2. All 34 facilitators and 5 supervisors in both sites consented to participate. For eight months after study inception, 211 children and youth enrolled in Wraparound in the two sites were referred to the study. " Your response is too large. Try shortening some answers.
subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This information can be found in Table 1 Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Race, gender, and attitudes toward standardized assessment were collected and reported among EHR user staff.
16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This study used an "intent to treat" approach that evaluated implementation outcomes for all clients served by providers in both groups. As an initial pilot study, analysis by subgroups was not possible.
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subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) 16-ii) Primary analysis should be intent-to-treat Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This study used an "intent to treat" approach that evaluated implementation outcomes for all clients served by providers in both groups. As an initial pilot study, analysis by subgroups was not possible.
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Means, SDs, and signi cance of between group differences are presented for all outcomes .
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subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespeci ed from exploratory 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study " Table 2 presents a summary of EHR activity by facilitators in each site for months 1 and 2, when activity was recorded and fed back during EHR consultation from the research team. As shown, EHR facilitators from both sites demonstrated robust use of the system. " Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Subgroup analyses were not possible in this small randomized pilot study.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Subgroup analyses were not possible in this small randomized pilot study.
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subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study One subscale from one measure of one dependent variable showed more positive outcomes for the non-EHR group; the possibility of unintended effects are discussed: "Not all signi cant results supported positive impacts of the EHR. First, there was a pattern of poorer scores for the EHR group on the WAI, including a trend toward signi cance (P = .10) on the subscale focused on agreement on tasks to achieve identi ed goals. While such ndings may have been spurious given the number of statistical tests conducted, they also may indicate that the time and effort needed to integrate a new EHR into work ow compromised engagement and alliance between EHR-assigned facilitators and families."

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].
Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
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subitem not at all important 1 2 3 4 5 essential 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Research on use of EHR systems in behavioral healthcare has lagged behind research in general healthcare, resulting in a dearth of empirical guidance around issues such as software design and the impact of EHR adoption on services. The current study attempted to ll gaps in the research base by asking whether care coordinators serving children and youth with complex behavioral health needs who were randomly assigned to use a EHR would demonstrate differences in service processes and service quality compared to providers using paper records. Results indicated that there were few such impacts."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Future studies would bene t from examination of the impact of usability of EHR systems (or impact across multiple stages of development or implementation of a single system) on outcomes. It is important to note that successful application of EHRs -and HIT in general -requires strategic implementation supports to be successfully applied [66][67][68]. The rapid timeframe for the current study meant that EHR training and initiation of youth/family study enrollment happened very quickly and with less development of readiness and local implementation support than may have been ideal." Your response is too large. Try shortening some answers. Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The current study has several major limitations. It focused only on short-term (4 month) outcomes, and these were limited to provider, work ow, and service variables. Actual impact on outcomes such as residential placement, symptoms, and functioning and family outcomes such as family functioning or caregiver strain were not assessed. The sample size was small, and over one-third of the initial sample of youth/caregivers was lost to follow-up, limiting our ability to detect signi cant differences." (See limitations section for rest).

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Results of the current study suggest that, even when implemented under unideal circumstances (e.g., a randomized study within an organization), introduction of an EHR may indeed facilitate measurable and bene cial shifts in practice, such as greater attention to measurement-based care. At the same time, results suggest that EHRs may give rise -at least initially -to measurable, if subtle, negative impacts, such as less capacity for practitioners to nurture engagement and alliance." 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Although research and experience suggests that practitioner perceptions of EHR system usability and provision of training and implementation support is often poor in behavioral health, this situation may reduce the generalizability of results. Conducting the study in the context of Wraparound facilitation, which consists of a relatively unique set of practice activities, also may limit generalizability to other service types. " Your response is too large. Try shortening some answers. 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Con icts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Clinicaltrials.gov NCT02421874, https://clinicaltrials.gov/ct2/show/NCT02421874" Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Clinicaltrials.gov NCT02421874, https://clinicaltrials.gov/ct2/show/NCT02421874" Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study was funded by the National Institute of Mental Health (R42-MH95516; PI Bruns)." Your response is too large. Try shortening some answers.