The Impact of a Clinical Decision Support System for Addressing Physical Activity and Healthy Eating During Smoking Cessation Treatment: Hybrid Type I Randomized Controlled Trial

Background People who smoke have other risk factors for chronic diseases, such as low levels of physical activity and poor diet. Clinical decision support systems (CDSSs) might help health care practitioners integrate interventions for diet and physical activity into their smoking cessation programming but could worsen quit rates. Objective The aims of this study are to assess the effects of the addition of a CDSS for physical activity and diet on smoking cessation outcomes and to assess the implementation of the study. Methods We conducted a pragmatic hybrid type I effectiveness-implementation trial with 232 team-based primary care practices in Ontario, Canada, from November 2019 to May 2021. We used a 2-arm randomized controlled trial comparing a CDSS addressing physical activity and diet to treatment as usual and used the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to measure implementation outcomes. The primary outcome was self-reported 7-day tobacco abstinence at 6 months. Results We enrolled 5331 participants in the study. Of these, 2732 (51.2%) were randomized to the intervention group and 2599 (48.8%) to the control group. At the 6-month follow-up, 29.7% (634/2137) of respondents in the intervention arm and 27.3% (552/2020) in the control arm reported abstinence from tobacco. After multiple imputation, the absolute group difference was 2.1% (95% CI −0.5 to 4.6; F1,1000.42=2.43; P=.12). Mean exercise minutes changed from 32 (SD 44.7) to 110 (SD 196.1) in the intervention arm and from 32 (SD 45.1) to 113 (SD 195.1) in the control arm (group effect: B=−3.7 minutes; 95% CI −17.8 to 10.4; P=.61). Servings of fruit and vegetables changed from 2.64 servings to 2.42 servings in the intervention group and from 2.52 servings to 2.45 servings in the control group (incidence rate ratio for intervention group=0.98; 95% CI 0.93-1.02; P=.35). Conclusions A CDSS for physical activity and diet may be added to a smoking cessation program without affecting the outcomes. Further research is needed to improve the impact of integrated health promotion interventions in primary care smoking cessation programs. Trial Registration ClinicalTrials.gov NCT04223336 https://www.clinicaltrials.gov/ct2/show/NCT04223336 International Registered Report Identifier (IRRID) RR2-10.2196/19157

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Other: not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet 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) T   1  a  )  T  I  T  L  E  :  I  d  e  n  t  i  f  i  c  a  t  i  o  n  a  s  a  r  a  n  d  o  m  i  z  e  d  t  r  i  a  l  i  n  t  h  e  t  i  t  l  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 offline 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.  T  R  A  C  T  :  S  t  r  u  c  t  u  r  e  d  s  u  m  m  a  r  y  o  f  t  r  i  a  l  d  e  s  i  g  n  ,  m  e  t  h  o  d  s  ,  r  e  s  u  l  t  s  ,  a  n  d  c  o  n  c  l  u  s  i  o  n  s   N  P  T  e  x  t  e  n  s  i  o  n  :  D  e  s  c  r  i  p  t  i  o  n  o  f  e  x  p  e  r  i  m  e  n  t  a  l  t  r  e  a  t  m  e  n  t  ,  c  o  m  p  a  r  a  t  o  r  ,  c  a  r  e  p  r  o  v  i  d  e  r  s  ,  c  e  n  t  e  r  s  ,  a  n  d  b  l  i  n  d  i  n  g  s  t  a  t  u  s  . subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study "We measured the effectiveness of the CDSS using a two-arm randomized control trial comparing a CDSS for addressing physical activity and diet as part of a smoking cessation program with treatment as usual, and used the RE-AIM Framework to measure implementation" outcomes." Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). 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 briefly explain why the item is not applicable/relevant for your study 3/11/22, 9: 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 briefly explain why the item is not applicable/relevant for your study Your answer 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 briefly explain why the item is not applicable/relevant for your study "the aims of this study are to: (1) assess whether adding a CDSS for physical activity and diet to a smoking cessation program positively or negatively affects smoking cessation outcomes, and (2) assess the implementation of the study using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework [36]." . Participants were also required to be English-speaking and provide at least one piece of contact information (email address or phone number) so study team could conduct follow-up surveys at six months following enrollment into the STOP program.
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. 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 briefly explain why the item is not applicable/relevant for your study Your answer a c e a s s e s s m e n t s : Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), 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 confirmation, phone calls) were used to detect/prevent these. 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 briefly explain why the item is not applicable/relevant for your study "Participants enrolled into the STOP Program through self-or practitioner-referral" 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.
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 briefly explain why the item is not applicable/relevant for your study "The trial was operationalized in team-based primary care practices in Ontario, Canada (Family Health Teams (n=153), Community Health Centers (n=61), and Nurse Practitionerled, Clinics (n=18)) implementing the STOP Program as of November 29, 2019." Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise. subitem not at all important 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 briefly explain why the item is not applicable/relevant for your study The trial was operationalized in team-based primary care practices in Ontario, Canada (Family Health Teams (n=153), Community Health Centers (n=61), and Nurse Practitionerled, Clinics (n=18)) implementing the STOP Program as of November 29, 2019. 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 briefly explain why the item is not applicable/relevant for your study Your answer 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 briefly explain why the item is not applicable/relevant for your study Your answer 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. 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). 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 briefly explain why the item is not applicable/relevant for your study "The primary outcome of interest for this study is self-reported smoking cessation (7-day point prevalence abstinence) at the six-month follow-up following enrollment. This outcome was measured by a response of 'No' to the following question: "Have you smoked a cigarette, even a puff, in the last 7 days." "The secondary outcomes are self-reported changes in physical activity levels and/or fruit/vegetable consumption levels between baseline to 6 month follow-up. The Exercise Vital Signs screener [47]was adapted to assess changes in physical activity. This screener has been validated [47] and consists of two questions: "On average, how many days per week do you engage in moderate-to-strenuous (vigorous) exercise (like a brisk walk)?" and "On these days, for how many minutes do you typically exercise at this level?" The responses to these two questions are multiplied together to produce the total minutes per week of moderate-to-strenuous exercise. Fruit and vegetable consumption was measured using a single question: "In a typical day, how many total servings of fruits and vegetables do you eat? (One serving is 1/2 cup of fresh, frozen, or canned fruits or vegetables, or 1/2 cup of 100% juice. Please DO NOT include potatoes 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 briefly explain why the item is not applicable/relevant for your study There were no changes to the primary or secondary outcomes. Since the trial right before the COVID-19 pandemic, we also include additional analyses around the impact of the pandemic on our outcomes. For our Maintenance outcome (under the RE-AIM framework), "Note, in our protocol manuscript, we had only outlined the patient level outcome for our maintenance outcome. Upon reflection, we also included the outcome at the setting level." 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 briefly explain why the item is not applicable/relevant for your study "The random allocation sequence was generated and implemented automatically by the STOP Portal." 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). 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 briefly explain why the item is not applicable/relevant for your study "Our analysis followed the principle of intention-to-treat, in which all participants are analyzed in the groups to which they were randomized. As specified by the study protocol, we tested differences in our primary outcome (the proportion of participants abstinent from cigarettes at six month follow-up) with a chi-square test and differences in our secondary outcomes by regressing the follow-up measure on the baseline value and the study group." 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]). 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 briefly explain why the item is not applicable/relevant for your study "To explore differences associated with the offering and acceptance of the resources, we conducted a secondary analysis in which we divided participants into 4 groups: the control arm; participant with whom practitioners conducted a risk communication discussion and offered the self-monitoring resources for these behaviours, participants receiving neither a risk communication discussion nor an offer of resources; and participants receiving either a discussion or an offer, but not both. These analyses were similar to those described above, but with four groups." 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 briefly explain why the item is not applicable/relevant for your study "In total, we enrolled 5331 patients with low levels of fruit/vegetable consumption and/or physical activity into the study. Figure 1 provides a breakdown of the number of participants allocated to intervention and control group and included in our primary and secondary data analyses. We randomized 2599 people to the control group and 2732 to the intervention group."  T  E  :  P  r  e  f  e  r  a  b  l  y  ,  t  h  i  s  i  s  s  h  o  w  n  i  n  a  C  O  N  S  O  R  T  f  l  o  w  d  i  a  g  r  a  m ) * 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 briefly explain why the item is not applicable/relevant for your study Yes, the CONSORT flow diagram can be found in Figure 1 1 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 figures or tables demonstrating usage/dose/engagement. Copy and paste relevant sections from the manuscript or cite the figure 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 briefly explain why the item is not applicable/relevant for your study 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 briefly explain why the item is not applicable/relevant for your study a  s  e  l  i  n  e  d  e  m  o  g  r  a  p  h  i  c  a  n  d  c  l  i  n  i  c  a  l  c  h  a  r  a  c  t  e  r  i  s  t  i  c  s  f  o  r  e  a  c  h  g  r  o  u  p   N  P  T  :  W  h  e  n  a  p  p  l  i  c  a  b  l  e  ,  a  d  e  s  c  r  i  p  t  i  o  n  o  f  c  a  r  e  p  r  o  v  i  d  e  r  s  (  c  a  s  e  v  o  l  u  m  e  ,  q  u  a  l  i  f  i  c  a  t  i  o  n  ,  e  x  p  e  r  t  i  s  e  ,  e  t  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 briefly explain why the item is not applicable/relevant for your study " Report multiple "denominators" and provide definitions: 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 specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention. 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 definitions 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 defined (e.g., timeout after idle time) However, these self-reported measures have been validated and there is no reason to believe that any self-report bias would be different between the intervention and control group." "While patients were blinded to their treatment allocation health care practitioners were not, since we used patient-level randomization. This lack of health care practitioner blinding increases the risk of group contamination as the health care practitioner could take their learnings from the intervention group patients and apply it to the control group participants. However, the physical activity and fruit/vegetable consumption selfmonitoring resources in the CDSS were only available to participants in the intervention group, which minimized the risk of any cross-contamination" 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 briefly explain why the item is not applicable/relevant for your study Your answer 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 briefly explain why the item is not applicable/relevant for your study "As outlined in our protocol manuscript [35]," Reference 35 is our published protocol. 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 briefly explain why the item is not applicable/relevant for your study Your answer