The MEC-U (Medical Research Ethics Committees United; numbers W23.192 and W24.066) and review boards of the participating hospitals (Red Cross Hospital Beverwijk, Martini Hospital Groningen, and Maasstad Hospital Rotterdam) approved this study. This study was conducted in accordance with the principles of the Declaration of Helsinki. Informed consent was obtained from all patients and HPs before participation. Oral consent was provided and recorded for the patient needs assessment interviews, the usability testing with patients and HPs, acceptability testing with HPs, the evaluation interviews with patients, and the evaluation focus groups with HPs. Digital informed consent was provided for the needs assessment survey and the Normalization Measure Development (NOMAD) questionnaire.

All study data were coded and stored digitally on a secured network drive accessible only to the dedicated research team. A key file linking codes to participant identities was stored separately and protected with a password to ensure confidentiality. Patients participating in the co-design session were compensated €100 (with a currency exchange rate in January 2024 of €1=US $1.091) per session for their contribution, and patients completing the usability test were compensated with a €25 gift card.

The DA was developed and implemented using a multimethods design. The development and implementation comprised three phases: (1) a needs assessment, (2) development of the DA by co-design sessions, and usability and acceptability testing, and (3) implementation by pilot testing and evaluation. All phases were facilitated and supported by ZorgKeuzeLab B.V. in Delft, the Netherlands (development and implementation partner who has extensive experience in DAs).

The organization structure consisted of a dedicated project team responsible for the coordination and supervision of the development and implementation process; a steering group involved in the co-design sessions that was responsible for the scope, content, and design of the DA; an HP panel and patient panel involved in the needs assessment, usability, and acceptability testing of the DA; and an implementation team at each burn center.

Mentally competent adults with sufficient Dutch language skills who had sustained deep partial-thickness burns and were treated at the Maasstad Hospital Rotterdam, Martini Hospital Groningen, or Red Cross Hospital Beverwijk burn center were eligible to participate in this study. For the usability test of phase 2, patients had to be treated within the past 4 years in one of the burn centers. For the co-design sessions of phase 2, only members of the patient advisory committee were recruited. Eligibility for the patient evaluation interviews in phase 3 required that patients had used the DA during the 6-month pilot period (November 5, 2024, to May 1, 2025), allowing opportunistic selection of those who provided relevant feedback. The number of patients, HPs, and researchers participating in each study component is summarized in Table 1. Throughout this study, purposive sampling was used, with a different strategy used for each study component, depending on whether the aim was to capture variation or focus on similarities [24].

For the phase 1 needs assessment interviews with patients, a purposive sampling with a maximum variation strategy was applied to explore potential differences in information needs, taking patient characteristics such as background, level of education, and age into account. This provided a mixed group of patients with different characteristics. Patients for the co-design sessions were selected using homogeneous sampling, as only patients of the patient advisory committee were eligible. This group was intentionally chosen because they share similar experiences with patient participation, familiarity with burn care, and the ability to reflect on information needs from a patient perspective. Patients for the usability testing were selected using a purposive criterion sampling strategy, including only patients who sustained deep partial-thickness burns within the past 4 years. For the evaluation interviews, sampling followed a purposive opportunistic sampling strategy; an HP and researcher identified patients who had provided relevant feedback during the use of the DA and were therefore considered most suitable to inform the evaluation.

Patient selection was done by both the treating HP and the dedicated researcher. After identification, the HP approached the patient and, upon agreement, the researcher informed the participant about the aim and procedures of this study and scheduled the interview. No personal characteristics, assumptions, or personal motivations were shared.

Eligible HPs for the needs assessment survey had to be working at 1 of the 3 burn centers and were identified through complete departmental mailing lists provided by this project’s coordinators of each burn center (DvU, RAFV, and SJGG). A complete sampling approach was used to capture perspectives across different professionals, years of experience, and burn centers. HPs were invited by email. Eligible HPs in the co-design sessions, usability, acceptability, and evaluation with HPs had to be working at 1 of the 3 burn centers and be involved in care and decision-making for deep partial-thickness burns. A criterion-based strategy was used to target HPs working in Dutch burn care who are involved in decision-making and the implementation of the DA. These HPs were approached directly by the researcher.

No formal sample size calculation was performed as no reliable prior data were available to estimate the expected effect size. The time period for recruitment was September 2023 until October 2025.

In all phases, Amberscript was used to transcribe the audio recordings of the interviews. Necessary corrections were made by researchers RFCS and DvU for the needs assessment interviews and by researcher DvU for the evaluation interviews. For the usability and acceptability testing, Microsoft Teams (version 2023) was used to transcribe the video recordings, and field notes were taken during testing. Online surveys were completed using Castor Electronic Data Capture (version 2024.4.1.1). MaxQDA (VERBI software GmbH, version 24.6) was used for qualitative analyses. All quantitative data were analyzed with IBM SPSS (version 29).

Subsequently, the DA was put into clinical practice using a multifaceted and tailored implementation strategy guided by the expertise of ZorgKeuzeLab and the CFIR-identified facilitators and barriers of phase 2. As personal engagement and local conditions were key facilitators, the implementation team was actively involved in shaping the implementation strategy, defining implementation goals, allocating tasks and responsibilities, and addressing logistics, which had been identified as a major barrier. The implementation began with an initiation meeting at each burn center 1 month before the start of the pilot. This meeting was attended by the dedicated implementation team, including HPs involved in handing out the DA. The meeting was led by 2 researchers (RAFV and DvU), with researcher KFJ to assist with field notes. Sessions were audio-recorded on Microsoft Teams (version 2023) and supplemented with field notes, allowing researchers to observe both verbal and nonverbal responses. Its purpose was to set the implementation goals, determine the patient journey for the DA, and divide tasks needed for successful implementation. The team collaboratively mapped the patient journey and determined how to integrate the DA into existing workflows. In addition, HPs received instructions on the practical use of the DA, including task assignments. Points of attention and implementation goals were formulated, and estimations for several indicators were made, such as the expected annual number of eligible patients. To raise awareness and encourage engagement among the entire burn care team, a kick-off meeting was held to introduce all HPs to the DA and its intended use in routine care, officially launching the pilot period. Broad involvement and knowledge among all HPs was considered essential, as all team members needed to be able to support patients who might have difficulty accessing or using the DA. Executive boards were involved to secure institutional support and strengthen commitment throughout the organization. To determine the implementation of the DA, it was pilot-tested for 6 months, starting on November 5, 2024, and ending on May 1, 2025. Throughout the pilot period, HPs received monthly reports that included the predefined implementation indicators, and interim evaluation meetings were held to allow the team to refine logistical processes and make adjustments as needed. All HPs were trained on SDM before the start of the implementation.

After the pilot period, evaluation with patients and HPs followed. A structured interview guide was used to evaluate patients. Interviews were conducted by telephone, audio-recorded, and transcribed verbatim. No one other than the researcher (DvU) and the participant was present during data collection, and field notes were taken. Data were analyzed using a descriptive thematic analysis of patients’ experiences of using the DA. The transcripts were reviewed by a single researcher (DvU), who coded segments describing positive and negative experiences and grouped these codes into descriptive themes. Illustrative quotes reflecting patients’ experiences with the DA were identified within each theme to exemplify the experiences. As this component aimed primarily to provide a descriptive summary of user experiences and illustrative quotations, a single-researcher analysis (DvU) was considered appropriate. Three focus groups were conducted with HPs to evaluate their experiences using the DA. Sessions were facilitated by 2 researchers (RAFV and DvU), recorded via Microsoft Teams, and supplemented with field notes. Subsequently, a descriptive thematic analysis was conducted by RFCS and DvU, in which codes were grouped into themes describing experiences with the DA. Both researchers independently reviewed the transcripts and coded statements reflecting HPs’ experiences with the DA. Codes were then discussed in consensus meetings to compare interpretations and resolve any discrepancies, after which they were grouped into descriptive themes summarizing HPs’ experiences. Additionally, during the pilot period, ZorgKeuzeLab collected usage data of the DA, including the number of patients who received and used it, the participation rate, and the time spent using it. The degree of normalization among HPs was assessed once at the end of the pilot using the NOMAD questionnaire [30]. The NOMAD questionnaire is a validated instrument based on Normalization Process Theory that measures the extent to which a complex intervention is embedded in routine practice from the perspective of HPs. The results were analyzed using descriptive statistical analysis, with the results presented as numbers and percentages.

In this study, we developed and implemented the first DA to support SDM between patients and HPs regarding the treatment of deep partial-thickness burns. The DA supports decisions about early vs “late or no” surgery and includes a paper handout sheet, an interactive website, and a summary sheet capturing patients’ values and preferences. The DA provides a uniform and clear source of information and supports SDM between patients and HPs. The DA has been implemented, and there is a positive attitude toward its future use.

Previous studies have shown that most patients wish to be involved in clinical decision-making, although the desired level of involvement varies substantially between individuals [17,31]. This aligns with our needs assessment, in which some patients expressed a preference for active participation while others preferred to rely on the HP’s recommendation. These differences underline that SDM in burn care must be inherently patient-centered, with information and support tailored to individual preferences and capacities rather than assuming a uniform level of involvement. A DA increases knowledge of the different treatment options and can facilitate information provision [17]. By offering layered information via the paper handout sheet, the interactive website, and a summary sheet, the DA allows patients to access and revisit content at their own pace and to select sections that are most relevant to their personal situation and informational needs.

Health literacy is increasingly recognized as a critical determinant of whether patients are able to participate effectively in SDM [32]. A recent analysis of 198 DAs showed that although most DAs perform well in terms of layout and visual presentation, many fall short in providing understandable content, such as defining medical terminology or using a short and simple sentence structure [33]. Moreover, only a minority of these DAs were cocreated with patients with low health literacy. Similarly, in our research, the patients participating in the co-design sessions did not have low health literacy, which may have limited the extent to which the DA reflects the needs of this group. We improved accessibility by writing the text in common Dutch (B1 level), using short sentences and bullet points, and adding illustrations to clarify the provided information. In burn care, challenges extend beyond health literacy alone, as many patients have a language barrier and the DA contains an online component which may pose barriers for patients with limited digital skills [34]. We intended to improve accessibility for patients with low health literacy and digital literacy by stimulating support from relatives or HPs in clinic. However, future refinement of the DA should explore additional formats, such as video animations, multilingual versions, or more extensive clinical support, to better accommodate patients with lower health and digital literacy [35,36]. Despite these challenges, uptake of the DA was relatively high, and most patients who started the DA also completed it.

The implementation of a DA might face different barriers and facilitators, as was demonstrated by the systematic review of Waddell et al [12]. The identified barriers were mostly logistic-related, such as the perception that acuity limits SDM, or a lack of space and time. This matched the identified barrier on infrastructure in our acceptability test. Especially facilitating adequate time for a patient to use the DA was difficult due to the logistics of acute patient care. On the other hand, HPs acknowledged that the DA could ultimately save time by structuring explanations about the different treatment options.

The NOMAD questionnaire showed that, despite several anticipated barriers before implementation, HPs perceived clear added value of the DA compared to usual care. The relatively high normalization potential suggests that HPs saw clear added value and felt the DA could be integrated into daily clinical practice. This suggests that the DA was successfully integrated into the existing workflow, which likely reflects the active involvement of the implementation team. HPs reported that incorporating the DA into their work processes was straightforward, which aligns with the efforts made to optimize logistics in the implementation strategy, such as mapping the patient journey, dividing tasks and responsibilities, and having interim evaluation meetings. These strategies align with implementation literature emphasizing structured process mapping, team coordination, and early involvement of stakeholders as facilitators of workflow integration for DAs in daily clinical practice [37].

Visible leadership has been identified as an important factor for sustained use of SDM and DAs [38]. In our study, HPs reported that the role of key stakeholders was not fully clear and that stronger institutional involvement would likely further support sustained use of the DA. Future efforts should address factors such as appointing local stakeholders or early adopters, embedding the DA in formal protocols, and ensuring that management recognizes and supports the time and resources needed for the use of the DA. Particularly in acute burn care, this is important as high workload and operational schedules can easily overrule SDM.

A recent systematic review and meta-analysis suggests that patient DAs developed using systematic, user-centered processes, which explicitly involve patients, tend to be of a higher quality and are associated with better patient outcomes [39]. Collaboration between the steering and implementation groups, HPs, and patient panels ensured that all relevant perspectives were integrated into the DA. This integration likely contributed to the DA’s perceived relevance and usability for both patients and HPs. At the same time, the relatively small number of patient participants in the co-design sessions might introduce a power imbalance. Participation required substantial time investment and preparatory work, which limited the number of patients able to participate. However, the participating patient representatives were highly experienced, and the co-design session leaders ensured equal contribution between patients and HPs.

To enhance the DA, subsequent research is desired to add outcome information [40]. Therefore, we are currently undertaking a multicenter prospective study to gain information regarding scar quality, clinical outcomes, and patient-reported outcomes for both early surgery and “late or no” surgery in deep partial-thickness burns [4]. This will provide up-to-date and evidence-based information on outcomes, helping patients to better understand possible risks and compare treatment expectations [41]. Incorporating outcomes, such as scar elasticity, satisfaction with scar and donor site, number of dressing changes and surgeries, and broader patient-reported outcomes such as quality of life and return to work, can enhance the DA and can be meaningful for the treatment decision. The correct visual representation of the outcome data should also be discussed, as it allows patients to fully understand the information provided.

Several limitations of this study should be considered. The number of patients participating in phase 2 co-design sessions and in the pilot use of the DA was modest, partly due to the time required for participation and lower than expected admissions during the pilot period, which may limit representativeness of patient experiences. In addition, this study did not include a formal effectiveness evaluation of the DA’s impact on SDM, so conclusions about effectiveness rely on qualitative data from interviews with patients and focus groups with HPs, rather than controlled comparisons.

Finally, the DA was developed specifically for patients with deep partial-thickness burns, in whom the treatment decision is clinically relevant. It does not explicitly incorporate other burn characteristics, such as different burn depth or specific burn size. As burn and patient characteristics can significantly influence course, treatment, and outcome, clinicians should use the DA in combination with clinical judgment to determine its applicability to individual patients, particularly in cases involving extensive burns or other relevant clinical scenarios.

This study outlines a comprehensive, user-centered approach for developing and implementing a DA in acute burn care, integrating patients and HPs throughout the whole process. Our findings suggest that, when clinical teams are involved early and implementation strategies such as patient-journey mapping, role clarification, and iterative feedback are used, a DA can be normalized within the high-pressure context of acute burn care and support more patient-centered treatment decisions. The DA enhances access to uniform information, helps clarify patient values and preferences, and supports perceived SDM, while also highlighting ongoing challenges around health literacy, digital access, and organizational support. Its successful integration offers a model for implementing a DA in other acute clinical contexts with time pressure and complex decisions.