Impact of MyDiabetesPlan, a Web-Based Patient Decision Aid on Decisional Conflict, Diabetes Distress, Quality of Life, and Chronic Illness Care in Patients With Diabetes: Cluster Randomized Controlled Trial

Abstract

Background Person-centered care is critical for delivering high-quality diabetes care. Shared decision making (SDM) is central to person-centered care, and in diabetes care, it can improve decision quality, patient knowledge, and patient risk perception. Delivery of person-centered care can be facilitated with the use of patient decision aids (PtDAs). We developed MyDiabetesPlan, an interactive SDM and goal-setting PtDA designed to help individualize care priorities and support an interprofessional approach to SDM. Objective This study aims to assess the impact of MyDiabetesPlan on decisional conflict, diabetes distress, health-related quality of life, and patient assessment of chronic illness care at the individual patient level. Methods A two-step, parallel, 10-site cluster randomized controlled trial (first step: provider-directed implementation only; second step: both provider- and patient-directed implementation 6 months later) was conducted. Participants were adults 18 years and older with diabetes and 2 other comorbidities at 10 family health teams (FHTs) in Southwestern Ontario. FHTs were randomly assigned to MyDiabetesPlan (n=5) or control (n=5) through a computer-generated algorithm. MyDiabetesPlan was integrated into intervention practices, and clinicians (first step) followed by patients (second step) were trained on its use. Control participants received static generic Diabetes Canada resources. Patients were not blinded. Participants completed validated questionnaires at baseline, 6 months, and 12 months. The primary outcome at the individual patient level was decisional conflict; secondary outcomes were diabetes distress, health-related quality of life, chronic illness care, and clinician intention to practice interprofessional SDM. Multilevel hierarchical regression models were used. Results At the end of the study, the intervention group (5 clusters, n=111) had a modest reduction in total decisional conflicts compared with the control group (5 clusters, n=102; −3.5, 95% CI −7.4 to 0.42). Although there was no difference in diabetes distress or health-related quality of life, there was an increase in patient assessment of chronic illness care (0.7, 95% CI 0.4 to 1.0). Conclusions Use of goal-setting decision aids modestly improved decision quality and chronic illness care but not quality of life. Our findings may be due to a gap between goal setting and attainment, suggesting a role for optimizing patient engagement and behavioral support. The next steps include clarifying the mechanisms by which decision aids impact outcomes and revising MyDiabetesPlan and its delivery. Trial Registration ClinicalTrials.gov NCT02379078; https://clinicaltrials.gov/ct2/show/NCT02379078

Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial

“…We assessed the following predetermined outcomes [ 19 ]: recruitment period length, recruitment response rate, participant retention rate, questionnaire completion rate (interim and final), and resource use (personnel and funds; divided into resources required for delivery of the intervention and resources required for evaluation). The estimated sample size was 112 individuals for the primary outcome of decisional conflict [ 10 ]. We deemed the study to be feasible if we were able to complete patient recruitment within a 12-month period and attained a questionnaire response rate of 75% or higher.…”

“…Similarly, in our prior work, patients identified their lack of assertiveness and knowledge, limited access to their health care team, and the lack of a therapeutic relationship as barriers to SDM [ 1 ]. Clinicians struggled with decision-making when there was a disconnect between the potential goals they selected for the patient and the goals the patient set for themselves [ 10 ]. The use of an interprofessional (IP) team approach may facilitate SDM.…”

Decision Making When Cancer Becomes Chronic: Needs Assessment for a Web-Based Medullary Thyroid Carcinoma Patient Decision Aid

“…Since the 2017 review of internet-based patient decision aids [19], several studies have been published that may inform the design of web-based tools [65][66][67][68][69][70][71][72]. Overall, these studies continue to report positive ratings of acceptability, usability, and satisfaction as well as improved knowledge, decisional conflict, decision self-efficacy, preparation for decision making, and satisfaction.…”

“In my age, we didn’t have the computers”: Using a complexity lens to understand uptake of diabetes eHealth innovations into primary care—A qualitative study

“…Despite this, successful integration of PtDAs into clinical care continues to be elusive, with rates as low as 9.3% [ 7 ]. For example, in our previous work, we conducted a cluster randomized controlled trial of MyDiabetesPlan , an web-based PtDA to facilitate goal-setting in patients with diabetes [ 8 ]. While single-decision PtDAs exist in diabetes care (e.g.…”

“…This suboptimal use occurred despite the research team undertaking an iterative user-centred design and evidence-based approach within a Knowledge-to-Action framework [ 11 ]. Throughout the design process, we engaged users (patients, clinicians), and conducted literature searches to identify barriers and facilitators to use, then refined MyDiabetesPlan based on this input [ 8 , 10 ]. However, this approach was arguably “linear” and unidirectional, and did not fully consider the full context of the clinical encounter and how MyDiabetesPlan’s fit into the health care system and patients’ lives, nor the multi-directional interactions and relationship between these factors.…”