Abstract
BackgroundCompeting health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Guideline implementation interventions rarely acknowledge this, leaving both patients and providers feeling overwhelmed by the volume of recommended actions. Interprofessional (IP) shared decision-making (SDM) with the use of decision aids may help to set treatment priorities. We developed an evidence-based SDM intervention for patients with diabetes and other conditions that was framed by the IP-SDM model and followed a user-centered approach. Our objective in the present study is to pilot an IP-SDM and goal-setting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care.Methods/DesignA two-step, parallel-group, clustered randomized controlled trial (RCT) will be conducted, with the primary goal being to assess intervention fidelity and the feasibility of conducting a larger RCT. The first step is a provider-directed implementation only; the second (after a 6-month delay) involves both provider- and patient-directed implementation. Half of the clusters will be assigned to receive the IP-SDM toolkit, and the other will be assigned to be mailed a diabetes guidelines summary. Individual interviews with patients, their family members and health care providers will be conducted upon trial completion to explore toolkit use. A secondary purpose of this trial is to gather estimates of the toolkit’s impact on decisional conflict. Secondary outcomes include diabetes distress, quality of life and chronic illness care, which will be assessed on the basis of patient-completed questionnaires of validated scales at baseline and at 6 and 12 months. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.DiscussionAn individualized approach to patients with multiple chronic conditions using SDM and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion. Our pilot trial will provide insights regarding strategies for the routine implementation of such interventions in clinical practice, and it will offer an assessment of the impact of this approach.Trial registrationClinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0797-8) contains supplementary material, which is available to authorized users.
Highlights
Competing health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers
An individualized approach to patients with multiple chronic conditions using shared decision-making (SDM) and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion
The authors of a systematic review of randomized controlled trials (RCTs) of SDM identified 11 studies [2], 2 of which examined long-term decisions that occurred over multiple sessions in a 9- and 12-month time frame and reported improved adherence, reduced depression and improved well-being
Summary
Competing health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Our objective in the present study is to pilot an IP-SDM and goalsetting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care. An IP approach to SDM is the process whereby two or more health care professionals are involved in making the decision with the patient [12]. This approach may occur synchronously, but it more often occurs asynchronously and requires a shared framework with a common understanding. Achieving a common understanding of the essential elements of the SDM process among the IP team, as well as recognizing the influence of the various individuals on this process, will improve success in reaching a shared decision
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