Clinical trial NCT02379078: Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes
Official title: Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes - A Pilot Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Shared decision-making
Priority setting
Patient decision aid
Interprofessional care
Diabetes mellitus
Patient education
Medical informatics
Toolkit development
Study protocol
User-centred design
Qualitative methods
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-03-04
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Diabetes care is complicated for people with diabetes as well as for health care providers: they have to watch their diet, exercise, take medications, checking blood sugars and blood pressure, get tests and see multiple doctors. On top of that, many with diabetes have other health problems, such as high blood pressure or arthritis, that make care even more complicated. Guidelines for improving the care of people with diabetes try to help by summarizing the best practices for care, but because diabetes care is so complicated, it is hard for them to be put into practice. One solution to this is a tool that can help people with diabetes set health care goals that are important to them, and participate actively in decisions about their own health care, together with health care providers. This tool would have an information booklet for patients with facts that can help them make a decision, a worksheet to help spell out what their goals are and how they want to get there, and a cheat-sheet for health care providers that gives them tips on how to do this. The purpose of this project is to find out if a tool like this would be helpful, how to make it more helpful and usable, and what the best way would be to make sure that people use it.

An interprofessional (IP) shared decision-making (SDM) and goal-setting tool kit, including a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented successfully in clinical practice and will reduce decisional conflict and diabetes distress and improve chronic care delivery and quality of life in patients with type 1 or type 2 diabetes and 2 other comorbid chronic diseases. The investigators hypothesize that patients in the intervention arm of the study will have reduced decisional conflict and diabetes distress, and improved decision-making satisfaction, chronic care delivery and quality of life.

Detailed description: Significance:

Diabetes is prevalent and results in major morbidity. Care of the patient with diabetes is complex and often occurs in the context of other chronic illness; this multimorbidity negatively impacts morbidity and mortality. The Canadian Diabetes Association (CDA) Clinical Practice Guidelines (CPG) are a rigorously developed knowledge tool that comprehensively address all aspects of diabetes care, conforming to AGREE II standards for guideline development. However, guideline adherence in the patient with multimorbidity is challenging both for the provider and the patient, who are overwhelmed by numerous, often conflicting recommendations. An individualized approach to the multimorbid diabetic patient using shared decision-making (SDM) and goal setting may overcome challenges to guideline adherence; however these strategies have not been taken up extensively in clinical practice. Barriers to uptake can be overcome by incorporating SDM into the context of interprofessional care: in diabetes care, role expansion, active participation by more than one discipline and adding additional team members have been demonstrated to improve clinical outcomes. While SDM and decision aids have typically focused on one issue, the precedent and potential exists for their use in the translation of the CDA CPG into practice through the prioritization of complex guideline recommendations. Given the growing prevalence of diabetes and multimorbidity in Canada, effectively bridging the knowledge to practice gap in this area has the potential to significantly improve patient-important outcomes, health care delivery and system sustainability.

Objectives:

1. To enhance the implementation of a complex guidelines document (CDA 2013 CPG) by assisting in prioritizing care for patients with diabetes and multiple other comorbidities through the use of a diabetes-focused SDM intervention;
2. To systematically develop, test and pilot a SDM and goal-setting intervention following the United Kingdom Medical Research Council and Knowledge to Action Frameworks;
3. To build a team consisting of members of the research community, patients, health care providers, CDA, and Local Health Integration Networks of the Ministry of Health and Long-Term Care, in order to increase the relevance of research conducted and enable dissemination of these research results into practice.

Hypothesis An interprofessional SDM and goal-setting tool kit, including a 1-page provider enabler, a point-of-care worksheet and a patient workbook, can be implemented successfully in clinical practice and will reduce decisional conflict and diabetes distress and improve chronic care delivery and quality of life in patients with type 1 or type 2 diabetes and 2 other comorbid chronic diseases.

Research Plan Development, testing and refinement: An evidence-based multi-component SDM intervention will be developed, framed by the Interprofessional SDM Model and based on user input from individual interviews regarding feasibility, acceptability and mediators of use. Usability testing will be done using cognitive task analysis to assess paths users take to accomplish tasks, errors made, when and where they encountered confusion or frustration, degree of satisfaction and quality of decision support. Based on feedback received, the tool will be refined through several iterative cycles of feedback and redesign.

Pilot trial: The tool kit will be piloted in a two-step parallel clustered randomized controlled trial (RCT) whose primary purpose is to assess intervention fidelity and to test the feasibility of conducting a larger RCT. The first step will be a provider-directed phase; the second step (which will occur 6 months later) will be a provider- and patient-directed phase. A secondary purpose of this study is to estimate the impact of the decision aid on decisional conflict; secondary outcomes include diabetes distress, chronic illness care and quality of life, assessed by patient-completed questionnaires of validated scales at baseline, 6 and 12 months. Analysis will be done by intention to treat. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Type 1 or Type 2 diabetes and
* have 2 or more other chronic comorbidities

Exclusion Criteria:

* do not speak English
* have documented cognitive deficits
* unable to give informed consent
* have limited life expectancy (\<1 year)
* not available for follow-up
* seen primarily by a resident physician
* are pregnant or considering conception

Primary outcomes:
measure: Decisional Conflict in Patients With Diabetes
timeFrame: This outcome is measured at 0, 6 and 12 months.
Secondary outcomes:
measure: Patient With Diabetes' Assessment of Their Chronic Illness Care
timeFrame: This outcome is measured at 0, 6 and 12 months.
measure: Diabetes Distress in Patients With Diabetes
timeFrame: This outcome is measured at 0, 6 and 12 months.
measure: Health-related Quality of Life in Patients With Diabetes
timeFrame: This outcome is measured at 0, 6 and 12 months.
measure: Intention to Engage in Shared Decision-making in Health Care Providers
timeFrame: This outcome is measured at 0, 6 and 12 months.
Other outcomes:
Locations:
Study officials:
affiliation: St. Michael's Hospital (Unity Health Toronto)
name: Catherine H Yu, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu CH, Ivers NM, Stacey D, Rezmovitz J, Telner D, Thorpe K, Hall S, Settino M, Kaplan DM, Coons M, Sodhi S, Sale J, Straus SE. Impact of an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes on decisional conflict--study protocol for a randomized controlled trial. Trials. 2015 Jun 27;16:286. doi: 10.1186/s13063-015-0797-8.
citation: Yu CH, Stacey D, Sale J, Hall S, Kaplan DM, Ivers N, Rezmovitz J, Leung FH, Shah BR, Straus SE. Designing and evaluating an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes in clinical care--systematic decision aid development and study protocol. Implement Sci. 2014 Jan 22;9:16. doi: 10.1186/1748-5908-9-16.
citation: Yu CH, Medleg F, Choi D, Spagnuolo CM, Pinnaduwage L, Straus SE, Cantarutti P, Chu K, Frydrych P, Hoang-Kim A, Ivers N, Kaplan D, Leung FH, Maxted J, Rezmovitz J, Sale J, Sodhi S, Stacey D, Telner D. Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial. BMC Med Inform Decis Mak. 2021 Nov 22;21(1):323. doi: 10.1186/s12911-021-01673-w.
citation: Yu CH, McCann M, Sale J. "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. PLoS One. 2021 Jul 7;16(7):e0254157. doi: 10.1371/journal.pone.0254157. eCollection 2021.
citation: Yu C, Choi D, Bruno BA, Thorpe KE, Straus SE, Cantarutti P, Chu K, Frydrych P, Hoang-Kim A, Ivers N, Kaplan D, Leung FH, Maxted J, Rezmovitz J, Sale J, Sodhi-Helou S, Stacey D, Telner D. 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. J Med Internet Res. 2020 Sep 30;22(9):e16984. doi: 10.2196/16984.
citation: Yu CH, Ke C, Jovicic A, Hall S, Straus SE; IP-SDM Team;. Beyond pros and cons - developing a patient decision aid to cultivate dialog to build relationships: insights from a qualitative study and decision aid development. BMC Med Inform Decis Mak. 2019 Sep 18;19(1):186. doi: 10.1186/s12911-019-0898-5.