Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments shared decision-making aid, generic hard copy diabetes resources, generic online diabetes resources
Sponsor St. Michael's Hospital, Toronto
Collaborator Canadian Institutes of Health Research (CIHR)
Start date March 2016
End date March 2017
Trial size 273 participants
Trial identifier NCT02379078, 13-014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
At study start (step 1: provider-directed intervention phase): Online shared decision-making aid, 1-page provider enabler, provider training video made available to health care providers At 6 months (step 2: provider- and patient-directed phase): Online shared decision-making aid, 1-page patient enabler, patient training video also made available to patients (in addition to health care providers)
shared decision-making aid
The IP-SDM toolkit consists of an online shared decision-making aid, 1-page provider enabler, a provider training video,1-page patient enabler, and a patient training video.
generic online diabetes resources
Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website
(Placebo Comparator)
At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the CDA CPG and postcard outlining online resources made available to health care providers At 6 months (step 2: provider- and patient-directed phase): A CDA patient education pamphlet regarding diabetes self-management also made available to patients In addition, provider- and patient-directed guideline dissemination tools (not incorporating SDM) will also be publicly accessible from the CDA website.
generic hard copy diabetes resources
A hard copy of the executive summary of the CDA CPG and postcard outlining online resources, CDA patient education pamphlet
generic online diabetes resources
Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website

Primary Outcomes

Measure
Decisional conflict
time frame: 12 months

Secondary Outcomes

Measure
Decisional conflict
time frame: 6 months
Diabetes distress
time frame: 6 months
Diabetes distress
time frame: 12 months
Quality of Life
time frame: 6 months
Quality of Life
time frame: 12 months
Chronic illness care
time frame: 6 months
Chronic illness care
time frame: 12 months
Intention to engage in shared decision-making
time frame: 6 months
Intention to engage in shared decision-making
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes - A Pilot Cluster Randomized Controlled Trial
Principal investigator Catherine H Yu, MD FRCPC
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by St. Michael's Hospital, Toronto.