Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes

NCT02379078 | Completed Results

• 1 other identifier: 13-014
• Study Type: interventional
• Target: 225
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict in Patients With Diabetes

  Decisional conflict was chosen to allow us to assess the impact of our decision aid on the quality of the decision-making process, an important first measure of the effectiveness of a decision aid and the shared decision making process. This outcome is assessed by the Decisional Conflict Scale (DCS), a well-validated, patient-completed measure. DCS consists of 16 items, with 5 subscales (informed, values clarity, support, uncertainty, and effective decision) and an overall summary score. IT is scored on a 5-item Likert scale ranging from '0- strongly agree' to '4- strongly disagree'. It's minimum total score is 0 and it's maximum total score is 100. The higher the score, the worse the outcome. The lower the score, the better the outcome.

  This outcome is measured at 0, 6 and 12 months.

Secondary Outcomes (4)

• Patient With Diabetes' Assessment of Their Chronic Illness Care

  This outcome is measured at 0, 6 and 12 months.

• Diabetes Distress in Patients With Diabetes

  This outcome is measured at 0, 6 and 12 months.

• Health-related Quality of Life in Patients With Diabetes

  This outcome is measured at 0, 6 and 12 months.

• Intention to Engage in Shared Decision-making in Health Care Providers

  This outcome is measured at 0, 6 and 12 months.

Study Arms (2)

Shared decision-making aid

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)

Other: Shared decision-making aid

Generic hard-copy diabetes resources

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.

Other: Generic hard copy diabetes resources; Other: Generic online diabetes resources

Interventions

Shared decision-making aid OTHER

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.

Shared decision-making aid

Generic hard copy diabetes resources OTHER

A hard copy of the executive summary of the CDA CPG and postcard outlining online resources, CDA patient education pamphlet

Generic hard-copy diabetes resources

Generic online diabetes resources OTHER

Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website

Generic hard-copy diabetes resources

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Related Publications (6)

• 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.

  PMID: 26116444 BACKGROUND

• 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.

  PMID: 24450385 BACKGROUND

• 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.

  PMID: 34809626 DERIVED

• 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.

  PMID: 34234368 DERIVED

• 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.

  PMID: 32996893 DERIVED

• 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.

  PMID: 31533828 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

* Lack of blinding of participants (patients and clinicians) due to nature of the intervention * Potential response bias (online and hard-copy survey) * Attrition rate 29% * Less than anticipated MyDiabetesPlan use * Lack of clinical outcomes

Results Point of Contact

• Title: Dr. Catherine Yu
• Organization: St. Michael's Hospital (Unity Health Toronto)

catherine.yu@unityhealth.to

(416) 360-4000

Study Officials

• Catherine H Yu, MD FRCPC

  St. Michael's Hospital (Unity Health Toronto)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: March 4, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share