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

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ClinicalTrials.gov Identifier: NCT02379078
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : December 10, 2020
Last Update Posted : December 10, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Unity Health Toronto

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Shared decision-making aid Other: Generic hard copy diabetes resources Other: Generic online diabetes resources Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes - A Pilot Cluster Randomized Controlled Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Shared decision-making aid

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
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.

Placebo Comparator: Generic hard-copy diabetes resources

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

Other: Generic online diabetes resources
Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website




Primary Outcome Measures :
  1. Decisional Conflict in Patients With Diabetes [ Time Frame: This outcome is measured at 0, 6 and 12 months. ]
    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.


Secondary Outcome Measures :
  1. Patient With Diabetes' Assessment of Their Chronic Illness Care [ Time Frame: This outcome is measured at 0, 6 and 12 months. ]

    This outcome was selected because it is a direct measure of knowledge use by patients that will allow us to better understand mediating variables of knowledge use such as patient activation, goal-setting, problem-solving, and decision support.

    This outcome is assessed by the Patient Assessment of Care for Chronic Conditions (PACIC), a well-validated patient-completed questionnaire. PACIC includes 20 items, scored on a 5 point Likert scale ranging from '1 - None of the time' to '5 - Always'. PACIC consists of 5 sub-scales (patient activation, delivery system design, goal setting, problem solving, and follow-up/coordination) and an overall summary score. The minimum total score is 0 and the maximum total score is 50. A higher score indicates a better outcome.


  2. Diabetes Distress in Patients With Diabetes [ Time Frame: This outcome is measured at 0, 6 and 12 months. ]

    This outcome was selected because it is a direct measure of knowledge use by patients that will allow us to better understand mediating variables of knowledge use such as patient activation, goal-setting, problem-solving, and decision support.

    This outcome is assessed by the Diabetes Distress Scale (DDS), a well-validated, patient-completed questionnaire. The DDS is a 17-item scale with 4 subscales (emotional burden, regimen distress, interpersonal distress and physician distress) with an overall summary score. It is scored on a 6-point Likert scale, ranging from '1 - no problem' to '6 - serious problem'. It's minimum total score is 0 and it's maximum total score is 6. The higher the score, the worse the outcome. The lower the score, the better the outcome.


  3. Health-related Quality of Life in Patients With Diabetes [ Time Frame: This outcome is measured at 0, 6 and 12 months. ]

    Quality of life was selected to inform future sample size calculations, as more holistic and patient-centred measure of knowledge use that uniquely acknowledges patient prioritization of health care goals.

    This outcome is assessed by the Short Form 12 (SF-12), a well-validated, patient-completed questionnaire. The SF-12 consists of 12 items (minimum score is 0 and maximum score is 100; the higher the score, the better the quality of life.)


  4. Intention to Engage in Shared Decision-making in Health Care Providers [ Time Frame: This outcome is measured at 0, 6 and 12 months. ]
    This outcome is assessed by the Continuing Professional Development (CPD) Reaction Questionnaire, a theory-based instrument to assess the impact of continuing professional development on clinical behavioral intentions. This outcome was selected to assess provider's intention to engage in shared decision-making, as a potential facilitator or barrier to shared decision-making. The CPD Reaction Questionnaire consists of 12 items with 5 subscales (intention, social influence, beliefs about capabilities, moral norm, and beliefs about consequences) and is scored on a 7-point Likert scale. It's minimum score is 1 and it's maximum score is 7. The higher the score, the better the outcome.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379078


Sponsors and Collaborators
Unity Health Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Catherine H Yu, MD FRCPC St. Michael's Hospital (Unity Health Toronto)
  Study Documents (Full-Text)

Documents provided by Unity Health Toronto:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT02379078    
Other Study ID Numbers: 13-014
First Posted: March 4, 2015    Key Record Dates
Results First Posted: December 10, 2020
Last Update Posted: December 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Unity Health Toronto:
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
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases