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N/A Completed N=225 Randomized Single-blind Health Services Research

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

Source: ClinicalTrials.gov NCT02379078 ↗
Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Decisional Conflict in Patients With Diabetes — 25.53; 23.56; 21.97; 21.10 score on a scale — p=0.0246

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Decisional Conflict in Patients With Diabetes
25.53; 23.56; 21.97; 21.10; 17.35; 19.58 0.0246 sig
SECONDARY
Patient With Diabetes' Assessment of Their Chronic Illness Care
2.82; 3.16; 3.16; 3.41; 3.68; 3.22 <0.0001 sig
SECONDARY
Diabetes Distress in Patients With Diabetes
2.08; 1.93; 1.92; 1.88; 1.86; 1.90 0.12
SECONDARY
Health-related Quality of Life in Patients With Diabetes
87.35; 89.69; 88.88; 87.77; 87.94; 86.99 0.468
SECONDARY
Intention to Engage in Shared Decision-making in Health Care Providers
6.0; 6.0; 6.0; 6.5; 5.7; 6.0 0.60

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02379078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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