Trial Outcomes & Findings for Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes (NCT NCT02379078)

Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for 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 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.

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.

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.)

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.