Trial Outcomes & Findings for Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes (NCT NCT02379078)
NCT ID: NCT02379078
Last Updated: 2020-12-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
This outcome is measured at 0, 6 and 12 months.
Results posted on
2020-12-10
Participant Flow
Participant milestones
| Measure |
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)
Shared decision-making aid: The interprofessional (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 Canadian Diabetes Association website
|
Generic Hard-copy Diabetes Resources
At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the Canadian Diabetes Association (CDA) Clinical Practice Guidelines (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
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
114
|
|
Overall Study
COMPLETED
|
72
|
79
|
|
Overall Study
NOT COMPLETED
|
39
|
35
|
Reasons for withdrawal
| Measure |
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)
Shared decision-making aid: The interprofessional (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 Canadian Diabetes Association website
|
Generic Hard-copy Diabetes Resources
At study start (step 1: Provider-directed intervention phase): A hard copy of the executive summary of the Canadian Diabetes Association (CDA) Clinical Practice Guidelines (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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
33
|
30
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
Baseline Characteristics
Impact of an Interprofessional Shared Decision-making and Goal-setting Decision Aid for Patients With Diabetes
Baseline characteristics by cohort
| Measure |
Shared Decision-making Aid
n=102 Participants
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
|
Generic Hard-copy Diabetes Resources
n=111 Participants
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
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Ethnicity · Black/African
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Aboriginal
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Latin American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Undisclosed
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Language
English
|
81 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Language
Other
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Language
Undisclosed
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
Bachelor
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Education
Below Bachelor
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education
College
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Education
High School
|
19 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Education
Post-Grad
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Education
Below High School
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Education
Undisclosed
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Employment
Retired
|
54 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Employment
Full time with employee health benefits
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Employment
Full/part time without employee health benefits
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Employment
Government assistance/disability
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Employment
Unemployed
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Employment
Stay at home parent, student or volunteer
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Employment
Other
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Employment
Prefer not to answer
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Employment
Undisclosed
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Income
Less than $10k
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Income
$10-$19k
|
6 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Income
$20-$29k
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Income
$30-$39k
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Income
$40-$49k
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Income
$50-$59k
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Income
$60-$69k
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Income
$70-$79k
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Income
$80-$89k
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Income
$90-$99k
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Income
$100k-$149k
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Income
More than $150k
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Income
Undisclosed
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Living Arrangements
Alone
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Living Arrangements
With family members
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Living Arrangements
With partner/spouse
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Living Arrangements
With roommates
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Living Arrangements
Other
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Living Arrangements
Undisclosed
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
Age · 18-44 years
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
Age · 45-54 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Customized
Age · 55-64 years
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Customized
Age · 65-74 years
|
47 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Age, Customized
Age · 75-84 years
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Customized
Age · 85+ years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
Age · Undisclosed
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex at Birth · Male
|
46 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex at Birth · Female
|
56 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex at Birth · Undisclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White/Caucasian
|
62 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This outcome is measured at 0, 6 and 12 months.Population: Patients with diabetes and 2 or more comorbidities.
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.
Outcome measures
| Measure |
Shared Decision-making Aid
n=102 Participants
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
|
Generic Hard-copy Diabetes Resources
n=111 Participants
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
|
|---|---|---|
|
Decisional Conflict in Patients With Diabetes
Baseline
|
25.53 score on a scale
Standard Deviation 14.73
|
23.56 score on a scale
Standard Deviation 15.00
|
|
Decisional Conflict in Patients With Diabetes
6 months
|
21.97 score on a scale
Standard Deviation 14.87
|
21.10 score on a scale
Standard Deviation 12.79
|
|
Decisional Conflict in Patients With Diabetes
12 months
|
17.35 score on a scale
Standard Deviation 11.21
|
19.58 score on a scale
Standard Deviation 9.11
|
SECONDARY outcome
Timeframe: This outcome is measured at 0, 6 and 12 months.Population: Patients with diabetes and 2 or more comorbidities.
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.
Outcome measures
| Measure |
Shared Decision-making Aid
n=111 Participants
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
|
Generic Hard-copy Diabetes Resources
n=102 Participants
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
|
|---|---|---|
|
Patient With Diabetes' Assessment of Their Chronic Illness Care
Baseline
|
2.82 score on a scale
Standard Deviation 1.10
|
3.16 score on a scale
Standard Deviation 0.95
|
|
Patient With Diabetes' Assessment of Their Chronic Illness Care
6 months
|
3.16 score on a scale
Standard Deviation 1.10
|
3.41 score on a scale
Standard Deviation 1.05
|
|
Patient With Diabetes' Assessment of Their Chronic Illness Care
12 months
|
3.68 score on a scale
Standard Deviation 0.99
|
3.22 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: This outcome is measured at 0, 6 and 12 months.Population: Patients with diabetes and 2 or more comorbidities.
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.
Outcome measures
| Measure |
Shared Decision-making Aid
n=102 Participants
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
|
Generic Hard-copy Diabetes Resources
n=111 Participants
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
|
|---|---|---|
|
Diabetes Distress in Patients With Diabetes
Baseline
|
2.08 score on a scale
Standard Deviation 1.02
|
1.93 score on a scale
Standard Deviation 0.83
|
|
Diabetes Distress in Patients With Diabetes
6 months
|
1.92 score on a scale
Standard Deviation 1.09
|
1.88 score on a scale
Standard Deviation 0.78
|
|
Diabetes Distress in Patients With Diabetes
12 months
|
1.86 score on a scale
Standard Deviation 0.87
|
1.90 score on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: This outcome is measured at 0, 6 and 12 months.Population: Patients with diabetes and 2 or more comorbidities.
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.)
Outcome measures
| Measure |
Shared Decision-making Aid
n=102 Participants
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
|
Generic Hard-copy Diabetes Resources
n=111 Participants
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
|
|---|---|---|
|
Health-related Quality of Life in Patients With Diabetes
Baseline
|
87.35 score on a scale
Standard Deviation 14.25
|
89.69 score on a scale
Standard Deviation 12.48
|
|
Health-related Quality of Life in Patients With Diabetes
6 months
|
88.88 score on a scale
Standard Deviation 13.56
|
87.77 score on a scale
Standard Deviation 12.87
|
|
Health-related Quality of Life in Patients With Diabetes
12 months
|
87.94 score on a scale
Standard Deviation 12.87
|
86.99 score on a scale
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: This outcome is measured at 0, 6 and 12 months.Population: Clinicians
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.
Outcome measures
| Measure |
Shared Decision-making Aid
n=29 Participants
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
|
Generic Hard-copy Diabetes Resources
n=24 Participants
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
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|---|---|---|
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Intention to Engage in Shared Decision-making in Health Care Providers
Baseline
|
6.0 score on a scale
Standard Deviation 0.7
|
6.0 score on a scale
Standard Deviation 1.1
|
|
Intention to Engage in Shared Decision-making in Health Care Providers
6 months
|
6.0 score on a scale
Standard Deviation 1.8
|
6.5 score on a scale
Standard Deviation 0.6
|
|
Intention to Engage in Shared Decision-making in Health Care Providers
12 months
|
5.7 score on a scale
Standard Deviation 1.4
|
6.0 score on a scale
Standard Deviation 1.2
|
Adverse Events
Shared Decision-making Aid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Generic Hard-copy Diabetes Resources
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Catherine Yu
St. Michael's Hospital (Unity Health Toronto)
Phone: (416) 360-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place