Trial Outcomes & Findings for INTEGRATE-D: A Pilot Test to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes (NCT NCT04461405)
NCT ID: NCT04461405
Last Updated: 2025-02-07
Results Overview
A post-intervention four-item survey that evaluates the extent to which the intervention meets practice members' approval, is appealing and is liked and welcomed. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).
COMPLETED
NA
294 participants
At 15 months, post-intervention
2025-02-07
Participant Flow
We recruited four clinics that varied on location, size, ownership, and specialty mix. Clinics were enrolled in March 2020. Data collection was completed in July 2022.
From each of the four recruited clinics, two samples of patients were randomly selected for chart abstraction: (1) 50 patients with a diagnosis of type 2 diabetes and (2) 30 patients with a diagnosis of type 2 diabetes and depression or Diabetes Distress (DD), with the exception of the second Intervention clinic, for which only 4 patients could be recruited for the second sample. Between Intervention and Control arms, a total of 294 patients were selected for chart abstraction.
Unit of analysis: Clinics
Participant milestones
| Measure |
Intervention Arm
INTEGRATE-D is a step-by-step blueprint that will assist practices with employing American Diabetes Association recommendations for integrating medical and psychosocial care. INTEGRATE-D consists of a set of implementation strategies that enable clinical teams to put evidence-based care in place. The intervention consists of training and education; audit and feedback materials; a facilitation implementation protocol; and health information technology support materials.
INTEGRATE-D: INTEGRATE-D provides primary care practices with evidence-based training and support which includes: (1) Electronic health record (EHR)-based support-to help align EHR use with ADA recommendations and enable screening for depression, anxiety, DM distress, cognitive impairment, and self-management, and support identifying and tracking progress on patient treatments and goals; (2) Audit and feedback which involves assisting practices in accessing clinically relevant, actionable data reports to inform measurement and identification of care gaps in DMII and behavioral health care; (3) Skill-building resources including training on ADA-recommended care; and (4) Facilitation-to help implement the above strategies and the practice changes needed to align care with ADA recommendations.
|
Control Arm
Usual care
|
|---|---|---|
|
Overall Study
STARTED
|
134 2
|
160 2
|
|
Overall Study
COMPLETED
|
134 2
|
160 2
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INTEGRATE-D: A Pilot Test to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=134 Participants
INTEGRATE-D is a step-by-step blueprint that will assist practices with employing American Diabetes Association recommendations for integrating medical and psychosocial care. INTEGRATE-D consists of a set of implementation strategies that enable clinical teams to put evidence-based care in place. The intervention consists of training and education; audit and feedback materials; a facilitation implementation protocol; and health information technology support materials.
INTEGRATE-D: INTEGRATE-D provides primary care practices with evidence-based training and support which includes: (1) Electronic health record (EHR)-based support-to help align EHR use with ADA recommendations and enable screening for depression, anxiety, DM distress, cognitive impairment, and self-management, and support identifying and tracking progress on patient treatments and goals; (2) Audit and feedback which involves assisting practices in accessing clinically relevant, actionable data reports to inform measurement and identification of care gaps in DMII and behavioral health care; (3) Skill-building resources including training on ADA-recommended care; and (4) Facilitation-to help implement the above strategies and the practice changes needed to align care with ADA recommendations.
|
Control Arm
n=160 Participants
Usual care
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
58 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Age, Continuous
mean (SD)
|
60.28 years
STANDARD_DEVIATION 13.11 • n=5 Participants
|
65.53 years
STANDARD_DEVIATION 13.41 • n=7 Participants
|
63.14 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
116 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
134 participants
n=5 Participants
|
160 participants
n=7 Participants
|
294 participants
n=5 Participants
|
|
Hba1c
|
7.50 percentage of Hba1c
STANDARD_DEVIATION 1.63 • n=5 Participants
|
7.12 percentage of Hba1c
STANDARD_DEVIATION 1.34 • n=7 Participants
|
7.30 percentage of Hba1c
STANDARD_DEVIATION 1.49 • n=5 Participants
|
PRIMARY outcome
Timeframe: At 15 months, post-interventionPopulation: Practice members at intervention clinics.
A post-intervention four-item survey that evaluates the extent to which the intervention meets practice members' approval, is appealing and is liked and welcomed. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).
Outcome measures
| Measure |
Intervention Clinics
n=2 Clinics
A survey measuring the acceptability, appropriateness, and feasibility of the intervention was collected from clinic members exposed to the intervention.
|
Control Arm
Usual care
|
|---|---|---|
|
Acceptability of Intervention
|
0.60 units on a scale
Standard Deviation 0.50
|
—
|
PRIMARY outcome
Timeframe: At 15 months, post-interventionPopulation: Practice members at intervention clinics
A post-intervention four-item survey that evaluates the extent to which the intervention is implementable, seems possible, seems doable, and seems easy to use. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).
Outcome measures
| Measure |
Intervention Clinics
n=2 Clinics
A survey measuring the acceptability, appropriateness, and feasibility of the intervention was collected from clinic members exposed to the intervention.
|
Control Arm
Usual care
|
|---|---|---|
|
Feasibility of the Intervention
|
0.50 units on a scale
Standard Deviation 0.43
|
—
|
PRIMARY outcome
Timeframe: At 15 months, post-interventionPopulation: Practice members at intervention clinics
A post-intervention four-item survey that evaluates the extent to which the intervention meets practice members' approval, is appealing and is liked and welcomed. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).
Outcome measures
| Measure |
Intervention Clinics
n=2 Clinics
A survey measuring the acceptability, appropriateness, and feasibility of the intervention was collected from clinic members exposed to the intervention.
|
Control Arm
Usual care
|
|---|---|---|
|
Appropriateness of Intervention
|
0.79 units on a scale
Standard Deviation 0.45
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-intervention) and 15-months (post-intervention).Difference between baseline and end-of-intervention average blood sugar levels.
Outcome measures
| Measure |
Intervention Clinics
n=134 Participants
A survey measuring the acceptability, appropriateness, and feasibility of the intervention was collected from clinic members exposed to the intervention.
|
Control Arm
n=160 Participants
Usual care
|
|---|---|---|
|
Change in Hemoglobin A1c
|
-0.04 percentage of Hba1c
Standard Deviation 1.56
|
-0.08 percentage of Hba1c
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Baseline (pre-intervention) and 15-months (post-intervention).Population: This outcome measure was only assessed among the sample of patients with a diagnosis of type 2 diabetes and depression or Diabetes Distress (DD).
Difference between baseline and end-of-intervention PHQ-9 score. PHQ-9: This nine-item validated screener measures depression severity. Questionnaire items are on a Likert scale and range from 0 (i.e., not at all) to +3 (i.e., nearly every day), and the total score ranges from 0 (i.e., minimal to none) to 27 (i.e., severe).
Outcome measures
| Measure |
Intervention Clinics
n=34 Participants
A survey measuring the acceptability, appropriateness, and feasibility of the intervention was collected from clinic members exposed to the intervention.
|
Control Arm
n=60 Participants
Usual care
|
|---|---|---|
|
Change in Patient Health Questionnaire-9 (PHQ-9)
|
-1.25 units on a scale
Standard Deviation 6.72
|
2.44 units on a scale
Standard Deviation 6.69
|
Adverse Events
Intervention Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place