Trial Outcomes & Findings for Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics (NCT NCT02299791)
NCT ID: NCT02299791
Last Updated: 2017-10-04
Results Overview
Number of patients indicated for ACE/ARB and statin who had an active prescription for both, as a proportion of patients indicated for ACE/ARB and statin.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4856 participants
Primary outcome timeframe
Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months
Results posted on
2017-10-04
Participant Flow
Recruitment was done at the clinic level. All patients seen in the clinics were potentially eligible for the intervention based on clinic visit and clinical criteria.
Unit of analysis: Clinics
Participant milestones
| Measure |
Early Intervention Number of Patients
Patients in 6 study clinics received the ALL intervention starting 6/1/11
ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
1. EHR tools to expedite identification
a. EHR automated point-of-care alerts (Best Practice Alerts)
2. EHR tools to expedite prescribing
1. EHR order sets
2. EHR text shortcuts for notation
3. patient education materials (handout, poster)
3. EHR-based outreach support tools a. EHR registries
|
Late Interventions Number of Patients
5 study clinics received the ALL intervention starting 6/1/12
ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.
|
|---|---|---|
|
Overall Study
STARTED
|
2053 6
|
2803 5
|
|
Overall Study
COMPLETED
|
2053 6
|
2803 5
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics
Baseline characteristics by cohort
| Measure |
Early Intervention
n=2053 Participants
6 study clinics received the ALL intervention starting 6/1/11
ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
1. EHR tools to expedite identification
a. EHR automated point-of-care alerts (Best Practice Alerts)
2. EHR tools to expedite prescribing
1. EHR order sets
2. EHR text shortcuts for notation
3. patient education materials (handout, poster)
3. EHR-based outreach support tools a. EHR registries
|
Late Implementation
n=2803 Participants
5 study clinics received the ALL intervention starting 6/1/12
ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.
|
Total
n=4856 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
|
1518 Participants
n=5 Participants
|
2244 Participants
n=7 Participants
|
3762 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
535 Participants
n=5 Participants
|
559 Participants
n=7 Participants
|
1094 Participants
n=5 Participants
|
|
Age, Continuous
|
62 Years
n=5 Participants
|
63 Years
n=7 Participants
|
63 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1240 Participants
n=5 Participants
|
1634 Participants
n=7 Participants
|
2874 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
813 Participants
n=5 Participants
|
1169 Participants
n=7 Participants
|
1982 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
659 Participants
n=5 Participants
|
900 Participants
n=7 Participants
|
1559 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1374 Participants
n=5 Participants
|
1877 Participants
n=7 Participants
|
3251 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
101 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
179 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
423 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1258 Participants
n=5 Participants
|
1717 Participants
n=7 Participants
|
2975 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
485 Participants
n=5 Participants
|
663 Participants
n=7 Participants
|
1148 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2053 Participants
n=5 Participants
|
2803 Participants
n=7 Participants
|
4856 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 monthsPopulation: clinic patients with diabetes who had a clinic encounter (in person or by telephone) within the previous year and were indicated for ACE/ARB and statin per current national care guidelines
Number of patients indicated for ACE/ARB and statin who had an active prescription for both, as a proportion of patients indicated for ACE/ARB and statin.
Outcome measures
| Measure |
Early Intervention
n=2053 Participants
6 study clinics received the ALL intervention starting 6/1/11
ALL: This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
1. EHR tools to expedite identification
a. EHR automated point-of-care alerts (Best Practice Alerts)
2. EHR tools to expedite prescribing
1. EHR order sets
2. EHR text shortcuts for notation
3. patient education materials (handout, poster)
3. EHR-based outreach support tools a. EHR registries
|
Late Implementation
n=2803 Participants
5 study clinics received the ALL intervention starting 6/1/12
ALL: These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.
|
|---|---|---|
|
Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both
|
1279 Participants
|
1318 Participants
|
Adverse Events
Early Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Late Implementation
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
Rachel Gold
KaiserPermanente Center for Health Research
Phone: 503-528-3902
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place