Trial Outcomes & Findings for Bridging the Evidence-to-practice Gap (NCT NCT03713515)
NCT ID: NCT03713515
Last Updated: 2026-06-10
Results Overview
Defined as the percentage of eligible participants who were screened.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
652 participants
Primary outcome timeframe
Up to Month 12
Results posted on
2026-06-10
Participant Flow
Clinics were assigned to a Cohort which specified the timing of the Usual Care, Pre-Imp, and Intervention Periods. Participants were enrolled only during the Intervention Periods. No participants dropped out during the course of the study.
Unit of analysis: Clinics
Participant milestones
| Measure |
Sequence 1: Usual Care for Months 0-3; Pre-Imp for Months 4-8; Intervention for Months 9-12
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months.
|
Sequence 2: Usual Care for Months 2-5; Pre-Imp for Months 6-8; Intervention for Months 9-12
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months.
|
Sequence 3: Usual Care for Months 3-6; Pre-Imp for Months 7-9; Intervention for Months 10-13
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months.
|
Sequence 4: Usual Care for Months 1-4, Pre-Imp for Months 5-9; Intervention for Months 10-13
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months.
|
Sequence 5: Usual Care for Months 2-4; Pre-Imp for Months 5-11; Intervention for Months 12-15
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months.
|
Sequence 6: Usual Care for Months 9-12; Pre-Imp for Months 13-15; Intervention for Months 15-18.
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3 to 6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months.
|
|---|---|---|---|---|---|---|
|
Usual Care: Months 0-3
STARTED
|
81 1
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 0-3
COMPLETED
|
81 1
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 0-3
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 1-4
STARTED
|
0 0
|
0 0
|
0 0
|
353 1
|
0 0
|
0 0
|
|
Usual Care: Months 1-4
COMPLETED
|
0 0
|
0 0
|
0 0
|
353 1
|
0 0
|
0 0
|
|
Usual Care: Months 1-4
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 2-4
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
95 1
|
0 0
|
|
Usual Care: Months 2-4
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
95 1
|
0 0
|
|
Usual Care: Months 2-4
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 2-5
STARTED
|
0 0
|
56 1
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 2-5
COMPLETED
|
0 0
|
56 1
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 2-5
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 3-6
STARTED
|
0 0
|
0 0
|
57 1
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 3-6
COMPLETED
|
0 0
|
0 0
|
57 1
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 3-6
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Usual Care: Months 9-12
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
10 1
|
|
Usual Care: Months 9-12
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
10 1
|
|
Usual Care: Months 9-12
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 4-8
STARTED
|
81 1
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 4-8
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 4-8
NOT COMPLETED
|
81 1
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 5-9
STARTED
|
0 0
|
0 0
|
0 0
|
353 1
|
0 0
|
0 0
|
|
Pre-Implementation: Months 5-9
COMPLETED
|
0 0
|
0 0
|
0 0
|
353 1
|
0 0
|
0 0
|
|
Pre-Implementation: Months 5-9
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 5-11
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
95 1
|
0 0
|
|
Pre-Implementation: Months 5-11
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
95 1
|
0 0
|
|
Pre-Implementation: Months 5-11
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 6-8
STARTED
|
0 0
|
56 1
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 6-8
COMPLETED
|
0 0
|
56 1
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 6-8
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 7-9
STARTED
|
0 0
|
0 0
|
57 1
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 7-9
COMPLETED
|
0 0
|
0 0
|
57 1
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 7-9
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Pre-Implementation: Months 13-15
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
10 1
|
|
Pre-Implementation: Months 13-15
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
10 1
|
|
Pre-Implementation: Months 13-15
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Intervention for Months 9-12
STARTED
|
81 1
|
56 1
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Intervention for Months 9-12
COMPLETED
|
81 1
|
56 1
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Intervention for Months 9-12
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Intervention for Months 10-13
STARTED
|
0 0
|
0 0
|
57 1
|
353 1
|
0 0
|
0 0
|
|
Intervention for Months 10-13
COMPLETED
|
0 0
|
0 0
|
57 1
|
353 1
|
0 0
|
0 0
|
|
Intervention for Months 10-13
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Intervention for Months 12-15
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
95 1
|
0 0
|
|
Intervention for Months 12-15
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
95 1
|
0 0
|
|
Intervention for Months 12-15
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Intervention for Months 15-18
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
10 1
|
|
Intervention for Months 15-18
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
10 1
|
|
Intervention for Months 15-18
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bridging the Evidence-to-practice Gap
Baseline characteristics by cohort
| Measure |
Sequence 1
n=81 Participants
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months
|
Sequence 2
n=56 Participants
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months
|
Sequence 3
n=57 Participants
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months
|
Sequence 4
n=353 Participants
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months
|
Sequence 5
n=95 Participants
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months
|
Sequence 6
n=10 Participants
During the UC phase, patients at the sites will receive standard care delivered by their primary care providers. The pre-implementation phase will be the following 3-6 months of the trial to refine the PF strategy that will be used during the implementation/intervention phase. The intervention phase will be 3 months
|
Total
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=9 Participants
|
38 Participants
n=27 Participants
|
43 Participants
n=267 Participants
|
23 Participants
n=265 Participants
|
61 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
232 Participants
n=23 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 11.2 • n=9 Participants
|
53.4 years
STANDARD_DEVIATION 10.9 • n=27 Participants
|
54.8 years
STANDARD_DEVIATION 14.1 • n=267 Participants
|
54.2 years
STANDARD_DEVIATION 12.1 • n=265 Participants
|
53.8 years
STANDARD_DEVIATION 13 • n=568 Participants
|
52.9 years
STANDARD_DEVIATION 9.9 • n=22 Participants
|
53.3 years
STANDARD_DEVIATION 12.3 • n=23 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
36 Participants
n=267 Participants
|
264 Participants
n=265 Participants
|
49 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
410 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=9 Participants
|
32 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
89 Participants
n=265 Participants
|
46 Participants
n=568 Participants
|
8 Participants
n=22 Participants
|
242 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
271 Participants
n=265 Participants
|
26 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
340 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
59 Participants
n=265 Participants
|
8 Participants
n=568 Participants
|
4 Participants
n=22 Participants
|
80 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
19 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
39 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
11 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
328 Participants
n=265 Participants
|
25 Participants
n=568 Participants
|
6 Participants
n=22 Participants
|
397 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
15 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
56 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
19 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
52 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
41 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
129 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=9 Participants
|
56 participants
n=27 Participants
|
57 participants
n=267 Participants
|
353 participants
n=265 Participants
|
95 participants
n=568 Participants
|
10 participants
n=22 Participants
|
652 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12Defined as the percentage of eligible participants who were screened.
Outcome measures
| Measure |
Eligible Participants
n=3103 Participants
Defined as participants who were eligible to receive the intervention.
|
|---|---|
|
Implementation Fidelity - Adherence: Screening
|
1649 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12Defined as the percentage of screened participants who were referred.
Outcome measures
| Measure |
Eligible Participants
n=1649 Participants
Defined as participants who were eligible to receive the intervention.
|
|---|---|
|
Implementation Fidelity - Adherence: Referrals
|
1200 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12Defined as the percentage of referred participants who were enrolled.
Outcome measures
| Measure |
Eligible Participants
n=1200 Participants
Defined as participants who were eligible to receive the intervention.
|
|---|---|
|
Implementation Fidelity - Adherence: Enrollment
|
652 Participants
|
SECONDARY outcome
Timeframe: Baseline, Post Intervention (Months 24-36)Population: Defined as participants who were eligible to receive the intervention who ALSO had available BP measurements - only 387 participants met this criteria.
Assessed as the change in percentage of participants with blood pressure (BP) control, defined as systolic BP (SBP) \<140 and diastolyic BP (DBP) \<90 mmHg.
Outcome measures
| Measure |
Eligible Participants
n=387 Participants
Defined as participants who were eligible to receive the intervention.
|
|---|---|
|
Change in Blood Pressure (BP) Control
|
10.9 Percentage of participants
Interval 3.8 to 17.8
|
SECONDARY outcome
Timeframe: Baseline, Post Intervention (Months 24-36)Population: Defined as participants who were eligible to receive the intervention with available medication data - only 333 participants met this criteria.
Assessed via pharmacy refills obtained from prescription orders in the clinic EHR using the proportion of days covered (PDC) metric; medication adherence defined as PDC ≥ 80; this outcome will be measured as the change in percentage of participants who meet medication adherence.
Outcome measures
| Measure |
Eligible Participants
n=333 Participants
Defined as participants who were eligible to receive the intervention.
|
|---|---|
|
Change in Medication Adherence
|
-1.8 Percentage of participants
Interval -5.8 to 2.2
|
Adverse Events
All Enrolled Participants
Serious events: 50 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Enrolled Participants
n=652 participants at risk
All participants enrolled.
|
|---|---|
|
Cardiac disorders
Blood pressure related hospitalization
|
7.7%
50/652 • 12 Months
Systematic assessment. Hospitalizations were systematically ascertained through structured extraction of electronic health record (EHR) data by the study team. For each hospitalization, the specific event, date of occurrence, and duration of stay were collected. Data were obtained following completion of the 12-month intervention phase according to prespecified study procedures.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place