Trial Outcomes & Findings for Motivational Interviewing (MI) Intervention to Improve Adherence (NCT NCT03985098)
NCT ID: NCT03985098
Last Updated: 2023-06-15
Results Overview
Proportion of days covered (PDC): measured by examining refill data, both as a continuous measure as well as a categorical measure with a PDC of 0.8 or more considered adherent. It ranges from 0-1.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
727 participants
Primary outcome timeframe
12 months following initial call
Results posted on
2023-06-15
Participant Flow
Participant milestones
| Measure |
Motivational Interviewing Intervention Arm
The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
Motivational interviewing intervention arm: The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
|
Control
usual care
|
|---|---|---|
|
Overall Study
STARTED
|
247
|
480
|
|
Overall Study
COMPLETED
|
240
|
480
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Motivational Interviewing Intervention Arm
n=240 Participants
The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
Motivational interviewing intervention arm: The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
|
Control
n=480 Participants
usual care
|
Total
n=720 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · <70 years
|
123 Participants
n=240 Participants
|
257 Participants
n=480 Participants
|
380 Participants
n=720 Participants
|
|
Age, Customized
Age · ≥70 years
|
117 Participants
n=240 Participants
|
223 Participants
n=480 Participants
|
340 Participants
n=720 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=240 Participants
|
272 Participants
n=480 Participants
|
417 Participants
n=720 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=240 Participants
|
208 Participants
n=480 Participants
|
303 Participants
n=720 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
240 participants
n=240 Participants
|
480 participants
n=480 Participants
|
720 participants
n=720 Participants
|
|
health plan
Low-income subsidy
|
118 Participants
n=240 Participants
|
236 Participants
n=480 Participants
|
354 Participants
n=720 Participants
|
|
health plan
No-subsidy
|
122 Participants
n=240 Participants
|
244 Participants
n=480 Participants
|
366 Participants
n=720 Participants
|
|
prescriber specialty
General
|
207 Participants
n=240 Participants
|
410 Participants
n=480 Participants
|
617 Participants
n=720 Participants
|
|
prescriber specialty
Specialty
|
27 Participants
n=240 Participants
|
54 Participants
n=480 Participants
|
81 Participants
n=720 Participants
|
|
prescriber specialty
Missing
|
6 Participants
n=240 Participants
|
16 Participants
n=480 Participants
|
22 Participants
n=720 Participants
|
|
refill type
<90 days
|
26 Participants
n=240 Participants
|
55 Participants
n=480 Participants
|
81 Participants
n=720 Participants
|
|
refill type
≥90 days
|
214 Participants
n=240 Participants
|
425 Participants
n=480 Participants
|
639 Participants
n=720 Participants
|
|
Comorbidities
Myocardial infarction · Yes
|
4 Participants
n=240 Participants
|
10 Participants
n=480 Participants
|
14 Participants
n=720 Participants
|
|
Comorbidities
Myocardial infarction · No
|
236 Participants
n=240 Participants
|
470 Participants
n=480 Participants
|
706 Participants
n=720 Participants
|
|
Comorbidities
Depression · Yes
|
31 Participants
n=240 Participants
|
56 Participants
n=480 Participants
|
87 Participants
n=720 Participants
|
|
Comorbidities
Depression · No
|
209 Participants
n=240 Participants
|
424 Participants
n=480 Participants
|
633 Participants
n=720 Participants
|
|
Comorbidities
Congestive heart failure · Yes
|
26 Participants
n=240 Participants
|
30 Participants
n=480 Participants
|
56 Participants
n=720 Participants
|
|
Comorbidities
Congestive heart failure · No
|
214 Participants
n=240 Participants
|
450 Participants
n=480 Participants
|
664 Participants
n=720 Participants
|
|
Comorbidities
Stroke · Yes
|
10 Participants
n=240 Participants
|
18 Participants
n=480 Participants
|
28 Participants
n=720 Participants
|
|
Comorbidities
Stroke · No
|
230 Participants
n=240 Participants
|
462 Participants
n=480 Participants
|
692 Participants
n=720 Participants
|
|
Comorbidities
Coronary artery disease · Yes
|
63 Participants
n=240 Participants
|
92 Participants
n=480 Participants
|
155 Participants
n=720 Participants
|
|
Comorbidities
Coronary artery disease · No
|
177 Participants
n=240 Participants
|
388 Participants
n=480 Participants
|
565 Participants
n=720 Participants
|
|
number of concomitant medications
≤2
|
169 Participants
n=240 Participants
|
340 Participants
n=480 Participants
|
509 Participants
n=720 Participants
|
|
number of concomitant medications
>2
|
71 Participants
n=240 Participants
|
140 Participants
n=480 Participants
|
211 Participants
n=720 Participants
|
|
regimen complexity
|
4.27 scores on a scale
STANDARD_DEVIATION 4.32 • n=240 Participants
|
3.86 scores on a scale
STANDARD_DEVIATION 3.94 • n=480 Participants
|
3.99 scores on a scale
STANDARD_DEVIATION 4.07 • n=720 Participants
|
|
prevalent users
No
|
25 Participants
n=240 Participants
|
90 Participants
n=480 Participants
|
115 Participants
n=720 Participants
|
|
prevalent users
Yes
|
215 Participants
n=240 Participants
|
390 Participants
n=480 Participants
|
605 Participants
n=720 Participants
|
|
prior hospitalizations
≥1
|
26 Participants
n=240 Participants
|
45 Participants
n=480 Participants
|
71 Participants
n=720 Participants
|
|
prior hospitalizations
None
|
214 Participants
n=240 Participants
|
435 Participants
n=480 Participants
|
649 Participants
n=720 Participants
|
|
CMS risk score
|
1.50 scores on a scale
STANDARD_DEVIATION 0.99 • n=240 Participants
|
1.36 scores on a scale
STANDARD_DEVIATION 0.83 • n=480 Participants
|
1.41 scores on a scale
STANDARD_DEVIATION 0.89 • n=720 Participants
|
PRIMARY outcome
Timeframe: 12 months following initial callProportion of days covered (PDC): measured by examining refill data, both as a continuous measure as well as a categorical measure with a PDC of 0.8 or more considered adherent. It ranges from 0-1.
Outcome measures
| Measure |
Motivational Interviewing Intervention Arm
n=240 Participants
The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
Motivational interviewing intervention arm: The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
|
Control
n=480 Participants
usual care
|
|---|---|---|
|
Adherence Measure
|
0.63 Proportion of days covered
Standard Error 0.34
|
0.56 Proportion of days covered
Standard Error 0.35
|
Adverse Events
Motivational Interviewing Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place