Trial Outcomes & Findings for Medication Adherence Clinical Decision Support (NCT NCT03748420)
NCT ID: NCT03748420
Last Updated: 2024-02-26
Results Overview
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for at least one antihypertensive medication in each currently prescribed blood pressure medication class at 12 months following the index office visit date.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5421 participants
Primary outcome timeframe
12 months after an index visit
Results posted on
2024-02-26
Participant Flow
Participants were identified as eligible using an automated algorithm designed to display the adherence enhanced decision support at the point of care at a primary care clinic visit. The first visit where a participant met eligibility criteria (and prior to applying exclusion criteria) was considered their index visit. There was no direct contact between study participants and the study team. The study was granted a waiver of informed consent from HealthPartners IRB.
Patients were randomly allocated 1:1 through a computer generated program to either control or intervention. The number "Completed" reflects the number of participants included in the final analysis after exclusions were applied.
Participant milestones
| Measure |
Usual Care
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
Overall Study
STARTED
|
2676
|
2745
|
|
Overall Study
COMPLETED
|
2421
|
2486
|
|
Overall Study
NOT COMPLETED
|
255
|
259
|
Reasons for withdrawal
| Measure |
Usual Care
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
Overall Study
No 12 month medication adherence data available
|
0
|
1
|
|
Overall Study
Death
|
24
|
28
|
|
Overall Study
Lost to Follow-up
|
231
|
230
|
Baseline Characteristics
Medication Adherence Clinical Decision Support
Baseline characteristics by cohort
| Measure |
Usual Care
n=2676 Participants
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
n=2745 Participants
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Total
n=5421 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 10.6 • n=39 Participants
|
57.2 years
STANDARD_DEVIATION 10.9 • n=41 Participants
|
57.4 years
STANDARD_DEVIATION 10.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
1196 Participants
n=39 Participants
|
1235 Participants
n=41 Participants
|
2431 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1480 Participants
n=39 Participants
|
1510 Participants
n=41 Participants
|
2990 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
114 Participants
n=39 Participants
|
116 Participants
n=41 Participants
|
230 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2045 Participants
n=39 Participants
|
2119 Participants
n=41 Participants
|
4164 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
517 Participants
n=39 Participants
|
510 Participants
n=41 Participants
|
1027 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
207 Participants
n=39 Participants
|
189 Participants
n=41 Participants
|
396 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
700 Participants
n=39 Participants
|
688 Participants
n=41 Participants
|
1388 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
1559 Participants
n=39 Participants
|
1630 Participants
n=41 Participants
|
3189 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
197 Participants
n=39 Participants
|
216 Participants
n=41 Participants
|
413 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
2676 participants
n=39 Participants
|
2745 participants
n=41 Participants
|
5421 participants
n=35 Participants
|
|
Presence of cardiovascular disease (CVD)
|
323 Participants
n=39 Participants
|
353 Participants
n=41 Participants
|
676 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 months after an index visitPopulation: Participants that were not at evidence-based goals for blood pressure (BP) and had PDC less than 80% with moderate to high confidence.
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for at least one antihypertensive medication in each currently prescribed blood pressure medication class at 12 months following the index office visit date.
Outcome measures
| Measure |
Usual Care
n=843 Participants
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
n=887 Participants
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
Blood Pressure Medication Adherence
|
396 Participants
|
470 Participants
|
PRIMARY outcome
Timeframe: 12 months after an index visitPopulation: Participants that were not at evidence-based goals for glucose (A1c) and had PDC less than 80% with moderate to high confidence.
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for at least one non-insulin glycemic medication in each currently prescribed glycemic medication class at 12 months following the index office visit date.
Outcome measures
| Measure |
Usual Care
n=596 Participants
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
n=628 Participants
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
Non-Insulin Glycemic Medication Adherence
|
279 Participants
|
296 Participants
|
PRIMARY outcome
Timeframe: 12 months after an index visitPopulation: Participants that had PDC less than 80% with moderate to high confidence.
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for a statin medication if currently prescribed at 12 months following the index office visit date.
Outcome measures
| Measure |
Usual Care
n=1039 Participants
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
n=1063 Participants
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
Statin Medication Adherence
|
529 Participants
|
586 Participants
|
PRIMARY outcome
Timeframe: 12 months after an index visitPopulation: Not at evidence-based clinical goals for SBP and had proportion of days covered (PDC) greater than or equal to 80%.
Mean change in systolic blood pressure (SBP) from index to the last SBP value within 12 months after the index visit.
Outcome measures
| Measure |
Usual Care
n=723 Participants
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
n=772 Participants
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
Mean Change in Systolic Blood Pressure
|
-15.2 mm Hg
Interval -16.7 to -13.6
|
-13.8 mm Hg
Interval -15.3 to -12.3
|
PRIMARY outcome
Timeframe: 12 months after an index visitPopulation: Participants that were not at evidence-based goals for hemoglobin A1c and had PDC less than 80% with moderate to high confidence.
Mean change in A1c (glycated hemoglobin) value from the index visit to the last lab test within 12 months after the index visit.
Outcome measures
| Measure |
Usual Care
n=567 Participants
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
n=589 Participants
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
Mean Change in A1c
|
-1.1 percentage of glycated hemoglobin
Interval -1.2 to -0.9
|
-1.2 percentage of glycated hemoglobin
Interval -1.4 to -1.0
|
SECONDARY outcome
Timeframe: 12 months after an index visitPopulation: All enrolled participants that were not at evidence-based goals for blood pressure (BP) or glucose and had proportion of days covered (PDC) less than 80% with moderate to high confidence for blood pressure, glucose, or statin medications.
Change in annual clinic-based medical care costs, defined from the health system perspective.
Outcome measures
| Measure |
Usual Care
n=2676 Participants
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
n=2745 Participants
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
Clinic-based Medical Care Costs
|
1210.15 US dollars
Standard Error 40.59
|
1202.68 US dollars
Standard Error 44.13
|
Adverse Events
Usual Care
Serious events: 557 serious events
Other events: 127 other events
Deaths: 24 deaths
Adherence Intervention
Serious events: 559 serious events
Other events: 127 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Usual Care
n=2808 participants at risk
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
n=2879 participants at risk
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
General disorders
Emergency Department visits post-index
|
19.1%
535/2808 • Number of events 535 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
18.9%
543/2879 • Number of events 543 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
|
General disorders
Inpatient admissions post-index
|
6.6%
186/2808 • Number of events 186 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
6.2%
178/2879 • Number of events 178 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
Other adverse events
| Measure |
Usual Care
n=2808 participants at risk
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
Adherence Intervention
n=2879 participants at risk
Patients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
0.57%
16/2808 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
0.90%
26/2879 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
|
Vascular disorders
Hypotension
|
0.78%
22/2808 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
0.56%
16/2879 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.4%
67/2808 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
1.8%
52/2879 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.61%
17/2808 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
0.42%
12/2879 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.53%
15/2808 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
0.97%
28/2879 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis- post index
|
0.00%
0/2808 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
0.07%
2/2879 • Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.
The number of participants at Risk (safety analysis population) includes participants that were screened for eligibility and determined not eligible.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place