Trial Outcomes & Findings for Pharmacy-based Interdisciplinary Program for Patients With Chronic Heart Failure (NCT NCT01692119)
NCT ID: NCT01692119
Last Updated: 2021-04-22
Results Overview
Percentage of days covered (PDC) by prescribed medication and according to claims data
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
258 participants
Primary outcome timeframe
12 months
Results posted on
2021-04-22
Participant Flow
Participant milestones
| Measure |
Regular, Pharmacy-based Intervention
providing medication in weekly dosing aids and regular contacts with the local pharmacy
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:
* Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.
* Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.
|
Usual Care
usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
128
|
|
Overall Study
COMPLETED
|
110
|
127
|
|
Overall Study
NOT COMPLETED
|
20
|
1
|
Reasons for withdrawal
| Measure |
Regular, Pharmacy-based Intervention
providing medication in weekly dosing aids and regular contacts with the local pharmacy
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:
* Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.
* Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.
|
Usual Care
usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Intervention: pts. did not present to participating pharmacy
|
17
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Regular, Pharmacy-based Intervention
n=110 Participants
providing medication in weekly dosing aids and regular contacts with the local pharmacy
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:
* Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.
* Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.
|
Usual Care
n=127 Participants
usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 6.8 • n=110 Participants
|
74.1 years
STANDARD_DEVIATION 7.2 • n=127 Participants
|
74.1 years
STANDARD_DEVIATION 7.0 • n=237 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=110 Participants
|
49 Participants
n=127 Participants
|
91 Participants
n=237 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=110 Participants
|
78 Participants
n=127 Participants
|
146 Participants
n=237 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Patients for whom we were able to calculate a PDC.
Percentage of days covered (PDC) by prescribed medication and according to claims data
Outcome measures
| Measure |
Regular, Pharmacy-based Intervention
n=90 Participants
providing medication in weekly dosing aids and regular contacts with the local pharmacy
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:
* Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.
* Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.
|
Usual Care
n=112 Participants
usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
|
|---|---|---|
|
Medication Adherence
|
91.2 percentage of days covered
Standard Deviation 11.9
|
85.5 percentage of days covered
Standard Deviation 16.6
|
PRIMARY outcome
Timeframe: 12 monthsDays lost due to unplanned cardiovascular hospitalizations or death of any cause
Outcome measures
| Measure |
Regular, Pharmacy-based Intervention
n=110 Participants
providing medication in weekly dosing aids and regular contacts with the local pharmacy
Regular, pharmacy based intervention: Regular, pharmacy-based intervention conducted in cooperation with the treating physician:
* Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.
* Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician.
|
Usual Care
n=127 Participants
usual care; no medication review, no dose dispensing; study pharmacists unaware of patients in this group.
|
|---|---|---|
|
Days Lost Due to Unplanned Cardiovascular Hospitalizations or Death of Any Cause
|
24.8 days lost
Interval 10.6 to 38.9
|
16.5 days lost
Interval 6.1 to 26.8
|
Adverse Events
Regular, Pharmacy-based Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 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