Trial Outcomes & Findings for Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison (NCT NCT01002456)
NCT ID: NCT01002456
Last Updated: 2015-04-28
Results Overview
full adherence to guideline medication and dose
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
220 participants
Primary outcome timeframe
6 months
Results posted on
2015-04-28
Participant Flow
Participant milestones
| Measure |
Arm 1
provide site-specific information
Level 1 (Provide site-specific information): provide site-specific information on non-adherence to guideline
|
Arm 2
provide site- and patient-specific information
Level 2 (Provide site- and patient-specific information): provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
122
|
|
Overall Study
COMPLETED
|
98
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
Baseline characteristics by cohort
| Measure |
Level 1
n=98 Participants
site-specific information provided
|
Level 2
n=122 Participants
site- and patient-specific information provided
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
71 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
71 years
STANDARD_DEVIATION 11.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
215 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
98 patients
n=93 Participants
|
122 patients
n=4 Participants
|
220 patients
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsfull adherence to guideline medication and dose
Outcome measures
| Measure |
Level 1
n=98 Participants
provide site-specific information
|
Level 2
n=122 Participants
provide site- and patient-specific information
|
|---|---|---|
|
Rate of Adherence to Guideline Prescription
|
4 patients
|
6 patients
|
SECONDARY outcome
Timeframe: 6 monthseither change to a guideline agent or dose increase of a guideline agent
Outcome measures
| Measure |
Level 1
n=98 Participants
provide site-specific information
|
Level 2
n=122 Participants
provide site- and patient-specific information
|
|---|---|---|
|
Progress Toward Adherence to Guideline Prescription
|
10 patients
|
22 patients
|
Adverse Events
Level 1: Provide Site-specific Information
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Level 2: Provide Site- and Patient-specific Information
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