Trial Outcomes & Findings for Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence (NCT NCT01609842)
NCT ID: NCT01609842
Last Updated: 2023-07-21
Results Overview
Percentage of patients whose clopidogrel prescription is filled at hospital discharge following the PCI stent placement as well as the percentage of patients who are adherent based on the pharmacy refill data in the year after hospital discharge. We used mixed logistic regression models for clopidogrel adherence (y/n PDC \> 80%) as planned.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14573 participants
Primary outcome timeframe
12 months post PCI discharge
Results posted on
2023-07-21
Participant Flow
Participants were enrolled January 2014-March 2017 at 15 VA cardiac catheterization laboratory sites in 4 waves according to the study design protocol
The participants reported in the Control Arm/Group were all unique patients; they were assigned as follows: pre-intervention control (n=6,081), post-intervention control (n=2,917), and concurrent intervention controls (n=4,869); there was no overlap between the control groups.
Participant milestones
| Measure |
Intervention
Patients at intervention sites who received the intervention during the period of enrollment
|
Control
Patients who did not received the intervention
|
|---|---|---|
|
Pre-Intervention Control
STARTED
|
0
|
6081
|
|
Pre-Intervention Control
COMPLETED
|
0
|
6081
|
|
Pre-Intervention Control
NOT COMPLETED
|
0
|
0
|
|
Post-Intervention Control
STARTED
|
0
|
2917
|
|
Post-Intervention Control
COMPLETED
|
0
|
2917
|
|
Post-Intervention Control
NOT COMPLETED
|
0
|
0
|
|
Concurrent Intervention Control
STARTED
|
708
|
4869
|
|
Concurrent Intervention Control
COMPLETED
|
706
|
4869
|
|
Concurrent Intervention Control
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Intervention
Patients at intervention sites who received the intervention during the period of enrollment
|
Control
Patients who did not received the intervention
|
|---|---|---|
|
Concurrent Intervention Control
pharmacy data not available
|
2
|
0
|
Baseline Characteristics
Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence
Baseline characteristics by cohort
| Measure |
Intervention
n=706 Participants
Patients at intervention sites who received the intervention during the period of enrollment
|
Pre-Intervention Control
n=6081 Participants
Patients at intervention sites prior to the period of enrollment who did not received the intervention
|
Post-Intervention Control
n=2917 Participants
Patients from intervention sites after the period of enrollment ended and who did not receive the intervention
|
Concurrent Intervention Control
n=4869 Participants
Patients at nonintervention sites during the period of enrollment at the intervention sites
|
Total
n=14573 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
66.4 years
STANDARD_DEVIATION 8.8 • n=107 Participants
|
67.4 years
STANDARD_DEVIATION 8.9 • n=206 Participants
|
66.4 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
66.63 years
STANDARD_DEVIATION 8.83 • n=31 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
287 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
687 Participants
n=99 Participants
|
5970 Participants
n=107 Participants
|
2855 Participants
n=206 Participants
|
4774 Participants
n=7 Participants
|
14286 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
146 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
123 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
120 Participants
n=99 Participants
|
1028 Participants
n=107 Participants
|
597 Participants
n=206 Participants
|
584 Participants
n=7 Participants
|
2329 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
577 Participants
n=99 Participants
|
4906 Participants
n=107 Participants
|
2269 Participants
n=206 Participants
|
4183 Participants
n=7 Participants
|
11935 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 12 months post PCI dischargePercentage of patients whose clopidogrel prescription is filled at hospital discharge following the PCI stent placement as well as the percentage of patients who are adherent based on the pharmacy refill data in the year after hospital discharge. We used mixed logistic regression models for clopidogrel adherence (y/n PDC \> 80%) as planned.
Outcome measures
| Measure |
Intervention
n=706 Participants
Patients at intervention sites who received the intervention during the period of enrollment
|
Pre-intervention Control
n=6081 Participants
Patients at intervention sites prior to the period of enrollment who did not received the intervention
|
Post-intervention Control
n=2917 Participants
Patients from intervention sites after the period of enrollment ended and who did not receive the intervention
|
Concurrent Intervention Control
n=4869 Participants
Patients at nonintervention sites during the period for patients prior to enrollment and post enrollment at the intervention sites
|
|---|---|---|---|---|
|
Percentage of Adherent Patients
|
590 Participants
|
4484 Participants
|
2209 Participants
|
3633 Participants
|
PRIMARY outcome
Timeframe: 12 months post PCI dischargePercentage of Participants with Anti-Platelet Medication Delay. Delay is defined as filling anti-platelet medication \>1 day after PCI discharge and not filling the anti-platelet medication prescription by the refill date
Outcome measures
| Measure |
Intervention
n=706 Participants
Patients at intervention sites who received the intervention during the period of enrollment
|
Pre-intervention Control
n=6081 Participants
Patients at intervention sites prior to the period of enrollment who did not received the intervention
|
Post-intervention Control
n=2917 Participants
Patients from intervention sites after the period of enrollment ended and who did not receive the intervention
|
Concurrent Intervention Control
n=4869 Participants
Patients at nonintervention sites during the period for patients prior to enrollment and post enrollment at the intervention sites
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-Platelet Medication Delay
|
35 Participants
|
459 Participants
|
210 Participants
|
578 Participants
|
PRIMARY outcome
Timeframe: 12 months post PCI dischargeProportion of days covered. The number of days that the patient had a pill to take divided by the number of days of follow-up (follow-up terminated at death or at 365 days).
Outcome measures
| Measure |
Intervention
n=706 Participants
Patients at intervention sites who received the intervention during the period of enrollment
|
Pre-intervention Control
n=6081 Participants
Patients at intervention sites prior to the period of enrollment who did not received the intervention
|
Post-intervention Control
n=2917 Participants
Patients from intervention sites after the period of enrollment ended and who did not receive the intervention
|
Concurrent Intervention Control
n=4869 Participants
Patients at nonintervention sites during the period for patients prior to enrollment and post enrollment at the intervention sites
|
|---|---|---|---|---|
|
Mean PDC
|
0.912 proportion of days covered
Standard Deviation 0.172
|
0.851 proportion of days covered
Standard Deviation 0.231
|
0.867 proportion of days covered
Standard Deviation 0.217
|
0.858 proportion of days covered
Standard Deviation 0.232
|
SECONDARY outcome
Timeframe: 12 months post PCI dischargeNumber of participants with hospitalizations
Outcome measures
| Measure |
Intervention
n=706 Participants
Patients at intervention sites who received the intervention during the period of enrollment
|
Pre-intervention Control
n=6081 Participants
Patients at intervention sites prior to the period of enrollment who did not received the intervention
|
Post-intervention Control
n=2917 Participants
Patients from intervention sites after the period of enrollment ended and who did not receive the intervention
|
Concurrent Intervention Control
n=4869 Participants
Patients at nonintervention sites during the period for patients prior to enrollment and post enrollment at the intervention sites
|
|---|---|---|---|---|
|
Hospitalizations
|
99 Participants
|
792 Participants
|
387 Participants
|
603 Participants
|
SECONDARY outcome
Timeframe: 12 months post PCI dischargeMortality
Outcome measures
| Measure |
Intervention
n=706 Participants
Patients at intervention sites who received the intervention during the period of enrollment
|
Pre-intervention Control
n=6081 Participants
Patients at intervention sites prior to the period of enrollment who did not received the intervention
|
Post-intervention Control
n=2917 Participants
Patients from intervention sites after the period of enrollment ended and who did not receive the intervention
|
Concurrent Intervention Control
n=4869 Participants
Patients at nonintervention sites during the period for patients prior to enrollment and post enrollment at the intervention sites
|
|---|---|---|---|---|
|
Mortality
|
34 Participants
|
399 Participants
|
193 Participants
|
266 Participants
|
Adverse Events
Intervention Arm
Serious events: 99 serious events
Other events: 0 other events
Deaths: 34 deaths
Usual Care
Serious events: 1782 serious events
Other events: 0 other events
Deaths: 858 deaths
Serious adverse events
| Measure |
Intervention Arm
n=706 participants at risk
An alerted inpatient pharmacist or a designated study team member will bring the clopidogrel medication to the patient who has received a coronary stent. The patient will return home and receive IVR refill reminder calls.
Multifaceted Intervention with pharmacist and IVR: An alerted inpatient pharmacists will bring the clopidogrel medication to the patient who has received a stent. The patient will return home and receive IVR messages about the importance of their medication as well as a refill reminder call.
|
Usual Care
n=13867 participants at risk
The sites will have no interaction with the study personnel. The investigators will use database information to compare with the intervention sites
Multifaceted Intervention with pharmacist and IVR: An alerted inpatient pharmacists will bring the clopidogrel medication to the patient who has received a stent. The patient will return home and receive IVR messages about the importance of their medication as well as a refill reminder call.
|
|---|---|---|
|
Cardiac disorders
Reported hospitalizations of the participants
|
0.42%
3/706 • Number of events 3 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
0.00%
0/13867 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
|
Gastrointestinal disorders
Reported hospitalizations of the participants
|
0.28%
2/706 • Number of events 2 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
0.00%
0/13867 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
|
Respiratory, thoracic and mediastinal disorders
Reported hospitalizations of the participants
|
0.71%
5/706 • Number of events 5 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
0.00%
0/13867 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
|
Renal and urinary disorders
Reported hospitalizations of the participants
|
0.85%
6/706 • Number of events 6 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
0.00%
0/13867 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
|
Infections and infestations
Reported hospitalizations of the participants
|
0.42%
3/706 • Number of events 3 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
0.00%
0/13867 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
|
General disorders
Reported hospitalizations of the participants
|
0.57%
4/706 • Number of events 4 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
0.00%
0/13867 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
|
Blood and lymphatic system disorders
Reported hospitalizations of the participants
|
0.14%
1/706 • Number of events 1 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
0.00%
0/13867 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
|
General disorders
Other hospitalizations
|
10.6%
75/706 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
12.9%
1782/13867 • 12 months post PCI discharge
Only mortality data and serious adverse events collected; Other/Not Serious Adverse Events were not monitored/collected for the Intervention Arm/Group or Usual Care Arm/Group.
|
Other adverse events
Adverse event data not reported
Additional Information
Marina McCreight
VHA Eastern Colorado Health Care System
Phone: 720-857-2785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place