Trial Outcomes & Findings for Evaluation of the National Randomized Proton Pump Inhibitor De-prescribing (RaPPID) Program (NCT NCT03719170)
NCT ID: NCT03719170
Last Updated: 2024-07-15
Results Overview
The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
220306 participants
Primary outcome timeframe
12 months
Results posted on
2024-07-15
Participant Flow
This was a national Veterans Health Administration (VHA) program. Randomization was at the level of geographical regions called Veterans Integrated Service Networks (VISNs). At the date of randomization (8/27/2019), there were 18 VISNs. One VISN was excluded because it was the model for the national program. Out of 17 VISNs, 8 were randomized to the control arm and 9 to the intervention arm. Subjects were identified via an electronic algorithm during the recruitment year 9/16/2019 - 9/15/2020.
Unit of analysis: VA regional delivery network (VISN)
Participant milestones
| Measure |
De-prescribing Program
The 9 Veterans Integrated Service Networks (VISNs) randomly assigned to the Proton Pump Inhibitor (PPI) de-prescribing program. VISNs are the 18 geographical regions that make up the VHA.
PPI De-prescribing Program: The PPI de-prescribing program included alerts to clinical pharmacy specialists and primary care providers informing them of individual patients scheduled for upcoming primary care visits who meet criteria for PPI de-prescription; activation of clinical pharmacy specialists; education of primary care providers; and patient education.
|
No De-prescribing Program
The 8 Veterans Integrated Service Networks (VISNs) randomly assigned to usual care and did not receive the national de-prescribing program. VISNs are the 18 geographical regions that make up the VHA.
|
|---|---|---|
|
Overall Study
STARTED
|
119494 9
|
100812 8
|
|
Overall Study
COMPLETED
|
119494 9
|
100812 8
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Row population differs from the Overall because 10 participants had missing Sex data: 4 from the De-prescribing Program arm and 6 from the No De-prescribing Program arm.
Baseline characteristics by cohort
| Measure |
De-prescribing Program
n=119 Participants
The 9 Veterans Integrated Service Networks (VISNs) randomly assigned to the PPI de-prescribing program. VISNs are the 18 geographical regions that make up the VHA.
PPI De-prescribing Program: The PPI de-prescribing program included alerts to clinical pharmacy specialists and primary care providers informing them of individual patients scheduled for upcoming primary care visits who meet criteria for PPI de-prescription; activation of clinical pharmacy specialists; education of primary care providers; and patient education.
|
No De-prescribing Program
n=100 Participants
The 8 Veterans Integrated Service Networks (VISNs) randomly assigned to usual care and will not receive the national de-prescribing program. VISNs are the 18 geographical regions that make up the VHA.
|
Total
n=220306 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.74 years
STANDARD_DEVIATION 13.00 • n=119 Participants
|
64.63 years
STANDARD_DEVIATION 13.19 • n=100 Participants
|
64.69 years
STANDARD_DEVIATION 13.09 • n=220306 Participants
|
|
Sex: Female, Male
Sex · Female
|
8,101 Participants
n=119 Participants • Row population differs from the Overall because 10 participants had missing Sex data: 4 from the De-prescribing Program arm and 6 from the No De-prescribing Program arm.
|
7,036 Participants
n=100 Participants • Row population differs from the Overall because 10 participants had missing Sex data: 4 from the De-prescribing Program arm and 6 from the No De-prescribing Program arm.
|
15137 Participants
n=220296 Participants • Row population differs from the Overall because 10 participants had missing Sex data: 4 from the De-prescribing Program arm and 6 from the No De-prescribing Program arm.
|
|
Sex: Female, Male
Sex · Male
|
111,389 Participants
n=119 Participants • Row population differs from the Overall because 10 participants had missing Sex data: 4 from the De-prescribing Program arm and 6 from the No De-prescribing Program arm.
|
93,770 Participants
n=100 Participants • Row population differs from the Overall because 10 participants had missing Sex data: 4 from the De-prescribing Program arm and 6 from the No De-prescribing Program arm.
|
205159 Participants
n=220296 Participants • Row population differs from the Overall because 10 participants had missing Sex data: 4 from the De-prescribing Program arm and 6 from the No De-prescribing Program arm.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2,624 Participants
n=119 Participants
|
7,757 Participants
n=100 Participants
|
10381 Participants
n=220306 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116,866 Participants
n=119 Participants
|
93,049 Participants
n=100 Participants
|
209915 Participants
n=220306 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=119 Participants
|
6 Participants
n=100 Participants
|
10 Participants
n=220306 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
825 Participants
n=119 Participants
|
785 Participants
n=100 Participants
|
1610 Participants
n=220306 Participants
|
|
Race (NIH/OMB)
Asian
|
716 Participants
n=119 Participants
|
547 Participants
n=100 Participants
|
1263 Participants
n=220306 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
816 Participants
n=119 Participants
|
669 Participants
n=100 Participants
|
1485 Participants
n=220306 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16,964 Participants
n=119 Participants
|
13,948 Participants
n=100 Participants
|
30912 Participants
n=220306 Participants
|
|
Race (NIH/OMB)
White
|
93,976 Participants
n=119 Participants
|
79,990 Participants
n=100 Participants
|
173966 Participants
n=220306 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=119 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=220306 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6,197 Participants
n=119 Participants
|
4,873 Participants
n=100 Participants
|
11070 Participants
n=220306 Participants
|
|
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index = 0
|
44,970 Participants
n=119 Participants
|
37,710 Participants
n=100 Participants
|
82680 Participants
n=220306 Participants
|
|
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index = 1
|
30,391 Participants
n=119 Participants
|
24,781 Participants
n=100 Participants
|
55172 Participants
n=220306 Participants
|
|
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Score = 2
|
14,889 Participants
n=119 Participants
|
12,598 Participants
n=100 Participants
|
27487 Participants
n=220306 Participants
|
|
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index = 3
|
11,982 Participants
n=119 Participants
|
10,312 Participants
n=100 Participants
|
22294 Participants
n=220306 Participants
|
|
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index = 4
|
6,329 Participants
n=119 Participants
|
5,412 Participants
n=100 Participants
|
11741 Participants
n=220306 Participants
|
|
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index >= 5
|
10,933 Participants
n=119 Participants
|
9,999 Participants
n=100 Participants
|
20932 Participants
n=220306 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All participants from the 17 randomized VISNs meeting study criteria within the 1-year recruitment period.
The proportion of days proton pump inhibitors are prescribed in the 12 months following the index visit.
Outcome measures
| Measure |
De-prescribing Program
n=119494 Participants
The 9 Veterans Integrated Service Networks (VISNs) randomly assigned to the PPI de-prescribing program. VISNs are the 18 geographical regions that make up the VHA.
PPI De-prescribing Program: The PPI de-prescribing program included alerts to clinical pharmacy specialists and primary care providers informing them of individual patients scheduled for upcoming primary care visits who meet criteria for PPI de-prescription; activation of clinical pharmacy specialists; education of primary care providers; and patient education.
|
No De-prescribing Program
n=100812 Participants
The 8 Veterans Integrated Service Networks (VISNs) randomly assigned to usual care and which did not receive the national de-prescribing program. VISNs are the 18 geographical regions that make up the VHA.
|
|---|---|---|
|
PPI Prescribing (H1)
|
73.69 percentage of days on PPI
Standard Deviation 0.27
|
72.66 percentage of days on PPI
Standard Deviation 0.27
|
Adverse Events
De-prescribing Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No De-prescribing Program
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