Trial Outcomes & Findings for Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications (NCT NCT02694185)

Results Overview

Proportion of Days Covered (PDC) is measured by looking at the number of doses of medication a patient has versus days in the month (if a patient has 20 days of medication for a 30 day period their PDC is 20/30, 2/3, or 66.7%). Used to assess the effectiveness of the intervention, PDC will be tested among IHD patients in the year after PCI and among rheumatology clinic patients chronically prescribed DMARDs.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

5269 participants

Primary outcome timeframe

1 year

Results posted on

2024-09-19

Participant Flow

This study will employ an approach to consent similar to SDP-179 Hybrid Effectiveness-Implementation Study to Improve Clopidogrel Adherence which has previously been approved by (CIRB Protocol #12-12). The study will enroll all subjects undergoing PCI or using DMARDs at 16 VA Medical Centers. These Medical Centers are all tertiary referral hospitals within their respective VISN and provide a full spectrum of cardiac and rheumatologic care services.

Participant milestones

Participant milestones
Measure	Experimental Group This group will undergo the intervention as described in the protocol Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient.	Control Group This group will not receive the intervention, they will receive usual care
Overall Study STARTED	476	4793
Overall Study COMPLETED	431	4793
Overall Study NOT COMPLETED	45	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Group This group will undergo the intervention as described in the protocol Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient.	Control Group This group will not receive the intervention, they will receive usual care
Overall Study Withdrawal by Subject	45	0

Baseline Characteristics

Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=431 Participants This group will undergo the intervention as described in the protocol Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient.	Control Group n=4793 Participants This group will not receive the intervention, they will receive usual care	Total n=5224 Participants Total of all reporting groups
Age, Continuous	68.6 years n=5 Participants	68.7 years n=7 Participants	68.7 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	103 Participants n=7 Participants	115 Participants n=5 Participants
Sex: Female, Male Male	419 Participants n=5 Participants	4690 Participants n=7 Participants	5109 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	330 Participants n=5 Participants	3789 Participants n=7 Participants	4119 Participants n=5 Participants
Race/Ethnicity, Customized African American	89 Participants n=5 Participants	872 Participants n=7 Participants	961 Participants n=5 Participants
Race/Ethnicity, Customized Other	12 Participants n=5 Participants	132 Participants n=7 Participants	144 Participants n=5 Participants
Region of Enrollment Puerto Rico	42 Participants n=5 Participants	214 Participants n=7 Participants	256 Participants n=5 Participants
Region of Enrollment United States	389 Participants n=5 Participants	4579 Participants n=7 Participants	4968 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Participant numbers differ below because not all subjects are taking an anti-platelet, beta-blocker, and statin medication.

Proportion of Days Covered (PDC) is measured by looking at the number of doses of medication a patient has versus days in the month (if a patient has 20 days of medication for a 30 day period their PDC is 20/30, 2/3, or 66.7%). Used to assess the effectiveness of the intervention, PDC will be tested among IHD patients in the year after PCI and among rheumatology clinic patients chronically prescribed DMARDs.

Outcome measures

Outcome measures
Measure	Experimental Group n=431 Participants This group will undergo the intervention as described in the protocol Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient.	Control Group n=4793 Participants This group will not receive the intervention, they will receive usual care
Proportion of Days Covered (PDC) Anti-platelet	82.6 percentage of days covered Interval 77.9 to 86.2	75.6 percentage of days covered Interval 69.7 to 79.9
Proportion of Days Covered (PDC) Beta-Blocker	78.4 percentage of days covered Interval 71.5 to 82.7	73.3 percentage of days covered Interval 66.8 to 77.1
Proportion of Days Covered (PDC) Statin	78.8 percentage of days covered Interval 71.8 to 83.4	71.2 percentage of days covered Interval 64.9 to 75.1

SECONDARY outcome

Timeframe: 1 year

Cardiovascular Events (CVEs) such as mortality, myocardial infarction, stroke, or repeat revascularization among IHD patients at 12 months post-PCI and progressive erosive disease demonstrated in patients with rheumatic disease will be monitored. CVEs will be monitored to determine if there is a reduction in the occurrence of those events as a result of the intervention.

Outcome measures

Outcome measures
Measure	Experimental Group n=431 Participants This group will undergo the intervention as described in the protocol Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient.	Control Group n=4793 Participants This group will not receive the intervention, they will receive usual care
Cardiovascular Events (CVE)	15.2 Cardiovascular events Interval 10.9 to 25.5	14.3 Cardiovascular events Interval 12.3 to 16.7

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

To establish the cost to implement and maintain the intervention, above the cost of usual care. Incremental Cost Effectiveness (ICE) is the cost to achieve a 10% improvement in PDC, and the cost of CVE prevented.

Outcome measures

Outcome measures
Measure	Experimental Group n=431 Participants This group will undergo the intervention as described in the protocol Caplan IVR: This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient.	Control Group n=4793 Participants This group will not receive the intervention, they will receive usual care
Incremental Cost Effectiveness (ICE)	821.45 dollars per patient Interval 158.18 to 1541.91	893.55 dollars per patient Interval 437.85 to 1460.85

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 23 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 209 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Cheng

Rocky Mountain Regional VA Medical Center

Phone: 720-857-5101

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place