Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)

Kaiser Permanente

Status: Completed

Conditions: Diabetes Mellitus; Cardiovascular Disease

Treatments: Other: Interactive Voice Recognition (IVR) phone calls; Other: Educational mailings and follow-up for nonadherence

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01251757

R01HS019341-01

Details and patient eligibility

About

The purpose of this randomized clinical trial is to determine whether two low-intensity, technology based interventions, when compared to each other and to usual care, improve adherence to selected medications that are used to treat people with cardiovascular disease (CVD) and diabetes.

Full description

The frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. Many studies have linked medication non-adherence to treatment failure; unnecessary and dangerous intensification of therapy; and excess health care costs, hospitalizations, and deaths. Although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. Simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. The proposed PATIENT study will use health information technology (automated phone calls and access to an electronic medical record) to test two such interventions and compare them to each other and to usual care alone.

Enrollment: 21,752 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 40 years or older as of time of randomization.
• Flagged in KP's databases as having either diabetes or atherosclerotic cardiovascular disease(defined as coronary artery disease, peripheral vascular disease, or a history of atherosclerotic stroke) at the time of randomization
• At least one dispensing of an ACEI, ARB, or statin from a Kaiser Permanente (KP) outpatient pharmacy during the baseline year.
• Suboptimal adherence ((MPR<0.9) to either statins or ACEI/ARBs during the baseline year
• Continuous membership in KP for the 12 months prior to randomization.
• Qualified for an intervention call at the time of randomization.

Exclusion criteria

• Evidence in the electronic medical record (EMR) of allergy or intolerance to statins or ACE inhibitors/ARBs
• medical conditions that would contraindicate use of statins or ACEI/ARBs
• Absence of either a phone number or mailing address in the EMR
• for Kaiser Permanente Hawaii, clinics whose patients tend to fill prescriptions primarily at non-KP pharmacies
• on Kaiser Permanente's "do not contact" list or in other research studies that could add undue burden

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21,752 participants in 3 patient groups

Usual Care (UC)

No Intervention group

Description:

Participants in this arm received their usual care with no restrictions.

Interactive Voice Recognition (IVR)

Active Comparator group

Description:

automated phone calls

Treatment:

Other: Interactive Voice Recognition (IVR) phone calls

Enhanced IVR (IVR+)

Active Comparator group

Description:

automated phone calls \& Educational mailings and follow-up for nonadherence

Treatment:

Other: Educational mailings and follow-up for nonadherence

Other: Interactive Voice Recognition (IVR) phone calls