Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

University of Miami

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Behavioral: Motivational Interviewing (MINT); Behavioral: Mailed DVD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01651208

1RC1MD004327

Details and patient eligibility

About

The purpose of this study is to evaluate if the use of a phone based motivational interviewing among minority populations who received a coronary stent can improve adherence to antiplatelet agents from approximately 51% to 66% (15 percentage point increase) at 12 months post stent placement when compared to a mailed educational DVD.

Full description

Other aims are: 1) Improve the self reported adherence of antiplatelet medications 2) Identify specific barriers for the use of post PCI anti-platelet therapy among minority populations enrolled in Humana by administering a short survey at the baseline recruitment call and at the 12 month follow up call, 3) identify predictors of never filling an anti-platelet therapy prescription post PCIS.

Inclusion criteria:

We will include black or Hispanic patients having coronary stenting using the following codes for bare metal or drug eluting stents: ICD-9 procedure codes (36.06) or (36.07), MS-DRG codes 247-249 or CPT codes 92980, 92981, C1984 G0290, G0291. The identification period will last approximately 10 months.

Primary Outcome: Medication Possession ratio as a dichotomous variable (appropriate/not appropriate adherence) and as a continuous variable

Secondary outcomes:

Self reported adherence by 4- item Morisky Medication Adherence Scale (MMAS-4) Barriers to appropriate adherence Predictors of adherence

Enrollment: 452 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• We will identify prospectively all subjects who undergo coronary stenting using the following codes for bare metal or drug eluting stents: ICD-9 procedure codes (36.06) or (36.07), MS-DRG codes 247-249 or CPT codes 92980, 92981, C1984 G0290, G0291
• We will select subjects identified as Black or Hispanics by a validated algorithm that uses the Medicare race code, geocoding techniques and the Spanish Surname list.

Exclusion criteria

1. Lack of medical files to document stent placement.
2. Not receiving informed consent.
3. Subjects with contraindications for antiplatelet therapy

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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452 participants in 2 patient groups

Motivational interviewing (MINT)

Experimental group

Description:

The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters. MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.

Treatment:

Behavioral: Motivational Interviewing (MINT)

Mailed DVD

Active Comparator group

Description:

A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.

Treatment:

Behavioral: Mailed DVD