Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

NCT ID: NCT01651208

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-06-30

Brief Summary

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.

Detailed 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

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Motivational interviewing (MINT)

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.

Group Type: EXPERIMENTAL

Motivational Interviewing (MINT)

Intervention Type: BEHAVIORAL

We will hire a Latino and an AA nurse to deliver the interventions and will match their race/ethnicity with that of the subject. Past experience suggests that at 4-7 calls per subjects each lasting about 30-45 minutes, a nurse can carry a caseload of about 125-150 subject (we propose 125 per nurse) Each telephone encounter will have a patient centered approach having the following basic structure and goals:

a)Establishing a connection and reinforcing autonomy b)Empathizing with ambivalence and rolling with resistance.c)Coach the subject towards expressions of commitment.

Mailed DVD

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.

Group Type: ACTIVE_COMPARATOR

Mailed DVD

Intervention Type: BEHAVIORAL

The DVD will have a documentary format that will engage subjects as the portrayed real patients relate their struggles and successes, that will entertain and ultimately motivate subjects to succeed in a similar way as the role models in the video. That personal connection will activate patients to address their own adherence issues and will show real life ways to deal with the health behaviors recommended post PCIS. Key concepts regarding adherence to medications and other behaviors will be imbedded in the story telling. The DVD will also feature a humanistic perspective of a cardiologist talking about his concerns for his patients that do not adhere to the antiplatelet therapy, the difficulties that his patients face, and the merit of the success stories he witnesses.

Interventions

Motivational Interviewing (MINT)

We will hire a Latino and an AA nurse to deliver the interventions and will match their race/ethnicity with that of the subject. Past experience suggests that at 4-7 calls per subjects each lasting about 30-45 minutes, a nurse can carry a caseload of about 125-150 subject (we propose 125 per nurse) Each telephone encounter will have a patient centered approach having the following basic structure and goals:

a)Establishing a connection and reinforcing autonomy b)Empathizing with ambivalence and rolling with resistance.c)Coach the subject towards expressions of commitment.

Intervention Type: BEHAVIORAL

Mailed DVD

The DVD will have a documentary format that will engage subjects as the portrayed real patients relate their struggles and successes, that will entertain and ultimately motivate subjects to succeed in a similar way as the role models in the video. That personal connection will activate patients to address their own adherence issues and will show real life ways to deal with the health behaviors recommended post PCIS. Key concepts regarding adherence to medications and other behaviors will be imbedded in the story telling. The DVD will also feature a humanistic perspective of a cardiologist talking about his concerns for his patients that do not adhere to the antiplatelet therapy, the difficulties that his patients face, and the merit of the success stories he witnesses.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Humana Inc.

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Ana M. Palacio

Associate Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana M Palacio, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

References

Palacio AM, Tamariz LJ, Uribe C, Li H, Salkeld EJ, Hazel-Fernandez L, Carrasquillo O. Can claims-based data be used to recruit black and Hispanic subjects into clinical trials? Health Serv Res. 2012 Apr;47(2):770-82. doi: 10.1111/j.1475-6773.2011.01316.x. Epub 2011 Aug 30.

Reference Type: BACKGROUND

PMID: 22091834 (View on PubMed)

Other Identifiers

1RC1MD004327

Identifier Type: NIH

Identifier Source: org_study_id

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