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OpenTrials
Completed

NCT Number: NCT01651208

Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Disease Health Behavior Heart Diseases Medication Adherence Myocardial Ischemia Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Motivational Interviewing (MINT)

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

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.

Primary outcomes

  1. Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)

    Time frame: 12 months after receiving coronary stent

    Medication Possession ratio (MPR) is a continuous multiple interval measure of medication availability. This is a validated method of estimating medication adherence . The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill.We will use the previously validated cutpoint of MPR>=.80 to define the binary outcome of Appropriate Adherence

Secondary outcomes

  1. 4-Item Morisky Medication Adherence Scale (MMAS-4)

    Time frame: At 12 month post stent placement

    The Morisky 4-Item Medication Adherence Scale (MMAS-4) is a self-reported measure of medication-taking behavior. Available in 33 languages, it addresses barriers to medication-taking. Each question can be answer as Yes or No for a range of 0-4 points.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Humana Inc.

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 26, 2012
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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