Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

This study has been completed.
Sponsor:
Collaborator:
Humana, Inc
Information provided by (Responsible Party):
Ana M. Palacio, University of Miami
ClinicalTrials.gov Identifier:
NCT01651208
First received: July 24, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Behavioral: Motivational Interviewing (MINT)
Behavioral: Mailed DVD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR) [ Time Frame: 12 months after receiving coronary stent ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 4-Item Morisky Medication Adherence Scale (MMAS-4) [ Time Frame: At 12 month post stent placement ] [ Designated as safety issue: No ]
    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=0 (experiencing a barrier or difficulty taking the medication of interest as prescribed) or No=1 for a range of 0-4. A perfect score (reflecting best possible adherence) would be a score of 4.


Enrollment: 452
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.

Active Comparator: 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.
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.

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01651208

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Humana, Inc
Investigators
Principal Investigator: Ana M Palacio, MD, MPH University of Miami
  More Information

Publications:
Responsible Party: Ana M. Palacio, Associate Professor of Clinical Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT01651208     History of Changes
Other Study ID Numbers: 1RC1MD004327
Study First Received: July 24, 2012
Results First Received: May 14, 2014
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Coronary stents
Medication adherence
Antiplatelet medications
Motivational Interviewing

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014