Coronary Artery Disease
Conditions
Keywords
Coronary stents, Medication adherence, Antiplatelet medications, Motivational Interviewing
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
Interventions
BEHAVIORALMotivational 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.
BEHAVIORALMailed 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.
Sponsors
Humana Inc.
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR) | 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
| Measure | Time frame | Description |
|---|---|---|
| 4-Item Morisky Medication Adherence Scale (MMAS-4) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivational Interviewing (MINT) The MINT intervention will consist of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. .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-Contentedness, Self-Efficacy theory, and the Stages of Change model. | 227 |
| 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. | 225 |
| Total | 452 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 16 |
Baseline characteristics
| Characteristic | Mailed DVD | Motivational Interviewing (MINT) | Total |
|---|---|---|---|
| Age, Continuous | 69.94 years STANDARD_DEVIATION 9.01 | 69.11 years STANDARD_DEVIATION 8.65 | 69.52 years STANDARD_DEVIATION 8.83 |
| Educational level High School or Higher | 49 participants | 51 participants | 100 participants |
| Educational level Less than High School | 176 participants | 176 participants | 352 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 100 Participants | 101 Participants | 201 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants | 126 Participants | 251 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 125 Participants | 126 Participants | 251 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 100 Participants | 101 Participants | 201 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 89 Participants | 101 Participants | 190 Participants |
| Sex: Female, Male Male | 136 Participants | 126 Participants | 262 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 227 | 0 / 225 |
| serious Total, serious adverse events | 0 / 227 | 0 / 225 |
Outcome results
Primary
Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)
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
Time frame: 12 months after receiving coronary stent
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motivational Interviewing (MINT) | Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR) | 137 participants |
| Mailed DVD | Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR) | 105 participants |
Comparison: We hypothesized that in the MINT group, at least 70% of subjects will reach an MPR of 0.80 while in the DVD group, the proportion will remain at or below 55%. Our sample size estimates showed that, using a conservative 2-sided test at the 5% Alpha level and a 90% power, we will be able to detect a significant 15% difference (70% - 55%) with a sample of 217 in each study group.p-value: <0.01Chi-squared
Secondary
4-Item Morisky Medication Adherence Scale (MMAS-4)
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.
Time frame: At 12 month post stent placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MINT) | 4-Item Morisky Medication Adherence Scale (MMAS-4) | 3.82 Score on a Scale | Standard Deviation 0.45 |
| Mailed DVD | 4-Item Morisky Medication Adherence Scale (MMAS-4) | 3.60 Score on a Scale | Standard Deviation 0.69 |
Comparison: The null hypothesis is that the mean MMAS-4 score is similar in both intervention armsp-value: <0.01t-test, 2 sided