Diabetes Mellitus, Type 2, Hypertension
Conditions
Keywords
Motivational interviewing, trajectory modeling, medication adherence
Brief summary
The purpose of this study is to examine the effectiveness of a telephone motivational interviewing intervention by pharmacy students in enhancing adherence to angiotensin converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARB) (ACE/ARBs) among patients with diabetes and hypertension in a Medicare advantage plan.
Detailed description
Angiotensin converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARB) are highly recommended for patients with both diabetes (DM) and hypertension (HTN), and their efficacy in reducing macrovascular and microvascular complications of DM is well-documented. Poor adherence remains a significant barrier to achieving full effectiveness and optimal long-term outcomes. This study aims to develop innovative group-based trajectory models to identify patients with similar ACE/ARB medication filling behavior among patients with co-morbid HTN and DM. The proportion of days covered (PDC), often used as an adherence measure, reduces complex patterns of longitudinal observations into a single value that cannot adequately depict different adherence experiences. Group based trajectory models are designed to identify patients with similar longitudinal patterns while capturing the dynamic nature. A motivational interviewing (MI) pharmacy student telephone intervention will then be customized by the identified trajectories and tested to demonstrate effectiveness in enhancing adherence. In pilot work, the investigator's team has demonstrated improvements in adherence through a pharmacy student telephone MI intervention. Pharmacy students have the knowledge base and training to provide comparable services to pharmacists at a lower cost. MI fosters behavior change by setting desired goals and promoting self-efficacy in a supportive, collaborative way. The objectives are to 1. Develop group-based trajectory models to identify patients with similar medication filling behavior patterns among patients enrolled in a Medicare advantage plan and 2. Customize an MI pharmacy student telephone intervention by the adherence patterns identified, and demonstrate the benefit of the customized intervention in improving adherence. Phase 1 of the project will be a retrospective analysis of 12 month refill data to determine patient adherence patterns. Phase 2 will be a prospective study among non-adherent patients to evaluate the effectiveness of the customized intervention (n=500). The students will contact patients assigned to the intervention group and follow a protocol using the Ask-Provide-Ask approach of MI given the patient adherence pattern for a tailored education. Monthly follow-up calls will be carried out for 6 months. Adherence during the 6 and 12 months post-intervention will be evaluated for the intervention and control groups as PDC as well as a categorical variable. Chi-square and t-tests will be used to evaluate the intervention effect. Multivariable multiple and logistic regression will be carried out in case of any significant differences in baseline characteristics. Implementing this project will provide students a unique MI training as a new way of communicating with patients. The training is further strengthened by PhD students trained in research design and statistical analyses to assist in the automated data analysis. The project will formulate a strong adherence research team at University of Houston that will be instrumental in implementing customized innovative interventions to improve medication adherence and subsequent health outcomes.
Interventions
The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Continuous enrollment over the study period July 2016 to December 2018. 2. A prescription filled for an ACEI or ARB medication between July 1st, 2017- December 31st, 2017. This will be defined as the index date (for phase 1). 3. Diagnosis of both DM and HTN prior to index date, identified through the health plan's medical claims program (CCMS) using the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes only.
Exclusion criteria
1. Disenrollment from drug plan. 2. Death prior to end of the study. 3. Having a diagnosis of dementia in the one-year pre-index period. 4. Having an ACEI/ARB contraindication like angioedema, hyperkalemia, and renal artery stenosis in the one-year pre-index period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Measure | 12 months following initial call | Proportion of days covered (PDC): measured by examining refill data, both as a continuous measure as well as a categorical measure with a PDC of 0.8 or more considered adherent. It ranges from 0-1. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivational Interviewing Intervention Arm The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
Motivational interviewing intervention arm: The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls | 240 |
| Control usual care | 480 |
| Total | 720 |
Baseline characteristics
| Characteristic | Total | Motivational Interviewing Intervention Arm | Control |
|---|---|---|---|
| Age, Customized Age <70 years | 380 Participants | 123 Participants | 257 Participants |
| Age, Customized Age ≥70 years | 340 Participants | 117 Participants | 223 Participants |
| CMS risk score | 1.41 scores on a scale STANDARD_DEVIATION 0.89 | 1.50 scores on a scale STANDARD_DEVIATION 0.99 | 1.36 scores on a scale STANDARD_DEVIATION 0.83 |
| Comorbidities Congestive heart failure No | 664 Participants | 214 Participants | 450 Participants |
| Comorbidities Congestive heart failure Yes | 56 Participants | 26 Participants | 30 Participants |
| Comorbidities Coronary artery disease No | 565 Participants | 177 Participants | 388 Participants |
| Comorbidities Coronary artery disease Yes | 155 Participants | 63 Participants | 92 Participants |
| Comorbidities Depression No | 633 Participants | 209 Participants | 424 Participants |
| Comorbidities Depression Yes | 87 Participants | 31 Participants | 56 Participants |
| Comorbidities Myocardial infarction No | 706 Participants | 236 Participants | 470 Participants |
| Comorbidities Myocardial infarction Yes | 14 Participants | 4 Participants | 10 Participants |
| Comorbidities Stroke No | 692 Participants | 230 Participants | 462 Participants |
| Comorbidities Stroke Yes | 28 Participants | 10 Participants | 18 Participants |
| health plan Low-income subsidy | 354 Participants | 118 Participants | 236 Participants |
| health plan No-subsidy | 366 Participants | 122 Participants | 244 Participants |
| number of concomitant medications ≤2 | 509 Participants | 169 Participants | 340 Participants |
| number of concomitant medications >2 | 211 Participants | 71 Participants | 140 Participants |
| prescriber specialty General | 617 Participants | 207 Participants | 410 Participants |
| prescriber specialty Missing | 22 Participants | 6 Participants | 16 Participants |
| prescriber specialty Specialty | 81 Participants | 27 Participants | 54 Participants |
| prevalent users No | 115 Participants | 25 Participants | 90 Participants |
| prevalent users Yes | 605 Participants | 215 Participants | 390 Participants |
| prior hospitalizations ≥1 | 71 Participants | 26 Participants | 45 Participants |
| prior hospitalizations None | 649 Participants | 214 Participants | 435 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| refill type <90 days | 81 Participants | 26 Participants | 55 Participants |
| refill type ≥90 days | 639 Participants | 214 Participants | 425 Participants |
| regimen complexity | 3.99 scores on a scale STANDARD_DEVIATION 4.07 | 4.27 scores on a scale STANDARD_DEVIATION 4.32 | 3.86 scores on a scale STANDARD_DEVIATION 3.94 |
| Region of Enrollment United States | 720 participants | 240 participants | 480 participants |
| Sex: Female, Male Female | 417 Participants | 145 Participants | 272 Participants |
| Sex: Female, Male Male | 303 Participants | 95 Participants | 208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 240 | 0 / 480 |
| other Total, other adverse events | 0 / 240 | 0 / 480 |
| serious Total, serious adverse events | 0 / 240 | 0 / 480 |
Outcome results
Primary
Adherence Measure
Proportion of days covered (PDC): measured by examining refill data, both as a continuous measure as well as a categorical measure with a PDC of 0.8 or more considered adherent. It ranges from 0-1.
Time frame: 12 months following initial call
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing Intervention Arm | Adherence Measure | 0.63 Proportion of days covered | Standard Error 0.34 |
| Control | Adherence Measure | 0.56 Proportion of days covered | Standard Error 0.35 |