跳至主要内容
临床试验/NCT03985098
NCT03985098已完成不适用

A Motivational Interviewing Intervention Customized by Patient Adherence Patterns

University of Houston1 个研究点 分布在 1 个国家目标入组 727 人开始时间: 2019年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
727
试验地点
1
主要终点
Adherence Measure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Continuous enrollment over the study period July 2016 to December
  • •A prescription filled for an ACEI or ARB medication between July 1st, 2017- December 31st,
  • •This will be defined as the index date (for phase 1).
  • •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.

排除标准

  • •Disenrollment from drug plan.
  • •Death prior to end of the study.
  • •Having a diagnosis of dementia in the one-year pre-index period.
  • •Having an ACEI/ARB contraindication like angioedema, hyperkalemia, and renal artery stenosis in the one-year pre-index period.

研究组 & 干预措施

Motivational interviewing intervention arm

Experimental

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

干预措施: Motivational interviewing intervention arm (Behavioral)

Control

No Intervention

usual care

结局指标

主要结局

Adherence Measure

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Abughosh,

Associate Professor

University of Houston

研究点 (1)

Loading locations...

相似试验