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出境医 / 临床实验 / Motivational Interviewing (MI) Intervention to Improve Adherence (MI)
Motivational Interviewing (MI) Intervention to Improve Adherence (MI)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 Hypertension | Behavioral: Motivational interviewing intervention arm | Not Applicable |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 504 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | A Motivational Interviewing Intervention Customized by Patient Adherence Patterns |
| Actual Study Start Date : | May 29, 2019 |
| Estimated Primary Completion Date : | March 30, 2021 |
| Estimated Study Completion Date : | August 30, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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
|
Behavioral: 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
|
|
No Intervention: Control
usual care
|
Outcome Measures
Primary Outcome Measures :
- Adherence measure [ Time Frame: 6 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
- Adherence measure [ Time Frame: 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
Eligibility Criteria
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Continuous enrollment over the study period July 2016 to December 2018.
- 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).
- 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:
- 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.
Contacts and Locations
Locations
| United States, Texas | |
| Omar Serna | |
| Houston, Texas, United States, 70092 | |
Sponsors and Collaborators
University of Houston
National Heart, Lung, and Blood Institute (NHLBI)
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 10, 2019 | ||||||
| First Posted Date ICMJE | June 13, 2019 | ||||||
| Last Update Posted Date | September 9, 2020 | ||||||
| Actual Study Start Date ICMJE | May 29, 2019 | ||||||
| Estimated Primary Completion Date | March 30, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Motivational Interviewing (MI) Intervention to Improve Adherence | ||||||
| Official Title ICMJE | A Motivational Interviewing Intervention Customized by Patient Adherence Patterns | ||||||
| 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. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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| Condition ICMJE |
|
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| Intervention ICMJE | Behavioral: 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
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||
| Actual Enrollment ICMJE |
504 | ||||||
| Original Estimated Enrollment ICMJE |
500 | ||||||
| Estimated Study Completion Date ICMJE | August 30, 2021 | ||||||
| Estimated Primary Completion Date | March 30, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 65 Years and older (Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03985098 | ||||||
| Other Study ID Numbers ICMJE | STUDY00000718 R15HL135700-01A1 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Susan Abughosh,, University of Houston | ||||||
| Study Sponsor ICMJE | University of Houston | ||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | University of Houston | ||||||
| Verification Date | September 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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