Clinical trial NCT04838457: Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease
Official title: Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease (CDA 19-035)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Misuse
Hypertension
Elevated Cardiovascular Risk
Keywords: Alcohol
Cardiovascular Disease
Telehealth
Cognitive Behavioral Therapy
SMS Text
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The interventional model takes place in two parts. Part 1 is a successive cohort design in which a small cohort of participants complete the treatment, and provide qualitative and quantitative feedback on the treatment. The treatment process is then revised accordingly. A second and third cohort of participants complete treatment, followed by the same revision process. Part 2 involves a single-arm pilot trial of acceptability and feasibility of recruiting methods, treatment, and measurement of outcomes for participants.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this project is to refine a cognitive-behavioral intervention for comorbid alcohol misuse and modifiable CVD risk with diverse stakeholder input, so that the intervention can be deployed within existing VA systems. The intervention will deliver telehealth CBT for alcohol misuse, tailored and timely text messages facilitating clinical traction with CVD risk reduction, and a telehealth coaching call to transition focus of treatment targets. The primary hypotheses of this study are that the developed intervention will be feasible to deliver, acceptable to Veterans and clinicians, and show signs of reducing alcohol misuse and increasing behaviors associated with cardiovascular health.

Detailed description: Specific Aims: Aim 1 -Characterize a national cohort of Veterans with alcohol misuse and modifiable CVD risk, their alcohol services utilization, and clinical outcomes. Aim 2 - Qualitatively assess barriers to treatment for Veterans with alcohol misuse and CVD risk across multiple stakeholders. Aim 3 - Use a successive cohort design to iteratively develop an intervention based on patient feedback. Aim 4 - Test the acceptability and feasibility of an intervention to reduce alcohol misuse and CVD risk in Veterans.

Innovation: This application is highly innovative in its attempt to address for the first time: 1) perceptions of barriers to treatment in this population, 2) the utility of a combined intervention for alcohol misuse and CVD risk, 3) multimorbid patient preferences for timing of treatments for multiple different targets, and 4) the sustainability of health behavior habits in VA formed by an intervention using "implementation intentions." Methodology: Aim 1 will use electronic health records to examine the status of key health criteria and services utilization among Veterans with alcohol misuse, both with and without comorbid CVD risk. Aim 2 will use qualitative interviews of both Veterans with comorbid alcohol misuse and elevated modifiable CVD risk, their providers across different settings, and systems-level stakeholders to assess current treatment barriers. Aim 3 will employ a successive cohort design to iteratively test the proposed intervention with rapid and early feedback from multiple Veteran cohorts. Aim 4 will test a refined intervention based on feedback from Aims 2 and 3 to determine the acceptability to Veteran patients, as well as the feasibility of recruitment, randomization, and intervention.

Eligibility criteria: Inclusion Criteria:

* Enrolled in 1 of 3 primary care clinics associated with the Durham VAHCS, as evidenced by at least one outpatient PCP visit recorded in Managerial Cost Accounting (MCA) system.
* Diagnosis of hypertension, hyperlipidemia, and/or diabetes mellitus in EHR (ICD-10 codes I10, E78.xx, and E11.xxxx) for at least one year.
* Uncontrolled BP (indicated by average outpatient past year systolic BP of \>140/100mmHg). \> 1 measurement required.
* Currently prescribed at least one oral medication for hypertension, hyperlipidemia, and/or diabetes mellitus as evidenced by at least one pharmacy refill within the previous year.
* Most recent EHR AUDIT-C 5 (suggestive of alcohol misuse).
* Self-reported access to any SMS text-capable phone.
* Appropriate medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor).

Exclusion Criteria:

* Current enrollment in another trial for CVD risk reduction or medication adherence specifically.
* Current participation in other alcohol misuse treatment programming.
* EHR AUDIT-C suggestive of severe alcohol dependence requiring medical treatment, defined as 10-12 for both men and women.
* Any recent or impending procedures that would warrant inpatient hospital stays or considerable changes to current medications (e.g., any changes other than altered doses).
* Current palliative care or care through a nursing/hospice home.
* History of clinically significant alcohol withdrawal symptoms, as evidenced by a score 10 on the CIWA.
* Contraindicated medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor).

Primary outcomes:
measure: Enrollment Feasibility
timeFrame: Baseline Only
measure: Treatment Feasibility
timeFrame: 10 Weeks Post-Baseline
measure: Treatment Acceptability
timeFrame: 10 Weeks Post-Baseline
measure: Therapist Fidelity
timeFrame: 6 Weeks Post-Baseline
measure: SMS Text Acceptability
timeFrame: 10 Weeks Post-Baseline
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: 6 months Post-Baseline
measure: Past-Month Self-Reported Heavy Drinking Days
timeFrame: 6 months Post-Baseline
measure: ReComp Pharmacy Refill Compliance Estimate for CVD medications
timeFrame: 6 months Post-Baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Daniel Blalock, PhD
role: PRINCIPAL_INVESTIGATOR
References: