TeleMonitoring to Improve Substance Use Disorder Treatment After Detoxification

NCT ID: NCT02269787

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2018-03-30

Brief Summary

This research program is intended to improve the treatment engagement and outcomes of Veterans who receive inpatient detoxification, and decrease their use of VA inpatient and emergency department services. It is intended to increase the use of substance use disorder care and 12-step mutual-help groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.

Detailed Description

Annually, about 25,000 Veterans receive inpatient detoxification (detox) for substance use disorders (SUDs). Detox is not SUD treatment; it is the medical management of withdrawal to prevent complications, which may be fatal. Detox inpatients who enter SUD treatment and peer-based mutual-help groups (e.g., Alcoholics Anonymous) have much better outcomes (less substance use, HIV/HCV risk behaviors, homelessness, rehospitalizations, Emergency Department visits) than those who do not. However, because of their unique characteristics (severe and chronic addictions, co-morbidities, lack of resources, self- and provider-perceptions as unsuitable for treatment), most Veterans discharged from inpatient detox do not enter SUD treatment. For many Veterans, a pattern of repeated inpatient detox, with each episode incurring a higher risk of overdose, occurs. Therefore, in its Uniform Services Handbook, Mental Health Operations places major emphasis on increasing the rate of SUD treatment initiation and engagement following detox to benefit Veterans' outcomes and prevent more use of costly health care.

The primary objective of this project is to implement and evaluate Enhanced Telephone Monitoring (ETM) as a new and innovative telehealth intervention to facilitate the transition from inpatient detox to SUD specialty treatment (residential, outpatient, pharmacotherapy), thereby improving Veterans' outcomes and decreasing VA health care costs. In a randomized trial at two sites (VA Palo Alto and Boston), investigators hypothesize that patients receiving ETM, compared to patients in usual care (UC), will be more likely to enter and engage in SUD treatment and mutual-help, have better SUD and related outcomes, and have fewer and delayed acute care episodes. This project will also conduct a formative evaluation of how to implement ETM VA-wide, focusing on diverse subgroups of Veterans. Further, it will conduct a Budget Impact Analysis (BIA) to determine the impact of ETM on total costs of VA care. Investigators hypothesize that the higher costs associated with ETM (because patients will engage in SUD treatment) will be more than offset by its lower costs of acute care.

Patients in the ETM condition will receive an in-person session while in detox, followed by coaching over the telephone for 3 months after discharge. The intervention will incorporate Motivational Interviewing, and Contracting, Prompting, and Reinforcing, to provide support while waiting for treatment, and facilitate entry into treatment and mutual-help, and improved responses to crises. Patients will be assessed at baseline and 3 and 6 months post-discharge for outcomes and non-VA health care; VA health care will be assessed with VA databases. GLMM analyses will be conducted to compare the UC and ETM groups on course of outcomes over time. The formative evaluation to inform the implementation of ETM will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Semi-structured interviews will be conducted with inpatient detox staff and patients to yield facilitators of ETM implementation and modifiable barriers with associated action plans. For the BIA, costs of ETM will be measured through microcosting methods. For patients in both the ETM and UC groups, all inpatient, residential, outpatient, and pharmacy care will be measured from VA utilization and cost files.

In summary, Mental Health Operations is committed to eradicating the dangerous, costly pattern of Veterans obtaining inpatient detox services but not receiving the SUD treatment they need. Telehealth interventions, a promising way to improve treatment access and outcomes by SUD patients, have not been utilized with the challenging population of detox inpatients before. In accordance with others in this CREATE, this project will help to accomplish Mental Health Operations' goal of implementing the Uniform Handbook by increasing Veterans' access to, engagement in, and benefit from, SUD treatment services, particularly among Veterans who are using VA medical services and need SUD services but are not receiving them.

Conditions

Enhanced Telephone Monitoring; Usual Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Enhanced Telephone Monitoring

Detox inpatients in the ETM condition will be expected to complete one 15-minute telephone call per week for 12 weeks.

Group Type: EXPERIMENTAL

Enhanced Telephone Monitoring

Intervention Type: BEHAVIORAL

Detox inpatients in the ETM condition will be expected to complete one session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).

Usual Care

Patients in the usual care condition will receive the care they would receive in the absence of a research project.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Enhanced Telephone Monitoring

Detox inpatients in the ETM condition will be expected to complete one session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).

Intervention Type: BEHAVIORAL

Other Intervention Names

ETM

Eligibility Criteria

Inclusion Criteria

• Beginning an episode of inpatient detoxification at the Boston or Palo Alto Veterans Affairs medical facilities, and
• have ongoing access to cell phone or land line telephone

Exclusion Criteria

• Significant cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Timko, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CRE 12-010

Identifier Type: -

Identifier Source: org_study_id