Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02269787 |
| Other study ID # |
CRE 12-010 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2014 |
| Est. completion date |
March 30, 2018 |
Study information
| Verified date |
February 2019 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
