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TeleMonitoring to Improve Substance Use Disorder Treatment After Detoxification

TeleMonitoring to Improve Substance Use Disorder Treatment After Detoxification

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02269787
Enrollment
298
Registered
2014-10-21
Start date
2014-10-01
Completion date
2018-03-30
Last updated
2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enhanced Telephone Monitoring, Usual Care

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.

Interventions

BEHAVIORALEnhanced 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).

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent of Participants Who Had an Additional Inpatient Detoxification6-month follow-upPercent that had (yes) an additional inpatient detoxification 6 months following baseline assessment- additional inpatient detoxification was dichotomous, yes or no.

Countries

United States

Participant flow

Participants by arm

ArmCount
Enhanced Telephone Monitoring
Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
148
Usual Care
Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
150
Total298

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath23
Overall StudyIncapacitated01
Overall StudyLost to Follow-up206

Baseline characteristics

CharacteristicEnhanced Telephone MonitoringTotalUsual Care
Age, Continuous51.4 years
STANDARD_DEVIATION 12.9
50.1 years
STANDARD_DEVIATION 13.2
48.9 years
STANDARD_DEVIATION 13.5
ASI, Alcohol severity.564 units on a scale
STANDARD_DEVIATION 0.29
.565 units on a scale
STANDARD_DEVIATION 0.299
.565 units on a scale
STANDARD_DEVIATION 0.29
ASI, Drugs severity.134 units on a scale
STANDARD_DEVIATION 0.151
.130 units on a scale
STANDARD_DEVIATION 0.154
.125 units on a scale
STANDARD_DEVIATION 0.157
ASI, Psychiatric.479 units on a scale
STANDARD_DEVIATION 0.226
.485 units on a scale
STANDARD_DEVIATION 0.231
.490 units on a scale
STANDARD_DEVIATION 0.236
Attempted suicide (past 30 days)15 Participants30 Participants15 Participants
Attended 12-step meeting (past 3 months)81 Participants160 Participants79 Participants
BAM, Alcohol and drug use7.2 units on a scale
STANDARD_DEVIATION 3.1
7.1 units on a scale
STANDARD_DEVIATION 3
7.0 units on a scale
STANDARD_DEVIATION 2.9
BAM, Risk factors15.0 units on a scale
STANDARD_DEVIATION 4.6
15.3 units on a scale
STANDARD_DEVIATION 4.5
15.6 units on a scale
STANDARD_DEVIATION 4.3
Days used alcohol (past 30 days)16.0 days
STANDARD_DEVIATION 10.7
15.7 days
STANDARD_DEVIATION 10.8
15.3 days
STANDARD_DEVIATION 10.8
Days used opioids (past 30 days)5.1 days
STANDARD_DEVIATION 11
5.3 days
STANDARD_DEVIATION 11.3
5.6 days
STANDARD_DEVIATION 11.7
Detoxification, lifetime145 Participants290 Participants145 Participants
Employed46 Participants101 Participants55 Participants
Homeless23 Participants43 Participants20 Participants
Married28 Participants54 Participants26 Participants
Number of meetings (past 3 months)7.0 meetings
STANDARD_DEVIATION 14.3
8.5 meetings
STANDARD_DEVIATION 22.7
8.6 meetings
STANDARD_DEVIATION 15.8
Race/Ethnicity, Customized
Other
36 Participants73 Participants37 Participants
Race/Ethnicity, Customized
White
112 Participants225 Participants113 Participants
Self-efficacy, Confidence62.1 units on a scale
STANDARD_DEVIATION 29
60.2 units on a scale
STANDARD_DEVIATION 27.9
58.4 units on a scale
STANDARD_DEVIATION 26.7
Serious ideas suicide (past 30 days)47 Participants96 Participants49 Participants
Sex: Female, Male
Female
7 Participants15 Participants8 Participants
Sex: Female, Male
Male
141 Participants283 Participants142 Participants
Treatment, 30 days16 Participants30 Participants14 Participants
Treatment, lifetime91 Participants179 Participants88 Participants
Years education13.0 years
STANDARD_DEVIATION 1.8
13.1 years
STANDARD_DEVIATION 1.8
13.3 years
STANDARD_DEVIATION 1.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 1483 / 150
other
Total, other adverse events
0 / 1480 / 150
serious
Total, serious adverse events
0 / 1481 / 150

Outcome results

Primary

Percent of Participants Who Had an Additional Inpatient Detoxification

Percent that had (yes) an additional inpatient detoxification 6 months following baseline assessment- additional inpatient detoxification was dichotomous, yes or no.

Time frame: 6-month follow-up

Population: Of 298 baseline participants, 266 participated in follow-up at 6 months.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Enhanced Telephone MonitoringPercent of Participants Who Had an Additional Inpatient Detoxification33 Participants
Usual CarePercent of Participants Who Had an Additional Inpatient Detoxification47 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026