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Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes

Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01135420
Enrollment
406
Registered
2010-06-02
Start date
2011-04-30
Completion date
2015-06-30
Last updated
2016-12-29

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

Conditions

Diagnosis, Dual (Psychiatry)

Brief summary

This research program will improve the care and treatment outcomes of dually diagnosed veterans who receive inpatient psychiatry care, and decrease their use of VA inpatient mental health services. It will increase the use of substance abuse outpatient care and 12-step groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.

Detailed description

Background: Substance use disorders (SUDs) are highly prevalent among veteran psychiatry inpatients. Dual substance use and psychiatric disorders are related to poor outcomes and rehospitalizations, which are quite costly. However, relatively little is known about how to effectively help dually diagnosed psychiatry inpatients. Telephone Monitoring (TM) is effective among SUD patients at increasing SUD continuing care and self-help utilization and improving SUD outcomes. This study will build on these findings and contribute important new clinical knowledge by determining whether TM is similarly effective when adapted for dually diagnosed veteran psychiatry inpatients. It will evaluate the effectiveness of a manual-guided TM intervention. Objectives: Primary hypotheses are that patients in the TM condition, compared to patients in usual care (UC), will attend more SUD continuing care sessions and 12-step group meetings, and have better SUD and psychiatric outcomes. Secondary hypotheses are that TM patients will have fewer and delayed rehospitalizations, and their better outcomes will be mediated by SUD outpatient treatment and 12-step group participation. Methods: This study will take place at two VAs: Palo Alto (VISN 21) and Ann Arbor (VISN 11). Dually diagnosed patients in psychiatry inpatient treatment will be randomly assigned to UC or TM. Patients in the TM condition will receive an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment if a relapse occurs, and encourage 12-step self-help group participation. Patients will be assessed at baseline, end-of-intervention, and six months and one-year post-intervention for primary and secondary 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 TM groups on course of primary and secondary outcomes over time; Cox regression models will compare groups on time to rehospitalization; and sequential regression analyses will examine whether outcomes associated with TM are mediated by more SUD continuing care and 12-step group participation. Status: As of this time, this project is in the follow-up data collection phase.

Interventions

BEHAVIORALTelephone Monitoring (TM) with Motivational Interviewing

Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety.

OTHERUsual care

All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

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

Inclusion criteria

* Dually diagnosed veteran in VA inpatient psychiatry treatment

Exclusion criteria

* Current diagnosis of schizophrenia or schizoaffective disorder * too psychiatrically unstable or cognitively impaired to understand informed consent and other study procedures * does not have ongoing telephone access

Design outcomes

Primary

MeasureTime frameDescription
Readiness to Attend Substance Use Disorder Continuing Care3 months post-interventionReadiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.

Countries

United States

Participant flow

Recruitment details

Patients were recruited from inpatient psychiatry settings.

Participants by arm

ArmCount
Usual Care
Psychiatry inpatient usual care Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).
199
Telephone Monitoring
Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation. Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety
207
Total406

Baseline characteristics

CharacteristicUsual CareTelephone MonitoringTotal
Age, Continuous45 Years
STANDARD_DEVIATION 13
45 Years
STANDARD_DEVIATION 13
45 Years
STANDARD_DEVIATION 13
Gender
Female
16 Participants18 Participants34 Participants
Gender
Male
183 Participants189 Participants372 Participants
Region of Enrollment
United States
199 participants207 participants406 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 1994 / 207
serious
Total, serious adverse events
3 / 1994 / 207

Outcome results

Primary

Readiness to Attend Substance Use Disorder Continuing Care

Readiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.

Time frame: 3 months post-intervention

ArmMeasureValue (MEAN)Dispersion
Usual CareReadiness to Attend Substance Use Disorder Continuing Care1.8 units on a scaleStandard Deviation 1.1
Telephone MonitoringReadiness to Attend Substance Use Disorder Continuing Care2.2 units on a scaleStandard Deviation 1.3
p-value: <0.05ANCOVA

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