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Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes

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ClinicalTrials.gov Identifier: NCT01135420
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : December 29, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diagnosis, Dual (Psychiatry) Behavioral: Telephone Monitoring (TM) with Motivational Interviewing Other: Usual care Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes
Study Start Date : April 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dual Diagnosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Usual Care
Psychiatry inpatient usual care
 Other: 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).
Experimental: Telephone Monitoring
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, and encourage 12-step self-help group participation.
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Readiness to Attend Substance Use Disorder Continuing Care [ Time Frame: 3 months post-intervention ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135420


Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Christine Timko, PhD VA Palo Alto Health Care System, Palo Alto, CA
More Information
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Publications of Results:
Timko C, Bonn-Miller MO, McKellar JD, Ilgen MA. Detoxification history and two-year outcomes of substance use disorder treatment and mutual-help group participation. Journal of drug issues. 2014 Jan 1; 44(1):4-21.
Woodhead E, Cowden Hindash A, Timko C. Dual Diagnosis, Mutual-Help Use, and Outcomes: A Naturalistic Follow-Up. Journal of Dual Diagnosis. 2013 May 3; 9(2):158-164.

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01135420    
Other Study ID Numbers: IAC 09-055
First Posted: June 2, 2010    Key Record Dates
Results First Posted: December 29, 2016
Last Update Posted: December 29, 2016
Last Verified: November 2016