Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01135420
First received: June 1, 2010
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Use of substance use disorder continuing care and 12-step mutual help groups [ Time Frame: One-year post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: April 2011
Estimated Study Completion Date: March 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
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: Arm 2
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.
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).

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:

Currently, this project is in the follow-up data collection phase.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135420

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1207
United States, Michigan
Ann Arbor VA Medical Center
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Christine Timko, PhD VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01135420     History of Changes
Other Study ID Numbers: IAC 09-055
Study First Received: June 1, 2010
Last Updated: July 11, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 24, 2014