Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)

Stress Disorders, Post-Traumatic Clinical Trial

— TCM-PTSD  

Official title:

Telephone Case Monitoring for Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288860
• Other study ID #: TEL 03-135
• Status: Completed
• Phase: N/A
• First received: February 6, 2006
• Last updated: October 1, 2014
• Start date: October 2006
• Est. completion date: December 2011

Study information

• Verified date: September 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether providing PTSD patients additional support by telephone (in addition to usual outpatient care) after they discharge from residential treatment improves those patients' outcomes and keeps them out of the hospital longer.

Description:

Background: Poor compliance with aftercare may contribute to high rates of relapse and rehospitalization among veterans who received residential treatment for posttraumatic stress disorder (PTSD). Telephone case monitoring has been shown to improve treatment adherence and reduced relapse among patients with chronic medical and substance use disorders, but has not been tested in PTSD patients.

Objectives: This multisite randomized controlled trial tested whether augmenting usual aftercare with telephone monitoring improved resulted in 1) improved clinical outcomes (less violence, substance use, and PTSD symptoms; 2) longer time to rehospitalization; 3) better compliance with aftercare in the year after discharge from residential treatment for PTSD.

Methods: This trial recruited 837 subjects from 6 PTSD residential treatment programs at 5 VA medical centers, 94.7% of the 884 projected. Patients who completed at least 14 days of residential PTSD treatment and discharged to VA outpatient care were eligible to participate. Subjects were randomized to usual aftercare care (n = 425) or usual aftercare plus biweekly telephone case monitoring calls during the first three months after discharge (n = 412). Telephone case monitors assessed current problems, encouraged treatment adherence, provided problem-solving support, and alerted providers to emergent care needs. Patient self-report measures of psychiatric symptoms, substance use, and violence were obtained at intake to residential treatment and 4 months (69% completion rate) and 12 months (64% completion rate) after discharge. Retention was lower than our planned 70% to 75% rate due to difficulty locating some patients who moved (even their collateral informants did not know where they were) and 45 participants asking to discontinue due to lack of time (n = 10), general dissatisfaction with VA (n = 6), distress during phone calls (n = 5), dissatisfaction with compensation (n = 1), or no specified reason (n = 24). Treatment utilization data was obtained from the VA National Patient Care Database.

Intent-to-treat analyses used mixed modeling to compare clinical outcomes in the telephone monitoring and usual care groups and 4 and 12 months after discharge. Survival analysis was used to compare conditions on time to rehospitalization. Having a slightly smaller-than-intended sample size resulted in modest reductions in statistical power, e.g., power to detect the expected d = .25 effect on PTSD outcomes was reduced from about 90% to 82%, and power to detect the anticipated W = .105 difference in rehospitalization rates was reduced from 88% to 85%. Secondary analyses assessed whether differences in outcomes between the telephone case monitoring and usual care groups were mediated by attending more outpatient visits and completing more medication refills. Exploratory analyses examined whether the effect of telephone support on the clinical outcome measures, number of treatment visits, and medication refills was moderated by number of outpatient mental health visits in the prior year, distance from clinic, treatment expectancies, therapeutic alliance, or co-occurring substance use problems.

Results: Treatment utilization (mental health visits and medication refills) did not vary between treatment conditions. Clinical outcomes and time to rehospitalization did not differ between conditions. Contrary to our assumptions, patients in the usual care condition had high engagement in aftercare following discharge from residential treatment, completing an average of 36 outpatient mental health visits in 12 months. We speculate that telephone care coordination has little impact for patients who are already high utilizers of care.

Status: Enrollment, intervention, data collection, and primary analyses are completed. Primary results have been published in Psychiatric Services (Rosen, Tiet, Harris et al., 2013) and two secondary papers have been published in the Journal of Traumatic Stress (Belsher, Tiet, Garvert, & Rosen, 2012; Rosen, Adler, & Tiet, 2013).

A CDMRP-funded study extending this approach to PTSD outpatients at the Durham, Puget Sound and Palo Alto VA medical centers has recently been completed. Initial results of that second trial suggest that telephone care management improved treatment attendance but had weak effects on outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 926
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a PTSD diagnosis entering PTSD residential treatment with an intended length of stay of 15 days or longer (patients in brief evaluation or acute stabilization tracks will not be included, as their discharge plan may include readmission to residential treatment within a few months).

Exclusion Criteria:

1. Patients discharging from residential treatment within four days of admission(insufficient time to consent and assess them);

2. Active Duty military personnel;

3. Patients transferred from residential care to an inpatient medical unit due to emergent medical problems;

4. Patients with traumatic brain injury or other organic impairment that compromises capacity to consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Telephone case monitoring
Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)

Other:
• Treatment as Usual Control
Usual outpatient mental health care (psychotherapy and/or medications)

Locations

Country	Name	City	State
United States	VA Medical Center, Battle Creek	Battle Creek	Michigan
United States	VA Western New York Healthcare System, Buffalo, NY	Buffalo	New York
United States	VA Medical Center, Coatesville	Coatesville	Pennsylvania
United States	Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR	No. Little Rock	Arkansas
United States	VA Puget Sound Health Care System, Tacoma	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Belsher BE, Tiet QQ, Garvert DW, Rosen CS. Compensation and treatment: disability benefits and outcomes of U.S. veterans receiving residential PTSD treatment. J Trauma Stress. 2012 Oct;25(5):494-502. doi: 10.1002/jts.21747. Epub 2012 Oct 9. — View Citation

Rosen CS, Tiet QQ, Harris AH, Julian TF, McKay JR, Moore WM, Owen RR, Rogers S, Rosito O, Smith DE, Smith MW, Schnurr PP. Telephone monitoring and support after discharge from residential PTSD treatment: a randomized controlled trial. Psychiatr Serv. 2013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a) violence, substance use, PTSD symptoms; b) time to rehospitalization; c) costs		4 and 12 months post-discharge (1-8 months post intervention)	No
Secondary	d) depressive symptoms, subjective quality of life		4 and 12 months post-discharge (1-8 months post intervention)	No