Clinical trial NCT00288860: Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)
Official title: Telephone Case Monitoring for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: telemedicine
treatment compliance
mental health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-02-08
Enrollment: 837
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 the investigators' 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms
timeFrame: 12 months post-discharge (8 months post intervention)
measure: Rehospitalization
timeFrame: 12 months post discharge
Secondary outcomes:
measure: Depressive Symptoms, Subjective Quality of Life
timeFrame: 12 months post-discharge (8 months post intervention)
Other outcomes:
Locations:
city: No. Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
state: Arkansas
city: Battle Creek
country: United States
facility: VA Medical Center, Battle Creek
state: Michigan
city: Buffalo
country: United States
facility: VA Western New York Healthcare System, Buffalo, NY
state: New York
city: Coatesville
country: United States
facility: VA Medical Center, Coatesville
state: Pennsylvania
city: Tacoma
country: United States
facility: VA Puget Sound Health Care System, Tacoma
state: Washington
Study officials:
affiliation: VA Palo Alto Health Care System
name: Craig S. Rosen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 Jan;64(1):13-20. doi: 10.1176/appi.ps.201200142.
citation: 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.