Clinical trial NCT02655991: Homecoming Line: Telephone Support for Veterans
Official title: Homecoming Line: Telephone Support for Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Stress Disorders, Post-Traumatic
Ambulatory Care
Telemedicine
Remote Consultation
Health Services Accessibility
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: Durham VA Medical Center
name: VA Puget Sound Health Care System
First posted: 2016-01-14
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will determine whether telephone support improves clinical outcomes of veterans who begin outpatient treatment for posttraumatic stress disorder. Participants will be randomly assigned to receive either usual care or usual care supplemented by biweekly monitoring and support by telephone during the first 3 months of treatment. Patients in both conditions will be compared on PTSD symptoms, engagement in treatment, violence and drinking at 4 months and 12 months after entering treatment.

Detailed description: This multisite randomized controlled trial will test whether a 3-month period of providing telephone monitoring to PTSD patients as a supplement to usual specialty mental health care improves 12-month clinical outcomes (a reduction in PTSD symptoms, violence, and substance use). Secondarily, this study will determine whether telephone monitoring promotes better engagement in outpatient treatment (Number of mental health and psychotherapy visits during the 3-month intervention period).

Demand for VA PTSD treatment is increasing as troops return from combat deployments in Afghanistan and Iraq. Telemedicine is likely to be an important component in developing more effective and efficient models of PTSD care that improves patient functioning and treatment utilization. It is hoped that using telephone case monitoring as an inexpensive adjunct to standard care may improve clinical outcomes and reduce hospitalization among veterans with PTSD.

Eligibility criteria: Inclusion Criteria:

* VA patients newly entering outpatient treatment mental health treatment for PTSD starting a new phase of outpatient PTSD treatment (e.g., transitioning from a psycho-education group to active psychotherapy) at one of the study sites.

Exclusion Criteria:

* Active duty personnel
* Cognitive impairment which precludes giving informed consent
* Initiating residential or inpatient treatment rather than outpatient treatment

Primary outcomes:
measure: PTSD Checklist (PCL) Slope
timeFrame: 12 months
Secondary outcomes:
measure: PTSD psychotherapy visits - intervention period
timeFrame: 3 months
measure: Other mental health visits - intervention period
timeFrame: 3 months
measure: Depression slope
timeFrame: 12 months
measure: Alcohol problems slope
timeFrame: 12 months
measure: Drug problems slope
timeFrame: 12 months
measure: Aggression slope
timeFrame: 12 months
measure: Quality of Life slope
timeFrame: 12 months
measure: PTSD psychotherapy visits -- follow-up period
timeFrame: months 4-12
measure: Other mental health visits -- follow-up period
timeFrame: months 4-12
measure: Selective serotonin reuptake inhibitor refills (medication possession ratio)
timeFrame: 12 months
measure: Prazosin refills (medication possession ratio)
timeFrame: 12 months
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: VA Palo Alto Health Care System (Meno Park Division)
state: California
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Lakewood
country: United States
facility: VA Puget Sound Health Care System (American Lake)
state: Washington
Study officials:
affiliation: VA Palo Alto Health Care System
name: Craig S. Rosen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosen CS, Azevedo KJ, Tiet QQ, Greene CJ, Wood AE, Calhoun P, Bowe T, Capehart BP, Crawford EF, Greenbaum MA, Harris AH, Hertzberg M, Lindley SE, Smith BN, Schnurr PP. An RCT of Effects of Telephone Care Management on Treatment Adherence and Clinical Outcomes Among Veterans With PTSD. Psychiatr Serv. 2017 Feb 1;68(2):151-158. doi: 10.1176/appi.ps.201600069. Epub 2016 Oct 17.