Homecoming Line: Telephone Support for Veterans (HCL)

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: Telephone Case Monitoring; Behavioral: Treatment as Usual

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.

• Study Type: Interventional
• Enrollment (Actual): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Menlo Park, California, United States, 94025
      • VA Palo Alto Health Care System (Meno Park Division)
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center
  • Washington
    • Lakewood, Washington, United States, 98493
      • VA Puget Sound Health Care System (American Lake)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telephone Case Monitoring; Telephone care management augmenting treatment as usual	Behavioral: Telephone Case Monitoring; Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy) augmented by up to six fortnightly telephone monitoring and support calls from a case manager during the first three months of treatment.; Behavioral: Treatment as Usual; Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).
Active Comparator: Treatment as Usual; Case management, psychotherapy, and pharmacotherapy as usual	Behavioral: Treatment as Usual; Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist (PCL) Slope	Slope of improvement on the PTSD Checklist, a self-report measure of PTSD symptoms.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD psychotherapy visits - intervention period	Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the 3 month intervention period.	3 months
Other mental health visits - intervention period	Number of "other" mental health visits (mental health visits without psychotherapy procedure code and/or without a PTSD diagnosis code) completed during the 3 month intervention period.	3 months
Depression slope	Slope of improvement on the Center for Epidemiological Studies Scale, a self-report measure of depression symptoms.	12 months
Alcohol problems slope	Slope of improvement on the Addiction Severity Index Alcohol Composite, a self-report measure of alcohol-related problems.	12 months
Drug problems slope	Slope of improvement on the Addiction Severity Index Drug Composite, a self-report measure of drug-related problems.	12 months
Aggression slope	Slope of improvement on a six-item self-report measure of aggressive behaviors, adapted from the Conflict Tactics Scale.	12 months
Quality of Life slope	Slope of improvement on a self-report quality measure used in the Veterans Affairs Military Stress Treatment Assessment study.	12 months
PTSD psychotherapy visits -- follow-up period	Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the post-intervention period (months 4-12).	months 4-12
Other mental health visits -- follow-up period	Number of "other" mental health visits (mental health visits without psychotherapy procedure code and/or without a PTSD diagnosis code) completed during the post-intervention period (months 4-12).	months 4-12
Selective serotonin reuptake inhibitor refills (medication possession ratio)	Number of days' supply of selective serotonin reuptake inhibitors (SSRIs) obtained divided by 365 days.	12 months
Prazosin refills (medication possession ratio)	Number of days' supply of Prazosin obtained divided by 365 days.	12 months

Collaborators and Investigators

• Sponsor: VA Palo Alto Health Care System
• Collaborators: VA Puget Sound Health Care System; Durham VA Medical Center
• Investigators: Principal Investigator: Craig S. Rosen, Ph.D., VA Palo Alto Health Care System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Estimate): January 14, 2016
• Last Update Submitted That Met QC Criteria: January 12, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Telemedicine; Remote Consultation; Stress Disorders, Post-Traumatic; Ambulatory Care; Health Services Accessibility
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: W81XWH=08-2-0096

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No