Homecoming Line: Telephone Support for Veterans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Homecoming Line: Telephone Support for Veterans

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Telephone Case Monitoring
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone Case Monitoring<br>Telephone care management augmenting treatment as usual | Behavioral: Telephone Case Monitoring<br>* 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.<br>Behavioral: Treatment as Usual<br>* Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).<br>|
| Active Comparator: Treatment as Usual<br>Case management, psychotherapy, and pharmacotherapy as usual | Behavioral: Treatment as Usual<br>* Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Disorders, Post-Traumatic, Ambulatory Care, Telemedicine, Remote Consultation, Health Services Accessibility