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Homecoming Line: Telephone Support for Veterans (HCL)

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone Case Monitoring
Treatment as Usual
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress Disorders, Post-Traumatic focused on measuring Stress Disorders, Post-Traumatic, Ambulatory Care, Telemedicine, Remote Consultation, Health Services Accessibility

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System (Meno Park Division)
  • Durham VA Medical Center
  • VA Puget Sound Health Care System (American Lake)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telephone Case Monitoring

Treatment as Usual

Arm Description

Telephone care management augmenting treatment as usual

Case management, psychotherapy, and pharmacotherapy as usual

Outcomes

Primary Outcome Measures

PTSD Checklist (PCL) Slope
Slope of improvement on the PTSD Checklist, a self-report measure of PTSD symptoms.

Secondary Outcome Measures

PTSD psychotherapy visits - intervention period
Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the 3 month intervention period.
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.
Depression slope
Slope of improvement on the Center for Epidemiological Studies Scale, a self-report measure of depression symptoms.
Alcohol problems slope
Slope of improvement on the Addiction Severity Index Alcohol Composite, a self-report measure of alcohol-related problems.
Drug problems slope
Slope of improvement on the Addiction Severity Index Drug Composite, a self-report measure of drug-related problems.
Aggression slope
Slope of improvement on a six-item self-report measure of aggressive behaviors, adapted from the Conflict Tactics Scale.
Quality of Life slope
Slope of improvement on a self-report quality measure used in the Veterans Affairs Military Stress Treatment Assessment study.
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).
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).
Selective serotonin reuptake inhibitor refills (medication possession ratio)
Number of days' supply of selective serotonin reuptake inhibitors (SSRIs) obtained divided by 365 days.
Prazosin refills (medication possession ratio)
Number of days' supply of Prazosin obtained divided by 365 days.

Full Information

First Posted
January 12, 2016
Last Updated
January 12, 2016
Sponsor
VA Palo Alto Health Care System
Collaborators
Durham VA Medical Center, VA Puget Sound Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT02655991
Brief Title
Homecoming Line: Telephone Support for Veterans
Acronym
HCL
Official Title
Homecoming Line: Telephone Support for Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
Durham VA Medical Center, VA Puget Sound Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
Stress Disorders, Post-Traumatic, Ambulatory Care, Telemedicine, Remote Consultation, Health Services Accessibility

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone Case Monitoring
Arm Type
Experimental
Arm Description
Telephone care management augmenting treatment as usual
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Case management, psychotherapy, and pharmacotherapy as usual
Intervention Type
Behavioral
Intervention Name(s)
Telephone Case Monitoring
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).
Primary Outcome Measure Information:
Title
PTSD Checklist (PCL) Slope
Description
Slope of improvement on the PTSD Checklist, a self-report measure of PTSD symptoms.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PTSD psychotherapy visits - intervention period
Description
Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the 3 month intervention period.
Time Frame
3 months
Title
Other mental health visits - intervention period
Description
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.
Time Frame
3 months
Title
Depression slope
Description
Slope of improvement on the Center for Epidemiological Studies Scale, a self-report measure of depression symptoms.
Time Frame
12 months
Title
Alcohol problems slope
Description
Slope of improvement on the Addiction Severity Index Alcohol Composite, a self-report measure of alcohol-related problems.
Time Frame
12 months
Title
Drug problems slope
Description
Slope of improvement on the Addiction Severity Index Drug Composite, a self-report measure of drug-related problems.
Time Frame
12 months
Title
Aggression slope
Description
Slope of improvement on a six-item self-report measure of aggressive behaviors, adapted from the Conflict Tactics Scale.
Time Frame
12 months
Title
Quality of Life slope
Description
Slope of improvement on a self-report quality measure used in the Veterans Affairs Military Stress Treatment Assessment study.
Time Frame
12 months
Title
PTSD psychotherapy visits -- follow-up period
Description
Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the post-intervention period (months 4-12).
Time Frame
months 4-12
Title
Other mental health visits -- follow-up period
Description
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).
Time Frame
months 4-12
Title
Selective serotonin reuptake inhibitor refills (medication possession ratio)
Description
Number of days' supply of selective serotonin reuptake inhibitors (SSRIs) obtained divided by 365 days.
Time Frame
12 months
Title
Prazosin refills (medication possession ratio)
Description
Number of days' supply of Prazosin obtained divided by 365 days.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig S. Rosen, Ph.D.
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System (Meno Park Division)
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
VA Puget Sound Health Care System (American Lake)
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98493
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27745535
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.
Results Reference
derived

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