TCM-PTSD: Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Telephone Monitoring Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual. |
Behavioral: Telephone monitoring
Three months of biweekly telephone monitoring and support
Other: Treatment-As-Usual
Outpatient mental health Treatment As Usual (psychotherapy and/or medications)
|
| Active Comparator: Treatment-As-Usual Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy. |
Other: Treatment-As-Usual
Outpatient mental health Treatment As Usual (psychotherapy and/or medications)
|
Outcome Measures
Primary Outcome Measures
- Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms [12 months post-discharge (8 months post intervention)]
Higher scores are worse outcomes on all four measures: Aggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85)
- Rehospitalization [12 months post discharge]
Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program
Secondary Outcome Measures
- Depressive Symptoms, Subjective Quality of Life [12 months post-discharge (8 months post intervention)]
Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life)
Eligibility Criteria
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:
-
Patients discharging from residential treatment within four days of admission(insufficient time to consent and assess them);
-
Active Duty military personnel;
-
Patients transferred from residential care to an inpatient medical unit due to emergent medical problems;
-
Patients with traumatic brain injury or other organic impairment that compromises capacity to consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | No. Little Rock | Arkansas | United States | 72114-1706 |
| 2 | VA Medical Center, Battle Creek | Battle Creek | Michigan | United States | 49015 |
| 3 | VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | United States | 14215 |
| 4 | VA Medical Center, Coatesville | Coatesville | Pennsylvania | United States | 19320 |
| 5 | VA Puget Sound Health Care System, Tacoma | Tacoma | Washington | United States | 98493 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Craig S. Rosen, PhD, VA Palo Alto Health Care System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TEL 03-135
Study Results
Participant Flow
| Recruitment Details | Veterans entering treatment in five 30-to-90 day residential treatment programs for posttraumatic stress disorder |
|---|---|
| Pre-assignment Detail | 926 patients were initially consented into the study. 6 withdrew prior to randomization, and 83 met exclusion criteria after being consent (usually because they were discharged to another inpatient program, not to outpatient care). This left 837 subjects to be randomized. |
| Arm/Group Title | Telephone Monitoring | Treatment-As-Usual |
|---|---|---|
| Arm/Group Description | Telephone monitoring as augmentation to treatment as usual Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications) | Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications) |
| Period Title: Overall Study | ||
| STARTED | 412 | 425 |
| Completed Intake Survey | 408 | 417 |
| Completed 4 Month fu Survey | 275 | 299 |
| Completed 12 Month fu Survey | 257 | 281 |
| COMPLETED | 310 | 328 |
| NOT COMPLETED | 102 | 97 |
Baseline Characteristics
| Arm/Group Title | Telephone Monitoring | Treatment-As-Usual | Total |
|---|---|---|---|
| Arm/Group Description | Telephone monitoring as augmentation to treatment as usual Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications) | Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications) | Total of all reporting groups |
| Overall Participants | 412 | 425 | 837 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
50.2
(0.62)
|
49.9
(0.86)
|
50.0
(0.74)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
55
13.3%
|
57
13.4%
|
112
13.4%
|
| Male |
357
86.7%
|
368
86.6%
|
725
86.6%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Caucasian |
263
63.8%
|
256
60.2%
|
519
62%
|
| African American |
87
21.1%
|
93
21.9%
|
180
21.5%
|
| Asian American |
2
0.5%
|
0
0%
|
2
0.2%
|
| Native American |
11
2.7%
|
8
1.9%
|
19
2.3%
|
| Pacific Islander |
2
0.5%
|
2
0.5%
|
4
0.5%
|
| Latino |
19
4.6%
|
26
6.1%
|
45
5.4%
|
| Other |
22
5.3%
|
28
6.6%
|
50
6%
|
| Race/ethnicity missing |
6
1.5%
|
12
2.8%
|
18
2.2%
|
| Iraq or Afghanistan veteran (participants) [Number] | |||
| Iraq/Afghanistan veteran |
114
27.7%
|
114
26.8%
|
228
27.2%
|
| Served prior to current Iraq/Afghanistan conflicts |
298
72.3%
|
311
73.2%
|
609
72.8%
|
Outcome Measures
| Title | Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms |
|---|---|
| Description | Higher scores are worse outcomes on all four measures: Aggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85) |
| Time Frame | 12 months post-discharge (8 months post intervention) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telephone Monitoring | Treatment as Usual |
|---|---|---|
| Arm/Group Description | Telephone monitoring as augmentation to treatment as usual Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications) | Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications) |
| Measure Participants | 412 | 425 |
| PTSD Symptoms (PTSD Checklist) |
63.9
(13.0)
|
63.4
(12.5)
|
| Aggressive Behavior |
3.0
(2.2)
|
3.1
(2.2)
|
| Alcohol Problems (ASI) |
0.15
(0.19)
|
0.17
(0.19)
|
| Drug Problems (ASI) |
0.05
(0.09)
|
0.05
(0.08)
|
| Title | Depressive Symptoms, Subjective Quality of Life |
|---|---|
| Description | Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life) |
| Time Frame | 12 months post-discharge (8 months post intervention) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telephone Monitoring | Treatment-As-Usual |
|---|---|---|
| Arm/Group Description | Telephone monitoring as augmentation to treatment as usual Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications) | Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications) |
| Measure Participants | 408 | 417 |
| Depression (CES-D) |
38.0
(10.1)
|
38.4
(10.4)
|
| Quality of Life |
3.3
(1.1)
|
3.3
(1.1)
|
| Title | Rehospitalization |
|---|---|
| Description | Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program |
| Time Frame | 12 months post discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Telephone Monitoring | Treatment-As-Usual |
|---|---|---|
| Arm/Group Description | Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual. Telephone monitoring: Three months of biweekly telephone monitoring and support TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications) | Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy. TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications) |
| Measure Participants | 412 | 425 |
| Number [participants] |
45
10.9%
|
55
12.9%
|
Adverse Events
| Time Frame | 12 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study. | |||
| Arm/Group Title | Telephone Monitoring | Treatment-As-Usual | ||
| Arm/Group Description | Telephone monitoring as augmentation to treatment as usual Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications) | Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications) | ||
All Cause Mortality |
||||
| Telephone Monitoring | Treatment-As-Usual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Telephone Monitoring | Treatment-As-Usual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/412 (3.9%) | 12/425 (2.8%) | ||
| Cardiac disorders | ||||
| Hospitalization for cardiology or chest pain | 2/412 (0.5%) | 2 | 1/425 (0.2%) | 1 |
| Gastrointestinal disorders | ||||
| Gastroenteritis | 0/412 (0%) | 0 | 1/425 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Hospitalization for overdose | 2/412 (0.5%) | 2 | 1/425 (0.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Scheduled laminotomy | 1/412 (0.2%) | 1 | 0/425 (0%) | 0 |
| Psychiatric disorders | ||||
| Psychiatric Hospitalization | 10/412 (2.4%) | 10 | 7/425 (1.6%) | 7 |
| Renal and urinary disorders | ||||
| kidney failure | 1/412 (0.2%) | 1 | 0/425 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| hospitalized for cellulitis | 0/412 (0%) | 0 | 1/425 (0.2%) | 1 |
| Social circumstances | ||||
| Death doe to causes not known | 4/412 (1%) | 4 | 3/425 (0.7%) | 3 |
| Arrest or incarceration | 2/412 (0.5%) | 2 | 1/425 (0.2%) | 1 |
| Admitted to nursing home - reason not known | 1/412 (0.2%) | 1 | 0/425 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Telephone Monitoring | Treatment-As-Usual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/412 (0.2%) | 0/0 (NaN) | ||
| Psychiatric disorders | ||||
| Phone telephone care management upsetting | 1/412 (0.2%) | 1 | 0/0 (NaN) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Craig S. Rosen |
|---|---|
| Organization | Nationa Center for PTSD Dissemination & Training Division |
| Phone | 650-493-5000 ext 22812 |
| craig.rosen@va.gov |
- TEL 03-135