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Telemedicine Outreach for Post Traumatic Stress in CBOCs (TOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821678
Recruitment Status : Completed
First Posted : January 13, 2009
Results First Posted : April 23, 2015
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorder
Intervention Other: Telemedicine Outreach for PTSD
Enrollment 265
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual
Period Title: Overall Study
Started 133 132
Completed 112 118
Not Completed 21 14
Reason Not Completed
Withdrawal by Subject             8             0
Lost to Follow-up             13             12
Death             0             2
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual Total
Hide Arm/Group Description

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual Total of all reporting groups
Overall Number of Baseline Participants 133 132 265
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 132 participants 265 participants
51.9  (14.0) 52.5  (13.6) 52.2  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 132 participants 265 participants
Female
15
  11.3%
12
   9.1%
27
  10.2%
Male
118
  88.7%
120
  90.9%
238
  89.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 133 participants 132 participants 265 participants
Caucasian Non-Hispanic 77 92 169
Caucasian Hispanic 12 8 20
African American 31 21 52
Other Race/Ethnicity 13 11 24
1.Primary Outcome
Title Change in PTSD Symptom Severity (PDS)
Hide Description range - 0-51 (higher score represents greater severity)
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description:

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual
Overall Number of Participants Analyzed 112 118
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.31  (10.91) -1.07  (7.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 Telemedicine Outreach for PTSD, Arm 2 Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -3.81
Confidence Interval (2-Sided) 95%
-6.19 to -1.43
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Continuous Measure of Depression Symptom Severity (SCL-20)
Hide Description range - 0-4 (higher score represents greater severity
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description:

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual
Overall Number of Participants Analyzed 112 118
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.43  (0.62) -0.16  (0.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 Telemedicine Outreach for PTSD, Arm 2 Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.4 to -0.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Continuous Measure of Alcohol Use (Audit Score)
Hide Description range - 0-12 (higher score represents greater severity)
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description:

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual
Overall Number of Participants Analyzed 112 118
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.36  (2.19) -0.17  (1.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 Telemedicine Outreach for PTSD, Arm 2 Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.33 to 0.70
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Continuous Measure of Health Status (SF12V PCS)
Hide Description range - 0-100 (higher score represents greater physical health status)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description:

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual
Overall Number of Participants Analyzed 112 118
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.77  (7.50) -1.45  (9.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 Telemedicine Outreach for PTSD, Arm 2 Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 2.67
Confidence Interval (2-Sided) 95%
0.45 to 4.91
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Continuous Measure of Quality of Life (QWB)
Hide Description range - 0-1 (higher score represents greater wellbeing)
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full sample
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description:

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The intervention involves an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and uses telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager educates/activates patients, identifies preferences, overcomes treatment barriers, monitors symptoms, side-effects and adherence, identifies psychiatric comorbidities, and encourages patient self-management. Tele-pharmacists provide medication management by phone. Tele-psychologists provide Cognitive Processing Therapy via interactive video. Tele-psychiatrists supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Usual Care
Overall Number of Participants Analyzed 112 118
Mean (Standard Deviation)
Unit of Measure: Units on a Scale from 0-1
-0.00407  (0.1086) -0.00800  (0.1019)
6.Secondary Outcome
Title Satisfaction With Care (ECHO)
Hide Description Using any number from 0 to 10, where 0 is the worst care possible and 10 is the best care possible, what number would you use to rate all the care you received for personal or emotional problems in the last 6 months?
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full sample. Data missing for 1 Arm 1 subject and 3 Arm 2 subjects
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description:

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual
Overall Number of Participants Analyzed 111 115
Mean (Standard Deviation)
Unit of Measure: 0-10 self reported rating
8.83423  (1.17964) 7.7043  (2.2671)
7.Secondary Outcome
Title Medication Adherence, Defined as Taking Medication <80% of Days
Hide Description 0 - taking medication <80% of days; 1 - taking medications >=80%
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Sample only for 205 patients prescribed medications.
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description:

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual
Overall Number of Participants Analyzed 104 101
Measure Type: Number
Unit of Measure: participants
62 68
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 Telemedicine Outreach for PTSD, Arm 2 Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.46 to 1.62
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Received at Least 8 Sessions of Exposure Based Therapy
Hide Description 0 - received <8 sessions of exposure based therapy; 1 - received >=8 sessions of exposure based therapy
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Baseline Sample
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description:

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual
Overall Number of Participants Analyzed 133 132
Measure Type: Number
Unit of Measure: participants
36 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 Telemedicine Outreach for PTSD, Arm 2 Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
3.2 to 19.6
Estimation Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description Death (Not Study Related). Death was the only adverse event monitored.
 
Arm/Group Title Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Hide Arm/Group Description

Telemedicine-Based Collaborative Care

Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video.

Treatment as usual
All-Cause Mortality
Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/133 (0.00%)      5/132 (3.79%)    
General disorders     
Death (Not Study Related)  1  0/133 (0.00%)  0 5/132 (3.79%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, Chart Review
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Telemedicine Outreach for PTSD Arm 2 Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/133 (0.00%)      0/132 (0.00%)    
High enrollment refusal rates may limit external validity.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Fortney
Organization: VA HSR&D
Phone: 206.764.2821
EMail: john.fortney@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00821678    
Other Study ID Numbers: MHI 08-098
First Submitted: January 9, 2009
First Posted: January 13, 2009
Results First Submitted: February 19, 2015
Results First Posted: April 23, 2015
Last Update Posted: January 8, 2019