Trial Outcomes & Findings for Telemedicine Outreach for Post Traumatic Stress in CBOCs (NCT NCT00821678)

NCT ID: NCT00821678

Last Updated: 2019-01-08

Results Overview

range - 0-51 (higher score represents greater severity)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 265 participants
• Primary outcome timeframe: Baseline, 6 months
• Results posted on: 2019-01-08

Participant Flow

Participant milestones

Measure	Arm 1 Telemedicine Outreach for PTSD 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.	Arm 2 Treatment as Usual Treatment as usual
Overall Study STARTED	133	132
Overall Study COMPLETED	112	118
Overall Study NOT COMPLETED	21	14

Reasons for withdrawal

Measure	Arm 1 Telemedicine Outreach for PTSD 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.	Arm 2 Treatment as Usual Treatment as usual
Overall Study Withdrawal by Subject	8	0
Overall Study Lost to Follow-up	13	12
Overall Study Death	0	2

Baseline Characteristics

Telemedicine Outreach for Post Traumatic Stress in CBOCs

Baseline characteristics by cohort

Measure	Arm 1 Telemedicine Outreach for PTSD n=133 Participants 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.	Arm 2 Treatment as Usual n=132 Participants Treatment as usual	Total n=265 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 14.0 • n=93 Participants	52.5 years STANDARD_DEVIATION 13.6 • n=4 Participants	52.2 years STANDARD_DEVIATION 13.8 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	12 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	118 Participants n=93 Participants	120 Participants n=4 Participants	238 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian Non-Hispanic	77 participants n=93 Participants	92 participants n=4 Participants	169 participants n=27 Participants
Race/Ethnicity, Customized Caucasian Hispanic	12 participants n=93 Participants	8 participants n=4 Participants	20 participants n=27 Participants
Race/Ethnicity, Customized African American	31 participants n=93 Participants	21 participants n=4 Participants	52 participants n=27 Participants
Race/Ethnicity, Customized Other Race/Ethnicity	13 participants n=93 Participants	11 participants n=4 Participants	24 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

range - 0-51 (higher score represents greater severity)

Outcome measures

Measure	Arm 1 Telemedicine Outreach for PTSD n=112 Participants 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.	Arm 2 Treatment as Usual n=118 Participants Treatment as usual
Change in PTSD Symptom Severity (PDS)	-5.31 units on a scale Standard Deviation 10.91	-1.07 units on a scale Standard Deviation 7.73

SECONDARY outcome

Timeframe: Baseline, 6 months

range - 0-4 (higher score represents greater severity

Outcome measures

Measure	Arm 1 Telemedicine Outreach for PTSD n=112 Participants 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.	Arm 2 Treatment as Usual n=118 Participants Treatment as usual
Change in Continuous Measure of Depression Symptom Severity (SCL-20)	-0.43 units on a scale Standard Deviation 0.62	-0.16 units on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: Baseline, 6 months

range - 0-12 (higher score represents greater severity)

Outcome measures

Measure	Arm 1 Telemedicine Outreach for PTSD n=112 Participants 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.	Arm 2 Treatment as Usual n=118 Participants Treatment as usual
Change in Continuous Measure of Alcohol Use (Audit Score)	-0.36 units on a scale Standard Deviation 2.19	-0.17 units on a scale Standard Deviation 1.73

SECONDARY outcome

Timeframe: 6 months

range - 0-100 (higher score represents greater physical health status)

Outcome measures

Measure	Arm 1 Telemedicine Outreach for PTSD n=112 Participants 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.	Arm 2 Treatment as Usual n=118 Participants Treatment as usual
Change in Continuous Measure of Health Status (SF12V PCS)	0.77 units on a scale Standard Deviation 7.50	-1.45 units on a scale Standard Deviation 9.47

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Full sample

range - 0-1 (higher score represents greater wellbeing)

Outcome measures

Measure	Arm 1 Telemedicine Outreach for PTSD n=112 Participants 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.	Arm 2 Treatment as Usual n=118 Participants Treatment as usual
Change in Continuous Measure of Quality of Life (QWB)	-0.00407 Units on a Scale from 0-1 Standard Deviation 0.1086	-0.00800 Units on a Scale from 0-1 Standard Deviation 0.1019

SECONDARY outcome

Timeframe: 6 months

Population: Full sample. Data missing for 1 Arm 1 subject and 3 Arm 2 subjects

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?

Outcome measures

Measure	Arm 1 Telemedicine Outreach for PTSD n=111 Participants 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.	Arm 2 Treatment as Usual n=115 Participants Treatment as usual
Satisfaction With Care (ECHO)	8.83423 0-10 self reported rating Standard Deviation 1.17964	7.7043 0-10 self reported rating Standard Deviation 2.2671

SECONDARY outcome

Timeframe: 6 months

Population: Sample only for 205 patients prescribed medications.

0 - taking medication <80% of days; 1 - taking medications >=80%

Outcome measures

Measure	Arm 1 Telemedicine Outreach for PTSD n=104 Participants 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.	Arm 2 Treatment as Usual n=101 Participants Treatment as usual
Medication Adherence, Defined as Taking Medication <80% of Days	62 participants	68 participants

SECONDARY outcome

Timeframe: 12 months

Population: Full Baseline Sample

0 - received <8 sessions of exposure based therapy; 1 - received >=8 sessions of exposure based therapy

Outcome measures

Measure	Arm 1 Telemedicine Outreach for PTSD n=133 Participants 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.	Arm 2 Treatment as Usual n=132 Participants Treatment as usual
Received at Least 8 Sessions of Exposure Based Therapy	36 participants	7 participants

Adverse Events

Arm 1 Telemedicine Outreach for PTSD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 Treatment as Usual

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1 Telemedicine Outreach for PTSD n=133 participants at risk 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.	Arm 2 Treatment as Usual n=132 participants at risk Treatment as usual
General disorders Death (Not Study Related)	0.00% 0/133 • 1 year Death (Not Study Related). Death was the only adverse event monitored.	3.8% 5/132 • Number of events 5 • 1 year Death (Not Study Related). Death was the only adverse event monitored.

Other adverse events

Adverse event data not reported

Additional Information

John Fortney

VA HSR&D

Phone: 206.764.2821

Email: john.fortney@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place