Trial Outcomes & Findings for TOP Implementation Project (NCT NCT02737098)
NCT ID: NCT02737098
Last Updated: 2026-05-01
Results Overview
The reach implementation outcome measure will be specified as the proportion of sampled patients who received the core element of the TOP intervention (documentation in the electronic health record of a care manager encounter).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
544 participants
Primary outcome timeframe
31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)
Results posted on
2026-05-01
Participant Flow
Patients were recruited from 6 VA Medical Centers. We attempted to recruit 100 patients from each site in the two months prior to that VA Medical Center's implementation start date. This cohort of 100 patients completed a baseline survey and three follow-up surveys (at the end of Steps 1, 2, and 3 respectively).
After Steps 1 and 2, there was a 2 month gap during which implementation success was assessed.
Unit of analysis: VA Medical Center
Participant milestones
| Measure |
Step 1 Standard Implementation
In Step 1, all VA Medical Centers start out in Standard Implementation. Standard VA implementation strategies will include disseminating a clinical intervention manual, a local champion guide, care manager training materials, PTSD case-finder tool, and technical support from the facility level telehealth technician. Internal facilitation will be conducted by the designated local champion. In addition, each VAMC will receive funds to hire a full time telephone care manager.
|
Step 2 Randomized Enhanced Implementation Strategy
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to Enhanced Implementation.
|
Step 2 Randomized Standard Implementation
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to continued Standard Implementation.
|
Step 2 Non-Randomized Standard Implementation
In Step 2, VA Medical Centers achieving performance metrics continue to receive Standard Implementation.
|
Step 3 - Randomized Enhanced Implementation
In Step 3, all VA Medical Centers not achieving performance metrics receive Enhanced Implementation.
|
Step 3 Non-Randomized Standard Implementation
In Step 3, VA Medical Centers achieving performance metrics in Step 1 receive continued Standard Implementation.
|
|---|---|---|---|---|---|---|
|
Step 1 (Months 1-9)
STARTED
|
544 6
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 1 (Months 1-9)
COMPLETED
|
447 5
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 1 (Months 1-9)
NOT COMPLETED
|
97 1
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Step 2 (Months 12-20)
STARTED
|
0 0
|
169 2
|
189 2
|
89 1
|
0 0
|
0 0
|
|
Step 2 (Months 12-20)
COMPLETED
|
0 0
|
135 2
|
139 2
|
64 1
|
0 0
|
0 0
|
|
Step 2 (Months 12-20)
NOT COMPLETED
|
0 0
|
34 0
|
50 0
|
25 0
|
0 0
|
0 0
|
|
Step 3 (Months 23-31)
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
358 4
|
89 1
|
|
Step 3 (Months 23-31)
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
237 4
|
55 1
|
|
Step 3 (Months 23-31)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
121 0
|
34 0
|
Reasons for withdrawal
| Measure |
Step 1 Standard Implementation
In Step 1, all VA Medical Centers start out in Standard Implementation. Standard VA implementation strategies will include disseminating a clinical intervention manual, a local champion guide, care manager training materials, PTSD case-finder tool, and technical support from the facility level telehealth technician. Internal facilitation will be conducted by the designated local champion. In addition, each VAMC will receive funds to hire a full time telephone care manager.
|
Step 2 Randomized Enhanced Implementation Strategy
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to Enhanced Implementation.
|
Step 2 Randomized Standard Implementation
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to continued Standard Implementation.
|
Step 2 Non-Randomized Standard Implementation
In Step 2, VA Medical Centers achieving performance metrics continue to receive Standard Implementation.
|
Step 3 - Randomized Enhanced Implementation
In Step 3, all VA Medical Centers not achieving performance metrics receive Enhanced Implementation.
|
Step 3 Non-Randomized Standard Implementation
In Step 3, VA Medical Centers achieving performance metrics in Step 1 receive continued Standard Implementation.
|
|---|---|---|---|---|---|---|
|
Step 1 (Months 1-9)
VA did not implement TOP
|
97
|
0
|
0
|
0
|
0
|
0
|
|
Step 2 (Months 12-20)
Lost to Follow-up
|
0
|
34
|
50
|
25
|
0
|
0
|
|
Step 3 (Months 23-31)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
121
|
34
|
Baseline Characteristics
TOP Implementation Project
Baseline characteristics by cohort
| Measure |
Standard Implementation
n=544 Participants
Standard VA implementation strategies will include disseminating a clinical intervention manual, a local champion guide, care manager training materials, PTSD case-finder tool, and technical support from the facility level telehealth technician. Internal facilitation will be conducted by the designated local champion. In addition, each VAMC will receive funds to hire a full time telephone care manager.
|
Enhanced Implementation Strategy
The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs using System Redesign methods. The external facilitation team will then generate a clinical workflow chart that describes the current process of care. With advice from the external facilitation team, the local champion will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart, making changes to the TOP intervention and/or current clinical workflow as needed. The local champion will also meet monthly with external facilitators to troubleshoot and make refinements.
|
Total
n=544 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 Years
STANDARD_DEVIATION 15.0 • n=14 Participants
|
—
|
51.8 Years
STANDARD_DEVIATION 15.0 • n=69 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
53 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
491 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
491 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, non-Hispanic
|
336 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
336 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, Hispanic
|
75 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
75 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
80 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
80 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
31 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
31 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown
|
22 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
22 Participants
n=69 Participants
|
|
PCL-5
|
45 units on a scale
STANDARD_DEVIATION 10 • n=14 Participants
|
—
|
45 units on a scale
STANDARD_DEVIATION 10 • n=69 Participants
|
PRIMARY outcome
Timeframe: 31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)The reach implementation outcome measure will be specified as the proportion of sampled patients who received the core element of the TOP intervention (documentation in the electronic health record of a care manager encounter).
Outcome measures
| Measure |
Step 3 Non-Randomized Standard Implementation
n=89 Participants
In Step 3, VA Medical Centers achieving performance metrics in Step 1 receive continued Standard Implementation.
|
Step 1 Standard Implementation
n=447 Participants
In Step 1, all VA Medical Centers start out in Standard Implementation.
|
Step 2 Randomized Enhanced Implementation Strategy
n=169 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to Enhanced Implementation.
|
Step 2 Randomized Standard Implementation
n=189 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to continued Standard Implementation.
|
Step 2 Non-Randomized Standard Implementation
n=89 Participants
In Step 2, VA Medical Centers achieving performance metrics continue to receive Standard Implementation.
|
Step 3 Enhanced Implementation
n=358 Participants
In Step 3, all VA Medical Centers not achieving performance metrics receive Enhanced Implementation.
|
|---|---|---|---|---|---|---|
|
Reach: the Proportion of Sampled Patients Who Received the Core Element of the TOP Intervention
|
0 Participants
|
172 Participants
|
43 Participants
|
41 Participants
|
13 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)PTSD symptom severity will be measured using the PTSD Check List (version 5). The outcome will be the average change score on this scale (from baseline to follow-up). Minimum=0; Maximum=80; higher scores indicate worse outcomes.
Outcome measures
| Measure |
Step 3 Non-Randomized Standard Implementation
n=89 Participants
In Step 3, VA Medical Centers achieving performance metrics in Step 1 receive continued Standard Implementation.
|
Step 1 Standard Implementation
n=447 Participants
In Step 1, all VA Medical Centers start out in Standard Implementation.
|
Step 2 Randomized Enhanced Implementation Strategy
n=169 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to Enhanced Implementation.
|
Step 2 Randomized Standard Implementation
n=189 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to continued Standard Implementation.
|
Step 2 Non-Randomized Standard Implementation
n=89 Participants
In Step 2, VA Medical Centers achieving performance metrics continue to receive Standard Implementation.
|
Step 3 Enhanced Implementation
n=358 Participants
In Step 3, all VA Medical Centers not achieving performance metrics receive Enhanced Implementation.
|
|---|---|---|---|---|---|---|
|
PTSD Symptom Severity
|
-5.0 units on a scale
Standard Deviation 11.0
|
-2.0 units on a scale
Standard Deviation 11.8
|
-2.6 units on a scale
Standard Deviation 11.6
|
-2.0 units on a scale
Standard Deviation 11.8
|
-5.5 units on a scale
Standard Deviation 10.9
|
-4.2 units on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)How much does having to travel to VA appointments interfere with getting the PTSD services you want? Would you say it? Completely interferes, Interferes a great deal, Interferes somewhat, Interferes a little bit, Does not interfere at all. The outcome will be the proportion responding that it completely interferes or interferes a great deal.
Outcome measures
| Measure |
Step 3 Non-Randomized Standard Implementation
n=55 Participants
In Step 3, VA Medical Centers achieving performance metrics in Step 1 receive continued Standard Implementation.
|
Step 1 Standard Implementation
n=354 Participants
In Step 1, all VA Medical Centers start out in Standard Implementation.
|
Step 2 Randomized Enhanced Implementation Strategy
n=135 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to Enhanced Implementation.
|
Step 2 Randomized Standard Implementation
n=139 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to continued Standard Implementation.
|
Step 2 Non-Randomized Standard Implementation
n=64 Participants
In Step 2, VA Medical Centers achieving performance metrics continue to receive Standard Implementation.
|
Step 3 Enhanced Implementation
n=237 Participants
In Step 3, all VA Medical Centers not achieving performance metrics receive Enhanced Implementation.
|
|---|---|---|---|---|---|---|
|
Perceived Travel Burden: Degree to Which Sampled Patients Report That Traveling Interferes With Getting Services.
|
16 Participants
|
185 Participants
|
68 Participants
|
76 Participants
|
24 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: 31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)How much does having to wait for VA appointments interfere with getting the PTSD services you want? Would you say it? Completely interferes, Interferes a great deal, Interferes somewhat, Interferes a little bit, Does not interfere at all. The outcome will be the proportion responding that it completely interferes or interferes a great deal.
Outcome measures
| Measure |
Step 3 Non-Randomized Standard Implementation
n=55 Participants
In Step 3, VA Medical Centers achieving performance metrics in Step 1 receive continued Standard Implementation.
|
Step 1 Standard Implementation
n=354 Participants
In Step 1, all VA Medical Centers start out in Standard Implementation.
|
Step 2 Randomized Enhanced Implementation Strategy
n=135 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to Enhanced Implementation.
|
Step 2 Randomized Standard Implementation
n=139 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to continued Standard Implementation.
|
Step 2 Non-Randomized Standard Implementation
n=64 Participants
In Step 2, VA Medical Centers achieving performance metrics continue to receive Standard Implementation.
|
Step 3 Enhanced Implementation
n=237 Participants
In Step 3, all VA Medical Centers not achieving performance metrics receive Enhanced Implementation.
|
|---|---|---|---|---|---|---|
|
Perceived Wait Time: Degree to Which Sampled Patients Report That Appointment Wait Time Interferes With Getting Services.
|
26 Participants
|
209 Participants
|
80 Participants
|
78 Participants
|
32 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: 31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)How much does lack of trust in VA providers interfere with getting the PTSD services you want? Would you say it? Completely interferes, Interferes a great deal, Interferes somewhat, Interferes a little bit, Does not interfere at all. The outcome will be the proportion responding that it completely interferes or interferes a great deal.
Outcome measures
| Measure |
Step 3 Non-Randomized Standard Implementation
n=55 Participants
In Step 3, VA Medical Centers achieving performance metrics in Step 1 receive continued Standard Implementation.
|
Step 1 Standard Implementation
n=354 Participants
In Step 1, all VA Medical Centers start out in Standard Implementation.
|
Step 2 Randomized Enhanced Implementation Strategy
n=135 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to Enhanced Implementation.
|
Step 2 Randomized Standard Implementation
n=139 Participants
In Step 2, half of VA Medical Centers not achieving performance metrics are randomized to continued Standard Implementation.
|
Step 2 Non-Randomized Standard Implementation
n=64 Participants
In Step 2, VA Medical Centers achieving performance metrics continue to receive Standard Implementation.
|
Step 3 Enhanced Implementation
n=237 Participants
In Step 3, all VA Medical Centers not achieving performance metrics receive Enhanced Implementation.
|
|---|---|---|---|---|---|---|
|
Perceived Trust: Degree to Which Sampled Patients Report That Lack of Trust in Providers Interferes With Getting Services.
|
28 Participants
|
201 Participants
|
80 Participants
|
73 Participants
|
33 Participants
|
119 Participants
|
Adverse Events
Standard Implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Implementation Strategy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place