Trial Outcomes & Findings for Enhancing Access to Insomnia (EASI) Care in VA PCMHI Clinics (NCT NCT04350866)
NCT ID: NCT04350866
Last Updated: 2026-01-12
Results Overview
The number of Veterans in PCMHI who engaged in BBTI as indicated in the medical records
Recruitment status
COMPLETED
Target enrollment
277920 participants
Primary outcome timeframe
54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)
Results posted on
2026-01-12
Participant Flow
Four (4) VA Medical Centers (VAMC) were enrolled in this project. Within each VAMC, we identified Veterans (Participants) who engaged in care within PCMHI clinics. Veterans' data was collected retrospectively starting from January 1, 2020 until July 31, 2024. PCMHI providers (Staff) at each site were also consented for feedback and intervention fidelity ratings. 277,920 unique Veteran Participants and Staff were enrolled across all phases; however, enrollment differs at each phase.
Staff did not participate in the Pre-Training phase. Data collection for a site could have ranged from 36 to 54 months (including phases 1-4; excluding the 1-month BBTI training period January 1, 2021 - January 31, 2021).
Participant milestones
| Measure |
Minneapolis VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1-12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Durham VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
Baltimore VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
|---|---|---|---|---|
|
Pre-Training (12 Months)
STARTED
|
74207
|
42663
|
56179
|
42218
|
|
Pre-Training (12 Months)
PCMHI Participants
|
4725
|
4481
|
3939
|
2833
|
|
Pre-Training (12 Months)
Primary Care Participants
|
69482
|
38182
|
52240
|
39385
|
|
Pre-Training (12 Months)
Staff
|
0
|
0
|
0
|
0
|
|
Pre-Training (12 Months)
COMPLETED
|
74207
|
42663
|
56179
|
42218
|
|
Pre-Training (12 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Pre-Implementation (0, 6, 12, 18 Months)
STARTED
|
0
|
30888
|
56655
|
42568
|
|
Pre-Implementation (0, 6, 12, 18 Months)
PCMHI Participants
|
0
|
2759
|
4792
|
3580
|
|
Pre-Implementation (0, 6, 12, 18 Months)
Primary Care Participants
|
0
|
28124
|
51858
|
38979
|
|
Pre-Implementation (0, 6, 12, 18 Months)
Staff
|
0
|
5
|
5
|
9
|
|
Pre-Implementation (0, 6, 12, 18 Months)
COMPLETED
|
0
|
30888
|
56655
|
42568
|
|
Pre-Implementation (0, 6, 12, 18 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Implementation (12 Months)
STARTED
|
75154
|
37582
|
49859
|
33558
|
|
Implementation (12 Months)
PCMHI Participants
|
4924
|
3927
|
2975
|
2258
|
|
Implementation (12 Months)
Primary Care Participants
|
70223
|
33650
|
46878
|
31291
|
|
Implementation (12 Months)
Staff
|
7
|
5
|
6
|
9
|
|
Implementation (12 Months)
COMPLETED
|
75154
|
37582
|
49859
|
33558
|
|
Implementation (12 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Post-Implementation (12 Months)
STARTED
|
65411
|
33401
|
46797
|
32677
|
|
Post-Implementation (12 Months)
PCMHI Participants
|
3669
|
3107
|
2511
|
2324
|
|
Post-Implementation (12 Months)
Primary Care Participants
|
61735
|
30289
|
44280
|
30344
|
|
Post-Implementation (12 Months)
Staff
|
7
|
5
|
6
|
9
|
|
Post-Implementation (12 Months)
COMPLETED
|
65411
|
33401
|
46797
|
32677
|
|
Post-Implementation (12 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Veteran and Staff participants analyzed separately
Baseline characteristics by cohort
| Measure |
Minneapolis VAMC
n=75147 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
n=37577 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Durham VAMC
n=49853 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
Baltimore VAMC
n=33549 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
Staff
n=27 Participants
Staff consented from all 4 sites in the Pre-Implementation, Implementation, and Post-Implementation phases.
|
Total
n=196153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
PCMHI Participants
|
57.18 years
STANDARD_DEVIATION 17.57 • n=4924 Participants • Veteran and Staff participants analyzed separately
|
55.35 years
STANDARD_DEVIATION 16.05 • n=3927 Participants • Veteran and Staff participants analyzed separately
|
52.75 years
STANDARD_DEVIATION 15.23 • n=2975 Participants • Veteran and Staff participants analyzed separately
|
54.19 years
STANDARD_DEVIATION 14.35 • n=2258 Participants • Veteran and Staff participants analyzed separately
|
—
|
55.25 years
STANDARD_DEVIATION 16.26 • n=14084 Participants • Veteran and Staff participants analyzed separately
|
|
Age, Continuous
Primary Care Participants
|
65.46 years
STANDARD_DEVIATION 15.87 • n=70223 Participants • Veteran and Staff participants analyzed separately
|
64.08 years
STANDARD_DEVIATION 15.70 • n=33650 Participants • Veteran and Staff participants analyzed separately
|
60.57 years
STANDARD_DEVIATION 15.16 • n=46878 Participants • Veteran and Staff participants analyzed separately
|
61.69 years
STANDARD_DEVIATION 14.90 • n=31291 Participants • Veteran and Staff participants analyzed separately
|
—
|
63.30 years
STANDARD_DEVIATION 15.63 • n=182042 Participants • Veteran and Staff participants analyzed separately
|
|
Age, Continuous
Staff
|
—
|
—
|
—
|
—
|
40.23 years
STANDARD_DEVIATION 9.50 • n=27 Participants • Veteran and Staff participants analyzed separately
|
40.23 years
STANDARD_DEVIATION 9.50 • n=27 Participants • Veteran and Staff participants analyzed separately
|
|
Sex: Female, Male
PCMHI Participants · Female
|
832 Participants
n=4924 Participants • Veteran and Staff participants analyzed separately
|
646 Participants
n=3927 Participants • Veteran and Staff participants analyzed separately
|
557 Participants
n=2975 Participants • Veteran and Staff participants analyzed separately
|
561 Participants
n=2258 Participants • Veteran and Staff participants analyzed separately
|
—
|
2596 Participants
n=14084 Participants • Veteran and Staff participants analyzed separately
|
|
Sex: Female, Male
PCMHI Participants · Male
|
4092 Participants
n=4924 Participants • Veteran and Staff participants analyzed separately
|
3281 Participants
n=3927 Participants • Veteran and Staff participants analyzed separately
|
2418 Participants
n=2975 Participants • Veteran and Staff participants analyzed separately
|
1697 Participants
n=2258 Participants • Veteran and Staff participants analyzed separately
|
—
|
11488 Participants
n=14084 Participants • Veteran and Staff participants analyzed separately
|
|
Sex: Female, Male
Primary Care Participants · Female
|
4610 Participants
n=70223 Participants • Veteran and Staff participants analyzed separately
|
3167 Participants
n=33650 Participants • Veteran and Staff participants analyzed separately
|
5936 Participants
n=46878 Participants • Veteran and Staff participants analyzed separately
|
4386 Participants
n=31291 Participants • Veteran and Staff participants analyzed separately
|
—
|
18099 Participants
n=182042 Participants • Veteran and Staff participants analyzed separately
|
|
Sex: Female, Male
Primary Care Participants · Male
|
65613 Participants
n=70223 Participants • Veteran and Staff participants analyzed separately
|
30483 Participants
n=33650 Participants • Veteran and Staff participants analyzed separately
|
40942 Participants
n=46878 Participants • Veteran and Staff participants analyzed separately
|
26905 Participants
n=31291 Participants • Veteran and Staff participants analyzed separately
|
—
|
163943 Participants
n=182042 Participants • Veteran and Staff participants analyzed separately
|
|
Sex: Female, Male
Staff · Female
|
—
|
—
|
—
|
—
|
22 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
22 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
|
Sex: Female, Male
Staff · Male
|
—
|
—
|
—
|
—
|
5 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
5 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
|
Race/Ethnicity, Customized
PCMHI Participants · White
|
4024 Participants
n=4924 Participants • Veteran and Staff participants analyzed separately
|
1679 Participants
n=3927 Participants • Veteran and Staff participants analyzed separately
|
1276 Participants
n=2975 Participants • Veteran and Staff participants analyzed separately
|
784 Participants
n=2258 Participants • Veteran and Staff participants analyzed separately
|
—
|
7763 Participants
n=14084 Participants • Veteran and Staff participants analyzed separately
|
|
Race/Ethnicity, Customized
PCMHI Participants · Non-White
|
495 Participants
n=4924 Participants • Veteran and Staff participants analyzed separately
|
1985 Participants
n=3927 Participants • Veteran and Staff participants analyzed separately
|
1543 Participants
n=2975 Participants • Veteran and Staff participants analyzed separately
|
1345 Participants
n=2258 Participants • Veteran and Staff participants analyzed separately
|
—
|
5368 Participants
n=14084 Participants • Veteran and Staff participants analyzed separately
|
|
Race/Ethnicity, Customized
PCMHI Participants · Unknown
|
405 Participants
n=4924 Participants • Veteran and Staff participants analyzed separately
|
263 Participants
n=3927 Participants • Veteran and Staff participants analyzed separately
|
156 Participants
n=2975 Participants • Veteran and Staff participants analyzed separately
|
129 Participants
n=2258 Participants • Veteran and Staff participants analyzed separately
|
—
|
953 Participants
n=14084 Participants • Veteran and Staff participants analyzed separately
|
|
Race/Ethnicity, Customized
Primary Care Participants · White
|
59513 Participants
n=70223 Participants • Veteran and Staff participants analyzed separately
|
17456 Participants
n=33650 Participants • Veteran and Staff participants analyzed separately
|
24280 Participants
n=46878 Participants • Veteran and Staff participants analyzed separately
|
14456 Participants
n=31291 Participants • Veteran and Staff participants analyzed separately
|
—
|
115705 Participants
n=182042 Participants • Veteran and Staff participants analyzed separately
|
|
Race/Ethnicity, Customized
Primary Care Participants · Non-White
|
4195 Participants
n=70223 Participants • Veteran and Staff participants analyzed separately
|
14620 Participants
n=33650 Participants • Veteran and Staff participants analyzed separately
|
20842 Participants
n=46878 Participants • Veteran and Staff participants analyzed separately
|
15203 Participants
n=31291 Participants • Veteran and Staff participants analyzed separately
|
—
|
54860 Participants
n=182042 Participants • Veteran and Staff participants analyzed separately
|
|
Race/Ethnicity, Customized
Primary Care Participants · Unknown
|
6515 Participants
n=70223 Participants • Veteran and Staff participants analyzed separately
|
1574 Participants
n=33650 Participants • Veteran and Staff participants analyzed separately
|
1756 Participants
n=46878 Participants • Veteran and Staff participants analyzed separately
|
1632 Participants
n=31291 Participants • Veteran and Staff participants analyzed separately
|
—
|
11477 Participants
n=182042 Participants • Veteran and Staff participants analyzed separately
|
|
Race/Ethnicity, Customized
Staff · White
|
—
|
—
|
—
|
—
|
25 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
25 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
|
Race/Ethnicity, Customized
Staff · Non-White
|
—
|
—
|
—
|
—
|
2 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
2 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
|
Race/Ethnicity, Customized
Staff · Unknown
|
—
|
—
|
—
|
—
|
0 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
0 Participants
n=27 Participants • Veteran and Staff participants analyzed separately
|
|
Sleep Medication
PCMHI Participants · Yes
|
556 Participants
n=4924 Participants • Staff - sleep medication not measured
|
243 Participants
n=3927 Participants • Staff - sleep medication not measured
|
452 Participants
n=2975 Participants • Staff - sleep medication not measured
|
138 Participants
n=2258 Participants • Staff - sleep medication not measured
|
0 Participants
Staff - sleep medication not measured
|
1389 Participants
n=14084 Participants • Staff - sleep medication not measured
|
|
Sleep Medication
PCMHI Participants · No
|
4368 Participants
n=4924 Participants • Staff - sleep medication not measured
|
3684 Participants
n=3927 Participants • Staff - sleep medication not measured
|
2523 Participants
n=2975 Participants • Staff - sleep medication not measured
|
2120 Participants
n=2258 Participants • Staff - sleep medication not measured
|
0 Participants
Staff - sleep medication not measured
|
12695 Participants
n=14084 Participants • Staff - sleep medication not measured
|
|
Sleep Medication
Primary Care Participants · Yes
|
4483 Participants
n=70223 Participants • Staff - sleep medication not measured
|
1404 Participants
n=33650 Participants • Staff - sleep medication not measured
|
4094 Participants
n=46878 Participants • Staff - sleep medication not measured
|
1027 Participants
n=31291 Participants • Staff - sleep medication not measured
|
—
|
11008 Participants
n=182042 Participants • Staff - sleep medication not measured
|
|
Sleep Medication
Primary Care Participants · No
|
65740 Participants
n=70223 Participants • Staff - sleep medication not measured
|
32246 Participants
n=33650 Participants • Staff - sleep medication not measured
|
42784 Participants
n=46878 Participants • Staff - sleep medication not measured
|
30264 Participants
n=31291 Participants • Staff - sleep medication not measured
|
—
|
171034 Participants
n=182042 Participants • Staff - sleep medication not measured
|
PRIMARY outcome
Timeframe: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)Population: Veterans in PCMHI who engaged in BBTI
The number of Veterans in PCMHI who engaged in BBTI as indicated in the medical records
Outcome measures
| Measure |
Minneapolis VAMC
n=434 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
n=78 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Baltimore VAMC
n=192 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
Durham VAMC
n=361 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
|---|---|---|---|---|
|
Veteran Participants Who Engaged in BBTI
Pre-Training
|
14 Participants
|
1 Participants
|
0 Participants
|
21 Participants
|
|
Veteran Participants Who Engaged in BBTI
Pre-Implementation
|
0 Participants
|
14 Participants
|
67 Participants
|
90 Participants
|
|
Veteran Participants Who Engaged in BBTI
Implementation
|
203 Participants
|
35 Participants
|
50 Participants
|
88 Participants
|
|
Veteran Participants Who Engaged in BBTI
Post-Implementation
|
217 Participants
|
28 Participants
|
75 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)The number of Veterans with encounters in PCMHI related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication.
Outcome measures
| Measure |
Minneapolis VAMC
n=2255 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
n=924 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Baltimore VAMC
n=1141 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
Durham VAMC
n=2386 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
|---|---|---|---|---|
|
Veterans in PCMHI Identified With Insomnia
Implementation
|
857 Participants
|
280 Participants
|
217 Participants
|
505 Participants
|
|
Veterans in PCMHI Identified With Insomnia
Post-Implementation
|
680 Participants
|
163 Participants
|
243 Participants
|
386 Participants
|
|
Veterans in PCMHI Identified With Insomnia
Pre-Training
|
718 Participants
|
314 Participants
|
354 Participants
|
717 Participants
|
|
Veterans in PCMHI Identified With Insomnia
Pre-Implementation
|
0 Participants
|
167 Participants
|
327 Participants
|
778 Participants
|
SECONDARY outcome
Timeframe: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)The number of Veterans with encounters in Primary Care related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication.
Outcome measures
| Measure |
Minneapolis VAMC
n=17693 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
n=8728 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Baltimore VAMC
n=7799 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
Durham VAMC
n=23757 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
|---|---|---|---|---|
|
Veterans in Primary Care Identified With Insomnia
Pre-Training
|
6383 Participants
|
2737 Participants
|
2378 Participants
|
7038 Participants
|
|
Veterans in Primary Care Identified With Insomnia
Pre-Implementation
|
0 Participants
|
1875 Participants
|
2383 Participants
|
6547 Participants
|
|
Veterans in Primary Care Identified With Insomnia
Implementation
|
6135 Participants
|
2257 Participants
|
1571 Participants
|
5482 Participants
|
|
Veterans in Primary Care Identified With Insomnia
Post-Implementation
|
5175 Participants
|
1859 Participants
|
1467 Participants
|
4690 Participants
|
SECONDARY outcome
Timeframe: 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 1-13 weeks.Population: This is the intent to treat (ITT) analysis and all ISI data are included from participants who initiated BBTI. Results provided for all sites combined and individual sites. Data at the participant-level (Veterans in PCMHI), with data extracted from BBTI progress notes in the electronic health records, retrospectively.
Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session.
Outcome measures
| Measure |
Minneapolis VAMC
n=515 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
n=183 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Baltimore VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
Durham VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
|---|---|---|---|---|
|
BBTI Effectiveness (Intent to Treat)
All Sites
|
16.85 score on a scale
Standard Deviation 5.79
|
13.41 score on a scale
Standard Deviation 7.02
|
—
|
—
|
|
BBTI Effectiveness (Intent to Treat)
Minneapolis VAMC
|
16.09 score on a scale
Standard Deviation 5.46
|
11.40 score on a scale
Standard Deviation 7.60
|
—
|
—
|
|
BBTI Effectiveness (Intent to Treat)
Philadelphia VAMC
|
18.30 score on a scale
Standard Deviation 5.32
|
13.69 score on a scale
Standard Deviation 6.17
|
—
|
—
|
|
BBTI Effectiveness (Intent to Treat)
Durham VAMC
|
18.05 score on a scale
Standard Deviation 6.03
|
14.30 score on a scale
Standard Deviation 6.69
|
—
|
—
|
|
BBTI Effectiveness (Intent to Treat)
Baltimore VAMC
|
18.36 score on a scale
Standard Deviation 5.34
|
12.70 score on a scale
Standard Deviation 6.99
|
—
|
—
|
SECONDARY outcome
Timeframe: 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 2-13 weeks.Population: This is the per protocol (PP) analysis and all ISI data are included from participants who completed at least 3 sessions of BBTI. Results provided for all sites combined and individual sites. Data at the participant-level (Veterans in PCMHI), with data extracted from BBTI progress notes in the electronic health records, retrospectively.
Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session.
Outcome measures
| Measure |
Minneapolis VAMC
n=101 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
n=101 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Baltimore VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
Durham VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
|---|---|---|---|---|
|
BBTI Effectiveness (Per Protocol)
All Sites
|
18.48 score on a scale
Standard Deviation 5.42
|
12.31 score on a scale
Standard Deviation 6.38
|
—
|
—
|
|
BBTI Effectiveness (Per Protocol)
Minneapolis VAMC
|
17.13 score on a scale
Standard Deviation 4.70
|
8.13 score on a scale
Standard Deviation 6.04
|
—
|
—
|
|
BBTI Effectiveness (Per Protocol)
Philadelphia VAMC
|
18.88 score on a scale
Standard Deviation 5.34
|
13.79 score on a scale
Standard Deviation 5.84
|
—
|
—
|
|
BBTI Effectiveness (Per Protocol)
Durham VAMC
|
18.00 score on a scale
Standard Deviation 6.14
|
13.00 score on a scale
Standard Deviation 6.19
|
—
|
—
|
|
BBTI Effectiveness (Per Protocol)
Baltimore VAMC
|
20.05 score on a scale
Standard Deviation 4.32
|
12.45 score on a scale
Standard Deviation 6.71
|
—
|
—
|
SECONDARY outcome
Timeframe: 42 months; during the pre-implementation, implementation, and post-implementation phases.Population: Number of PCMHI providers who delivered BBTI relative to providers who were eligible to deliver BBTI. Not all of these providers were considered enrolled in the study.
PCMHI providers (Staff) who delivered (adopted) BBTI (adopted) to at least 1 Veteran - measured in each phase (pre-implementation, implementation, post-implementation).
Outcome measures
| Measure |
Minneapolis VAMC
n=91 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
n=142 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Baltimore VAMC
n=82 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
Durham VAMC
n=94 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
|---|---|---|---|---|
|
PCMHI Providers (Staff) Who Delivered (Adopted) BBTI
Implementation
|
23 providers
|
29 providers
|
17 providers
|
27 providers
|
|
PCMHI Providers (Staff) Who Delivered (Adopted) BBTI
Post-Implementation
|
27 providers
|
20 providers
|
17 providers
|
27 providers
|
|
PCMHI Providers (Staff) Who Delivered (Adopted) BBTI
Pre-Implementation
|
—
|
17 providers
|
17 providers
|
33 providers
|
SECONDARY outcome
Timeframe: 42 months; the BBTI-CRS was administered during pre-implementation (up to 3 times), implementation (1 time, at the end), and post-implementation (1 time, at the end)Population: PCMHI providers (Staff) trained in BBTI who consented to participate in the competency ratings. Not all Staff completed ratings at all phases and there was no plan to compare between sites. Only descriptive statistics (Mean/Standard Deviation) reported.
Mean Competency Rating Score (0-36, higher scores indicate higher competency, \>17 indicates competency) PCMHI providers (Staff) were measured via mock treatment sessions by site PIs/subject matter experts using the BBTI-Competency Rating Scale (BBTI-CRS) during the pre-implementation, implementation, and post-implementation phases. Overall refers to aggregate ratings (averaged) from all phases in which BBTI-CRS was delivered - providers could complete up to 5 ratings (up to 3 for pre-implementation, 1 for implementation, and 1 for post-implementation).
Outcome measures
| Measure |
Minneapolis VAMC
n=18 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Baltimore VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
Durham VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
|---|---|---|---|---|
|
Implementation/Treatment Fidelity (Staff)
Overall (phases 2-4)
|
31.46 score on a scale
Standard Deviation 5.14
|
—
|
—
|
—
|
|
Implementation/Treatment Fidelity (Staff)
Pre-Implementation (phase 2)
|
31.02 score on a scale
Standard Deviation 5.57
|
—
|
—
|
—
|
|
Implementation/Treatment Fidelity (Staff)
Implementation (phase 3)
|
33.64 score on a scale
Standard Deviation 3.52
|
—
|
—
|
—
|
|
Implementation/Treatment Fidelity (Staff)
Post-Implementation (phase 4)
|
33.55 score on a scale
Standard Deviation 2.77
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 42 months; qualitative interviews took place at the end of the pre-implementation, implementation, and post-implementation phases.Population: 16 Staff participants were engaged in CFIR interviews with 3 study team members coding the interviews and conducting strength and valence ratings. Strength (0, 1, 2) and valence (- / +) ratings help to determine how helpful or harmful an identified CFIR determinant is for implementation of BBTI.
Strength and valence rating for identified barriers and facilitators (determinants) from the Consolidated Framework for Implementation Research (CFIR) qualitative interviews. CFIR determinants, identified through qualitative interviews with PCMHI providers, were rated on strength (0, 1, 2; higher numbers indicate stronger influence) and valence (- indicates negative/harmful influence; + indicates positive/helpful influence) to determine how helpful or harmful an identified CFIR determinant is for implementing BBTI in PCMHI. Ratings were aggregated across sites and phases (consensus by 3 raters with adjudication by PI as needed).
Outcome measures
| Measure |
Minneapolis VAMC
n=16 Participants
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2).
|
Philadelphia VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30).
|
Baltimore VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42).
|
Durham VAMC
All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36).
|
|---|---|---|---|---|
|
Barriers & Facilitators (CFIR Determinants)
Innovation: Adaptability
|
1 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Innovation: Trialability
|
1 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Innovation: Relative Advantage
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Innovation: Design
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Outer: Partnerships & Connections
|
1 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Individuals: Innovation Recipients - Motivation
|
-1 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Inner: Work Infrastructure
|
-2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Inner: Communications
|
1 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Inner: Compatibility
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Inner: Mission Alignment
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Inner: Available Resources
|
1 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Inner: Access to Knowledge & Information
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Inner: Relative Priority
|
-1 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Process: Teaming
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Individuals: Innovation Deliverers - Capability
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Individuals: Innovation Recipients - Need
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Process: Tailoring Strategies
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Process: Engaging Recipients
|
-1 rating score for each CFIR determinant
|
—
|
—
|
—
|
|
Barriers & Facilitators (CFIR Determinants)
Process: Adapting
|
2 rating score for each CFIR determinant
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months: 4 times - every 3-months during the Implementation phase.Population: This measure was abandoned during the study, early on with no data collected, since much of the data intended to be collected through this survey could be captured/collected as part of the CFIR interviews and ratings (Outcome #8).
Indication of implementation strategy utilization (yes/no) and rating of its importance (1 = not at all important, 5 = very important) and feasibility ((1 = not at all feasible, 5 = very feasible).
Outcome measures
Outcome data not reported
Adverse Events
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