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Implementation of Women's Health Patient Aligned Care Teams (WH-PACT)

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ClinicalTrials.gov Identifier: NCT02039856
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
University of California, Los Angeles
RAND
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Patient-centered Medical Home Implementation
Interventions Other: Multilevel stakeholder engagement
Other: Quality improvement (QI) education/training
Other: Technical support
Other: Formative feedback
Other: External practice facilitation
Other: National policy guidance
Enrollment 3900
Recruitment Details Random samples of women Veteran clinic users (patient surveys) and census of each VAMC's primary care and women's health providers and staff in PACT and WH-PACT (web surveys) at 12 participating VAMCs recruited through the WH Practice Based Research Network
Pre-assignment Details  
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance. PACT implementation is a nationally mandated VA initiative for medical home implementation in VA primary care and women's health clinics, supported by VA Handbooks on PACT and Women's Health policy and practice guidance from national VA primary care and women's health program offices that are disseminated nationally to all VA facilities.
Period Title: Overall Study
Number of participants Number of units (VA medical centers) Number of participants Number of units (VA medical centers)
Started 2720 8 1180 4
Baseline Started - Patients 2183 8 919 4
Baseline Completed - Patients 953 8 442 4
Baseline Started - Providers/Staff 537 8 261 4
Baseline Completed -Providers/Staff 194 8 94 4
Total Baseline Completed 1147 8 536 4
12-month Started-patients 953 8 442 4
12-month Completed- Patients 580 8 241 4
12-month Providers/Staff 0 0 0 0
24-month Started 1518 8 746 4
24-month Started - Patients 953 8 442 4
24-month Completed - Patients 519 8 222 4
24-month Started Providers/Staff 565 8 304 4
24-month Completed Providers/Staff 174 8 105 4
Total 24-month Completed 693 8 327 4
Completed 693 8 327 4
Not Completed 2027 0 853 0
Reason Not Completed
Death             5                         3            
Partial survey completion             61                         26            
Lost to Follow-up             388                         206            
Withdrawal by Subject             1573                         618            
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation Total
Hide Arm/Group Description Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance. VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities Total of all reporting groups
Overall Number of Baseline Participants 1147 536 1683
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Patients Number Analyzed 952 participants 439 participants 1391 participants
53.39  (13.99) 51.54  (13.76) 52.80  (13.94)
[1]
Measure Description: Patients only: Age obtained from surveys and VA administrative data during sampling as well as from birth date verified by patients as part of computer-assisted telephone interviews (CATI)
[2]
Measure Analysis Population Description: There are 4 patients with missing age information, 1 in the EBQI arm and 3 in the control arm.
Age, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
20-29 years Number Analyzed 194 participants 94 participants 288 participants
7
   3.6%
3
   3.2%
10
   3.5%
30-39 years Number Analyzed 194 participants 94 participants 288 participants
36
  18.6%
19
  20.2%
55
  19.1%
40-49 years Number Analyzed 194 participants 94 participants 288 participants
48
  24.7%
20
  21.3%
68
  23.6%
50-59 years Number Analyzed 194 participants 94 participants 288 participants
65
  33.5%
30
  31.9%
95
  33.0%
60+ years Number Analyzed 194 participants 94 participants 288 participants
23
  11.9%
10
  10.6%
33
  11.5%
missing Number Analyzed 194 participants 94 participants 288 participants
15
   7.7%
12
  12.8%
27
   9.4%
[1]
Measure Description: Providers/staff only: Age obtained from the surveys
[2]
Measure Analysis Population Description: There are 27 providers and staff with missing age information; 15 in the EBQI arm and 12 in the control arm.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 94 participants 288 participants
Female
150
  77.3%
72
  76.6%
222
  77.1%
Male
44
  22.7%
22
  23.4%
66
  22.9%
[1]
Measure Description: Provider/staff specification of sex based on self-report data in web surveys
[2]
Measure Analysis Population Description: Providers/staff
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 953 participants 442 participants 1395 participants
Female
953
 100.0%
442
 100.0%
1395
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Only female patients were sampled for participation in the computer-assisted telephone interview (CATI) survey using VA administrative data; self-reported sex/gender identity questions were then asked of survey participants.
[2]
Measure Analysis Population Description: Patients only
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
American Indian or Alaska Native Number Analyzed 194 participants 94 participants 288 participants
4
   2.1%
0
   0.0%
4
   1.4%
Asian Number Analyzed 194 participants 94 participants 288 participants
7
   3.6%
9
   9.6%
16
   5.6%
Black or African American Number Analyzed 194 participants 94 participants 288 participants
25
  12.9%
11
  11.7%
36
  12.5%
White Number Analyzed 194 participants 94 participants 288 participants
140
  72.2%
55
  58.5%
195
  67.7%
More than one race Number Analyzed 194 participants 94 participants 288 participants
0
   0.0%
1
   1.1%
1
   0.3%
Hispanic or Latino Number Analyzed 194 participants 94 participants 288 participants
4
   2.1%
4
   4.3%
8
   2.8%
Unknown or Not Reported Number Analyzed 194 participants 94 participants 288 participants
18
   9.3%
18
  19.1%
36
  12.5%
[1]
Measure Analysis Population Description: Providers/staff
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 953 participants 442 participants 1395 participants
7
   0.7%
3
   0.7%
10
   0.7%
Black or African American Number Analyzed 953 participants 442 participants 1395 participants
190
  19.9%
129
  29.2%
319
  22.9%
White Number Analyzed 953 participants 442 participants 1395 participants
630
  66.1%
225
  50.9%
855
  61.3%
Hispanic or Latino Number Analyzed 953 participants 442 participants 1395 participants
33
   3.5%
37
   8.4%
70
   5.0%
More than one race Number Analyzed 953 participants 442 participants 1395 participants
83
   8.7%
40
   9.0%
123
   8.8%
Unknown or Not Reported Number Analyzed 953 participants 442 participants 1395 participants
10
   1.0%
8
   1.8%
18
   1.3%
[1]
Measure Analysis Population Description: Patients only
Post-traumatic stress disorder (PTSD)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 953 participants 442 participants 1395 participants
PTSD positive
364
  38.2%
194
  43.9%
558
  40.0%
PTSD negative
578
  60.7%
244
  55.2%
822
  58.9%
Missing
11
   1.2%
4
   0.9%
15
   1.1%
[1]
Measure Analysis Population Description: Patients only
Military Sexual Trauma (MST)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 953 participants 442 participants 1395 participants
MST positive
575
  60.3%
266
  60.2%
841
  60.3%
MST negative
362
  38.0%
167
  37.8%
529
  37.9%
Missing
16
   1.7%
9
   2.0%
25
   1.8%
[1]
Measure Analysis Population Description: Patients only
VA care utilization   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 953 participants 442 participants 1395 participants
VA-only
608
  63.8%
259
  58.6%
867
  62.2%
VA and non-VA
345
  36.2%
183
  41.4%
528
  37.8%
[1]
Measure Analysis Population Description: Patients only
Education   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 953 participants 442 participants 1395 participants
Less than college
180
  18.9%
72
  16.3%
252
  18.1%
Some college
416
  43.7%
193
  43.7%
609
  43.7%
College degree
355
  37.3%
176
  39.8%
531
  38.1%
missing
2
   0.2%
1
   0.2%
3
   0.2%
[1]
Measure Analysis Population Description: Patients only
Employment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 953 participants 442 participants 1395 participants
Employed
356
  37.4%
193
  43.7%
549
  39.4%
un-employed
44
   4.6%
29
   6.6%
73
   5.2%
Not in labor force
330
  34.6%
125
  28.3%
455
  32.6%
Not in labor force due to disability
220
  23.1%
90
  20.4%
310
  22.2%
missing
3
   0.3%
5
   1.1%
8
   0.6%
[1]
Measure Analysis Population Description: Patients only
Stranger harassment from male veterans   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 953 participants 442 participants 1395 participants
Never
737
  77.3%
324
  73.3%
1061
  76.1%
Sometimes
144
  15.1%
90
  20.4%
234
  16.8%
Usually
36
   3.8%
14
   3.2%
50
   3.6%
Always
29
   3.0%
13
   2.9%
42
   3.0%
Missing
7
   0.7%
1
   0.2%
8
   0.6%
[1]
Measure Analysis Population Description: Patients only
Marital status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 953 participants 442 participants 1395 participants
Single/windowed/divorced/seperated
573
  60.1%
277
  62.7%
850
  60.9%
Married/civil union/ significant other
371
  38.9%
159
  36.0%
530
  38.0%
Missing
9
   0.9%
6
   1.4%
15
   1.1%
[1]
Measure Analysis Population Description: Patients only
Are you currently working in WH-PACT?   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 94 participants 288 participants
WH-PACTs
84
  43.3%
27
  28.7%
111
  38.5%
PACTs
97
  50.0%
58
  61.7%
155
  53.8%
not sure
11
   5.7%
5
   5.3%
16
   5.6%
unkown/not reported
2
   1.0%
4
   4.3%
6
   2.1%
[1]
Measure Analysis Population Description: Providers/staff
Proportion of time interacting with patients   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 94 participants 288 participants
1%-24% of my total VA time
16
   8.2%
8
   8.5%
24
   8.3%
25%-49% of my total VA time
19
   9.8%
8
   8.5%
27
   9.4%
50%-75% of my total VA time
35
  18.0%
18
  19.1%
53
  18.4%
>75% of my total VA time
124
  63.9%
60
  63.8%
184
  63.9%
[1]
Measure Analysis Population Description: Providers/staff
Full-time VA employee   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 94 participants 288 participants
Full-time
178
  91.8%
89
  94.7%
267
  92.7%
Part-time
15
   7.7%
5
   5.3%
20
   6.9%
Missing
1
   0.5%
0
   0.0%
1
   0.3%
[1]
Measure Analysis Population Description: Providers/staff
How often do you see or care for women patients in the clinic?   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 94 participants 288 participants
Never
11
   5.7%
10
  10.6%
21
   7.3%
Less than once per month
57
  29.4%
41
  43.6%
98
  34.0%
1-2 times per month
31
  16.0%
7
   7.4%
38
  13.2%
1-2 times per week
33
  17.0%
8
   8.5%
41
  14.2%
several times each week
20
  10.3%
11
  11.7%
31
  10.8%
almost everyday or every day
40
  20.6%
12
  12.8%
52
  18.1%
Missing/not reported
2
   1.0%
5
   5.3%
7
   2.4%
[1]
Measure Analysis Population Description: Providers/staff
Years of service at VA   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 194 participants 94 participants 288 participants
14.26  (11.77) 14.75  (10.64) 14.42  (11.40)
[1]
Measure Analysis Population Description: Providers/staff
1.Primary Outcome
Title WH-PACT Achievement
Hide Description The Women's Health Patient-Aligned Care Team achievement, based on four patient-reported measures of access to care, patient-provider communication, comprehensiveness of care, and gender-appropriateness of care. The WH-PACT achievement is an aggregate score from -4 to +4, with the higher score meaning better PACT achievement.
Time Frame Baseline to 24-month
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis included the patients who had completed the 24-month survey. One patient in the EBQI arm had missing data for outcome measure and was excluded from the analysis.
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description:
Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.
VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities.
Overall Number of Participants Analyzed 518 222
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline -4
30
   5.8%
23
  10.4%
-3
49
   9.5%
20
   9.0%
-2
51
   9.8%
26
  11.7%
-1
49
   9.5%
24
  10.8%
0
59
  11.4%
23
  10.4%
+1
73
  14.1%
31
  14.0%
+2
79
  15.3%
27
  12.2%
+3
75
  14.5%
28
  12.6%
+4
53
  10.2%
20
   9.0%
24 month -4
34
   6.6%
17
   7.7%
-3
40
   7.7%
27
  12.2%
-2
35
   6.8%
15
   6.8%
-1
41
   7.9%
21
   9.5%
0
57
  11.0%
20
   9.0%
+1
72
  13.9%
24
  10.8%
+2
93
  18.0%
34
  15.3%
+3
83
  16.0%
35
  15.8%
+4
63
  12.2%
29
  13.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EBQI-Supported WH-PACT Implementation, Routine WH-PACT Implementation
Comments Change in the odds of achieving a higher WH-PACT element.
Type of Statistical Test Superiority
Comments Difference-in-differences using ordered logistic regression, adjusting for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights. We verified that proportional odds assumption was met.
Statistical Test of Hypothesis P-Value 0.637
Comments [Not Specified]
Method difference-in-differences analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.913
Confidence Interval (2-Sided) 95%
0.627 to 1.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.175
Estimation Comments The estimated value is predicted change in the odds of WH-PACT achievement, adjusting for characteristics described in the statistical analysis overview.
2.Secondary Outcome
Title Providers' and Staff Gender Sensitivity
Hide Description Gender sensitivity score based on 10 survey items related to providers' and staff's sensitivity towards women Veterans during patient care. The score ranged from 1 to 5 with the higher score reflecting greater gender sensitivity toward women Veterans.
Time Frame Baseline to 24-month
Hide Outcome Measure Data
Hide Analysis Population Description
Primary care and women's health providers and staff. The analysis was based on cases with non-missing outcome data. There were 28 missing cases in the EBQI arm and 9 missing in the control arm.
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description:

Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.

Multilevel stakeholder engagement: Structured, in-person stakeholder panel meeting of VA network, VA medical center, and primary care and women's health leaders using modified Delphi panel techniques to come to consensus on a quality improvement (QI) roadmap within each participating VA network, followed by intermittent progress reporting and post-24 months in-person capstone stakeholder panel meetings.

Quality improvement (QI) education/training: Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement

Technical support: Research team provided technical review of and feedback

National policy guidance

National policy guidance: VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

Overall Number of Participants Analyzed 146 96
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 4.04  (0.59) 4.15  (0.57)
24-month 4.20  (0.48) 4.14  (0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EBQI-Supported WH-PACT Implementation, Routine WH-PACT Implementation
Comments Change in gender sensitivity score between EBQI and control over time
Type of Statistical Test Superiority
Comments Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.10 to 0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1195
Estimation Comments The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.
3.Secondary Outcome
Title Team Functioning
Hide Description Perceived team functioning of primary care and women's health providers and staff, measured based on responses to 7 survey items. The team functioning score ranged from 1 to 5 , with the higher score indicating better team functioning.
Time Frame Baseline to 24-month
Hide Outcome Measure Data
Hide Analysis Population Description
Primary care and women's health providers and staff. The analysis was based on cases with non-missing outcome data. There are 80 missing cases in the EBQI arm and 74 in the control arm.
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description:

Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.

Multilevel stakeholder engagement: Structured, in-person stakeholder panel meeting of VA network, VA medical center, and primary care and women's health leaders using modified Delphi panel techniques to come to consensus on a quality improvement (QI) roadmap within each participating VA network, followed by intermittent progress reporting and post-24 months in-person capstone stakeholder panel meetings.

Quality improvement (QI) education/training: Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement

Technical support: Research team provided technical review of and feedback

National policy guidance

National policy guidance: VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

Overall Number of Participants Analyzed 94 31
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 3.70  (0.84) 4.10  (0.71)
24 month 3.84  (0.75) 3.98  (0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EBQI-Supported WH-PACT Implementation, Routine WH-PACT Implementation
Comments Change in team functioning score between EBQI and control over time.
Type of Statistical Test Superiority
Comments Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
-0.01 to 0.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2253
Estimation Comments The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.
4.Secondary Outcome
Title Providers and Staff Burnout
Hide Description Burnout was measured using one item: "How often does the following statement apply to you: I feel burned out from my work" with options for 1.Never, 2. A few times a year, 3. Every month, 4. A few times a month, 5. Every week, 6. A few times a week, 7. Every day. We recoded the responses into a binary value: never/less than a few times a month (1-4) and every week-to-everyday (5-7).
Time Frame 24-month
Hide Outcome Measure Data
Hide Analysis Population Description
Primary care and women's health providers and staff. The analysis was based on cases with non-missing burnout data. There were 30 missing cases in the EBQI arm and 10 in the control arm.
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description:

Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.

Multilevel stakeholder engagement: Structured, in-person stakeholder panel meeting of VA network, VA medical center, and primary care and women's health leaders using modified Delphi panel techniques to come to consensus on a quality improvement (QI) roadmap within each participating VA network, followed by intermittent progress reporting and post-24 months in-person capstone stakeholder panel meetings.

Quality improvement (QI) education/training: Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement

Technical support: Research team provided technical review of and feedback

National policy guidance

National policy guidance: VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

Overall Number of Participants Analyzed 144 95
Measure Type: Count of Participants
Unit of Measure: Participants
nver/less than a few times a month (1-4)
112
  77.8%
72
  75.8%
everyweek to everyday (5-7)
32
  22.2%
23
  24.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EBQI-Supported WH-PACT Implementation, Routine WH-PACT Implementation
Comments [Not Specified]
Type of Statistical Test Superiority
Comments We adjusted our analysis using the population weights, which were the product of design weights and non-response weights
Statistical Test of Hypothesis P-Value 0.058
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.13 to 1.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1922
Estimation Comments The estimated value is the predicted mean, adjusting for weights, worked in women's health vs general PC clinic, years worked at the VA, race/ethnicity, gender, full-time employment, and percent of women veterans enrolled at the VA facility.
5.Secondary Outcome
Title Patient VA Primary Care Visits Per Year
Hide Description Average number of visits to VA primary care per year
Time Frame Baseline to 24month
Hide Outcome Measure Data
Hide Analysis Population Description
Patients only. One patient in the EBQI arm had missing outcome information and was excluded from the analysis.
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description:
Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.
VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities.
Overall Number of Participants Analyzed 518 222
Mean (Standard Deviation)
Unit of Measure: average visits per year for all patients
Baseline 6.96  (5.57) 6.46  (5.14)
24month 6.78  (7.21) 5.16  (5.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EBQI-Supported WH-PACT Implementation, Routine WH-PACT Implementation
Comments Change in number of patient primary care visits between EBQI and control over time
Type of Statistical Test Superiority
Comments Difference-in-differences analysis using linear regression, adjusted for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.14 to 2.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.56
Estimation Comments The estimated value is predicted change in the number of VA primary care visits, adjusting for characteristics described in the statistical analysis overview.
6.Secondary Outcome
Title Patient VA Women's Health Care Visits Per Year
Hide Description Average number of patient visits to VA women's health care per year
Time Frame Baseline to 24month
Hide Outcome Measure Data
Hide Analysis Population Description
Patients only. One patient in the EBQI arm had missing outcome information and was excluded from the analysis.
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description:

Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.

Multilevel stakeholder engagement: Structured, in-person stakeholder panel meeting of VA network, VA medical center, and primary care and women's health leaders using modified Delphi panel techniques to come to consensus on a quality improvement (QI) roadmap within each participating VA network, followed by intermittent progress reporting and post-24 months in-person capstone stakeholder panel meetings.

Quality improvement (QI) education/training: Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement

Technical support: Research team provided technical review of and feedback

National policy guidance

National policy guidance: VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

Overall Number of Participants Analyzed 518 222
Mean (Standard Deviation)
Unit of Measure: Average visits per year for all patients
Baseline 4.05  (4.41) 4.63  (3.74)
24month 4.23  (6.23) 3.24  (3.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EBQI-Supported WH-PACT Implementation, Routine WH-PACT Implementation
Comments Change in number of patient visits to women's health care between EBQI and control over time
Type of Statistical Test Superiority
Comments Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights.
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 1.69
Confidence Interval (2-Sided) 95%
0.88 to 2.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.413
Estimation Comments The estimated value is predicted change in the number of VA women's health visits, adjusting for characteristics described in the statistical analysis overview.
7.Secondary Outcome
Title Patient VA Hospitalization
Hide Description Average number of patient hospitalization for any cause in a year
Time Frame Baseline to 24-month
Hide Outcome Measure Data
Hide Analysis Population Description
Patients only. One patient in the EBQI arm had missing outcome information and was excluded from the analysis.
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description:

Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.

Multilevel stakeholder engagement: Structured, in-person stakeholder panel meeting of VA network, VA medical center, and primary care and women's health leaders using modified Delphi panel techniques to come to consensus on a quality improvement (QI) roadmap within each participating VA network, followed by intermittent progress reporting and post-24 months in-person capstone stakeholder panel meetings.

Quality improvement (QI) education/training: Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement

Technical support: Research team provided technical review of and feedback

National policy guidance

National policy guidance: VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

Overall Number of Participants Analyzed 518 222
Mean (Standard Deviation)
Unit of Measure: Average visits per year for all patients
Baseline 0.26  (0.82) 0.19  (0.63)
24-month 0.17  (0.60) 0.15  (0.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EBQI-Supported WH-PACT Implementation, Routine WH-PACT Implementation
Comments Change in number of patient hospitalization for any cause between EBQI and control over time
Type of Statistical Test Superiority
Comments Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.
Statistical Test of Hypothesis P-Value 0.794
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.018
Confidence Interval (2-Sided) 95%
-0.15 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.068
Estimation Comments The estimated value is predicted change in the number of VA hospitalization, adjusting for characteristics described in the statistical analysis overview.
8.Secondary Outcome
Title Patient Emergency Room Visits
Hide Description Average number of patient emergency room visits for any cause in a year
Time Frame baseline to 24-month
Hide Outcome Measure Data
Hide Analysis Population Description
Patients only. One patient in the EBQI arm had missing outcome information and was excluded from the analysis.
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description:

Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance.

Multilevel stakeholder engagement: Structured, in-person stakeholder panel meeting of VA network, VA medical center, and primary care and women's health leaders using modified Delphi panel techniques to come to consensus on a quality improvement (QI) roadmap within each participating VA network, followed by intermittent progress reporting and post-24 months in-person capstone stakeholder panel meetings.

Quality improvement (QI) education/training: Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement

Technical support: Research team provided technical review of and feedback

National policy guidance

National policy guidance: VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

Overall Number of Participants Analyzed 518 222
Mean (Standard Deviation)
Unit of Measure: Average visits per year for all patients
Baseline 0.90  (1.89) 0.72  (1.31)
24-month 0.78  (1.50) 0.55  (1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EBQI-Supported WH-PACT Implementation, Routine WH-PACT Implementation
Comments Change in number of emergency room visits for any cause between EBQI and control over time
Type of Statistical Test Superiority
Comments Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.
Statistical Test of Hypothesis P-Value 0.888
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.021
Confidence Interval (2-Sided) 95%
-0.265 to 0.306
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments The estimated value is predicted change in the number of VA emergency room visits, adjusting for characteristics described in the statistical analysis overview.
Time Frame No adverse events were expected for EBQI-supported WH-PACT implementation (target of action is VA employees). However, we did collect data from women Veteran routine primary care patients. Eligible patients were considered low-risk, so a formal suicidality assessment was not included. However, in an abundance of caution, any survey respondent who endorsed feeling down, depressed or hopeless at baseline, 12-months or 24-months received information about VA's suicide hotline.
Adverse Event Reporting Description Patients were not directly involved in this research other than to participate in a survey.
 
Arm/Group Title EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Hide Arm/Group Description Evidence-based Quality Improvement (EBQI) is a structured research-clinical partnership approach to facilitating implementation of new care models, including multilevel stakeholder engagement, quality improvement (QI) education/training, technical support, formative feedback, external practice facilitation, and national policy guidance. National policy guidance including VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities.
All-Cause Mortality
EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Affected / at Risk (%) Affected / at Risk (%)
Total   5/2720 (0.18%)   3/1180 (0.25%) 
Show Serious Adverse Events Hide Serious Adverse Events
EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2720 (0.00%)   0/1180 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EBQI-Supported WH-PACT Implementation Routine WH-PACT Implementation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2720 (0.00%)   0/1180 (0.00%) 
Control arm VAMCs are active controls given national mandates to implement PACT and WH PACT. Low response rates among providers/staff may have resulted in under- or over-estimation of effects, despite weighting for non-response.
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: Elizabeth M. Yano, PhD, MSPH
Organization: VA Greater Los Angeles Healthcare System
Phone: (818) 891-7711 ext 36031
EMail: elizabeth.yano@va.gov
Publications of Results:
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02039856     History of Changes
Other Study ID Numbers: CRE 12-026
First Submitted: January 14, 2014
First Posted: January 20, 2014
Results First Submitted: January 15, 2019
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019