Patient-centered Medical Home ImplementationWH-PACTNCT02039856

Implementation of Women's Health Patient Aligned Care Teams

A study testing Multilevel stakeholder engagement, Quality improvement (QI) education/training and Technical support in people with Patient-centered Medical Home Implementation, run by VA Office of Research and Development at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Patient-centered Medical Home Implementation
What is being tested?: Multilevel stakeholder engagement, Quality improvement (QI) education/training and Technical support
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,900 participants
Where: 13 sitesUnited States
Study dates: 9 May 2014to 30 Sep 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Facility inclusion criteria:
VA medical center (VAMC)
Located in a VISN that has 3 or more VAMCs
Membership in the Women's Health Practice Based Research Network (PBRN)
Key Stakeholder (interviews) inclusion criteria:
VISN and VAMC leaders, VAMC primary care/PACT directors, VAMC women's health medical directors, Women Veteran Program Managers (VISN and VAMC), VISN representatives in mental health, health information technology/informatics, quality improvement/system redesign, at least one Nurse Executive (VISN or VAMC)

Show all 17Show fewer

Intervention and control VAMCs
Provider (surveys and interviews) inclusion criteria:
Primary care providers (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner [NP], physician assistant [PA]) who have seen 1+ women Veterans in the past year
Teamlet primary care provider interviews (MD, DO, NP, PA) at intervention VAMCs
Surveys of primary care providers (MD, DO, NP, PA) at intervention and control VAMCs
Surveys of larger primary care/PACT team members (e.g., clinical pharmacists, health coaches)
Staff (surveys and interviews) inclusion criteria:
Primary care/PACT clinical staff (non-providers) in primary care/PACT teams/teamlets that have seen 1+ women Veterans in the past year
Teamlet member interviews at Intervention VAMCs
Patient inclusion criteria:
Women Veterans seen in participating VAMCs with 3+ primary care visits in general primary care and/or women's health clinics in the past year

Who cannot join

Facility exclusion criteria:
VA facilities that are not VAMCs (e.g., community-based outpatient clinics or CBOCs)
VAMCs in VISNs with fewer than 3 VAMCs
VAMCs that are not members of the WH PBRN
Key Stakeholder (interviews) exclusion criteria:
Stakeholders outside of the participating VISNs (1, 4, 12, 23) and VAMCs (see study sites)

Show all 17Show fewer

Provider (surveys and interviews) exclusion criteria:
VA providers who do not deliver primary care in participating VAMCs
VA primary care providers who have not seen or do not see women Veteran patients for primary care delivery at a participating VAMC
Teamlet providers at control VAMCs will not be interviewed
Staff (surveys and interviews) exclusion criteria:
Primary care clinical staff not participating in PACT (e.g., assigned to primary care rolls but not actually associated with primary care/PACT direct patient care delivery)
Primary care/PACT clinical staff at control VAMCs will not be interviewed
Patient exclusion criteria:
Women Veterans who do not use the VA for their health care or for their primary care needs
Women Veterans with fewer than 3 VA primary care visits in the prior year and therefore not exposed to PACT or WH PACT
Women Veterans with terminal illness and/or poor prognosis or other health concerns for whom enrollment and survey participation would prove an inappropriate burden

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV
Clarksburg, West Virginia, 26301
Fargo VA Healthcare System, Fargo, ND
Fargo, North Dakota, 58102
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: Implementation of VA Womens Health Patient Aligned Care Teams WH-PACTs

VA has undertaken a major initiative to transform care through implementation of Patient Aligned Care Teams (PACTs). Based on the patient-centered medical home (PCMH) concept, PACT aims to improve access, continuity, coordination and comprehensiveness using team-based care that is patient-driven and patient-centered. However, how VA should adapt PACT to meet the needs of special populations, such as women Veterans, is yet to be worked out. The main goal of this study was to develop and test an evidence-based quality improvement (EBQI) approach to adapting and implementing PACT for women Veterans, incorporating comprehensive women's health care in gender-sensitive care environments, thereby accelerating achievement of PACT tenets for women Veterans and reducing persistent gender disparities in VA quality of care.

Read the detailed description

Women Veterans' numerical minority in VA healthcare settings has created logistical challenges to delivering gender-sensitive comprehensive services. These challenges only grew as more women Veterans enrolled in VA care. Access and quality lagged behind that of male Veterans, while gender sensitivity, including adequate attention to privacy/safety and awareness of women's military roles and experiences, were often lacking. On-site availability of gender-specific services had also not kept pace, with women Veterans more likely to be outsourced for gender-specific care than they were ten years previously. Further, while the proportion of VA facilities having women's health (WH) clinics had increased, prior research demonstrated that as many as 40% of them were not delivering comprehensive primary care services, instead focusing only on gender-specific exams. Lack of gender-sensitive, comprehensive care for women has also been associated with measurable decrements in women's ratings of VA access, continuity and coordination, as well as measures of technical quality.

The investigators aimed to assess the effectiveness of evidence-based quality improvement (EBQI) methods for developing a WH PACT model using a cluster randomized controlled trial (cRCT) design (Aim #1); examine impacts of receipt of WH-PACT concordant care on women Veterans' outcomes (Aim #2); evaluate processes of EBQI-supported WH-PACT implementation (Aim #3); and develop implementation and evaluation tools for use in EBQI-supported WH-PACT model adaptation, implementation, sustainability and spread to additional VA facilities (Aim #4).

EBQI is a systematic approach to developing a multi-level research-clinical partnership approach to engaging local organizational senior leaders and quality improvement teams in adapting and implementing new care models in the context of prior evidence, local practice context, and provider behavior change methods, with researchers providing technical support and practice facilitation. In a cluster randomized trial, the investigators evaluated WH-PACT model achievement using patient, provider and practice surveys. The investigators examined intermediate changes in provider, staff and team knowledge and attitudes. Using analyses of secondary administrative and performance data, the investigators also explored impacts of receipt of WH-PACT care on quality of chronic disease care and prevention, health status, and utilization. Using mixed methods, the investigators assessed pre-post EBQI practice context; documented WH-PACT implementation; and examined barriers/facilitators to EBQI-supported WH-PACT implementation through a combination of semi-structured interviews and formative progress narratives and administrative data review.

Conditions: Patient-centered Medical Home Implementation
Being tested: Multilevel stakeholder engagement, Quality improvement (QI) education/training, Technical support, Formative feedback, External practice facilitation
Keywords: Patient-centered medical homes, Primary care, Women's health, Veterans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multilevel stakeholder engagementOther
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/trainingOther
Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement
Technical supportOther
Research team provided technical review of and feedback on local QI project proposals, helped develop and/or recommend process/outcome measures, identified and shared relevant published literature (e.g., measures, interventions), and provided general technical support (e.g., how to analyze local data, how to conduct a local focus group)
Formative feedbackOther
Research team provided aggregated all-site and local data from baseline patient and provider/staff surveys, 12-month patient surveys, and other data and findings to local teams for ongoing and new QI project idea development
External practice facilitationOther
Also called Facilitation
Within and across site calls with local teams to review progress, identify needs, help solve problems, discuss current and new projects, as well as potential for spread
National policy guidanceOther
VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities

Study groups in NCT02039856
Study group	Role	What they receive
EBQI-Supported WH-PACT Implementation	Experimental	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. Receives: Other: Multilevel stakeholder engagement; Other: Quality improvement (QI) education/training; Other: Technical support; Other: Formative feedback; Other: External practice facilitation; Other: National policy guidance
Routine WH-PACT Implementation	Active comparator	National policy guidance Receives: Other: National policy guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

WH-PACT Achievement
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.
Measured: Baseline to 24-month

Secondary outcomes (7)

Providers' and Staff Gender Sensitivity
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.
Measured: Baseline to 24-month
Team Functioning
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.
Measured: Baseline to 24-month
Providers and Staff Burnout
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).
Measured: 24-month
Patient VA Primary Care Visits Per Year
Average number of visits to VA primary care per year
Measured: Baseline to 24month
Patient VA Women's Health Care Visits Per Year
Average number of patient visits to VA women's health care per year
Measured: Baseline to 24month
Patient VA Hospitalization
Average number of patient hospitalization for any cause in a year
Measured: Baseline to 24-month
Patient Emergency Room Visits
Average number of patient emergency room visits for any cause in a year
Measured: baseline to 24-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 201430 Sep 2018

First posted20 Jan 2014 (estimated)
Study start9 May 2014
Primary completion30 Sep 2017
Study completion30 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Patient-centered Medical Home ImplementationStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Cluster randomized controlled trial (cRCT) among 12 VAMCs with unbalanced allocation (2:1) blocked on VA network (Veterans Integrated Service Network or VISN)
Masking: None (open label)
Enrolment: 3,900 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02039856
Sponsor's protocol ID: CRE 12-026
Acronym: WH-PACT
Status last verified: Jun 2023
First submitted: 14 Jan 2014
Last updated: 18 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yano EM, Bair MJ, Carrasquillo O, Krein SL, Rubenstein LV. Patient Aligned Care Teams (PACT): VA's journey to implement patient-centered medical homes. J Gen Intern Med. 2014 Jul;29 Suppl 2(Suppl 2):S547-9. doi: 10.1007/s11606-014-2835-8. No abstract available.
PubMed 24715407
Yano EM, Haskell S, Hayes P. Delivery of gender-sensitive comprehensive primary care to women veterans: implications for VA Patient Aligned Care Teams. J Gen Intern Med. 2014 Jul;29 Suppl 2(Suppl 2):S703-7. doi: 10.1007/s11606-013-2699-3.
PubMed 24715395
Chuang E, Brunner J, Mak S, Hamilton AB, Canelo I, Darling J, Rubenstein LV, Yano EM. Challenges with Implementing a Patient-Centered Medical Home Model for Women Veterans. Womens Health Issues. 2017 Mar-Apr;27(2):214-220. doi: 10.1016/j.whi.2016.11.005. Epub 2017 Jan 4.
PubMed 28063848
Hamilton AB, Brunner J, Cain C, Chuang E, Luger TM, Canelo I, Rubenstein L, Yano EM. Engaging multilevel stakeholders in an implementation trial of evidence-based quality improvement in VA women's health primary care. Transl Behav Med. 2017 Sep;7(3):478-485. doi: 10.1007/s13142-017-0501-5.
PubMed 28585163
Goldstein KM, Vogt D, Hamilton A, Frayne SM, Gierisch J, Blakeney J, Sadler A, Bean-Mayberry BM, Carney D, DiLeone B, Fox AB, Klap R, Yee E, Romodan Y, Strehlow H, Yosef J, Yano EM. Practice-based research networks add value to evidence-based quality improvement. Healthc (Amst). 2018 Jun;6(2):128-134. doi: 10.1016/j.hjdsi.2017.06.008. Epub 2017 Jul 13.
PubMed 28711505
Meredith LS, Azhar G, Okunogbe A, Canelo IA, Darling JE, Street AE, Yano EM. Primary Care Providers with More Experience and Stronger Self-Efficacy Beliefs Regarding Women Veterans Screen More Frequently for Interpersonal Violence. Womens Health Issues. 2017 Sep-Oct;27(5):586-591. doi: 10.1016/j.whi.2017.06.003. Epub 2017 Jul 25.
PubMed 28754476
Meredith LS, Wang Y, Okunogbe A, Bergman AA, Canelo IA, Darling JE, Yano EM. Attitudes, Practices, and Experiences with Implementing a Patient-Centered Medical Home for Women Veterans. Womens Health Issues. 2017 Mar-Apr;27(2):221-227. doi: 10.1016/j.whi.2016.11.008. Epub 2017 Jan 10.
PubMed 28087130
Yano EM, Hamilton AB. Accelerating delivery of trauma-sensitive care: Using multilevel stakeholder engagement to improve care for women veterans. Fam Syst Health. 2017 Sep;35(3):373-375. doi: 10.1037/fsh0000288.
PubMed 28945449
Hamilton AB, Yano EM. The importance of symbolic and engaged participation in evidence-based quality improvement in a complex integrated healthcare system: response to "The science of stakeholder engagement in research". Transl Behav Med. 2017 Sep;7(3):492-494. doi: 10.1007/s13142-017-0528-7.
PubMed 28929322
Brunner J, Chuang E, Washington DL, Rose DE, Chanfreau-Coffinier C, Darling JE, Canelo IA, Yano EM. Patient-Rated Access to Needed Care: Patient-Centered Medical Home Principles Intertwined. Womens Health Issues. 2018 Mar-Apr;28(2):165-171. doi: 10.1016/j.whi.2017.12.001. Epub 2018 Jan 12.
PubMed 29339012
Narain K, Bean-Mayberry B, Washington DL, Canelo IA, Darling JE, Yano EM. Access to Care and Health Outcomes Among Women Veterans Using Veterans Administration Health Care: Association With Food Insufficiency. Womens Health Issues. 2018 May-Jun;28(3):267-272. doi: 10.1016/j.whi.2018.01.002. Epub 2018 Feb 21.
PubMed 29475630
Hoggatt KJ, Simpson T, Schweizer CA, Drexler K, Yano EM. Identifying women veterans with unhealthy alcohol use using gender-tailored screening. Am J Addict. 2018 Mar;27(2):97-100. doi: 10.1111/ajad.12689.
PubMed 29489045
Yano EM, Darling JE, Hamilton AB, Canelo I, Chuang E, Meredith LS, Rubenstein LV. Cluster randomized trial of a multilevel evidence-based quality improvement approach to tailoring VA Patient Aligned Care Teams to the needs of women Veterans. Implement Sci. 2016 Jul 19;11(1):101. doi: 10.1186/s13012-016-0461-z.
PubMed 27435723
Brunner J, Cain CL, Yano EM, Hamilton AB. Local Leaders' Perspectives on Women Veterans' Health Care: What Would Ideal Look Like? Womens Health Issues. 2019 Jan-Feb;29(1):64-71. doi: 10.1016/j.whi.2018.10.005. Epub 2018 Nov 16.
PubMed 30455089
Klap R, Darling JE, Hamilton AB, Rose DE, Dyer K, Canelo I, Haskell S, Yano EM. Prevalence of Stranger Harassment of Women Veterans at Veterans Affairs Medical Centers and Impacts on Delayed and Missed Care. Womens Health Issues. 2019 Mar-Apr;29(2):107-115. doi: 10.1016/j.whi.2018.12.002. Epub 2019 Jan 25.
PubMed 30686577

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of VA Womens Health Patient Aligned Care Teams WH-PACTs
ClinicalTrials.gov ID: NCT02039856
Acronym / sponsor ID: WH-PACT / CRE 12-026
Conditions: Patient-centered Medical Home Implementation
Keywords: Patient-centered medical homes, Primary care, Women's health, Veterans
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,900 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: University of California, Los Angeles, RAND
Study start: 9 May 2014 (actual)
Primary completion: 30 Sep 2017 (actual)
Study completion: 30 Sep 2018 (actual)
First posted: 20 Jan 2014 (estimated)
Results: Posted 21 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Cluster randomized controlled trial (cRCT) among 12 VAMCs with unbalanced allocation (2:1) blocked on VA network (Veterans Integrated Service Network or VISN)

Arm	Type	Receives
EBQI-Supported WH-PACT Implementation	Experimental	Other: Multilevel stakeholder engagement, Other: Quality improvement (QI) education/training, Other: Technical support, Other: Formative feedback, Other: External practice facilitation, Other: National policy guidanceEvidence-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.
Routine WH-PACT Implementation	Active comparator	Other: National policy guidanceNational policy guidance

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

VA medical center (VAMC)
Located in a VISN that has 3 or more VAMCs
Membership in the Women's Health Practice Based Research Network (PBRN)
VISN and VAMC leaders, VAMC primary care/PACT directors, VAMC women's health medical directors, Women Veteran Program Managers (VISN and VAMC), VISN representatives in mental health, health information technology/informatics, quality improvement/system redesign, at least one Nurse Executive (VISN or VAMC)
Intervention and control VAMCs

Key exclusion criteria (17 listed)

VA facilities that are not VAMCs (e.g., community-based outpatient clinics or CBOCs)
VAMCs in VISNs with fewer than 3 VAMCs
VAMCs that are not members of the WH PBRN
Stakeholders outside of the participating VISNs (1, 4, 12, 23) and VAMCs (see study sites)
VA providers who do not deliver primary care in participating VAMCs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multilevel stakeholder engagementStructured, 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	Other	EBQI-Supported WH-PACT Implementation
Quality improvement (QI) education/trainingInitial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement	Other	EBQI-Supported WH-PACT Implementation
Technical supportResearch team provided technical review of and feedback on local QI project proposals, helped develop and/or recommend process/outcome measures, identified and shared relevant published literature (e.g., measures, interventions), and provided general technical support (e.g., how to analyze local data, how to conduct a local focus group)	Other	EBQI-Supported WH-PACT Implementation
Formative feedbackResearch team provided aggregated all-site and local data from baseline patient and provider/staff surveys, 12-month patient surveys, and other data and findings to local teams for ongoing and new QI project idea development	Other	EBQI-Supported WH-PACT Implementation
External practice facilitationAlso: FacilitationWithin and across site calls with local teams to review progress, identify needs, help solve problems, discuss current and new projects, as well as potential for spread	Other	EBQI-Supported WH-PACT Implementation
National policy guidanceVA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities	Other	EBQI-Supported WH-PACT Implementation, Routine WH-PACT Implementation

Primary outcome

WH-PACT Achievement
Time frame: Baseline to 24-month
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.

7 secondary outcomes

Providers' and Staff Gender Sensitivity
Time frame: Baseline to 24-month
Team Functioning
Time frame: Baseline to 24-month
Providers and Staff Burnout
Time frame: 24-month
Patient VA Primary Care Visits Per Year
Time frame: Baseline to 24month
Patient VA Women's Health Care Visits Per Year
Time frame: Baseline to 24month
Patient VA Hospitalization
Time frame: Baseline to 24-month
Patient Emergency Room Visits
Time frame: baseline to 24-month

Results and safety

Results posted to the registry on 21 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EBQI-Supported WH-PACT Implementation	2,720	693
Routine WH-PACT Implementation	1,180	327

Primary outcome: WH-PACT Achievement

Time frame: Baseline to 24-month. Count of participants. Unit: Participants

Measure	EBQI-Supported WH-PACT Implementation n = 518	Routine WH-PACT Implementation n = 222
Baseline: -4	30	23
Baseline: -3	49	20
Baseline: -2	51	26
Baseline: -1	49	24
Baseline: 0	59	23
Baseline: +1	73	31
Baseline: +2	79	27
Baseline: +3	75	28

EBQI-Supported WH-PACT Implementation vs Routine WH-PACT Implementation: Odds Ratio (OR): 0.913 (95% CI 0.627 to 1.33), p = 0.637, difference-in-differences analysis

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EBQI-Supported WH-PACT Implementation	0 of 2,720 (0%)	0 of 2,720 (0%)	5 of 2,720
Routine WH-PACT Implementation	0 of 1,180 (0%)	0 of 1,180 (0%)	3 of 1,180

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24715407Yano EM, Bair MJ, Carrasquillo O, Krein SL, Rubenstein LV. Patient Aligned Care Teams (PACT): VA's journey to implement patient-centered medical homes. J Gen Intern Med. 2014 Jul;29 Suppl 2(Suppl 2):S547-9. doi: 10.1007/s11606-014-2835-8. No abstract available.
Background: PubMed 24715395Yano EM, Haskell S, Hayes P. Delivery of gender-sensitive comprehensive primary care to women veterans: implications for VA Patient Aligned Care Teams. J Gen Intern Med. 2014 Jul;29 Suppl 2(Suppl 2):S703-7. doi: 10.1007/s11606-013-2699-3.
Results publication: PubMed 28063848Chuang E, Brunner J, Mak S, Hamilton AB, Canelo I, Darling J, Rubenstein LV, Yano EM. Challenges with Implementing a Patient-Centered Medical Home Model for Women Veterans. Womens Health Issues. 2017 Mar-Apr;27(2):214-220. doi: 10.1016/j.whi.2016.11.005. Epub 2017 Jan 4.
Results publication: PubMed 28585163Hamilton AB, Brunner J, Cain C, Chuang E, Luger TM, Canelo I, Rubenstein L, Yano EM. Engaging multilevel stakeholders in an implementation trial of evidence-based quality improvement in VA women's health primary care. Transl Behav Med. 2017 Sep;7(3):478-485. doi: 10.1007/s13142-017-0501-5.
Results publication: PubMed 28711505Goldstein KM, Vogt D, Hamilton A, Frayne SM, Gierisch J, Blakeney J, Sadler A, Bean-Mayberry BM, Carney D, DiLeone B, Fox AB, Klap R, Yee E, Romodan Y, Strehlow H, Yosef J, Yano EM. Practice-based research networks add value to evidence-based quality improvement. Healthc (Amst). 2018 Jun;6(2):128-134. doi: 10.1016/j.hjdsi.2017.06.008. Epub 2017 Jul 13.
Results publication: PubMed 28754476Meredith LS, Azhar G, Okunogbe A, Canelo IA, Darling JE, Street AE, Yano EM. Primary Care Providers with More Experience and Stronger Self-Efficacy Beliefs Regarding Women Veterans Screen More Frequently for Interpersonal Violence. Womens Health Issues. 2017 Sep-Oct;27(5):586-591. doi: 10.1016/j.whi.2017.06.003. Epub 2017 Jul 25.
Results publication: PubMed 28087130Meredith LS, Wang Y, Okunogbe A, Bergman AA, Canelo IA, Darling JE, Yano EM. Attitudes, Practices, and Experiences with Implementing a Patient-Centered Medical Home for Women Veterans. Womens Health Issues. 2017 Mar-Apr;27(2):221-227. doi: 10.1016/j.whi.2016.11.008. Epub 2017 Jan 10.
Results publication: PubMed 28945449Yano EM, Hamilton AB. Accelerating delivery of trauma-sensitive care: Using multilevel stakeholder engagement to improve care for women veterans. Fam Syst Health. 2017 Sep;35(3):373-375. doi: 10.1037/fsh0000288.
Results publication: PubMed 28929322Hamilton AB, Yano EM. The importance of symbolic and engaged participation in evidence-based quality improvement in a complex integrated healthcare system: response to "The science of stakeholder engagement in research". Transl Behav Med. 2017 Sep;7(3):492-494. doi: 10.1007/s13142-017-0528-7.
Results publication: PubMed 29339012Brunner J, Chuang E, Washington DL, Rose DE, Chanfreau-Coffinier C, Darling JE, Canelo IA, Yano EM. Patient-Rated Access to Needed Care: Patient-Centered Medical Home Principles Intertwined. Womens Health Issues. 2018 Mar-Apr;28(2):165-171. doi: 10.1016/j.whi.2017.12.001. Epub 2018 Jan 12.
Results publication: PubMed 29475630Narain K, Bean-Mayberry B, Washington DL, Canelo IA, Darling JE, Yano EM. Access to Care and Health Outcomes Among Women Veterans Using Veterans Administration Health Care: Association With Food Insufficiency. Womens Health Issues. 2018 May-Jun;28(3):267-272. doi: 10.1016/j.whi.2018.01.002. Epub 2018 Feb 21.
Results publication: PubMed 29489045Hoggatt KJ, Simpson T, Schweizer CA, Drexler K, Yano EM. Identifying women veterans with unhealthy alcohol use using gender-tailored screening. Am J Addict. 2018 Mar;27(2):97-100. doi: 10.1111/ajad.12689.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth M. Yano, PhD MSPH principal investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WH-PACT Achievement (time frame: Baseline to 24-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02039856, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.