Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
VA community-based outpatient clinics (CBOCs) typically serve only a small number of women Veterans, and generally do not have the women's health care resources that are available in larger settings. Women Veterans using these sites for primary care must sometimes travel to other sites to receive women's health care. That can create travel burdens, reduce continuity of care, and negatively affect patient outcomes. To address this, VA is implementing a clinical operations innovation that supports women's primary care providers with a technology-based intervention that combines interactive communication with women's health specialists and ongoing education. This research study is evaluating the implementation and effects of this women's healthcare delivery innovation. Findings from this research will inform VA women's health clinical practice and education, and will advance science in delivering technology-supported non-face-to-face care that is applicable to other clinical conditions and patient populations.
Project Background/Rationale: Women Veterans are a rapidly growing proportion of VA patients. While entitled to receive care equivalent to their male counterparts, women Veterans may receive lower quality care, in part due to a VA primary care (PC) workforce that has limited experience caring for women, particularly their gender-specific conditions. This workforce may be especially challenged in community-based outpatient clinics (CBOCs), where access to women's health (WH) expertise may not be readily available. CBOC PC providers (PCPs) typically have small caseloads of women Veterans, making it difficult for these providers to maintain their WH knowledge and skills. To ensure quality care for women Veterans, VA mandated designated WH providers (DWHPs) in every VA facility, and instituted intensive training opportunities-"WH mini-residencies"-for these providers. Although highly valuable in delivering a standard level of specialized WH training, these one-time trainings are not sufficient, as knowledge attenuates over time. Serial education re-enforcement over time is needed to produce and maintain long-term gains in knowledge. Furthermore, additional supports, such as enhanced communication between PCPs and specialists, are necessary to achieve and sustain quality gains. To address these issues, VA is implementing a clinical operations innovation that is designed to improve CBOC-based DWHP delivery of comprehensive WH care. This innovation (entitled DWHP Support) combines: 1) advanced WH serial patient-based education that exposes DWHPs, over time, to a depth and breadth of WH cases and issues (SCAN-ECHO); and 2) interactive communication between CBOC DWHPs and VA Medical Center-based specialists for "just in time" support of DWHP WH care (electronic consultations). The intervention is technology-supported and delivered virtually. It is being implemented in a stepwise manner.
Objectives: Facilitators and barriers to use of DWHP Support, and its effect on patient management are unknown. The investigators hypothesize that DWHP Support will improve the quality and efficiency of WH care in CBOCs. The specific aims are:
Aim #1: To evaluate the effect of DWHP Support on WH care quality and efficiency, using a modified stepped wedge design; Aim #2: To explore the impact of DWHP Support in changing DWHP behavior and self-rated WH knowledge, skills, and self-efficacy; Aim #3: To assess attitudes about DWHP Support and its use, specialist time for its implementation, and other features that could influence DWHP Support's effectiveness, sustainability and spread; Aim #4: To develop tools to measure quality of WH care in VA.
Methods: The investigators will conduct an observational study of DWHP Support for CBOC DWHPs. The investigators will use a mixed methods analytic approach (combining a modified stepped wedge quantitative analysis with provider surveys and interviews) to measure the intervention's effect after 1 year, while also evaluating the implementation process and use of the intervention. The investigators will use quality assessment methods to translate existing evidence-based WH performance guidelines into quality measurement tools applicable to VA WH care.
Anticipated Impact: This proposal aims to evaluate an innovation to improve WH care in CBOCs that uses a technology-based educational and interactive communication intervention designed for WH providers. To measure the intervention's effectiveness, this project will develop WH quality measures that will be valuable tools for other VA efforts to improve WH care. The findings on effectiveness and implementation could influence VA's approach and use of technology-supported interventions for other clinical conditions and in other special populations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped wedge participants | Designated Women's Health Providers with one or more episodes of care for women patients during each period of the intervention. Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women. |
| |
| Electronic consultation survey participants | Designated Women's Health Providers who completed surveys about use of electronic consultations. Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women. |
| |
| Quality assessment participants | Primary care providers delivering women's health care for one or more of the following conditions: abnormal uterine bleeding; menopausal symptoms; urinary incontinence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical innovation | Other | Technology-based intervention that combines interactive communication with women's health specialists and ongoing education |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Women's Health Care (Control Period vs. Intervention Period) | Quality of care as defined by adherence to practice guidelines. This measure is the difference in the percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers at baseline versus after entering into the intervention. | Baseline through four months after the final time step when participants entered into the intervention (28 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Women's Health Care (Controlled Trial Steps) | Quality of care as defined by adherence to practice guidelines. This measure is the difference in the percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers, with each subsequent step, over the course of the controlled trial. | Baseline through four months after the final time step when participants entered into the intervention (28 months) |
Not provided
Inclusion Criteria:
US Department of Veterans Affairs Women's Health primary care provider in who participates in Veterans Affairs SCAN-ECHO learning sessions or uses Veterans Affairs gynecology electronic consults.
Exclusion Criteria:
none
Not provided
Not provided
Not provided
Not provided
VA Women's Health primary care provider in who participates in VA SCAN-ECHO learning sessions or uses VA gynecology electronic consults.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donna L Washington, MD MPH | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25767983 | Result | Cordasco KM, Zuchowski JL, Hamilton AB, Kirsh S, Veet L, Saavedra JO, Altman L, Knapp H, Canning M, Washington DL. Early lessons learned in implementing a women's health educational and virtual consultation program in VA. Med Care. 2015 Apr;53(4 Suppl 1):S88-92. doi: 10.1097/MLR.0000000000000313. | |
| 25767971 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
STEPPED WEDGE CONTROLLED TRIAL INCLUSION CRITERIA: Designated Women's Health Providers (DWHPs) with one or more episodes of care for women patients during each period of the intervention. ELECTRONIC CONSULTATION SURVEY INCLUSION CRITERIA: DWHPs who submitted and received a response to a gynecology electronic consult during the study timeframe.
Primary care providers (PCPs) delivering women's health care from June 2013 - September 2015 in VA healthcare systems that implemented the DWHP Support women's health clinical innovation, which is a technology-based program that combines interactive communication with women's health specialist and ongoing education.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stepped Wedge Participants | Designated Women's Health Providers with one or more episodes of care for women patients during each period of the intervention. Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women. |
| FG001 | Electronic Consultation Survey Participants | Designated Women's Health Providers who completed surveys about use of electronic consultations. Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women. |
| FG002 | Quality Assessment Participants | Primary care providers delivering women's health care for one or more of the following conditions: abnormal uterine bleeding; menopausal symptoms; urinary incontinence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Controlled Trial Step One - Six Months |
| |||||||||||||||||||
| Controlled Trial Step Two - Six Months |
| |||||||||||||||||||
| Controlled Trial Step Three - Six Months |
| |||||||||||||||||||
| Controlled Trial Step Four - Six Months |
| |||||||||||||||||||
| Controlled Trial Step Five - Four Months |
| |||||||||||||||||||
| E-consult Assessment Period |
| |||||||||||||||||||
| Quality Assessment Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VA Primary Care Providers Delivering Women's Health Care | Primary care providers in VA healthcare systems that implemented the DWHP Support women's health clinical innovation (a technology-based program that combines interactive communication with women's health specialist and ongoing education). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. E-CONSULT SURVEY: DWHPs who completed surveys about e-consult use. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quality of Women's Health Care (Control Period vs. Intervention Period) | Quality of care as defined by adherence to practice guidelines. This measure is the difference in the percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers at baseline versus after entering into the intervention. | Posted | Mean | Standard Error | percent of care adherent to guidelines | Baseline through four months after the final time step when participants entered into the intervention (28 months) |
|
Not provided
Serious and other [non-serious] adverse events were not collected or assessed as part of the study. To indicate that adverse events were not collected as part of the study, "0" is entered for the total number of participants at risk and affected for the three arms/groups listed in all adverse events tables.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stepped Wedge Participants | Designated Women's Health Providers with one or more episodes of care for women patients during each period of the intervention. Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna L. Washington, MD, MPH | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | 310-478-3711 | 49479 | donna.washington@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2015 | Sep 30, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not applicable - none
|
| Provider Referral Behavior | This measure is the number of providers that changed their referral plan for an in-person specialist-to-patient visit after an electronic consultation. | 1-7 days after receiving a response to the electronic consult |
| Quality of Abnormal Uterine Bleeding Care | Quality of abnormal uterine bleeding care as defined by adherence to practice guidelines. This measure is the mean percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers. | 28-month study timeframe |
| Quality of Menopausal Symptoms Care | Quality of menopausal symptoms care as defined by adherence to practice guidelines. This measure is the mean percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers. | 28-month study timeframe |
| Quality of Urinary Incontinence Care | Quality of urinary incontinence care as defined by adherence to practice guidelines. This measure is the mean percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers. | 28-month study timeframe |
| deKleijn M, Lagro-Janssen AL, Canelo I, Yano EM. Creating a roadmap for delivering gender-sensitive comprehensive care for women Veterans: results of a national expert panel. Med Care. 2015 Apr;53(4 Suppl 1):S156-64. doi: 10.1097/MLR.0000000000000307. |
| 25767962 | Result | Yano EM. A partnered research initiative to accelerate implementation of comprehensive care for women veterans: the VA women's health CREATE. Med Care. 2015 Apr;53(4 Suppl 1):S10-4. doi: 10.1097/MLR.0000000000000340. No abstract available. |
| 28817394 | Result | Zuchowski JL, Hamilton AB, Washington DL, Gomez AG, Veet L, Cordasco KM. Drivers of Continuing Education Learning Preferences for Veterans Affairs Women's Health Primary Care Providers. J Contin Educ Health Prof. 2017 Summer;37(3):168-172. doi: 10.1097/CEH.0000000000000164. |
| 30563732 | Result | Washington DL, Danz M, Jackson L, Cordasco KM. Development of Quality Indicators for the Care of Women with Abnormal Uterine Bleeding by Primary Care Providers in the Veterans Health Administration. Womens Health Issues. 2019 Mar-Apr;29(2):135-143. doi: 10.1016/j.whi.2018.11.002. Epub 2018 Dec 15. |
| 30723059 | Result | Cordasco KM, Yuan AH, Danz MJ, Farmer MM, Jackson L, Yee EF, Washington DL. Guideline Adherence of Veterans Health Administration Primary Care for Abnormal Uterine Bleeding. Womens Health Issues. 2019 Mar-Apr;29(2):144-152. doi: 10.1016/j.whi.2018.12.004. Epub 2019 Feb 2. |
| 30839493 | Result | Cordasco KM, Yuan AH, Danz MJ, Jackson L, Yee EF, Tcheung LS, Washington DL. Veterans Health Administration Primary Care Provider Adherence to Prescribing Guidelines for Systemic Hormone Therapy in Menopausal Women. J Healthc Qual. 2019 Mar/Apr;41(2):99-109. doi: 10.1097/JHQ.0000000000000183. |
| Control |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Control |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Control |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Control |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Count of Participants |
| Participants |
|
| Sex: Female, Male | STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence. E-CONSULT SURVEY: Sex data were not collected. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Designated Women's Health Provider (DWHP) status | This baseline measure was assessed for participants in the stepped wedge controlled trial. | Count of Participants | Participants |
|
| Professional degree | This baseline measure was assessed for participants in the stepped wedge controlled trial. | Count of Participants | Participants |
|
| Provider monthly encounters with women | This baseline measure was assessed for participants in the stepped wedge controlled trial. | Mean | Full Range | months |
|
| Healthcare setting | This baseline measure was assessed for participants in the stepped wedge controlled trial. | Count of Participants | Participants |
|
| Comprehensive women's health clinic setting | This baseline measure was assessed for participants in the stepped wedge controlled trial. | Count of Participants | Participants |
|
|
|
| Secondary | Change in Quality of Women's Health Care (Controlled Trial Steps) | Quality of care as defined by adherence to practice guidelines. This measure is the difference in the percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers, with each subsequent step, over the course of the controlled trial. | Posted | Mean | Standard Error | percent of care adherent to guidelines | Baseline through four months after the final time step when participants entered into the intervention (28 months) |
|
|
|
| Secondary | Provider Referral Behavior | This measure is the number of providers that changed their referral plan for an in-person specialist-to-patient visit after an electronic consultation. | Posted | Count of Participants | Participants | 1-7 days after receiving a response to the electronic consult |
|
|
|
| Secondary | Quality of Abnormal Uterine Bleeding Care | Quality of abnormal uterine bleeding care as defined by adherence to practice guidelines. This measure is the mean percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers. | The analysis included primary care providers providing care for abnormal uterine bleeding episodes during the 28-month study timeframe. | Posted | Mean | 95% Confidence Interval | percent of care adherent to guidelines | 28-month study timeframe |
|
|
|
| Secondary | Quality of Menopausal Symptoms Care | Quality of menopausal symptoms care as defined by adherence to practice guidelines. This measure is the mean percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers. | The analysis included primary care providers providing care for menopausal symptoms episodes during the 28-month study timeframe. | Posted | Mean | 95% Confidence Interval | percent of care adherent to guidelines | 28-month study timeframe |
|
|
|
| Secondary | Quality of Urinary Incontinence Care | Quality of urinary incontinence care as defined by adherence to practice guidelines. This measure is the mean percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers. | The analysis included primary care providers providing care for urinary incontinence episodes during the 28-month study timeframe. | Posted | Mean | 95% Confidence Interval | percent of care adherent to guidelines | 28-month study timeframe |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Electronic Consultation Survey Participants | Designated Women's Health Providers who completed surveys about use of electronic consultations. Designated Women's Health Provider: Primary care provider who are proficient in women's health, and should have a minimum of 10% of their patient panels being comprised by women. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Quality Assessment Participants | Primary care providers delivering women's health care for one or more of the following conditions: abnormal uterine bleeding; menopausal symptoms; urinary incontinence. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |