Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs (WH CREATE P4)

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Menopause; Videoconferencing; Remote Consultation; Metrorrhagia; Women's Health
• Intervention / Treatment: Other: Clinical innovation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• United States
  • California
    • West Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

VA Women's Health primary care provider in who participates in VA SCAN-ECHO learning sessions or uses VA gynecology electronic consults.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Clinical innovation; Technology-based intervention that combines interactive communication with women's health specialists and ongoing education; Other Names: "DWHP Support"
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.	Other: Clinical innovation; Technology-based intervention that combines interactive communication with women's health specialists and ongoing education; Other Names: "DWHP Support"
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.	Other: Clinical innovation; Technology-based intervention that combines interactive communication with women's health specialists and ongoing education; Other Names: "DWHP Support"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Donna L Washington, MD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• CREATE" Women Veterans Healthcare website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Hospitals, Veterans; Education; Women's Health; Videoconferencing; Remote consultation
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Uterine Diseases; Hemorrhage; Urination Disorders; Uterine Hemorrhage; Urinary Incontinence; Metrorrhagia
• Other Study ID Numbers: CRE 12-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No