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Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs

Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01918072
Acronym
WH CREATE P4
Enrollment
202
Registered
2013-08-07
Start date
2013-03-01
Completion date
2018-09-30
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Metrorrhagia, Remote Consultation, Urinary Incontinence, Videoconferencing, Women's Health

Keywords

Women's Health, Hospitals, Veterans, Education, Remote consultation, Videoconferencing

Brief summary

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.

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.

Interventions

OTHERClinical innovation

Technology-based intervention that combines interactive communication with women's health specialists and ongoing education

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Quality of Women's Health Care (Control Period vs. Intervention Period)Baseline through four months after the final time step when participants entered into the intervention (28 months)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.

Secondary

MeasureTime frameDescription
Change in Quality of Women's Health Care (Controlled Trial Steps)Baseline through four months after the final time step when participants entered into the intervention (28 months)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.
Provider Referral Behavior1-7 days after receiving a response to the electronic consultThis measure is the number of providers that changed their referral plan for an in-person specialist-to-patient visit after an electronic consultation.
Quality of Abnormal Uterine Bleeding Care28-month study timeframeQuality 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.
Quality of Menopausal Symptoms Care28-month study timeframeQuality 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.
Quality of Urinary Incontinence Care28-month study timeframeQuality 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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).
202
Total202

Baseline characteristics

CharacteristicVA Primary Care Providers Delivering Women's Health Care
Age, Customized
Electronic consultations
<18 years
0 Participants
Age, Customized
Electronic consultations
18 years or older
42 Participants
Age, Customized
Quality assessment
<18 years
0 Participants
Age, Customized
Quality assessment
18 years or older
202 Participants
Age, Customized
Stepped wedge
<18 years
0 Participants
Age, Customized
Stepped wedge
18 years or older
11 Participants
Comprehensive women's health clinic setting
VA comprehensive WH clinic
5 Participants
Comprehensive women's health clinic setting
VA general primary care clinic
6 Participants
Designated Women's Health Provider (DWHP) status
DWHP
11 Participants
Designated Women's Health Provider (DWHP) status
Non-DWHP
0 Participants
Healthcare setting
VA Community Based Outpatient Clinic
4 Participants
Healthcare setting
VA Medical Center
7 Participants
Professional degree
MD or DO
4 Participants
Professional degree
NP or PA
7 Participants
Provider monthly encounters with women159 months
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
202 participants
Sex: Female, Male
Quality assessment
Female
141 Participants
Sex: Female, Male
Quality assessment
Male
61 Participants
Sex: Female, Male
Stepped wedge
Female
10 Participants
Sex: Female, Male
Stepped wedge
Male
1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

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.

Time frame: Baseline through four months after the final time step when participants entered into the intervention (28 months)

ArmMeasureValue (MEAN)Dispersion
Stepped Wedge ParticipantsChange in Quality of Women's Health Care (Control Period vs. Intervention Period)7.1 percent of care adherent to guidelinesStandard Error 8.6
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.

Time frame: Baseline through four months after the final time step when participants entered into the intervention (28 months)

ArmMeasureValue (MEAN)Dispersion
Stepped Wedge ParticipantsChange in Quality of Women's Health Care (Controlled Trial Steps)9.6 percent of care adherent to guidelinesStandard Error 4.1
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.

Time frame: 1-7 days after receiving a response to the electronic consult

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Stepped Wedge ParticipantsProvider Referral Behavior13 Participants
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.

Time frame: 28-month study timeframe

Population: The analysis included primary care providers providing care for abnormal uterine bleeding episodes during the 28-month study timeframe.

ArmMeasureValue (MEAN)
Stepped Wedge ParticipantsQuality of Abnormal Uterine Bleeding Care53 percent of care adherent to guidelines
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.

Time frame: 28-month study timeframe

Population: The analysis included primary care providers providing care for menopausal symptoms episodes during the 28-month study timeframe.

ArmMeasureValue (MEAN)
Stepped Wedge ParticipantsQuality of Menopausal Symptoms Care58 percent of care adherent to guidelines
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.

Time frame: 28-month study timeframe

Population: The analysis included primary care providers providing care for urinary incontinence episodes during the 28-month study timeframe.

ArmMeasureValue (MEAN)
Stepped Wedge ParticipantsQuality of Urinary Incontinence Care39 percent of care adherent to guidelines

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026