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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01918072
• Collaborator: (none)
• Enrollment: 202
• Location: 1
• Actual Duration (Months): 67
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metrorrhagia; Urinary Incontinence; Remote Consultation; Videoconferencing; Women's Health; Menopause	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 Design

• Study Type: Observational
• Actual Enrollment: 202 participants
• Observational Model: Ecologic or Community
• Time Perspective: Retrospective
• Official Title: Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs
• Actual Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Sep 30, 2018
• Actual Study Completion Date: Sep 30, 2018

Arms and Interventions

Arm	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"

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Provider Referral Behavior [1-7 days after receiving a response to the electronic consult]

   This measure is the number of providers that changed their referral plan for an in-person specialist-to-patient visit after an electronic consultation.

3. Quality of Abnormal Uterine Bleeding Care [28-month study timeframe]

   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.

4. Quality of Menopausal Symptoms Care [28-month study timeframe]

   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.

5. Quality of Urinary Incontinence Care [28-month study timeframe]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California	United States	90073

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Donna L Washington, MD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 15, 2015

More Information

Additional Information:

• CREATE" Women Veterans Healthcare website

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01918072
• Other Study ID Numbers: CRE 12-031
• First Posted: Aug 7, 2013
• Last Update Posted: Nov 4, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by VA Office of Research and Development: Women's Health; Hospitals, Veterans; Education; Remote consultation; Videoconferencing
• Additional relevant MeSH terms: Urinary Incontinence; Metrorrhagia

Study Results

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 Detail	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.

Arm/Group Title	Stepped Wedge Participants	Electronic Consultation Survey Participants	Quality Assessment Participants
Arm/Group Description	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.	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.	Primary care providers delivering women's health care for one or more of the following conditions: abnormal uterine bleeding; menopausal symptoms; urinary incontinence.
Period Title: Controlled Trial Step One - Six Months
STARTED	11	0	0
Intervention	1	0	0
Control	10	0	0
COMPLETED	11	0	0
NOT COMPLETED	0	0	0
Period Title: Controlled Trial Step One - Six Months
STARTED	11	0	0
Intervention	7	0	0
Control	4	0	0
COMPLETED	11	0	0
NOT COMPLETED	0	0	0
Period Title: Controlled Trial Step One - Six Months
STARTED	11	0	0
Intervention	9	0	0
Control	2	0	0
COMPLETED	11	0	0
NOT COMPLETED	0	0	0
Period Title: Controlled Trial Step One - Six Months
STARTED	11	0	0
Intervention	11	0	0
Control	0	0	0
COMPLETED	11	0	0
NOT COMPLETED	0	0	0
Period Title: Controlled Trial Step One - Six Months
STARTED	11	0	0
Intervention	11	0	0
Control	0	0	0
COMPLETED	11	0	0
NOT COMPLETED	0	0	0
Period Title: Controlled Trial Step One - Six Months
STARTED	0	42	0
COMPLETED	0	42	0
NOT COMPLETED	0	0	0
Period Title: Controlled Trial Step One - Six Months
STARTED	0	0	202
COMPLETED	0	0	202
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	VA Primary Care Providers Delivering Women's Health Care
Arm/Group Description	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).
Overall Participants	202
Age, Customized (Count of Participants)
<18 years	0 0%
18 years or older	11 5.4%
<18 years	0 0%
18 years or older	42 20.8%
<18 years	0 0%
18 years or older	202 100%
Sex: Female, Male (Count of Participants)
Female	10 5%
Male	1 0.5%
Female	141 69.8%
Male	61 30.2%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	202 100%
Designated Women's Health Provider (DWHP) status (Count of Participants)
DWHP	11 5.4%
Non-DWHP	0 0%
Professional degree (Count of Participants)
MD or DO	4 2%
NP or PA	7 3.5%
Provider monthly encounters with women (months) [Mean (Full Range) ]
Mean (Full Range) [months]	159
Healthcare setting (Count of Participants)
VA Medical Center	7 3.5%
VA Community Based Outpatient Clinic	4 2%
Comprehensive women's health clinic setting (Count of Participants)
VA comprehensive WH clinic	5 2.5%
VA general primary care clinic	6 3%

Outcome Measures

1. Primary Outcome

Title	Change in Quality of Women's Health Care (Control Period vs. Intervention Period)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Wedge Participants
Arm/Group Description	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.
Measure Participants	11
Mean (Standard Error) [percent of care adherent to guidelines]	7.1 (8.6)

2. Secondary Outcome

Title	Change in Quality of Women's Health Care (Controlled Trial Steps)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Wedge Participants
Arm/Group Description	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.
Measure Participants	11
Mean (Standard Error) [percent of care adherent to guidelines]	9.6 (4.1)

3. Secondary Outcome

Title	Provider Referral Behavior
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Electronic Consultation Survey Participants
Arm/Group Description	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.
Measure Participants	42
Count of Participants [Participants]	13 6.4%

4. Secondary Outcome

Title	Quality of Abnormal Uterine Bleeding Care
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Quality Assessment Participants
Arm/Group Description	Primary care providers delivering women's health care for abnormal uterine bleeding.
Measure Participants	74
Mean (95% Confidence Interval) [percent of care adherent to guidelines]	53

5. Secondary Outcome

Title	Quality of Menopausal Symptoms Care
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Quality Assessment Participants
Arm/Group Description	Primary care providers delivering women's health care for menopausal symptoms.
Measure Participants	81
Mean (95% Confidence Interval) [percent of care adherent to guidelines]	58

6. Secondary Outcome

Title	Quality of Urinary Incontinence Care
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Quality Assessment Participants
Arm/Group Description	Primary care providers delivering women's health care for urinary incontinence.
Measure Participants	68
Mean (95% Confidence Interval) [percent of care adherent to guidelines]	39

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Stepped Wedge Participants		Electronic Consultation Survey Participants		Quality Assessment Participants
Arm/Group Description	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.		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.		Primary care providers delivering women's health care for one or more of the following conditions: abnormal uterine bleeding; menopausal symptoms; urinary incontinence.
All Cause Mortality
	Stepped Wedge Participants		Electronic Consultation Survey Participants		Quality Assessment Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Stepped Wedge Participants		Electronic Consultation Survey Participants		Quality Assessment Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Stepped Wedge Participants		Electronic Consultation Survey Participants		Quality Assessment Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.