MetrorrhagiaWH CREATE P4NCT01918072
Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs
An observational study of Metrorrhagia and Urinary Incontinence, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metrorrhagia, Urinary Incontinence, Remote Consultation
- What is being tested?
- Clinical innovation
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2013to 30 Sep 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: VA Women's Health primary care provider in who participates in VA SCAN-ECHO learning sessions or uses VA gynecology electronic consults.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
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.
Read the 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.
- Conditions
- Metrorrhagia, Urinary Incontinence, Remote Consultation, Videoconferencing, Women's Health, Menopause
- Being tested
- Clinical innovation
- Keywords
- Women's Health, Hospitals, Veterans, Education, Remote consultation, Videoconferencing
- Medical subject headings
- Metrorrhagia, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical innovationOther
Also called "DWHP Support"
Technology-based intervention that combines interactive communication with women's health specialists and ongoing education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical innovation | |
| 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. Receives: Other: Clinical innovation | |
| 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. Receives: Other: Clinical innovation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through four months after the final time step when participants entered into the intervention (28 months)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28-month study timeframe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study start1 Mar 2013
- Primary completion30 Sep 2018
- 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 (7)Papers the sponsor has linked to this study.
- Other trials for MetrorrhagiaStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Donna L Washington, MD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918072
- Sponsor's protocol ID
- CRE 12-031
- Acronym
- WH CREATE P4
- Status last verified
- Nov 2019
- First submitted
- 16 Jul 2013
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25767983deKleijn 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.
PubMed 25767971Yano 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.
PubMed 25767962Zuchowski 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.
PubMed 28817394Washington 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.
PubMed 30563732Cordasco 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.
PubMed 30723059Cordasco 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.
PubMed 30839493
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs
- ClinicalTrials.gov ID
- NCT01918072
- Acronym / sponsor ID
- WH CREATE P4 / CRE 12-031
- Conditions
- Metrorrhagia, Urinary Incontinence, Remote Consultation, Videoconferencing, Women's Health, Menopause
- Keywords
- Women's Health, Hospitals, Veterans, Education, Remote consultation, Videoconferencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stepped wedge participants | – | Other: Clinical innovationDesignated 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 | – | Other: Clinical innovationDesignated 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 | – | Other: Clinical innovationPrimary care providers delivering women's health care for one or more of the following conditions: abnormal uterine bleeding; menopausal symptoms; urinary incontinence. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- VA Women's Health primary care provider in who participates in VA SCAN-ECHO learning sessions or uses VA gynecology electronic consults.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Clinical innovationAlso: "DWHP Support"Technology-based intervention that combines interactive communication with women's health specialists and ongoing education | Other | Electronic consultation survey participants, Quality assessment participants, Stepped wedge participants |
Primary outcome
Change in Quality of Women's Health Care (Control Period vs. Intervention Period)
Time frame: 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.
5 secondary outcomes
Change in Quality of Women's Health Care (Controlled Trial Steps)
Time frame: Baseline through four months after the final time step when participants entered into the intervention (28 months)
Provider Referral Behavior
Time frame: 1-7 days after receiving a response to the electronic consult
Quality of Abnormal Uterine Bleeding Care
Time frame: 28-month study timeframe
Quality of Menopausal Symptoms Care
Time frame: 28-month study timeframe
Quality of Urinary Incontinence Care
Time frame: 28-month study timeframe
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25767983Cordasco 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.
- Results publication: PubMed 25767971deKleijn 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.
- Results publication: PubMed 25767962Yano 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.
- Results publication: PubMed 28817394Zuchowski 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.
- Results publication: PubMed 30563732Washington 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.
- Results publication: PubMed 30723059Cordasco 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.
- Results publication: PubMed 30839493Cordasco 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.
- Individual participant dataSharing planned: No
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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.
Donna L Washington, MD MPH principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metrorrhagia and Urinary Incontinence, run by VA Office of Research and Development at 1 site in United States.
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 1 inclusion and 1 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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 Nov 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?
Change in Quality of Women's Health Care (Control Period vs. Intervention Period) (time frame: Baseline through four months after the final time step when participants entered into the intervention (28 months)). 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 NCT01918072, which also lists 7 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 4 Nov 2019.