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

This study is currently recruiting participants.
Verified January 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01918072
First received: July 16, 2013
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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 Intervention
Metrorrhagia
Contraception
Preconception Care
Remote Consultation
Videoconferencing
Women's Health
Other: Clinical innovation

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in quality of women's health care [ Time Frame: Change from pre-implementation at 12 months after the clinical innovation is initiated in the final healthcare system ] [ Designated as safety issue: No ]
    Quality of care as defined by adherence to practice guidelines.


Secondary Outcome Measures:
  • Change in efficiency of women's health care delivery [ Time Frame: Change from pre-implementation at 12 months after the clinical innovation initiated in the final healthcare system ] [ Designated as safety issue: No ]
    Efficiency of care as defined by preventability of in-person specialist-to-patient visits.

  • Change in provider behavior and self-rated women's health knowledge, skills, and self-efficacy [ Time Frame: baseline - prior to or in the initial few months of exposure; 12 months after initial exposure ] [ Designated as safety issue: No ]
    Provider self-rated change in management of the patient whose care was the focus of the clinical innovation; provider self-rated knowledge, skills, and self-efficacy in women's health care delivery

  • Attitudes about and use of the clinical innovation [ Time Frame: baseline - prior to or in the initial few months of exposure; 12 months after initial exposure ] [ Designated as safety issue: No ]
    Attitudes and self-reported use as reported in semi-structured interviews


Biospecimen Retention:   None Retained

Not applicable - none


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1/PCP before innovation initiated
primary care providers in healthcare systems before the innovation has been initiated in those healthcare system
Other: Clinical innovation
Technology-based intervention that combines interactive communication with women's health specialists and ongoing education
Other Name: "DWHP Support"
2/PCP after innovation initiated
primary care providers in the same healthcare systems after the innovation has been initiated in those healthcare systems
Other: Clinical innovation
Technology-based intervention that combines interactive communication with women's health specialists and ongoing education
Other Name: "DWHP Support"

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 within VISN 22; 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

VA Women's Health primary care provider in Southern California or Southern Nevada

Criteria

Inclusion Criteria:

  • VA Women's Health primary care provider in Southern California or Southern Nevada

Exclusion Criteria:

none

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01918072

Contacts
Contact: Donna L Washington, MD MPH (310) 478-3711 ext 49479 donna.washington@va.gov
Contact: Kristina M Cordasco, MD MPH MSHS Kristina.Cordasco@va.gov

Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA Recruiting
West Los Angeles, California, United States, 90073
Contact: Donna L Washington, MD MPH    310-478-3711 ext 49479    donna.washington@va.gov   
Principal Investigator: Donna L. Washington, MD MPH         
Sub-Investigator: Kristina M Cordasco, MD MPH MSHS         
Sponsors and Collaborators
Investigators
Principal Investigator: Donna L. Washington, MD MPH VA Greater Los Angeles Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01918072     History of Changes
Other Study ID Numbers: CRE 12-031
Study First Received: July 16, 2013
Last Updated: January 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Women's Health
Hospitals, Veterans
Education
Remote consultation
Videoconferencing

Additional relevant MeSH terms:
Metrorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014