Trial Outcomes & Findings for Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs (NCT NCT01918072)
NCT ID: NCT01918072
Last Updated: 2019-11-04
Results Overview
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.
COMPLETED
202 participants
Baseline through four months after the final time step when participants entered into the intervention (28 months)
2019-11-04
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Controlled Trial Step One - Six Months
STARTED
|
11
|
0
|
0
|
|
Controlled Trial Step One - Six Months
Intervention
|
1
|
0
|
0
|
|
Controlled Trial Step One - Six Months
Control
|
10
|
0
|
0
|
|
Controlled Trial Step One - Six Months
COMPLETED
|
11
|
0
|
0
|
|
Controlled Trial Step One - Six Months
NOT COMPLETED
|
0
|
0
|
0
|
|
Controlled Trial Step Two - Six Months
STARTED
|
11
|
0
|
0
|
|
Controlled Trial Step Two - Six Months
Intervention
|
7
|
0
|
0
|
|
Controlled Trial Step Two - Six Months
Control
|
4
|
0
|
0
|
|
Controlled Trial Step Two - Six Months
COMPLETED
|
11
|
0
|
0
|
|
Controlled Trial Step Two - Six Months
NOT COMPLETED
|
0
|
0
|
0
|
|
Controlled Trial Step Three - Six Months
STARTED
|
11
|
0
|
0
|
|
Controlled Trial Step Three - Six Months
Intervention
|
9
|
0
|
0
|
|
Controlled Trial Step Three - Six Months
Control
|
2
|
0
|
0
|
|
Controlled Trial Step Three - Six Months
COMPLETED
|
11
|
0
|
0
|
|
Controlled Trial Step Three - Six Months
NOT COMPLETED
|
0
|
0
|
0
|
|
Controlled Trial Step Four - Six Months
STARTED
|
11
|
0
|
0
|
|
Controlled Trial Step Four - Six Months
Intervention
|
11
|
0
|
0
|
|
Controlled Trial Step Four - Six Months
Control
|
0
|
0
|
0
|
|
Controlled Trial Step Four - Six Months
COMPLETED
|
11
|
0
|
0
|
|
Controlled Trial Step Four - Six Months
NOT COMPLETED
|
0
|
0
|
0
|
|
Controlled Trial Step Five - Four Months
STARTED
|
11
|
0
|
0
|
|
Controlled Trial Step Five - Four Months
Intervention
|
11
|
0
|
0
|
|
Controlled Trial Step Five - Four Months
Control
|
0
|
0
|
0
|
|
Controlled Trial Step Five - Four Months
COMPLETED
|
11
|
0
|
0
|
|
Controlled Trial Step Five - Four Months
NOT COMPLETED
|
0
|
0
|
0
|
|
E-consult Assessment Period
STARTED
|
0
|
42
|
0
|
|
E-consult Assessment Period
COMPLETED
|
0
|
42
|
0
|
|
E-consult Assessment Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Quality Assessment Period
STARTED
|
0
|
0
|
202
|
|
Quality Assessment Period
COMPLETED
|
0
|
0
|
202
|
|
Quality Assessment Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. E-CONSULT SURVEY: DWHPs who completed surveys about e-consult use. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence.
Baseline characteristics by cohort
| Measure |
VA Primary Care Providers Delivering Women's Health Care
n=202 Participants
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).
|
|---|---|
|
Age, Customized
Stepped wedge · <18 years
|
0 Participants
n=11 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. E-CONSULT SURVEY: DWHPs who completed surveys about e-consult use. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence.
|
|
Age, Customized
Stepped wedge · 18 years or older
|
11 Participants
n=11 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. E-CONSULT SURVEY: DWHPs who completed surveys about e-consult use. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence.
|
|
Age, Customized
Electronic consultations · <18 years
|
0 Participants
n=42 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. E-CONSULT SURVEY: DWHPs who completed surveys about e-consult use. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence.
|
|
Age, Customized
Electronic consultations · 18 years or older
|
42 Participants
n=42 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. E-CONSULT SURVEY: DWHPs who completed surveys about e-consult use. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence.
|
|
Age, Customized
Quality assessment · <18 years
|
0 Participants
n=202 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. E-CONSULT SURVEY: DWHPs who completed surveys about e-consult use. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence.
|
|
Age, Customized
Quality assessment · 18 years or older
|
202 Participants
n=202 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. E-CONSULT SURVEY: DWHPs who completed surveys about e-consult use. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence.
|
|
Sex: Female, Male
Stepped wedge · Female
|
10 Participants
n=11 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence. E-CONSULT SURVEY: Sex data were not collected.
|
|
Sex: Female, Male
Stepped wedge · Male
|
1 Participants
n=11 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence. E-CONSULT SURVEY: Sex data were not collected.
|
|
Sex: Female, Male
Quality assessment · Female
|
141 Participants
n=202 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence. E-CONSULT SURVEY: Sex data were not collected.
|
|
Sex: Female, Male
Quality assessment · Male
|
61 Participants
n=202 Participants • STEPPED WEDGE CONTROLLED TRIAL: DWHPs with one or more episodes of care for women patients during each period of the intervention. QUALITY ASSESSMENT: PCPs delivering women's health care for abnormal uterine bleeding, menopausal symptoms, or urinary incontinence. E-CONSULT SURVEY: Sex data were not collected.
|
|
Region of Enrollment
United States
|
202 participants
n=202 Participants
|
|
Designated Women's Health Provider (DWHP) status
DWHP
|
11 Participants
n=11 Participants • This baseline measure was assessed for participants in the stepped wedge controlled trial.
|
|
Designated Women's Health Provider (DWHP) status
Non-DWHP
|
0 Participants
n=11 Participants • This baseline measure was assessed for participants in the stepped wedge controlled trial.
|
|
Professional degree
MD or DO
|
4 Participants
n=11 Participants • This baseline measure was assessed for participants in the stepped wedge controlled trial.
|
|
Professional degree
NP or PA
|
7 Participants
n=11 Participants • This baseline measure was assessed for participants in the stepped wedge controlled trial.
|
|
Provider monthly encounters with women
|
159 months
n=11 Participants • This baseline measure was assessed for participants in the stepped wedge controlled trial.
|
|
Healthcare setting
VA Medical Center
|
7 Participants
n=11 Participants • This baseline measure was assessed for participants in the stepped wedge controlled trial.
|
|
Healthcare setting
VA Community Based Outpatient Clinic
|
4 Participants
n=11 Participants • This baseline measure was assessed for participants in the stepped wedge controlled trial.
|
|
Comprehensive women's health clinic setting
VA comprehensive WH clinic
|
5 Participants
n=11 Participants • This baseline measure was assessed for participants in the stepped wedge controlled trial.
|
|
Comprehensive women's health clinic setting
VA general primary care clinic
|
6 Participants
n=11 Participants • This baseline measure was assessed for participants in the stepped wedge controlled trial.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Stepped Wedge Participants
n=11 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.
|
|---|---|
|
Change in Quality of Women's Health Care (Control Period vs. Intervention Period)
|
7.1 percent of care adherent to guidelines
Standard Error 8.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Stepped Wedge Participants
n=11 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.
|
|---|---|
|
Change in Quality of Women's Health Care (Controlled Trial Steps)
|
9.6 percent of care adherent to guidelines
Standard Error 4.1
|
SECONDARY outcome
Timeframe: 1-7 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.
Outcome measures
| Measure |
Stepped Wedge Participants
n=42 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.
|
|---|---|
|
Provider Referral Behavior
|
13 Participants
|
SECONDARY outcome
Timeframe: 28-month study timeframePopulation: The analysis included primary care providers providing care for abnormal uterine bleeding episodes during the 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.
Outcome measures
| Measure |
Stepped Wedge Participants
n=74 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.
|
|---|---|
|
Quality of Abnormal Uterine Bleeding Care
|
53 percent of care adherent to guidelines
Interval 51.0 to 56.0
|
SECONDARY outcome
Timeframe: 28-month study timeframePopulation: The analysis included primary care providers providing care for menopausal symptoms episodes during the 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.
Outcome measures
| Measure |
Stepped Wedge Participants
n=81 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.
|
|---|---|
|
Quality of Menopausal Symptoms Care
|
58 percent of care adherent to guidelines
Interval 55.0 to 60.0
|
SECONDARY outcome
Timeframe: 28-month study timeframePopulation: The analysis included primary care providers providing care for urinary incontinence episodes during the 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.
Outcome measures
| Measure |
Stepped Wedge Participants
n=68 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.
|
|---|---|
|
Quality of Urinary Incontinence Care
|
39 percent of care adherent to guidelines
Interval 36.0 to 42.0
|
Adverse Events
Stepped Wedge Participants
Electronic Consultation Survey Participants
Quality Assessment Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Donna L. Washington, MD, MPH
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place