Urinary Incontinence Clinical Trial
— WH CREATE P4Official title:
Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs
NCT number | NCT01918072 |
Other study ID # | CRE 12-031 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2013 |
Est. completion date | September 30, 2018 |
Verified date | November 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 202 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Cordasco 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.2018.12.00 — View Citation
Cordasco 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):99-1 — View Citation
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): — View Citation
deKleijn 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. — View Citation
Washington 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: — View Citation
Yano 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. — View Citation
Zuchowski 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/CE — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Baseline through four months after the final time step when participants entered into the intervention (28 months) | |
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. | Baseline through four months after the final time step when participants entered into the intervention (28 months) | |
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. | 1-7 days after receiving a response to the electronic consult | |
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. | 28-month study timeframe | |
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. | 28-month study timeframe | |
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. | 28-month study timeframe |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05534412 -
A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence
|
N/A | |
Recruiting |
NCT05515198 -
Improving Care for Women With Urinary Incontinence (EMPOWER)
|
N/A | |
Completed |
NCT04071301 -
Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
|
N/A | |
Completed |
NCT03623880 -
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
|
N/A | |
Recruiting |
NCT05880862 -
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
|
Early Phase 1 | |
Recruiting |
NCT04159467 -
Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet
|
N/A | |
Completed |
NCT05485922 -
Performance of a Single-use Intermittent Micro-hole Zone Catheter
|
N/A | |
Completed |
NCT06268782 -
The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
|
N/A | |
Not yet recruiting |
NCT03027986 -
Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
|
N/A | |
Recruiting |
NCT02490917 -
ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence
|
N/A | |
Enrolling by invitation |
NCT02530372 -
Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
|
N/A | |
Enrolling by invitation |
NCT02529371 -
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
|
N/A | |
Completed |
NCT02549729 -
Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy
|
N/A | |
Completed |
NCT02600676 -
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
|
N/A | |
Completed |
NCT02338726 -
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
|
N/A | |
Completed |
NCT02368262 -
Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy
|
N/A | |
Completed |
NCT02239796 -
Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence
|
N/A | |
Completed |
NCT01942681 -
Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride
|
N/A | |
Recruiting |
NCT01804153 -
Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)
|
Phase 1/Phase 2 | |
Completed |
NCT01520948 -
Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
|
Phase 3 |