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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| Cedars-Sinai Medical Center | OTHER |
| University of California, Los Angeles | OTHER |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
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The main goal of this clinical trial is to improve the care for urinary incontinence (UI) provided to adult women by primary care providers. The main questions it aims to answer are:
Provider participants will be randomized at the office level to either an intervention group or a delayed intervention (control) group. The intervention group will receive an intervention consisting of academic detailing, clinical decision support tools, electronic referral, and the ability to refer to an advanced practice provider for co-management. The delayed intervention group will provide usual care until the crossover phase of the study, at which point they will receive the same intervention as the intervention group.
Patient participants will bring up urinary incontinence with their primary care provider and complete three electronic surveys.
Researchers will compare the intervention group to the delayed intervention (control) group to see if the intervention results in increased adherence to evidence-based quality indicators.
The burden of urinary incontinence (UI) on American women is immense in human and financial terms, and continues to rise with the growing population of older adults. The goal of this proposal is to improve the care for UI provided to women and, in doing so, decrease the utilization of specialty care while improving patient outcomes. Specific Aim 1 seeks to improve the quality of incontinence care provided to an ethnically diverse population of women through a controlled practice-based intervention involving primary care providers. The intervention involves the implementation of PCOR measures. Four Southern California medical groups will participate in a cluster randomized controlled trial in which 60 offices (15 per site) will be randomized to undergo a practice-based incontinence intervention led by a "clinical champion dyad" comprised of a primary care provider and urologist/urogynecologist, both of whom are members of that specific medical group. The intervention will include physician education, individual performance feedback, electronic decision support, patient education using dedicated advanced practice providers (APPs), and the implementation of an electronic referral service. The quality of patient care, as evidenced by compliance with primary care UI quality indicators the investigators developed and pilot-tested, will be measured across the two randomized arms after implementation of the intervention. Compliance with these quality indicators will be the key means to implement PCOR evidence, while, at the same time, measure quality. In Specific Aim 2, utilization of specialists will be compared before and after the intervention. The investigators hypothesize that improved care at the level of the primary care physician will reduce the number of specialty referrals. Specific Aim 3 will seek to measure the effect of the intervention on patient outcomes. Under the hypothesis that a practice-based intervention will improve disease-specific outcomes, symptom severity, quality of life, and patient knowledge will be measured at baseline using validated questionnaires. After implementation of the intervention, these questionnaires will be given a second time six months later and outcomes will be compared between control and intervention groups. The investigators expect that this intervention will also reduce disparities in care for underrepresented minorities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Practice-Based Intervention | Experimental | The intervention will include physician education, electronic decision support, implementation of an electronic referral system, and patient education/co-management by an advance practice provider. |
|
| Control | No Intervention | Offices in this group will not receive the four-pronged intervention. However, after the study trial, there will be a "validation phase" in which the initial control group will then receive the intervention. This cross-over deign will then allow all 60 offices to receive the intervention. Data from the cross-over intervention group will be analyzed as a separate cohort to confirm improvements in patient care and outcomes as measured in the intervention group under the study trial can be duplicated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Academic Detailing | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to evidence-based quality-of-care indicators | Adherence to the QIs for patients who screen positive for UI will be compared across the two randomized arms at baseline and again at 3 and 6 months after intervention implementation. | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Referral rates to a specialist | The number of referrals to a specialist over the intervention period (urologist or gynecologist) will be quantified and compared between intervention and control groups. For patients screened as positive for new or worsening UI at their primary care physician office from Specific Aim 1, the investigators will record if and when the patient was referred to a specialist for treatment. Dates of each level of care provided will be incorporated into each chart abstraction so that the timing can be calculated. Investigators will also record the baseline rate of specialty referrals for each office during the baseline chart review. |
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Inclusion Criteria of Primary Care Physicians:
Inclusion Criteria of Patients
Exclusion Criteria of Primary Care Physicians:
Exclusion Criteria of Patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States | ||
| Cedars-Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12114899 | Background | Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Am J Obstet Gynecol. 2002 Jul;187(1):116-26. doi: 10.1067/mob.2002.125704. No abstract available. | |
| 21684555 |
| Label | URL |
|---|---|
| Care ICI. The Chronic Care Model | View source |
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Available by request.
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| OTHER |
| RAND | OTHER |
Four Southern California medical groups will participate in a cluster randomized controlled trial in which 60 offices (15 per site) will be randomized to undergo a practice-based incontinence intervention or control for 6 months. After the study trial, the control offices will then undergo the intervention as part of a "validation phase" of the study.
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Patients will be aware that their primary care physician is participating in the study. However, they will not be informed of which arm the physician belongs to. Primary care physicians will be aware of which arm their office was assigned to based on whether or not they receive the intervention.
|
| Electronic Clinical Decision Support | Other | Intervention physicians will have access to electronic clinical decision support consisting of note templates, order sets, interruptive alerts, and a notification of patients who screen positive for UI. |
|
| APP Co-management | Other | To reduce additional burden of care on the PCPs, the investigators will incorporate Advanced Practices Providers into the patient education and self-management portion of care. The APPs will be trained together with the intervention physicians, but they will also undergo additional standardized training on patient education, UI knowledge, providing instruction on Kegel exercises, shared decision making, and self management. Patients will then be scheduled for a UI education and self-management session with the APP by telemedicine (video visit or telephone visit) within one month of their initial visit. For patients in need of an annual pelvic examination, and if the patient's PCP prefers to have the APP conduct the pelvic exam, a separate visit will be scheduled with the APP. A followup televisit will then be scheduled within three months of the initial APP visit, in order to assess the outcome of non-surgical treatment and determine if a specialist referral is indicated. |
|
| Electronic Referral | Other | In implementing the electronic consultation system in the private sector, the investigators will model the Expected Practice developed by the Los Angeles County Specialty-Primary Care Work Group. This eConsult system utilizes a "kickback" mechanism by which a specialist, who reviews the referral, can return it if it has not met certain baseline criteria (e.g. for a woman with OAB/urinary urgency: document negative UA, scheduled voids, titrate fluids to thirst, Kegels, antimuscarinics, optimize diuretic control, adjust any diuretics). |
|
| Baseline, 6 months |
| ICIQ-SF | Four-item questionnaire that evaluates frequency, severity and impact on quality of life of UI. | Baseline, 3 months, 6 months |
| UDI-6 | Six-item questionnaire that measures quality of life and symptom distress for UI in women. | Baseline, 3 months, 6 months |
| PGI-I | Global index (transition scale) that measures symptom improvement. | 3 months, 6 months |
| PFAKS | Thirty-one-item questionnaire assessing patient knowledge in three domains: POP (11 items), SUI (10 items) and OAB (10 items) with questions on condition pathophysiology, management, and quality of life. | Baseline, 6 months |
| SDM-Q-9 | Nine-item questionnaire that measures the extent to which patients are involved in the process of decision-making. | 6 months |
| Net Promoter Score | Single-item questionnaire to evaluate the patient's willingness to refer their provider to a friend | 3 months, 6 months |
| IIQ-7 | Seven-item questionnaire to assess quality-of-life impact of UI | Baseline, 3 months, 6 months |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
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| L.A. WL. Race Ethnicity Pie Chart. | View source |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
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