Outcomes of Urinary Incontinence Treatment in Primary Care: APP Co-Management and Electronic Consult

NCT06040645 | Enrolling By Invitation

• 1 other identifier: 806024
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 3

Brief Summary

The burden of urinary incontinence (UI) on American women is immense in both human and financial terms, and continues to rise with the aging US population. Although numerous non-surgical management strategies have proven efficacy for both stress and urge urinary incontinence, there remains a lack of appropriate UI management in the primary care setting. The goal of this multi-site cluster randomized comparative effectiveness trial is to compare the effects of two methods of nonsurgical UI care delivery - electronic consult vs. advanced practice provider (APP) co-management. These two evidence-based, practice-changing strategies are designed to improve the quality of care for an ethnically diverse population of women with UI, and, by reducing deficits in care, obtain better patient-reported outcomes. Both arms of the study will include basic physician education (academic detailing) and electronic clinical decision support. In Arm 1, the investigators will implement an electronic referral system (electronic referral), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided. In Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and assisting with patient self-management through dedicated televisits (APP co-management).

Conditions

Urinary Incontinence

Keywords

Practice-based intervention; Patient-centered outcomes research; Disparities; Referrals; Quality of care indicators; Primary care

Outcome Measures

Primary Outcomes (3)

• Provider Quality of Care - Evidence-Based Quality Indicators

  Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.

  Baseline

• Provider Quality of Care - Evidence-Based Quality Indicators

  Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.

  6 months

• Change in provider quality of care measured by evidence-based quality indicators

  Provider adherence to 13 evidence-based quality indicators will be compared across the E-Consult and Advanced Practice Provider (APP) Co-management arms.

  Baseline, 6 months

Secondary Outcomes (20)

• Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

  Baseline

• Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

  3 months

• Patient Symptoms - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

  6 months

• Change in patients' urinary incontinence symptoms as measured by ICIQ-SF

  Baseline, 3 months, 6 months

• Patient Symptoms - Urogenital Distress Inventory (UDI-6)

  Baseline

Study Arms (2)

Electronic Consult (E-consult)

EXPERIMENTAL

In Arm 1, the investigators will implement an electronic referral system (electronic co-management), in which specialists will electronically review referrals and make additional recommendations if appropriate primary UI care was not provided.

Other: E-consult

Advanced Practice Provider (APP) Co-management

EXPERIMENTAL

In Arm 2, Advanced Practice Provider (APP) co-management will reduce the burden of care on the PCPs by providing UI care, patient education, and assisting with patient self-management through dedicated televisits (APP co-management).

Other: APP Co-management

Interventions

E-consult 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).

Electronic Consult (E-consult)

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.

Advanced Practice Provider (APP) Co-management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Primary care physician belonging to a recruited office among one of three participating sites: UCSD, UCLA, KUMC
• Age \>18 y/o
• English or Spanish fluency
• Female
• Answers \"yes\" to incontinence screening tool and agrees to participate

You may not qualify if:

• Non-primary care specialty
• Does not belong to one of the participating offices
• Age \<18 y/o
• Answers \"no\" to incontinence screening tool and/or does not agree to participate
• Primary care provider (who reviews a list of patients that screen positive) deems patient ineligible due to pregnant, severe memory impairment, or psychiatric history preventing participation

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute: collaborator
• University of Kansas: collaborator
• University of California, San Diego: lead
• University of California, Los Angeles: collaborator

Study Sites (3)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (26)

• Dieter AA, Wilkins MF, Wu JM. Epidemiological trends and future care needs for pelvic floor disorders. Curr Opin Obstet Gynecol. 2015 Oct;27(5):380-4. doi: 10.1097/GCO.0000000000000200.

  PMID: 26308198 BACKGROUND

• Anger JT, Scott VC, Kiyosaki K, Khan AA, Weinberg A, Connor SE, Roth CP, Wenger N, Shekelle P, Litwin MS. Development of quality indicators for women with urinary incontinence. Neurourol Urodyn. 2013 Nov;32(8):1058-63. doi: 10.1002/nau.22353. Epub 2013 Sep 16.

  PMID: 24105879 BACKGROUND

• Anger JT, Alas A, Litwin MS, Chu SD, Bresee C, Roth CP, Rashid R, Shekelle P, Wenger NS. The Quality of Care Provided to Women with Urinary Incontinence in 2 Clinical Settings. J Urol. 2016 Oct;196(4):1196-200. doi: 10.1016/j.juro.2016.05.005. Epub 2016 May 7.

  PMID: 27164512 BACKGROUND

• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.

  PMID: 12559262 BACKGROUND

• Anger JT, Saigal CS, Litwin MS; Urologic Diseases of America Project. The prevalence of urinary incontinence among community dwelling adult women: results from the National Health and Nutrition Examination Survey. J Urol. 2006 Feb;175(2):601-4. doi: 10.1016/S0022-5347(05)00242-9.

  PMID: 16407004 BACKGROUND

• Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol. 2011 Aug;186(2):589-93. doi: 10.1016/j.juro.2011.03.114.

  PMID: 21684555 BACKGROUND

• Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009 Dec;114(6):1278-1283. doi: 10.1097/AOG.0b013e3181c2ce96.

  PMID: 19935030 BACKGROUND

• Mesens T, Aich A, Bhal PS. Late erosions of mid-urethral tapes for stress urinary incontinence--need for long-term follow-up? Int Urogynecol J Pelvic Floor Dysfunct. 2007 Sep;18(9):1113-4. doi: 10.1007/s00192-007-0301-4. Epub 2007 Mar 9.

  PMID: 17347793 BACKGROUND

• Schnelle JF, Smith RL. Quality indicators for the management of urinary incontinence in vulnerable community-dwelling elders. Ann Intern Med. 2001 Oct 16;135(8 Pt 2):752-8. doi: 10.7326/0003-4819-135-8_part_2-200110161-00015. No abstract available.

  PMID: 11601959 BACKGROUND

• Gnanadesigan N, Saliba D, Roth CP, Solomon DH, Chang JT, Schnelle J, Smith R, Shekelle PG, Wenger NS. The quality of care provided to vulnerable older community-based patients with urinary incontinence. J Am Med Dir Assoc. 2004 May-Jun;5(3):141-6. doi: 10.1097/01.JAM.0000123026.47700.1A.

  PMID: 15115573 BACKGROUND

• Bisgaier J, Rhodes KV. Auditing access to specialty care for children with public insurance. N Engl J Med. 2011 Jun 16;364(24):2324-33. doi: 10.1056/NEJMsa1013285.

  PMID: 21675891 BACKGROUND

• Rhodes KV, Bisgaier J, Lawson CC, Soglin D, Krug S, Van Haitsma M. "Patients who can't get an appointment go to the ER": access to specialty care for publicly insured children. Ann Emerg Med. 2013 Apr;61(4):394-403. doi: 10.1016/j.annemergmed.2012.10.030. Epub 2013 Jan 8.

  PMID: 23312670 BACKGROUND

• Mehrotra A, Forrest CB, Lin CY. Dropping the baton: specialty referrals in the United States. Milbank Q. 2011 Mar;89(1):39-68. doi: 10.1111/j.1468-0009.2011.00619.x.

  PMID: 21418312 BACKGROUND

• Dall TM, Gallo PD, Chakrabarti R, West T, Semilla AP, Storm MV. An aging population and growing disease burden will require a large and specialized health care workforce by 2025. Health Aff (Millwood). 2013 Nov;32(11):2013-20. doi: 10.1377/hlthaff.2013.0714.

  PMID: 24191094 BACKGROUND

• McKibben MJ, Kirby EW, Langston J, Raynor MC, Nielsen ME, Smith AB, Wallen EM, Woods ME, Pruthi RS. Projecting the Urology Workforce Over the Next 20 Years. Urology. 2016 Dec;98:21-26. doi: 10.1016/j.urology.2016.07.028. Epub 2016 Aug 1.

  PMID: 27491965 BACKGROUND

• Alas AN, Dunivan GC, Wieslander CK, Sevilla C, Barrera B, Rashid R, Maliski S, Eilber K, Rogers RG, Anger JT. Health Care Disparities Among English-Speaking and Spanish-Speaking Women With Pelvic Organ Prolapse at Public and Private Hospitals: What Are the Barriers? Female Pelvic Med Reconstr Surg. 2016 Nov/Dec;22(6):460-466. doi: 10.1097/SPV.0000000000000315.

  PMID: 27636216 BACKGROUND

• Khan AA, Sevilla C, Wieslander CK, Moran MB, Rashid R, Mittal B, Maliski SL, Rogers RG, Anger JT. Communication barriers among Spanish-speaking women with pelvic floor disorders: lost in translation? Female Pelvic Med Reconstr Surg. 2013 May-Jun;19(3):157-64. doi: 10.1097/SPV.0b013e318288ac1c.

  PMID: 23611934 BACKGROUND

• Min LC, Reuben DB, Adams J, Shekelle PG, Ganz DA, Roth CP, Wenger NS. Does better quality of care for falls and urinary incontinence result in better participant-reported outcomes? J Am Geriatr Soc. 2011 Aug;59(8):1435-43. doi: 10.1111/j.1532-5415.2011.03517.x. Epub 2011 Aug 1.

  PMID: 21806560 BACKGROUND

• Barnett ML, Yee HF Jr, Mehrotra A, Giboney P. Los Angeles Safety-Net Program eConsult System Was Rapidly Adopted And Decreased Wait Times To See Specialists. Health Aff (Millwood). 2017 Mar 1;36(3):492-499. doi: 10.1377/hlthaff.2016.1283.

  PMID: 28264951 BACKGROUND

• Soni SM, Giboney P, Yee HF Jr. Development and Implementation of Expected Practices to Reduce Inappropriate Variations in Clinical Practice. JAMA. 2016 May 24-31;315(20):2163-4. doi: 10.1001/jama.2016.4255. No abstract available.

  PMID: 27218624 BACKGROUND

• Jennings LA, Tan Z, Wenger NS, Cook EA, Han W, McCreath HE, Serrano KS, Roth CP, Reuben DB. Quality of Care Provided by a Comprehensive Dementia Care Comanagement Program. J Am Geriatr Soc. 2016 Aug;64(8):1724-30. doi: 10.1111/jgs.14251. Epub 2016 Jun 29.

  PMID: 27355394 BACKGROUND

• Bordeianou LG, Anger JT, Boutros M, Birnbaum E, Carmichael JC, Connell KA, De EJB, Mellgren A, Staller K, Vogler SA, Weinstein MM, Yafi FA, Hull TL; Members of the Pelvic Floor Disorders Consortium Working Groups on Patient-Reported Outcomes. Measuring Pelvic Floor Disorder Symptoms Using Patient-Reported Instruments: Proceedings of the Consensus Meeting of the Pelvic Floor Consortium of the American Society of Colon and Rectal Surgeons, the International Continence Society, the American Urogynecologic Society, and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction. Female Pelvic Med Reconstr Surg. 2020 Jan/Feb;26(1):1-15. doi: 10.1097/SPV.0000000000000817. No abstract available.

  PMID: 31833996 BACKGROUND

• McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, Kerr EA. The quality of health care delivered to adults in the United States. N Engl J Med. 2003 Jun 26;348(26):2635-45. doi: 10.1056/NEJMsa022615.

  PMID: 12826639 BACKGROUND

• Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.

  PMID: 12861145 BACKGROUND

• Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.

  PMID: 16021067 BACKGROUND

• Min LC, Reuben DB, MacLean CH, Shekelle PG, Solomon DH, Higashi T, Chang JT, Roth CP, Kamberg CJ, Adams J, Young RT, Wenger NS. Predictors of overall quality of care provided to vulnerable older people. J Am Geriatr Soc. 2005 Oct;53(10):1705-11. doi: 10.1111/j.1532-5415.2005.53520.x.

  PMID: 16181169 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology, Vice Chair of Research

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: September 15, 2023
• Study Start: February 16, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 8, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)