Expanding and Promoting Alternative Care and kNowledge in Decision-making Trial

NCT06243068 | Enrolling By Invitation DMC

• 2 other identifiers: NCR235148IHS-2022C2-27678
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 25

Brief Summary

The goal of this clinical trial is to compare two health system-based approaches for offering kidney failure treatment options to older patients with kidney failure, specifically, to ensure patients are actively involved in a shared decision making (SDM) process covering a full range of treatment choices and have meaningful access to that full range of choices. These include standard in-center or home dialysis as well as alternative treatment plans (ATPs): active medical care without dialysis, time-limited trial of dialysis, palliative dialysis, and deciding not to decide. Approach 1 - Educate and Engage: Nephrology practices encourage their patients to a) participate in a kidney disease education program providing a balanced presentation of all options including ATPs, b) use evidence-based patient decision aids that include ATPs, and c) engage in SDM with staff trained in communication skills and best practices. Approach 2 - Educate and Engage Plus Kidney Supportive Care Program: Nephrology practices add a primary palliative care program to support patients who choose ATPs and their families. The program provides care coordination, symptom management, advance care planning, and psychosocial support to supplement usual care from their nephrologist. To compare the two approaches, the investigators will conduct a repeated, cross-sectional stepped wedge cluster randomized trial involving 20-25 chronic kidney disease clinics at 8 practice organizations around the United States. Aim 1: Compare the effectiveness of Approaches 1 and 2 in a) increasing proportion of patients choosing ATP and b) reducing patient-reported decisional conflict about treatment. Aim 2: Compare the patient and family experience of ATP care between Approaches 1 and 2 in terms of quality of life, services used, and end of life (EOL) experience. Aim 2a will focus on experience while patients are receiving an ATP. Aim 2b will describe the EOL experience. Aim 3: Evaluate implementation of each approach through a mixed-methods design based on the expanded RE-AIM framework. For Aims 1 and 2, researchers will collect information by chart review and surveys with patients and caregivers. For Aim 3, clinic administrators, clinical providers, and staff will complete pre- and post-test surveys at the beginning and end of each training.

Conditions

Chronic Kidney Disease

Keywords

CKD; Alternative Treatment Plan; KDE; Kidney Disease Education; Palliative Care; Shared-Decision Making; Active Medical Management without Dialysis; AMCWD; Kidney Supportive Care; ESRD

Outcome Measures

Primary Outcomes (2)

• Proportion of patients choosing Alternative Treatment Plans (ATP)

  Numerator: number of patients choosing an alternative treatment plan. Denominator: enrolled patients with decision-making capacity.

  Month 4 after enrollment.

• Decisional Conflict Scale score

  Decisional Conflict Scale (O'Connor, 1995) score at month 4 survey, adjusted for baseline score. Score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).

  Month 4 after enrollment.

Secondary Outcomes (14)

• Rating of CKD Knowledge Among Older Adults (Know-CKD) score

  Four months after enrollment.

• Shared Decision Making Questionnaire (SDM-Q-9) score

  Month 4 after enrollment.

• CollaboRATE score

  Month 4 after enrollment.

• Patient reported decision regret

  Month 9 after enrollment.

• Advance care planning (ACP) documentation

  Month 4 after enrollment.

Other Outcomes (7)

• McGill Quality of Life Part A Score

  Starts after consent to participate in longitudinal interviews. Repeats every 4 months until first of project completion or patient death, assessed up to 40 months.

• ATP patient reports of experience of ATP care (qualitative)

  Starts after consent to participate in longitudinal interviews. Repeats every 4 months until first of project completion or patient death, assessed up to 40 months.]

• Caregiver reports of caregiving experience (qualitative)

  Starts after consent to participate in longitudinal interviews. Repeats every 4 months until first of project completion or patient death, assessed up to 40 months.

Study Arms (2)

Educate and Engage

EXPERIMENTAL

Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 1.

Behavioral: Educate and Engage

Educate and Engage Plus Kidney Supportive Care Program

EXPERIMENTAL

Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 2.

Behavioral: Educate and Engage Plus Kidney Supportive Care Program

Interventions

Educate and Engage BEHAVIORAL

Nephrology practices implement a bundle in which they will encourage their patients to a) participate in a kidney disease education program providing a balanced presentation of all options including ATPs, b) use evidence-based patient decision aids that include ATPs, and c) engage in shared decision-making with staff who have been trained in communication skills and best practices.

Educate and Engage

Educate and Engage Plus Kidney Supportive Care Program BEHAVIORAL

In addition to bundle described under "Educate and Engage," nephrology practices offer a systematic program integrating primary palliative care to support patients and their families who choose any ATP. The program closely follows patients and their families on ATP with care coordination, symptom management, advance care planning, and psychosocial support to supplement usual care from their nephrologist.

Educate and Engage Plus Kidney Supportive Care Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Most recent eGFR \<30 at time of screening AND meets practice site criteria for KDE referral
• Treatment naïve (no dialysis or kidney transplant prior to enrollment)

You may not qualify if:

• The patient is a transplant candidate.
• The current decrease in eGFR is thought to be due to an acute event.
• Education and initiation of shared decision-making process are not yet indicated for the patient, (per practice protocol and/or provider's judgment).
• \- Insufficient decision making capacity (Outcomes for this group will be described separately.)
• Insufficient decision making capacity
• Non-English and non-Spanish speaking
• Treating nephrologist/APP opts patient out (for example, if contraindicated for patient's health)
• Study Population 2: Family member or caregiver of patient in Study Population 1
• Family member or caregiver of Population 1 patient who has chosen alternative treatment plan
• + years old
• English or Spanish speaking
• Cognitively able to participate in surveys/interviews
• Study Population 3: Administrator, clinical provider, or staff at participating chronic kidney disease clinic
• \- Currently practicing or employed at participating clinic

Sponsors & Collaborators

• George Washington University: lead
• West Virginia University Research Corporation: collaborator
• University of Bristol: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (25)

UCSF/Zuckerberg San Francisco General Hospital and Trauma Center-Nephrology

San Francisco, California, 94110, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Southeast Kidney Associates

Canton, Georgia, 30114, United States

Location

Southeast Kidney Associates

East Point, Georgia, 30344, United States

Location

St. Clair Nephrology

Shelby, Michigan, 48315, United States

Location

The Rogosin Institute Manhattan Eat Dialysis

New York, New York, 10021, United States

Location

Clinical Renal Associates

Exton, Pennsylvania, 19341, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Renal Disease Research Institute

Dallas, Texas, 75246, United States

Location

Renal Disease Research Institute

Fort Worth, Texas, 76104, United States

Location

Renal Disease Research Institute

Garland, Texas, 75044, United States

Location

Renal Disease Research Institute

Irving, Texas, 75061, United States

Location

North Texas Kidney Disease Associates

Lewisville, Texas, 75057, United States

Location

Renal Disease Research Institute

McKinney, Texas, 75069, United States

Location

Renal Disease Research Institute

McKinney, Texas, 75071, United States

Location

Renal Disease Research Institute

Mesquite, Texas, 75150, United States

Location

North Texas Kidney Disease Associates

North Richland Hills, Texas, 76180, United States

Location

North Texas Kidney Disease Associates

Plano, Texas, 75093, United States

Location

Renal Disease Research Institute

Plano, Texas, 75093, United States

Location

Virginia Nephrology Group

Alexandria, Virginia, 22304, United States

Location

Virginia Nephrology Group

Arlington, Virginia, 22205, United States

Location

Virginia Nephrology Group

Fairfax, Virginia, 22030, United States

Location

West Virginia University Medicine

Fairmont, West Virginia, 26554, United States

Location

West Virginia University Medicine

Morgantown, West Virginia, 26506, United States

Location

Related Publications (33)

• Cohen SR, Mount BM, Bruera E, Provost M, Rowe J, Tong K. Validity of the McGill Quality of Life Questionnaire in the palliative care setting: a multi-centre Canadian study demonstrating the importance of the existential domain. Palliat Med. 1997 Jan;11(1):3-20. doi: 10.1177/026921639701100102.

  PMID: 9068681 BACKGROUND

• Engelberg R, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98. doi: 10.1089/jpm.2006.9.1086.

  PMID: 17040146 BACKGROUND

• Ladin K, Tighiouart H, Bronzi O, Koch-Weser S, Wong JB, Levine S, Agarwal A, Ren L, Degnan J, Sewall LN, Kuramitsu B, Fox P, Gordon EJ, Isakova T, Rifkin D, Rossi A, Weiner DE. Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease : A Randomized Controlled Trial. Ann Intern Med. 2023 Jan;176(1):29-38. doi: 10.7326/M22-1543. Epub 2022 Dec 20.

  PMID: 36534976 BACKGROUND

• Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.

  PMID: 23768763 BACKGROUND

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Davison SN. End-of-life care preferences and needs: perceptions of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010 Feb;5(2):195-204. doi: 10.2215/CJN.05960809. Epub 2010 Jan 14.

  PMID: 20089488 BACKGROUND

• Reilly KL, Kennedy S, Porter G, Estabrooks P. Comparing, Contrasting, and Integrating Dissemination and Implementation Outcomes Included in the RE-AIM and Implementation Outcomes Frameworks. Front Public Health. 2020 Sep 2;8:430. doi: 10.3389/fpubh.2020.00430. eCollection 2020.

  PMID: 32984239 BACKGROUND

• Wong SPY, McFarland LV, Liu CF, Laundry RJ, Hebert PL, O'Hare AM. Care Practices for Patients With Advanced Kidney Disease Who Forgo Maintenance Dialysis. JAMA Intern Med. 2019 Mar 1;179(3):305-313. doi: 10.1001/jamainternmed.2018.6197.

  PMID: 30667475 BACKGROUND

• Morton RL, Tong A, Howard K, Snelling P, Webster AC. The views of patients and carers in treatment decision making for chronic kidney disease: systematic review and thematic synthesis of qualitative studies. BMJ. 2010 Jan 19;340:c112. doi: 10.1136/bmj.c112.

  PMID: 20085970 BACKGROUND

• Murtagh FEM, Burns A, Moranne O, Morton RL, Naicker S. Supportive Care: Comprehensive Conservative Care in End-Stage Kidney Disease. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1909-1914. doi: 10.2215/CJN.04840516. Epub 2016 Aug 10.

  PMID: 27510453 BACKGROUND

• Saeed F, Ladwig SA, Epstein RM, Monk RD, Duberstein PR. Dialysis Regret: Prevalence and Correlates. Clin J Am Soc Nephrol. 2020 Jul 1;15(7):957-963. doi: 10.2215/CJN.13781119. Epub 2020 Jun 4.

  PMID: 32499230 BACKGROUND

• Chandna SM, Da Silva-Gane M, Marshall C, Warwicker P, Greenwood RN, Farrington K. Survival of elderly patients with stage 5 CKD: comparison of conservative management and renal replacement therapy. Nephrol Dial Transplant. 2011 May;26(5):1608-14. doi: 10.1093/ndt/gfq630. Epub 2010 Nov 22.

  PMID: 21098012 BACKGROUND

• USRDS. USRDS Annual Data Report USRDS Annual Data Report. Chapter 1: Incidence, Prevalence, Patient Characteristics, and Treatment Modalities, United States Renal Data System. 2018. 42.

  BACKGROUND

• Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019 Feb 1;14(1):11. doi: 10.1186/s13012-019-0853-y.

  PMID: 30709368 BACKGROUND

• Rhodes T, Stimson GV, Fitch C, Ball A, Renton A. Rapid assessment, injecting drug use, and public health. Lancet. 1999 Jul 3;354(9172):65-8. doi: 10.1016/S0140-6736(98)07612-0. No abstract available.

  PMID: 10406380 BACKGROUND

• Lupu DE, Aldous A, Anderson E, Schell JO, Groninger H, Sherman MJ, Aiello JR, Simmens SJ. Advance Care Planning Coaching in CKD Clinics: A Pragmatic Randomized Clinical Trial. Am J Kidney Dis. 2022 May;79(5):699-708.e1. doi: 10.1053/j.ajkd.2021.08.019. Epub 2021 Oct 12.

  PMID: 34648897 BACKGROUND

• Teerenstra S, Eldridge S, Graff M, de Hoop E, Borm GF. A simple sample size formula for analysis of covariance in cluster randomized trials. Stat Med. 2012 Sep 10;31(20):2169-78. doi: 10.1002/sim.5352. Epub 2012 Apr 11.

  PMID: 22495809 BACKGROUND

• Carson RC, Juszczak M, Davenport A, Burns A. Is maximum conservative management an equivalent treatment option to dialysis for elderly patients with significant comorbid disease? Clin J Am Soc Nephrol. 2009 Oct;4(10):1611-9. doi: 10.2215/CJN.00510109. Epub 2009 Sep 24.

  PMID: 19808244 BACKGROUND

• Morton RL, Webster AC, McGeechan K, Howard K, Murtagh FEM, Gray NA, Kerr PG, Germain MJ, Snelling P. Conservative Management and End-of-Life Care in an Australian Cohort with ESRD. Clin J Am Soc Nephrol. 2016 Dec 7;11(12):2195-2203. doi: 10.2215/CJN.11861115. Epub 2016 Oct 3.

  PMID: 27697783 BACKGROUND

• Saeed F, Schell JO. Shared Decision Making for Older Adults: Time to Move Beyond Dialysis as a Default. Ann Intern Med. 2023 Jan;176(1):129-130. doi: 10.7326/M22-3431. Epub 2022 Dec 20. No abstract available.

  PMID: 36534979 BACKGROUND

• Korevaar E, Kasza J, Taljaard M, Hemming K, Haines T, Turner EL, Thompson JA, Hughes JP, Forbes AB. Intra-cluster correlations from the CLustered OUtcome Dataset bank to inform the design of longitudinal cluster trials. Clin Trials. 2021 Oct;18(5):529-540. doi: 10.1177/17407745211020852. Epub 2021 Jun 4.

  PMID: 34088230 BACKGROUND

• Voldal EC, Hakhu NR, Xia F, Heagerty PJ, Hughes JP. swCRTdesign: An RPackage for Stepped Wedge Trial Design and Analysis. Comput Methods Programs Biomed. 2020 Nov;196:105514. doi: 10.1016/j.cmpb.2020.105514. Epub 2020 May 21.

  PMID: 32554025 BACKGROUND

• Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.

  PMID: 30984733 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.

  PMID: 19879711 BACKGROUND

• Wongrakpanich S, Susantitaphong P, Isaranuwatchai S, Chenbhanich J, Eiam-Ong S, Jaber BL. Dialysis Therapy and Conservative Management of Advanced Chronic Kidney Disease in the Elderly: A Systematic Review. Nephron. 2017;137(3):178-189. doi: 10.1159/000477361. Epub 2017 May 25.

  PMID: 28538218 BACKGROUND

• Buur LE, Madsen JK, Eidemak I, Krarup E, Lauridsen TG, Taasti LH, Finderup J. Does conservative kidney management offer a quantity or quality of life benefit compared to dialysis? A systematic review. BMC Nephrol. 2021 Sep 11;22(1):307. doi: 10.1186/s12882-021-02516-6.

  PMID: 34507554 BACKGROUND

• Seow YY, Cheung YB, Qu LM, Yee AC. Trajectory of quality of life for poor prognosis stage 5D chronic kidney disease with and without dialysis. Am J Nephrol. 2013;37(3):231-8. doi: 10.1159/000347220. Epub 2013 Mar 2.

  PMID: 23467046 BACKGROUND

• Foote C, Kotwal S, Gallagher M, Cass A, Brown M, Jardine M. Survival outcomes of supportive care versus dialysis therapies for elderly patients with end-stage kidney disease: A systematic review and meta-analysis. Nephrology (Carlton). 2016 Mar;21(3):241-53. doi: 10.1111/nep.12586.

  PMID: 26265214 BACKGROUND

• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

  PMID: 7898294 BACKGROUND

• Galla JH. Clinical practice guideline on shared decision-making in the appropriate initiation of and withdrawal from dialysis. The Renal Physicians Association and the American Society of Nephrology. J Am Soc Nephrol. 2000 Jul;11(7):1340-1342. doi: 10.1681/ASN.V1171340. No abstract available.

  PMID: 10864592 BACKGROUND

• Koch-Weser S, Kennefick K, Tighiouart H, Wong JB, Gordon EJ, Isakova T, Rifkin D, Rossi A, Weiner DE, Ladin K. Development and Validation of the Rating of CKD Knowledge Among Older Adults (Know-CKD) With Kidney Failure. Am J Kidney Dis. 2024 May;83(5):569-577. doi: 10.1053/j.ajkd.2023.09.024. Epub 2023 Dec 7.

  PMID: 38070590 BACKGROUND

• Wong SP, Kreuter W, O'Hare AM. Treatment intensity at the end of life in older adults receiving long-term dialysis. Arch Intern Med. 2012 Apr 23;172(8):661-3; discussion 663-4. doi: 10.1001/archinternmed.2012.268. No abstract available.

  PMID: 22529233 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will use a repeated cross-sectional stepped wedge design with randomization at the practice level.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: February 6, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Per PCORI guidelines
• Access Criteria: Per PCORI guidelines

Locations

US (25)