Putting Patients at the Center of Kidney Care Transitions (PREPARE NOW)

NCT02722382 | Completed

• 1 other identifier: Pro00074588
• Study Type: interventional
• Target: 1,572
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The investigators will change the health system to improve care patients receive as they transition through earlier stages of kidney disease toward kidney failure. They will study whether these changes lead to patients' improved health and well-being. Methods: The investigators will conduct this study in Geisinger Health System kidney specialty clinics. The study will implement 'Patient Centered Kidney Transitions Care' which will (1) give doctors tools to help them recognize when patients should prepare for kidney failure and help them support patients' early and informed treatment decisions; and (2) add a 'Kidney Transitions Specialist' to the health care team to help patients learn about kidney disease, learn self-care skills, make informed decisions, get psychosocial support, and coordinate their care. Four (4) clinics will be randomly assigned to provide Patient Centered Kidney Transitions Care, and four (4) to provide their usual care. The investigators will study differences in patients' outcomes among those treated in clinics providing Patient Centered Kidney Transitions Care compared to those treated in clinics providing usual care. Patient Outcomes: Patients have told us they want to have 'control' over their disease transitions and to have the best quality of life possible. The investigators will measure patients' empowerment, confidence with their self-care, their decisions to start self-care treatments for kidney failure, and their hospitalizations. They will also measure whether doctors record patients' treatment preferences in the medical record before patients develop kidney failure. Patient and Stakeholder Engagement: This study responds to reports from hundreds of patients and caregivers who want better care. Patients and caregivers from around the US are part of our investigative team, and they will participate in all aspects of our study. The investigators are also engaging key stakeholders in the kidney community, including patients, providers, payers, and regulators. Anticipated Impact: If effective, Patient Centered Kidney Transitions Care will provide a model of care can improve the lives of patients and families with kidney disease across the US.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (3)

• Change in % patients feeling in control of their decision-making

  Change in % patients feeling in control of their decision-making

  Baseline, 36 months

• Change in number of Hospitalizations

  Change in number of Hospitalizations

  Baseline, 36 months

• Change in % patients with advance directives for kidney care

  Change in % patients with advance directives for kidney care

  Baseline, 36 months

Secondary Outcomes (6)

• Change in % self-care patients with biomedical care plans

  Baseline, 36 months

• Change in % patients with values aligned care

  Baseline, 36 months

• Change in % patients with preferences for renal replacement therapy documented

  Baseline, 36 months

• Change in % patients with emergency dialysis initiation

  Baseline, 36 months

• Change in months to kidney failure

  Baseline, 36 months

Study Arms (2)

Usual Nephrology Care

NO INTERVENTION

Nephrology care at Geisinger Health System.

Patient-Centered Kidney Transitions Care

ACTIVE COMPARATOR

Health system intervention which will implement informatics tools (including a disease registry, predictive modeling, and advance directives) and a disease specific care manager who will provide services and navigate patients through kidney disease transitions.

Other: Patient-Centered Kidney Transitions Care

Interventions

Patient-Centered Kidney Transitions Care OTHER

In a multi-faceted pragmatic approach, the intervention will 1) implement new electronic health information tools to help providers recognize patents in need of Kidney Transitions Care and focus their attention on patients' values and treatment preferences; and 2) implement a Kidney Transitions Specialist who will provide and facilitate integrated delivery of patient support programs that provide patients with knowledge, skills, and assistance to manage their disease, make high-quality treatment decisions, obtain needed psychosocial support, and navigate complex treatment plans.

Also known as: PREPARE NOW

Patient-Centered Kidney Transitions Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently receiving care at Geisinger nephrology practices
• Age 18 and older
• Advanced Kidney disease (determined by estimated glomerular filtration rates (eGFR) or presence of albuminuria)

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead
• Geisinger Clinic: collaborator
• Johns Hopkins University: collaborator
• University of South Carolina: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21210, United States

Location

Related Publications (5)

• Browne T, Jones S, Cabacungan AN, Lang-Lindsey K, Schmidt L, Jackson G, Schatell D, Damron KC, Ephraim PL, Hill-Briggs F, Bolden S, Swoboda A, Ruff S, Danielson P, Littlewood D, Singer D, Stewart S, Vinson B, Clynes D, Green JA, Strigo TS, Boulware LE. The Impact of COVID-19 on Patient, Family Member, and Stakeholder Research Engagement: Insights from the PREPARE NOW Study. J Gen Intern Med. 2022 Apr;37(Suppl 1):64-72. doi: 10.1007/s11606-021-07077-w. Epub 2022 Mar 29.

  PMID: 35349019 DERIVED

• Green JA, Ephraim PL, Hill-Briggs F, Browne T, Strigo TS, Hauer CL, Yule C, Stametz RA, Littlewood D, Pendergast JF, Peskoe S, Clair Russell JS, Norfolk E, Bucaloiu ID, Kethireddy S, Davis D, dePrisco J, Malloy D, Fulmer S, Martin J, Schatell D, Tangri N, Sees A, Siegrist C, Breed J Jr, Billet J, Hackenberg M, Bhavsar NA, Boulware LE. Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study. Kidney Med. 2021 May 24;3(4):565-575.e1. doi: 10.1016/j.xkme.2021.03.009. eCollection 2021 Jul-Aug.

  PMID: 34401724 DERIVED

• Browne T, Swoboda A, Ephraim PL, Lang-Lindsey K, Green JA, Hill-Briggs F, Jackson GL, Ruff S, Schmidt L, Woods P, Danielson P, Bolden S, Bankes B, Hauer C, Strigo T, Boulware LE. Engaging patients and family members to design and implement patient-centered kidney disease research. Res Involv Engagem. 2020 Nov 1;6(1):66. doi: 10.1186/s40900-020-00237-y.

  PMID: 33292683 DERIVED

• Green JA, Ephraim PL, Hill-Briggs FF, Browne T, Strigo TS, Hauer CL, Stametz RA, Darer JD, Patel UD, Lang-Lindsey K, Bankes BL, Bolden SA, Danielson P, Ruff S, Schmidt L, Swoboda A, Woods P, Vinson B, Littlewood D, Jackson G, Pendergast JF, St Clair Russell J, Collins K, Norfolk E, Bucaloiu ID, Kethireddy S, Collins C, Davis D, dePrisco J, Malloy D, Diamantidis CJ, Fulmer S, Martin J, Schatell D, Tangri N, Sees A, Siegrist C, Breed J Jr, Medley A, Graboski E, Billet J, Hackenberg M, Singer D, Stewart S, Alkon A, Bhavsar NA, Lewis-Boyer L, Martz C, Yule C, Greer RC, Saunders M, Cameron B, Boulware LE. Putting patients at the center of kidney care transitions: PREPARE NOW, a cluster randomized controlled trial. Contemp Clin Trials. 2018 Oct;73:98-110. doi: 10.1016/j.cct.2018.09.004. Epub 2018 Sep 12.

  PMID: 30218818 DERIVED

• Yee J. Improving Transitions in CKD: Failure Mode. Adv Chronic Kidney Dis. 2016 Jul;23(4):211-4. doi: 10.1053/j.ackd.2016.05.001. No abstract available.

  PMID: 27324671 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

Study Officials

• Leigh E Boulware, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 30, 2016
• Study Start: January 31, 2017
• Primary Completion: October 30, 2020
• Study Completion: October 31, 2020
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

US (1)