The Agenda-Setting for Kidney Disease Trial

NCT07024953 | Not Yet Recruiting

• 2 other identifiers: STUDY02002598_11K01DK139400
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. The SAS is called CKD Topics. The researchers will compare the SAS intervention to usual care (the way clinicians usually practice) to see how well it works for people with advanced CKD. This is a special type of clinical trial called a stepped wedge randomized clinical trial (RCT). In this type of trial, every participant will get to experience both usual care and CKD Topics, but for different amounts of time. The researchers will learn if doing a clinical trial of CKD Topics is possible (feasible) and get information about how well CKD Topics helps people with advanced CKD shape visit discussions (self-advocacy) in their appointments with their clinicians. The information the researchers collect in this trial will help design a future trial with more participants. The main questions the researchers aim to answer are:

• Is it possible to conduct this type of study of a SAS intervention? i.e. feasibility
• Does the SAS intervention help people with advanced CKD shape discussions (self-advocacy) with their clinicians? If so, how much? i.e. preliminary efficacy

Conditions

Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5

Keywords

Chronic Kidney Disease; Chronic kidney disease stage 4; Chronic kidney disease stage 5; Agenda-setting; Rural; Patient engagement; Randomized trial; Participatory research

Outcome Measures

Primary Outcomes (1)

• Primary Feasibility Outcome

  The primary outcome will be feasibility, assessed by the proportion of patients who received the intervention.

  From enrollment to the end of treatment at 16 months

Secondary Outcomes (1)

• Secondary Feasibility Outcome

  From enrollment to the end of treatment at 16 months

Other Outcomes (8)

• Primary Process Outcome: Enrollment Rate

  From enrollment to the end of treatment at 16 months

• Secondary Process Outcome: Loss to follow-up

  From enrollment to the end of treatment at 16 months

• Preliminary Efficacy Outcome: Patient Self-Advocacy Scale (PSAS)

  From enrollment to the end of treatment at 16 months

Study Arms (2)

Arm 1 is Usual Care

NO INTERVENTION

The clinicians in the nephrology clinic will proceed with usual care without intervention from the study team.

Arm 2 is Clinical Visit Agenda Setting Tool Intervention

EXPERIMENTAL

The study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for advanced chronic kidney disease, called Chronic Kidney Disease (CKD) Topics.

Other: Chronic Kidney Disease Structured Agenda-Setting Tool

Interventions

Chronic Kidney Disease Structured Agenda-Setting Tool OTHER

Chronic Kidney Disease (CKD) Topics is a novel clinical visit agenda-setting intervention developed through participatory research methods for people with CKD living in rural areas. CKD Topics includes structured discussion topic areas.

Arm 2 is Clinical Visit Agenda Setting Tool Intervention

Eligibility Criteria

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

You may qualify if:

• Adults \>18 years old who have been diagnosed with advanced CKD (stages 4-5).
• Care partners, clinicians and staff supporting these CKD patients who are willing and able to provide informed consent
• English-speaking
• Able to provide informed consent
• Patient must be attending outpatient visits \*(in-person and/or telehealth allowable).

You may not qualify if:

• Children under 18 years old will not be included
• Non-English-speaking patients and/or care partners
• Patients on dialysis
• Individuals unable or unwilling to provide informed consent

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator
• University of Washington: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (12)

• Brashers DE, Haas SM, Neidig JL. The patient self-advocacy scale: measuring patient involvement in health care decision-making interactions. Health Commun. 1999;11(2):97-121. doi: 10.1207/s15327027hc1102_1.

  PMID: 16370972 BACKGROUND

• Clayman ML, Pandit AU, Bergeron AR, Cameron KA, Ross E, Wolf MS. Ask, understand, remember: a brief measure of patient communication self-efficacy within clinical encounters. J Health Commun. 2010;15 Suppl 2(Suppl 2):72-9. doi: 10.1080/10810730.2010.500349.

  PMID: 20845194 BACKGROUND

• Frankel RM, Salyers MP, Bonfils KA, Oles SK, Matthias MS. Agenda setting in psychiatric consultations: an exploratory study. Psychiatr Rehabil J. 2013 Sep;36(3):195-201. doi: 10.1037/prj0000004. Epub 2013 Jul 1.

  PMID: 23815174 BACKGROUND

• Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group; Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17.

  PMID: 26596879 BACKGROUND

• Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.

  PMID: 25662947 BACKGROUND

• Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18.

  PMID: 17574367 BACKGROUND

• Saunders CH, Durand MA, Kirkland KB, MacMartin MA, Barnato AE, Elwyn G. Psychometric assessment of the consideRATE questions, a new measure of serious illness experience, with an online simulation study. Patient Educ Couns. 2022 Jul;105(7):2581-2589. doi: 10.1016/j.pec.2022.01.002. Epub 2022 Jan 22.

  PMID: 35260261 BACKGROUND

• Saunders CH, Durand MA, Scalia P, Kirkland KB, MacMartin MA, Barnato AE, Milne DW, Collison J, Bennett A, Wasp G, Nelson E, Elwyn G. "It helps us say what's important..." Developing Serious Illness Topics: A clinical visit agenda-setting tool. Patient Educ Couns. 2023 Aug;113:107764. doi: 10.1016/j.pec.2023.107764. Epub 2023 Apr 18.

  PMID: 37150152 BACKGROUND

• Saunders CH, Durand MA, Scalia P, Kirkland KB, MacMartin MA, Barnato AE, Milne DW, Collison J, Jaggars A, Butt T, Wasp G, Nelson E, Elwyn G. User-Centered Design of the consideRATE Questions, a Measure of People's Experiences When They Are Seriously Ill. J Pain Symptom Manage. 2021 Mar;61(3):555-565.e5. doi: 10.1016/j.jpainsymman.2020.08.002. Epub 2020 Aug 16.

  PMID: 32814165 BACKGROUND

• Sierpe A, Yen RW, Stevens G, Van Citters AD, Elwyn G, Saunders CH. Agenda-setting in the clinical encounter: A systematic review protocol. PLoS One. 2024 Oct 24;19(10):e0312613. doi: 10.1371/journal.pone.0312613. eCollection 2024.

  PMID: 39446854 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Wild MG, Wallston KA, Green JA, Beach LB, Umeukeje E, Wright Nunes JA, Ikizler TA, Steed J, Cavanaugh KL. The Perceived Medical Condition Self-Management Scale can be applied to patients with chronic kidney disease. Kidney Int. 2017 Oct;92(4):972-978. doi: 10.1016/j.kint.2017.03.018. Epub 2017 May 18.

  PMID: 28528132 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Patient Participation

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; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Catherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH

CONTACT

603-653-3436; Catherine.Hylas.Saunders@dartmouth.edu

Anne E. Dade, Research Associate, MPP

CONTACT

Anne.E.Dade@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist & Assistant Professor of Medicine and of Health Policy & Clinical Practice

Model Details: Stepped wedge randomized controlled trial with clustered cross-over assignment

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)