Structured Agenda-Setting Tool for Chronic Kidney Disease

(ASK Trial)

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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Children, Non-English, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool called CKD Topics, designed to help individuals with advanced chronic kidney disease (CKD) communicate more effectively with their doctors during clinic visits. The goal is to determine if this tool improves discussions and self-advocacy for those with CKD compared to the usual appointment methods. Participants will use both the CKD Topics tool and their usual care at different times to evaluate which is more effective. Individuals with advanced CKD (stages 4-5) who attend clinic visits and speak English may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance doctor-patient communication for CKD patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on how discussions are structured during clinic visits, so it's unlikely that medication changes are required.

What prior data suggests that the CKD Topics tool is safe for people with advanced chronic kidney disease?

Research shows that the CKD Topics tool helps people with chronic kidney disease have better discussions with their doctors. It provides a list of topics for patients to address during medical visits. As this tool is neither a medicine nor a treatment, it poses no direct safety concerns, such as side effects.

In past studies, patients used similar tools without any reports of harm. This study examines how the tool affects patient-doctor conversations, so safety is not the primary concern. The key question is whether the tool improves patient communication with their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the Structured Agenda-Setting Tool for managing chronic kidney disease (CKD) because it introduces a new approach to patient care. Unlike standard treatments that primarily focus on medication and dialysis, this tool enhances communication between patients and healthcare providers by creating a customized agenda for clinical visits. This agenda ensures that all important topics related to the patient's CKD are addressed, potentially improving patient engagement and outcomes. By organizing and prioritizing conversations, this method aims to make clinic visits more efficient and effective, leading to better management of the disease.

What evidence suggests that the CKD Topics tool is effective for advanced chronic kidney disease?

Research has shown that CKD Topics, a tool with a structured list of discussion points, can enhance conversations between people with chronic kidney disease (CKD) and their doctors. This trial will compare two groups: one using the CKD Topics tool, which offers a list of important topics specifically for CKD patients to prepare for clinic visits, and the other receiving usual care without this intervention. Early findings suggest that patients using CKD Topics feel more confident discussing their health concerns. This method aims to help patients express their needs and priorities during appointments. While more information is needed, early results are promising for improving communication in CKD care. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced chronic kidney disease (CKD) who are receiving care in rural clinics. Participants will use a structured clinical visit agenda-setting tool called CKD Topics to help shape discussions with their clinicians.

Inclusion Criteria

Able to provide informed consent

I am over 18 and have advanced chronic kidney disease.

Care partners, clinicians and staff supporting these CKD patients who are willing and able to provide informed consent

Exclusion Criteria

Non-English-speaking patients and/or care partners

I am unable or unwilling to give my consent for participation.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline

Participants are enrolled and complete a baseline survey

1-2 weeks

Usual Care

Participants receive usual care for at least 8 months during the enrollment period

8 months

Intervention Rollout

Clusters crossover to the intervention arm every four months, using the CKD Topics tool

8 months

Full Intervention

All clusters use CKD Topics with patients for the remaining 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CKD Topics

Trial Overview The study tests the 'CKD Topics' tool against usual care practices to see if it improves self-advocacy during clinic visits. It's a stepped wedge RCT, meaning all participants will experience both the intervention and usual care at different times.

How Is the Trial Designed?

Group I: Arm 2 is Clinical Visit Agenda Setting Tool Intervention Experimental Treatment 1 Intervention

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.

Group II: Arm 1 is Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07221604

The Agenda-Setting for Kidney Disease Open Pilot Trial CKD Topics includes 8 structured discussion topic areas with the option for patients to consider and indicate their priority topic areas and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07024953

NCT07024953 | The Agenda-Setting for Kidney Disease Trial Chronic Kidney Disease (CKD) Topics is a novel clinical visit agenda-setting intervention developed through participatory research methods for people with CKD ...

3. withpower.com withpower.com/trial/phase-renal-insufficiency-chronic-8-2026-23cd3

Structured Agenda-Setting Tool for Chronic Kidney ... Trial Overview The study tests the 'CKD Topics' tool against usual care practices to see if it improves self-advocacy during clinic visits. It's a stepped wedge ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1386505622001526

Optimizing the use of patients' individual outcome information We aimed to systematically develop a Chronic Kidney Disease (CKD) dashboard designed to support consultations, test its usability and explore conditions for ...

5. ctv.veeva.com ctv.veeva.com/study/the-agenda-setting-for-kidney-disease-open-pilot-trial

The Agenda-Setting for Kidney Disease Open Pilot Trial In this open pilot, the researchers will administer a novel structured agenda-setting tool (SAS) called Chronic Kidney Disease (CKD) Topics.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07024953

NCT07024953 | The Agenda-Setting for Kidney Disease Trial Chronic Kidney Disease (CKD) Topics is a novel clinical visit agenda-setting intervention developed through participatory research methods for people with CKD ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6713516/

Using chronic kidney disease trigger tools for safety and ... This tool notifies GP practices of falling eGFR values. By alerting clinicians to patients with possible CKD progression the tool invites clinical review.