Agenda-Setting Tool for Chronic Kidney Disease

(ASK Trial)

Overseen By Anne E. Dade, Research Associate, MPP

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: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool called Chronic Kidney Disease (CKD) Topics, designed to help patients with advanced CKD (stages 4-5) have more productive discussions during medical visits. Researchers aim to determine if the steps for using this tool and related surveys are effective before conducting a larger study. This trial targets individuals with advanced CKD who attend outpatient visits and can communicate in English. It suits those who wish to improve their healthcare discussions and live in rural areas. As an unphased trial, this study offers a unique opportunity for patients to contribute to developing tools that could enhance communication with healthcare providers.

Do I have to stop taking 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 discussion topics and surveys rather than medication changes.

What prior data suggests that this agenda-setting tool is safe for use with chronic kidney disease patients?

Research shows that the CKD Topics tool is being tested to guide conversations during medical visits for people with advanced chronic kidney disease (CKD). This tool provides a list of important topics to enhance communication between patients and healthcare providers.

The CKD Topics tool is a communication aid, not a drug or medical procedure, so it does not cause physical side effects like medications or surgeries. Its goal is to improve discussions between patients and doctors about health issues.

As the tool is being tested in a pilot study, no negative effects have been reported. The study aims to determine if the tool is user-friendly and improves conversations during medical visits. So far, research has not identified any safety concerns with using CKD Topics in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Agenda-Setting Tool for Chronic Kidney Disease because it offers a fresh approach to managing the condition by enhancing communication between patients and healthcare providers. Unlike traditional treatments that focus solely on medical interventions, this tool emphasizes patient engagement and personalized care plans. By structuring clinical visits around specific agenda items tailored to each patient's needs, it aims to improve patient outcomes and satisfaction. This innovative method could lead to more effective management of chronic kidney disease by ensuring that patients' concerns and priorities are addressed directly during consultations.

What evidence suggests that this agenda-setting tool is effective for chronic kidney disease?

Research has shown that structured tools for setting an agenda can help doctors and patients focus on important topics during medical visits. In this trial, participants will use a structured clinical visit agenda-setting tool specifically designed for advanced chronic kidney disease (CKD), called CKD Topics. This method aims to improve communication and ensure important health issues are discussed. Studies have found that using these tools in clinics can help patients better understand and participate in their own care. Although specific data on its effectiveness for CKD is limited, the approach shows promise for enhancing patient-doctor interactions and care outcomes. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced Chronic Kidney Disease (stages 4-5), particularly those living in rural areas. The study aims to include participants who can provide feedback on a structured clinical agenda-setting tool designed for their condition.

Inclusion Criteria

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

Exclusion Criteria

Non-English-speaking patients and/or care partners

I am 18 years old or older.

I am currently receiving dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Intervention

Participants receive the CKD Topics intervention, a structured clinical visit agenda-setting tool

1 day

1 visit (in-person)

Follow-up

Participants are monitored for feasibility and preliminary efficacy outcomes immediately after intervention

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Chronic Kidney Disease Topics

Trial Overview Researchers are testing a new intervention called 'CKD Topics', which is a list of discussion topics tailored for patients with advanced CKD. This open pilot will help refine the process before launching a larger trial, focusing on participant selection, intervention delivery, and survey administration.

How Is the Trial Designed?

Group I: Arm 1 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.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Citations

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

The Agenda-Setting for Kidney Disease Open Pilot Trial The study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for advanced chronic kidney disease, ...

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

NCT07024953 | The Agenda-Setting for Kidney Disease Trial 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.

3. reporter.nih.gov reporter.nih.gov/search/vi6lLB_w20WNa1FA3dClqw/project-details/10866110

Project Details Agenda-setting enables clinicians to collaboratively generate and prioritize discussion topics in clinical visits with patients and care partners. Agenda- ...

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

Structured Agenda-Setting Tool for Chronic Kidney ... This trial is for individuals with advanced chronic kidney disease (CKD) who are receiving care in rural clinics. Participants will use a structured clinical ...

5. nature.com nature.com/articles/s41746-024-01296-1

The effects of a digital health intervention on patient ... Secondary outcomes assessed changes in key self-management knowledge and behaviours. These were the: Chronic Kidney Disease Self-Management ...

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

NCT07024953 | The Agenda-Setting for Kidney Disease Trial The study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for advanced chronic kidney disease, called Chronic ...

7. 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 The goal of this open pilot is to practice using an intervention and surveys before a larger pilot stepped wedge clinical trial.