The Agenda-Setting for Kidney Disease Open Pilot Trial (ASK)

Dartmouth Health

Status: Begins enrollment in 6 months

Conditions: Chronic Kidney Disease Stage 4

Treatments: Behavioral: Chronic Kidney Disease Structured Agenda-Setting Tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07221604

1K01DK139400 (U.S. NIH Grant/Contract)

STUDY02002598_2

Details and patient eligibility

About

The goal of this open pilot is to practice using an intervention and surveys before a larger pilot stepped wedge clinical trial. The intervention the researchers plan to use is Chronic Kidney Disease (CKD) Topics, and it is a structured clinical agenda-setting intervention (SAS), or a customized list of discussion topics. The people the researchers are practicing using the SAS with have advanced CKD (stages 4-5), and many of them live in rural areas. The researchers will practice administering CKD Topics, along with survey questions. By doing the open pilot, the researchers will learn if they need to modify the steps they plan to take in the larger trial.

The main questions the researchers aim to answer are:

• Do the steps for identifying eligible participants work?
• Do the steps for administering CKD Topics work?
• Do the steps to administer survey questions work?

Full description

In this open pilot, the researchers will administer a novel structured agenda-setting tool (SAS) called Chronic Kidney Disease (CKD) Topics. The researchers will determine if their procedures for screening eligible participants, administering the intervention, and administering outcome and other questionnaires are appropriate. Learnings from the open pilot will feed forward into procedures in a larger planned pilot stepped wedge feasibility trial.

This study only has one arm, the intervention arm. The intervention, CKD Topics, will be administered as a quality improvement intervention.

Future Directions: This open pilot will inform procedural changes in an upcoming pilot stepped wedge feasibility trial.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Arm 1 is Clinical Visit Agenda Setting Tool Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Chronic Kidney Disease Structured Agenda-Setting Tool