The Agenda-Setting for Kidney Disease Open Pilot Trial

Purpose

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?

Condition

  • Chronic Kidney Disease Stage 4

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Open feasibility pilot trial
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 is Clinical Visit Agenda Setting Tool 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.
  • Behavioral: Chronic Kidney Disease Structured Agenda-Setting Tool
    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 8 structured discussion topic areas with the option for patients to consider and indicate their priority topic areas and take notes before, during, and after a clinical visit.

Recruiting Locations

Cheshire Medical Center/Dartmouth-Hitchcock
Keene, New Hampshire 03431
Contact:
Maryam Gul, MD
603-354-6622
mgul@cheshire-med.com

More Details

Status
Recruiting
Sponsor
Dartmouth-Hitchcock Medical Center

Study Contact

Catherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH
603-653-3436
Catherine.Hylas.Saunders@dartmouth.edu

Detailed 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.