Chronic Kidney Disease Stage 4
Conditions
Keywords
Chronic kidney disease, Chronic kidney disease stage 4, Chronic kidney disease stage 5, Agenda-setting, Patient engagement, Rural, Participatory research, Open pilot
Brief summary
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?
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.
Interventions
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.
Sponsors
Dartmouth-Hitchcock Medical Center
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Dartmouth College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Open feasibility pilot trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Feasibility Outcome: Intervention receipt | Day 1 | Our primary outcome will be feasibility, assessed by the proportion of patients who received the intervention. |
Countries
United States
Contacts
CONTACTCatherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH
CONTACTAnne E. Dade, Research Associate, MPP
Outcome results
None listed