Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5
Conditions
Keywords
Chronic Kidney Disease, Chronic kidney disease stage 4, Chronic kidney disease stage 5, Agenda-setting, Rural, Patient engagement, Randomized trial, Participatory research
Brief summary
The goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. The SAS is called CKD Topics. 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. This is a special type of clinical trial called a stepped wedge randomized clinical trial (RCT). In this type of trial, every participant will get to experience both usual care and CKD Topics, but for different amounts of time. The researchers will learn if doing a clinical trial of CKD Topics is possible (feasible) and get information about how well CKD Topics helps people with advanced CKD shape visit discussions (self-advocacy) in their appointments with their clinicians. The information the researchers collect in this trial will help design a future trial with more participants. The main questions the researchers aim to answer are: * Is it possible to conduct this type of study of a SAS intervention? i.e. feasibility * Does the SAS intervention help people with advanced CKD shape discussions (self-advocacy) with their clinicians? If so, how much? i.e. preliminary efficacy
Detailed description
This stepped-wedge pilot randomized controlled trial (RCT) is to test a new structured agenda-setting (SAS), called the Chronic Kidney Disease (CKD) Topics Agenda-Setting Tool, with patients, their care partners and their clinicians. This is a pilot study, so the researchers are collecting feasibility data to determine if a larger, fully-powered RCT can be moved forward. The researchers are also collecting preliminary efficacy data, which will help the design of a future study on the efficacy of clinical visits for people with advanced CKD. This study has two arms: 1) a usual care arm, and 2) an intervention arm where participants and their nephrology physicians will use CKD Topics during their visits. Physicians will initially be randomly assigned to one of three clusters, with two attending physicians and one fellow physician in each cluster. Each cluster will start out practicing usual care for at least eight months during the enrollment period. After that initial 8 months, one cluster will cross over to the intervention arm every four months, by using the CKD Topics tool in their visits, in what's called the rollout period. At 16 months into the trial, all clusters will be on the intervention arm, using CKD topics with patients, and will do so for the remaining 12 months of the trial. Patient participants will be enrolled in the study arm to which their physicians have been randomized. Participation is expected to last 24 months for patients and clinicians, and participants may use CKD Topics more than once during the study period. The researchers expect 108 patient participants, and nine clinicians will enroll in the study. Every participant will receive a baseline survey after enrollment and four subsequent surveys. The procedures in this study will include screening patients for study eligibility, consenting them to participate in study activities such as filling out surveys. The intervention, CKD topics, itself will be administered as quality improvement so will not be included as a research activity needing consent. Future Directions: Findings from this trial will forecast a range of participants required in the sample for a full-scale RCT and illustrate proof of concept for a future trial which will evaluate the intervention's impact on patient self-advocacy and clinical care outcomes in rural CKD populations.
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 structured discussion topic areas.
Sponsors
Dartmouth College
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped wedge randomized controlled trial with clustered cross-over assignment
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 | From enrollment to the end of treatment at 16 months | The primary outcome will be feasibility, assessed by the proportion of patients who received the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Feasibility Outcome | From enrollment to the end of treatment at 16 months | The secondary outcome will be feasibility assessed by the clinicians' intention to continue the intervention use, measured in a survey. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary Process Outcome: Enrollment Rate | From enrollment to the end of treatment at 16 months | As measured by participant enrollment in Redcap. |
| Secondary Process Outcome: Loss to follow-up | From enrollment to the end of treatment at 16 months | As measured by participant dropout (loss to follow-up) in Redcap. |
| Preliminary Efficacy Outcome: Patient Self-Advocacy Scale (PSAS) | From enrollment to the end of treatment at 16 months | The Patient Self-Advocacy Scale (PSAS); a 12-item validated scale assessing the latent construct of perceived self-advocacy for patients. |
| Preliminary Efficacy Outcome: Unplanned hospitalization or emergency department visit | From enrollment to the end of treatment at 16 months | Unplanned hospitalization or emergency department visit. EHR chart review and patient self-report. |
| Preliminary Efficacy Outcome: Patient self-management | From enrollment to the end of treatment at 16 months | Patient demonstration of self-management using the Perceived Medical Condition Self-Management Scale; an 8-item instrument validated to assess self-management among CKD patients; correlated with treatment adherence. |
| Preliminary Efficacy Outcome: Respect Experience Assessment | From enrollment to the end of treatment at 16 months | Respect experience assessment measured by the Heard and Understood tool. Heard and Understood is a validated Single-item PREM with Likert-like response options for patients. |
| Preliminary Efficacy Outcome: Patient self-efficacy | From enrollment to the end of treatment at 16 months | Patient self-efficacy measured using the Ask, Understand, Remember Assessment, (AURA); a validated 4-item assessment of self-efficacy completed by patients. |
| Preliminary Efficacy Outcome: Serious Illness Experience | From enrollment to the end of treatment at 16 months | Serious illness experience measured by the consideRATE questions; a validated 8-item, plain language (2nd grade) patient-reported experience measure (PREM) with Likert-like response options for patients, and care partners. |
Countries
United States
Contacts
Primary ContactCatherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH
Backup ContactAnne E. Dade, Research Associate, MPP
Outcome results
None listed