Multi-disciplinary Participatory Design of a Process to Deliver a CKD Diagnosis in Primary Care (EPIK)

University of Michigan

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Behavioral: Education worksheet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03084159

HUM00118819

4K23DK097183-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will use an adapted education worksheet to support patient-centered chronic kidney disease (CKD) communication, shared decision making, and patient engagement and will test its impact on intermediate patient modifiable characteristics in a primary care practice with patients who have pre-dialysis CKD.

The study team will enroll up to 100 patients with chronic kidney disease (CKD) from a primary care clinic to start. Patients will receive the intervention, which consists of the physicians using the education worksheet during appointments with patients, and patients and providers will complete surveys about its use and to measure impact on knowledge and other areas related to patient outcomes.

Once initial user testing is complete, the study team plans to submit an amendment to expand on this trial and incorporate comparison sites. This will be submitted and receive IRB approval prior to participant involvement.

The study hypothesis is that patients who receive the intervention will have greater knowledge about their CKD diagnosis, higher satisfaction with provider communication, and higher scores related to managing CKD to keep themselves healthy compared to control populations.

Full description

Amendment on 12/2018: The enrollment numbers were updated to include the control group.

Clarification 9/2021: After initial feasibility was assessed, the initial site was used additionally to enroll for the "second arm", rather than a new site as originally intended. A second site was then used for the control population.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old or older
• Have an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73 m2
• Able to read and understand English without an interpreter
• Diagnosed with chronic kidney disease on record

Exclusion criteria

• Patients with renal transplant or on dialysis
• Patients who have documented or provider known cognitive impairment or vision impairment that will prohibit meaningful interaction with education activation worksheet
• Patients who are not aware of their CKD diagnosis

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

Participatory design and intervention

Experimental group

Description:

Patients in this arm will receive the intervention of using an education worksheet during their appointment with their provider. They will be asked to complete post intervention surveys (for feasibility and feedback prior to actual trial enrollment). Providers and staff at this site have been involved in the design of the intervention process, to make it streamlined and efficient for application in practice.

Treatment:

Behavioral: Education worksheet

Intervention Only

Experimental group

Description:

This arm include new patients at the initial site that also received the intervention of using an education worksheet during their appointment and filled out post intervention surveys. Some of these providers/staff were not involved in the initial design of the intervention.

Treatment:

Behavioral: Education worksheet

Usual Care

No Intervention group

Description:

A second site included usual care, which did not include the intervention. Participants were given post visit surveys similar to those in the two other study / intervention arms. This site served as a usual care comparison.