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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
78
Patients who screen positive for CKD and give written informed consent to be a part of the study will have their chart flagged for the medical assistant and provider to give the education worksheet intervention. The education worksheet has been developed to be used as an electronic tool within the Electronic Medical Record. The provider will review it with the patient during the visit. A paper copy will print out for the patient at the end of the visit.
Canton Health Center
Canton, Michigan, United States
Northville Health Center
Northville, Michigan, United States
Level of objective understanding of CKD as measured by the Kidney Knowledge Survey (KiKS)
This will measure objective kidney disease knowledge, based on a score of 0-100, where 0 means poor level of kidney knowledge, and 100 means good level of kidney knowledge. The KiKS was developed by Dr. Wright.
Time frame: Length of doctor's appointment, e.g., 1-2 hours
Level of perceived understanding of CKD as measured by the Perceived Kidney Knowledge Survey (PiKS)
This will measure subjective kidney knowledge. Score range is 1-4, where 1 is low level of perceived kidney knowledge, and 4 is high level of perceived kidney knowledge. The PiKS was developed by Dr. Wright.
Time frame: Length of doctor's appointment, e.g., 1-2 hours
Level of positive perception of patient-provider communication as measured by the Patient Communication Assessment Tool (CAT)
This assesses the quality of physician to patient and physician's staff to patient communication. Score range is 1-5, where 1 means negative perception of communication and 5 means positive perception of communication.
Time frame: Length of doctor's appointment, e.g., 1-2 hours
Level of mental anxiety/stress related to condition as measured by the adapted NDBCSS scale
The 19-item NDBCSS (Newly Diagnosed Breast Cancer Stress Scale) is adapted to form the 21-item scale in the patient survey to measure stress associated with CKD. The score range is 1-4, where 1 means high level of stress associated with CKD and 4 means low level of stress associated with CKD.
Time frame: Length of doctor's appointment, e.g., 1-2 hours
Level of energy/fatigue and emotional well-being as measured by the SF-36 mental health component
The SF-36 mental health component is a 9-item scale that measures energy/fatigue and emotional well-being in the past 4 weeks.Score range is 0-100, where 0 means poor emotional well-being and low energy and 100 means good emotional well-being and high energy.
Time frame: 4 weeks
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