Clinical trial NCT03084159: Multi-disciplinary Participatory Design of a Process to Deliver a CKD Diagnosis in Primary Care
Official title: Multi-disciplinary Participatory Design of a Process to Deliver a CKD Diagnosis in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-03-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of objective understanding of CKD as measured by the Kidney Knowledge Survey (KiKS)
timeFrame: Length of doctor's appointment, e.g., 1-2 hours
measure: Level of perceived understanding of CKD as measured by the Perceived Kidney Knowledge Survey (PiKS)
timeFrame: Length of doctor's appointment, e.g., 1-2 hours
Secondary outcomes:
measure: Level of positive perception of patient-provider communication as measured by the Patient Communication Assessment Tool (CAT)
timeFrame: Length of doctor's appointment, e.g., 1-2 hours
measure: Level of mental anxiety/stress related to condition as measured by the adapted NDBCSS scale
timeFrame: Length of doctor's appointment, e.g., 1-2 hours
measure: Level of energy/fatigue and emotional well-being as measured by the SF-36 mental health component
timeFrame: 4 weeks
Other outcomes:
measure: Level of positive assessment of care as measured by the Patient Assessment of Care for Chronic Conditions (PACIC) scale
timeFrame: 6 months
Locations:
city: Canton
country: United States
facility: Canton Health Center
state: Michigan
city: Northville
country: United States
facility: Northville Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Julie Wright-Nunes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: