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

NCT03084159 | Completed

• 2 other identifiers: HUM001188194K23DK097183-04
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Length of doctor's appointment, e.g., 1-2 hours

Secondary Outcomes (3)

• Level of positive perception of patient-provider communication as measured by the Patient Communication Assessment Tool (CAT)

  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

  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

  4 weeks

Other Outcomes (1)

• Level of positive assessment of care as measured by the Patient Assessment of Care for Chronic Conditions (PACIC) scale

  6 months

Study Arms (3)

Participatory design and intervention

EXPERIMENTAL

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.

Behavioral: Education worksheet

Intervention Only

EXPERIMENTAL

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.

Behavioral: Education worksheet

Usual Care

NO INTERVENTION

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.

Interventions

Education worksheet BEHAVIORAL

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.

Also known as: Education Activation Worksheet

Intervention Only; Participatory design and intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Canton Health Center

Canton, Michigan, 48187, United States

Location

Northville Health Center

Northville, Michigan, 48168, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Wright-Nunes, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 20, 2017
• Study Start: June 5, 2017
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)