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Completed

NCT Number: NCT03084159

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canton Health Center, Canton, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Education Activation Worksheet

Primary outcomes

  1. Level of objective understanding of CKD as measured by the Kidney Knowledge Survey (KiKS)

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

    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.

  2. Level of perceived understanding of CKD as measured by the Perceived Kidney Knowledge Survey (PiKS)

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

    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.

Secondary outcomes

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

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

    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.

  2. Level of mental anxiety/stress related to condition as measured by the adapted NDBCSS scale

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

    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.

  3. Level of energy/fatigue and emotional well-being as measured by the SF-36 mental health component

    Time frame: 4 weeks

    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.

Other outcomes

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

    Time frame: 6 months

    This is a 11-item scale evaluating patient assessment of the quality of care that patients received in the past 6 months. Score range is 1-5, where 1 means poor assessment of quality of care and 5 means good assessment of quality of care.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: EPIK

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2017
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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