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Trial record 10 of 49 for:    Recruiting, Not yet recruiting, Available Studies | kidney disease | NIDDK

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

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ClinicalTrials.gov Identifier: NCT03084159
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Julie Wright-Nunes, University of Michigan

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.

Amendment on 12/2018: We have updated the enrollment numbers to include the control group.

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: Education worksheet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multi-disciplinary Participatory Design of a Process to Deliver a CKD Diagnosis in Primary Care
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Participatory design and intervention
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. 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
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 Name: Education Activation Worksheet

Experimental: Intervention Only
A future arm will include patients at another site that will also receive the intervention of using an education worksheet during their appointment and fill out post intervention surveys. Providers/staff have not been involved in the initial design of the intervention process but will use it as part of the intervention delivery.
Behavioral: Education worksheet
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 Name: Education Activation Worksheet

No Intervention: Usual Care
A third site will include usual care, which does not include the intervention. Participants will be given post visit surveys similar to those in the two other study / intervention arms. This site will serve as a usual care comparison.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084159


Contacts
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Contact: Emily Chen, MA 734-232-4508 emilypc@med.umich.edu

Locations
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United States, Michigan
Canton Health Center Not yet recruiting
Canton, Michigan, United States, 48187
Contact: Emily Chen, MA    734-232-4508    emilypc@med.umich.edu   
Northville Health Center Recruiting
Northville, Michigan, United States, 48168
Contact: Emily Chen, MA    734-232-4508    emilypc@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Julie Wright-Nunes, MD, MPH University of Michigan

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Responsible Party: Julie Wright-Nunes, Asst. Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03084159     History of Changes
Other Study ID Numbers: HUM00118819
4K23DK097183-04 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency