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

14. september 2021 opdateret af: Julie Wright-Nunes, University of Michigan

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

78

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Michigan
      • Canton, Michigan, Forenede Stater, 48187
        • Canton Health Center
      • Northville, Michigan, Forenede Stater, 48168
        • Northville Health Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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 (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.
Adfærdsmæssigt: 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.
Andre navne:
  • Education Activation Worksheet
Eksperimentel: Intervention Only
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.
Adfærdsmæssigt: 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.
Andre navne:
  • Education Activation Worksheet
Ingen indgriben: Usual Care
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Level of objective understanding of CKD as measured by the Kidney Knowledge Survey (KiKS)
Tidsramme: 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.
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)
Tidsramme: 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.
Length of doctor's appointment, e.g., 1-2 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Level of positive perception of patient-provider communication as measured by the Patient Communication Assessment Tool (CAT)
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
4 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Level of positive assessment of care as measured by the Patient Assessment of Care for Chronic Conditions (PACIC) scale
Tidsramme: 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.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Michigan

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Julie Wright-Nunes, MD, MPH, University of Michigan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. juni 2017

Primær færdiggørelse (Faktiske)

11. september 2020

Studieafslutning (Faktiske)

11. september 2020

Datoer for studieregistrering

Først indsendt

20. februar 2017

Først indsendt, der opfyldte QC-kriterier

13. marts 2017

Først opslået (Faktiske)

20. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUM00118819
  • 4K23DK097183-04 (U.S. NIH-bevilling/kontrakt)

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