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

14. September 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

78

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Michigan
      • Canton, Michigan, Vereinigte Staaten, 48187
        • Canton Health Center
      • Northville, Michigan, Vereinigte Staaten, 48168
        • Northville Health Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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 (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.
Verhalten: 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.
Andere Namen:
  • Education Activation Worksheet
Experimental: 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.
Verhalten: 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.
Andere Namen:
  • Education Activation Worksheet
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Level of objective understanding of CKD as measured by the Kidney Knowledge Survey (KiKS)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Level of positive perception of patient-provider communication as measured by the Patient Communication Assessment Tool (CAT)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Level of positive assessment of care as measured by the Patient Assessment of Care for Chronic Conditions (PACIC) scale
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Michigan

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. Juni 2017

Primärer Abschluss (Tatsächlich)

11. September 2020

Studienabschluss (Tatsächlich)

11. September 2020

Studienanmeldedaten

Zuerst eingereicht

20. Februar 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. März 2017

Zuerst gepostet (Tatsächlich)

20. März 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. September 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. September 2021

Zuletzt verifiziert

1. September 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HUM00118819
  • 4K23DK097183-04 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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