Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

14 september 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

78

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Canton, Michigan, Verenigde Staten, 48187
        • Canton Health Center
      • Northville, Michigan, Verenigde Staten, 48168
        • Northville Health Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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
Experimenteel: 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.
Gedragsmatig: 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
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Level of objective understanding of CKD as measured by the Kidney Knowledge Survey (KiKS)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Level of positive perception of patient-provider communication as measured by the Patient Communication Assessment Tool (CAT)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Level of positive assessment of care as measured by the Patient Assessment of Care for Chronic Conditions (PACIC) scale
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan

Medewerkers

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

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 juni 2017

Primaire voltooiing (Werkelijk)

11 september 2020

Studie voltooiing (Werkelijk)

11 september 2020

Studieregistratiedata

Eerst ingediend

20 februari 2017

Eerst ingediend dat voldeed aan de QC-criteria

13 maart 2017

Eerst geplaatst (Werkelijk)

20 maart 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 september 2021

Laatste update ingediend die voldeed aan QC-criteria

14 september 2021

Laatst geverifieerd

1 september 2021

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HUM00118819
  • 4K23DK097183-04 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Chronische nierziekte

Klinische onderzoeken op Education worksheet

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Portugal

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren