Studie om systeminterventioner för att uppnå tidiga och rättvisa transplantationer (STEPS).
This project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Carolina
-
Winston-Salem, North Carolina, Förenta staterna, 27101
- Wake Forest University Health Sciences
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Ability to provide oral informed consent
- Male or female, aged 18 to <=75 years
- Presence of CKD (2 eGFRs <60, 90 days apart) and at least 1 of the following: most recent eGFR less than 30 or KFRE greater than 10%
- English speaking with adequate ability to hear and understand questions over the phone
- Willing to comply with all study procedures and be available for the duration of the study
Exclusion Criteria:
- Male or female, aged <18 or > 75 years
- Non-English speaking
- Lack of ability to hear and comprehend verbal communication.
- Patients on dialysis
- Deceased
- Hospice/palliative care
- Prior kidney transplant
- Currently waitlisted at any transplant center
- Self-reported terminal illness or receipt of hospice services
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: STEPS Health System Surveillance och Outreach intervention
|
STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach |
|
Inget ingripande: Vanlig njurvård
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Health system reported completion of transplant evaluation
Tidsram: 18 months
|
Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports |
18 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Live donor inquires to transplant center
Tidsram: 6 months, 12 months, 18 months
|
the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire |
6 months, 12 months, 18 months
|
|
Live kidney donor transplants
Tidsram: 6 months, 12 months, 18 months
|
The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire |
6 months, 12 months, 18 months
|
|
Placement on deceased kidney donor waitlist
Tidsram: 6 months, 12 months, 18 months
|
The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS |
6 months, 12 months, 18 months
|
|
Deceased kidney donor transplants
Tidsram: 6 months, 12 months, 18 months
|
The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS |
6 months, 12 months, 18 months
|
|
Health system reported initiation of transplant evaluation
Tidsram: 18 months
|
Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports |
18 months
|
|
Patient reported physician discussions
Tidsram: baseline, 6 months, 12 months, 18 months
|
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported family discussions
Tidsram: baseline, 6 months, 12 months, 18 months
|
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported initiation of transplant evaluation
Tidsram: baseline, 6 months, 12 months, 18 months
|
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported completion of transplant evaluation
Tidsram: baseline, 6 months, 12 months, 18 months
|
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported identification of a living donor
Tidsram: baseline, 6 months, 12 months, 18 months
|
Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported kidney transplant knowledge
Tidsram: baseline, 6 months, 12 months, 18 months
|
Number of questions patients correctly answer measured by patient report in questionnaire |
baseline, 6 months, 12 months, 18 months
|
|
Patient reported empowerment
Tidsram: baseline, 6 months, 12 months, 18 months
|
Calculation of scaled questions from the adapted DES-SF form using a range of 1-5 for each question, with 5 being the best outcome, measured by patient report in questionnaire. |
baseline, 6 months, 12 months, 18 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Ebony Boulware, M.D., Wake Forest University Health Sciences
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens
- Patologiska tillstånd, tecken och symtom
- Njurinsufficiens, kronisk
Andra studie-ID-nummer
- IRB00097407
- 7U01DK127918-02 (U.S.S. NIH-anslag/kontrakt)
- IHS-2020C1-19350-IC (Annat bidrag/finansieringsnummer: PCORI)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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