Estudio de Intervenciones del Sistema para Lograr Trasplantes Tempranos y Equitativos (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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
North Carolina
-
Winston-Salem, North Carolina, Estados Unidos, 27101
- Wake Forest University Health Sciences
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervención STEPS Health System Surveillance and Outreach
|
STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach |
|
Sin intervención: Cuidado renal habitual
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health system reported completion of transplant evaluation
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Live donor inquires to transplant center
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ebony Boulware, M.D., Wake Forest University Health Sciences
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- IRB00097407
- 7U01DK127918-02 (Subvención/contrato del NIH de EE. UU.)
- IHS-2020C1-19350-IC (Otro número de subvención/financiamiento: PCORI)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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