Promoción de la toma de decisiones compartida para la estenosis aórtica grave (IMPACT SDM)
PCORI-CDR-2022C1-26333 Promoción de la toma de decisiones compartida sobre el tratamiento de la estenosis aórtica grave (estudio IMPACT SDM)
The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are:
- Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
- Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?
All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. Participants will complete surveys before and after their specialist visit.
Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The goal of this study is to promote shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are:
- Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations?
- Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course?
This study is a batched stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and interventional cardiologists, and will enroll about 1300 patients. All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. The interventions include a patient decision aid that was created by the American College of Cardiology CardioSmart program and a online shared decision making skills training course for clinicians. The coordinating center will provide implementation support to sites when they transition to the intervention arm. Data collection is similar across usual care and intervention groups. Patient participants will complete surveys before and after their specialist visit. Clinician participants will be randomly selected to complete a survey after the patient visit. Limited clinical data will be collected from the medical record.
Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions. Researchers will also calculate percentage of patients reached with decision aids and percentage of clinicians who complete training at each site to measure the success of the implementation.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94117
- The Regents of the University of California, San Francisco
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Colorado
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Aurora, Colorado, Estados Unidos, 80045-7202
- University of Colorado Denver
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308-0000
- Emory University
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-1350
- The University of North Carolina at Chapel Hill
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, Estados Unidos, 75390-9020
- UT Southwestern Medical Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Between 65-85 years of age
- Language is English or Spanish
- Diagnosed with severe aortic stenosis defined as (e.g. an aortic valve area < 1 cm2 or as determined by clinician)
- Attend a scheduled visit with an Interventional Cardiologist and/or Cardiac Surgeon from the Heart Valve Team at a participating site
Exclusion Criteria:
- Prior aortic valve replacement surgery
- High risk for either SAVR or TAVI (e.g., Society of Thoracic Surgery score >8% or clinician determined)
- Prior coronary artery bypass surgery (CABG)
- End stage renal disease on dialysis
- Severe lung disease (chronic obstructive pulmonary disease; COPD) requiring home oxygen
- Advanced Cirrhosis
- Unable to consent for self (proxy respondents are not allowed)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control (usual care)
This group will receive usual care without any support for using the decision aid and without any access to the clinician training. |
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Comparador activo: Intervention
The patients in this group will receive a decision aid that covers the main treatment options for aortic stenosis. The clinicians in this group will receive a 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies |
The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Shared Decision Making
Periodo de tiempo: About 1 week post visit
|
Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred. |
About 1 week post visit
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reach
Periodo de tiempo: About 1 week post visit
|
% of eligible patients who receive decision aid |
About 1 week post visit
|
|
Patient Knowledge
Periodo de tiempo: About 1 week post visit
|
Multiple choice knowledge score ranging from 0-100; higher scores indicate higher knowledge |
About 1 week post visit
|
|
Preference-treatment concordance
Periodo de tiempo: About 1 week post visit
|
% of patients who received preferred treatment within 6 months of visit |
About 1 week post visit
|
|
Patient experience
Periodo de tiempo: About 1 week post visit
|
CAHPS MD-patient communication subscale and visit rating score |
About 1 week post visit
|
|
Clinician satisfaction
Periodo de tiempo: About 1 week post visit
|
% of clinicians who mark "very" or "extremely" satisfied with visit |
About 1 week post visit
|
|
Adoption
Periodo de tiempo: 4 weeks from the start of intervention period for each site
|
% of eligible clinicians who complete the shared decision making skills training |
4 weeks from the start of intervention period for each site
|
|
Timeliness (time to decision)
Periodo de tiempo: About 1 week post visit
|
% of patients who report stage of decision making is "made a decision" |
About 1 week post visit
|
|
Timeliness (burden)
Periodo de tiempo: About 1 week post visit
|
% of visits where clinicians report visit length is "longer than normal" |
About 1 week post visit
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Karen Sepucha, PhD, Massachusetts General Hospital
- Investigador principal: Sammy Elmariah, MD, University of California, San Francisco
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- 2023P001413
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers. The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
Marco de tiempo para compartir IPD
The PCORI-designated repository will make the data available for third-party requests when PCORI makes the Final Research Report available, or at the time of publication the primary results, whichever comes first.
Criterios de acceso compartido de IPD
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
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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