Promuovere un processo decisionale condiviso per la stenosi aortica grave (IMPACT SDM)
PCORI-CDR-2022C1-26333 Promozione del processo decisionale condiviso per le decisioni sul trattamento della stenosi aortica grave (studio 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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California
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San Francisco, California, Stati Uniti, 94117
- The Regents of the University of California, San Francisco
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Colorado
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Aurora, Colorado, Stati Uniti, 80045-7202
- University of Colorado Denver
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Georgia
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Atlanta, Georgia, Stati Uniti, 30308-0000
- Emory University
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
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Missouri
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St Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599-1350
- The University of North Carolina at Chapel Hill
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, Stati Uniti, 75390-9020
- UT Southwestern Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: 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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Comparatore attivo: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Shared Decision Making
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Reach
Lasso di tempo: About 1 week post visit
|
% of eligible patients who receive decision aid |
About 1 week post visit
|
|
Patient Knowledge
Lasso di tempo: 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
Lasso di tempo: About 1 week post visit
|
% of patients who received preferred treatment within 6 months of visit |
About 1 week post visit
|
|
Patient experience
Lasso di tempo: About 1 week post visit
|
CAHPS MD-patient communication subscale and visit rating score |
About 1 week post visit
|
|
Clinician satisfaction
Lasso di tempo: About 1 week post visit
|
% of clinicians who mark "very" or "extremely" satisfied with visit |
About 1 week post visit
|
|
Adoption
Lasso di tempo: 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)
Lasso di tempo: About 1 week post visit
|
% of patients who report stage of decision making is "made a decision" |
About 1 week post visit
|
|
Timeliness (burden)
Lasso di tempo: About 1 week post visit
|
% of visits where clinicians report visit length is "longer than normal" |
About 1 week post visit
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Karen Sepucha, PhD, Massachusetts General Hospital
- Investigatore principale: Sammy Elmariah, MD, University of California, San Francisco
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2023P001413
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione IPD
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
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