Promowanie wspólnego podejmowania decyzji w przypadku ciężkiego zwężenia aorty (IMPACT SDM)
PCORI-CDR-2022C1-26333 Promowanie wspólnego podejmowania decyzji dotyczących leczenia ciężkiego zwężenia aorty (badanie 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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California
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San Francisco, California, Stany Zjednoczone, 94117
- The Regents of the University of California, San Francisco
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045-7202
- University of Colorado Denver
-
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30308-0000
- Emory University
-
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
- Massachusetts General Hospital
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-
Missouri
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St Louis, Missouri, Stany Zjednoczone, 63110
- Washington University School of Medicine
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North Carolina
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Chapel Hill, North Carolina, Stany Zjednoczone, 27599-1350
- The University of North Carolina at Chapel Hill
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- University of Pennsylvania
-
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Texas
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Dallas, Texas, Stany Zjednoczone, 75390-9020
- UT Southwestern Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: 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. |
|
|
Aktywny komparator: 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 |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Shared Decision Making
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Reach
Ramy czasowe: About 1 week post visit
|
% of eligible patients who receive decision aid |
About 1 week post visit
|
|
Patient Knowledge
Ramy czasowe: 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
Ramy czasowe: About 1 week post visit
|
% of patients who received preferred treatment within 6 months of visit |
About 1 week post visit
|
|
Patient experience
Ramy czasowe: About 1 week post visit
|
CAHPS MD-patient communication subscale and visit rating score |
About 1 week post visit
|
|
Clinician satisfaction
Ramy czasowe: About 1 week post visit
|
% of clinicians who mark "very" or "extremely" satisfied with visit |
About 1 week post visit
|
|
Adoption
Ramy czasowe: 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)
Ramy czasowe: About 1 week post visit
|
% of patients who report stage of decision making is "made a decision" |
About 1 week post visit
|
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Timeliness (burden)
Ramy czasowe: About 1 week post visit
|
% of visits where clinicians report visit length is "longer than normal" |
About 1 week post visit
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Karen Sepucha, PhD, Massachusetts General Hospital
- Główny śledczy: Sammy Elmariah, MD, University of California, San Francisco
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2023P001413
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Ramy czasowe udostępniania 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.
Kryteria dostępu do udostępniania IPD
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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