Förderung einer gemeinsamen Entscheidungsfindung bei schwerer Aortenstenose (IMPACT SDM)
PCORI-CDR-2022C1-26333 Förderung der gemeinsamen Entscheidungsfindung bei Entscheidungen über die Behandlung schwerer Aortenstenose (IMPACT SDM-Studie)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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California
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San Francisco, California, Vereinigte Staaten, 94117
- The Regents of the University of California, San Francisco
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045-7202
- University of Colorado Denver
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30308-0000
- Emory University
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27599-1350
- The University of North Carolina at Chapel Hill
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, Vereinigte Staaten, 75390-9020
- UT Southwestern Medical Center
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: 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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Aktiver 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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Shared Decision Making
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Reach
Zeitfenster: About 1 week post visit
|
% of eligible patients who receive decision aid |
About 1 week post visit
|
|
Patient Knowledge
Zeitfenster: 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
Zeitfenster: About 1 week post visit
|
% of patients who received preferred treatment within 6 months of visit |
About 1 week post visit
|
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Patient experience
Zeitfenster: About 1 week post visit
|
CAHPS MD-patient communication subscale and visit rating score |
About 1 week post visit
|
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Clinician satisfaction
Zeitfenster: About 1 week post visit
|
% of clinicians who mark "very" or "extremely" satisfied with visit |
About 1 week post visit
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Adoption
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: About 1 week post visit
|
% of visits where clinicians report visit length is "longer than normal" |
About 1 week post visit
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Karen Sepucha, PhD, Massachusetts General Hospital
- Hauptermittler: Sammy Elmariah, MD, University of California, San Francisco
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2023P001413
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
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.
IPD-Sharing-Zugriffskriterien
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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