Evidence map›Paper›PMID 39696639›Full record

ArticleTrials2024

The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) Study: study protocol for a cluster randomized stepped wedge trial.

Karen Sepucha, Sammy Elmariah, K D Valentine, Matthew A Cavender, Yuchiao Chang, Chandan M Devireddy, Neal W Dickert, Kristy D Gama, Christopher E Knoepke, Ethan Korngold and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06171737 (PCORI-CDR-2022C1-26333 Promoting Shared Decision Making for Decisions About Treatment of Severe Aortic Stenosis), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06171737 naenrolling by invitationnot on this map

PCORI-CDR-2022C1-26333 Promoting Shared Decision Making for Decisions About Treatment of Severe Aortic Stenosis (IMPACT SDM Study)

TypeinterventionalSponsorMassachusetts General HospitalRan2024 to 2027Enrolled1,300ConditionsAortic StenosisArmsDecision Aid, Shared Decision Making Skills Training
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Karen SepuchaDivision of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.
Sammy ElmariahDivision of Cardiology, University of California San Francisco, San Francisco, CA, USA.
K D ValentineDivision of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA. kvalentine2@mgh.harvard.edu.ORCID http://orcid.org/0000-0001-6349-5395
Matthew A CavenderDivision of Cardiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Yuchiao ChangDivision of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.
Chandan M DevireddyDivision of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, USA.
Neal W DickertDivision of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, USA.
Kristy D GamaDivision of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
Christopher E KnoepkeDivision of Cardiology, Adult and Child Center for Outcomes Research and Delivery Science (ACCORDS), Colorado Program for Patient-Centered Decisions, University of Colorado School of Medicine, Aurora, USA.
Ethan KorngoldDivision of Cardiology, Providence Heart Institute, Portland, OR, USA.
Dharam J KumbhaniDivision of Cardiology, UT Southwestern Medical Center, Dallas, TX, USA.
Daniel D MatlockDivision of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
John C MessengerDivision of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
Susan StrongHeart Valve Voice-US, Washington, D.C., USA.
Vinod H ThouraniDepartment of Cardiovascular Surgery, Marcus Valve Center, Piedmont Heart Institute, Atlanta, GA, USA.
Ashwin NathanDivision of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Nishath QuaderCardiovascular Division, Department of Medicine, Washington University in St. Louis, St. Louis, MO, USA.
Alexander A BresciaDivision of Cardiothoracic Surgery, Washington University in St. Louis, St. Louis, MO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe American College of Cardiology, American Heart Association, and Centers for Medicare and Medicaid Services recommend shared decision-making (SDM) for patients with severe aortic stenosis choosing between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Although tools such as patient decision aids (DAs) and training in SDM have been shown to improve SDM, implementation of SDM and DAs is limited. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) study aims to (1) determine the effectiveness of the interventions (a DA and clinician SDM training) in achieving SDM (primary outcome) and improving the quality of decisions about aortic valve replacement, (2) determine the reach of the DAs and adoption of training, and (3) explore potential mechanisms of effectiveness and implementation at the patient-, clinician-, and clinic-level.

methodsThe study is a hybrid type II effectiveness-implementation study using a cluster randomized batched stepped wedge trial with 8 sites across the USA. Eligible patients will be surveyed before and after visits with the heart valve team; clinicians will be surveyed after visits. Reach of DAs and adoption of training will be tracked. Clinicians will be interviewed regarding barriers and facilitators to implementation. DISCUSSION: The IMPACT SDM Study seeks to provide evidence of the ability of the interventions to improve SDM and decision quality, and also to shed light on barriers and facilitators to SDM implementation to promote future implementation efforts.

trial registrationClinicalTrials.gov NCT06171737. Registered on December 15, 2023.

Indexed as

Aortic Valve StenosisDecision Making, SharedMulticenter Studies as TopicRandomized Controlled Trials as TopicTranscatheter Aortic Valve ReplacementAortic ValveClinical Decision-MakingClinical Trials, Phase II as TopicDecision Support TechniquesHeart Valve Prosthesis ImplantationHumansPatient ParticipationTreatment OutcomeUnited StatesAortic valve stenosisCardiologyContinuing medical educationDecision aidDecision-makingSharedTranscatheter aortic valve replacement

Identifiers

PMID39696639
PMCPMC11654330

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.