Evidence map›Paper›PMID 33691760›Full record

ArticleTrials2021

Feasibility and efficacy of a decision aid for emergency department patients with suspected ureterolithiasis: protocol for an adaptive randomized controlled trial.

Elizabeth M Schoenfeld, Kye E Poronsky, Lauren M Westafer, Brianna M DiFronzo, Paul Visintainer, Charles D Scales, Erik P Hess, Peter K Lindenauer

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04234035 (Shared Decision-Making for the Promotion of Patient-Centered Imaging in the Emergency Department), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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.

NCT04234035 nacompletednot on this map

Shared Decision-Making for the Promotion of Patient-Centered Imaging in the Emergency Department: Suspected Kidney Stones

TypeinterventionalSponsorBaystate Medical CenterRan2019 to 2024Enrolled98ConditionsShared Decision-making, Kidney Stone, Emergencies, Radiation ExposureArmsDecision Aid, Standardized Educational Material (informational pamphlet)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. "Just give them a choice": Patients' perspectives on starting medications for opioid use disorder in the ED.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2022
    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

8 authors.

Elizabeth M SchoenfeldDepartment of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA. ElizSchoen@gmail.com.ORCID http://orcid.org/0000-0003-3661-4023
Kye E PoronskyDepartment of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.
Lauren M WestaferDepartment of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.
Brianna M DiFronzoDepartment of Emergency Medicine and Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.
Paul VisintainerDepartment of Medicine, and Institute for Healthcare Delivery and Population Science Epidemiology and Biostatistics Research Core, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.
Charles D ScalesDuke Clinical Research Institute and Division of Urologic Surgery, Duke University School of Medicine, Durham, NC, USA.
Erik P HessDepartment of Emergency Medicine, Vanderbilt University Medical Center, TN, Memphis, USA.
Peter K LindenauerInstitute for Healthcare Delivery and Population Science, University of Massachusetts Medical School - Baystate, Springfield, MA, USA.

Funding

Tufts Clinical and Translational Science Institute (Pilot Supplement)UL1TR002544 · NCATS · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2018 to 2022
$50.2M
Tufts Clinical and Translational Research InstituteUL1TR001064 · NCATS · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2013 to 2017
$26.4M
TUFTS CLINICAL AND TRANSLATION SCIENCE INSTITUTE (UL1): BPCAUL1RR025752 · NCRR · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2008 to 2011
$17.6M
Tufts Clinical and Translation Science Institute (UL1)UL1TR000073 · NCATS · TUFTS UNIVERSITY BOSTON · PI SELKER, HARRY P. · 2012 to 2013
$5.5M
Cardiovagal baroreflex deficits impair neurovascular coupling and cognition in Postural Tachycardia SyndromeR01HL134674 · NHLBI · NEW YORK MEDICAL COLLEGE · PI STEWART, JULIAN M · 2017 to 2020
$2.5M
Shared Decision-Making for the Promotion of Patient-Centered Imaging in the Emergency Department: Suspected Kidney StonesK08HS025701 · AHRQ · BAYSTATE MEDICAL CENTER, INC. · PI SCHOENFELD, ELIZABETH MAE · 2018 to 2022
$734k
Research and Mentoring in Comparative Effectiveness and Implementation ScienceK24HL132008 · NHLBI · BAYSTATE MEDICAL CENTER, INC. · PI LINDENAUER, PETER KYLE · 2016 to 2020
$574k
Agency for Healthcare Research and Quality 1K08HS025701AHRQ HHS K08 HS025701NCATS NIH HHS UL1 TR000073NCATS NIH HHS UL1 TR001064NCATS NIH HHS UL1 TR002544NCRR NIH HHS UL1 RR025752NHLBI NIH HHS K24 HL132008NHLBI NIH HHS K24HL132008NHLBI NIH HHS R01 HL134674NHLBI NIH HHS R01HL134674Patient-Centered Outcomes Research Institute DI-2017C1-6344
6 · The paper itself

Abstract

backgroundApproximately 2 million patients present to emergency departments in the USA annually with signs and symptoms of ureterolithiasis (or renal colic, the pain from an obstructing kidney stone). Both ultrasound and CT scan can be used for diagnosis, but the vast majority of patients receive a CT scan. Diagnostic pathways utilizing ultrasound have been shown to decrease radiation exposure to patients but are potentially less accurate. Because of these and other trade-offs, this decision has been proposed as appropriate for Shared Decision-Making (SDM), where clinicians and patients discuss clinical options and their consequences and arrive at a decision together. We developed a decision aid to facilitate SDM in this scenario. The objective of this study is to determine the effects of this decision aid, as compared to usual care, on patient knowledge, radiation exposure, engagement, safety, and healthcare utilization.

methodsThis is the protocol for an adaptive randomized controlled trial to determine the effects of the intervention-a decision aid ("Kidney Stone Choice")-on patient-centered outcomes, compared with usual care. Patients age 18-55 presenting to the emergency department with signs and symptoms consistent with acute uncomplicated ureterolithiasis will be consecutively enrolled and randomized. Participants will be blinded to group allocation. We will collect outcomes related to patient knowledge, radiation exposure, trust in physician, safety, and downstream healthcare utilization. DISCUSSION: We hypothesize that this study will demonstrate that "Kidney Stone Choice," the decision aid created for this scenario, improves patient knowledge and decreases exposure to ionizing radiation. The adaptive design of this study will allow us to identify issues with fidelity and feasibility and subsequently evaluate the intervention for efficacy.

trial registrationClinicalTrials.gov NCT04234035 . Registered on 21 January 2020 - Retrospectively Registered.

Indexed as

Decision Support TechniquesUreterolithiasisAdolescentAdultDecision Making, SharedEmergency Service, HospitalFeasibility StudiesHumansMiddle AgedRandomized Controlled Trials as TopicYoung AdultComputed tomographyKidney stonesMedical imagingRandomized controlled trialShared Decision-MakingUltrasound

Identifiers

PMID33691760
PMCPMC7944622

What OpenQuestion holds

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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.