Evidence map›Paper›PMID 38263088›Full record

ArticleResearch involvement and engagement2024

Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA).

Nicole Zhao, Allison M Cuthel, Owen Storms, Raina Zhang, Rebecca Liddicoat Yamarik, Jacob Hill, Regina Kaur, Kaitlyn Van Allen, Mara Flannery, Alex Chang and 21 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Research involvement and engagement, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03325985 (Emergency Medicine Palliative Care Access), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.2field-weighted citation impact, top 14% of its field
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.

NCT03325985 nacompletednot on this map

Emergency Medicine Palliative Care Access (EMPallA)

TypeinterventionalSponsorNYU Langone HealthRan2018 to 2023Enrolled1,606ConditionsAdvanced Cancer, End Stage Organ FailureArmsNurse-led telephonic case management, Facilitated,outpatient specialty palliative care
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Patient and Caregiver Information-seeking in Lung Cancer Treatment: A Real-world Sentiment Analysis of Reddit Communities.Journal of cancer education : the official journal of the American Association for Cancer Education · 2026
    Article
  3. 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

31 authors at 16 institutions in 2 countries.

Nicole ZhaoRenaissance School of Medicine at Stony, Brook University, Stony Brook, NY, USA.
Allison M CuthelRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA. Allison.Cuthel@nyulangone.org.
Owen StormsRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Raina ZhangRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Rebecca Liddicoat YamarikDepartment of Medicine, Tibor Rubin Long Beach Veteran Affairs, Long Beach, CA, USA.
Jacob HillRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Regina KaurRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Kaitlyn Van AllenRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Mara FlanneryRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Alex ChangRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Frank ChungRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Sumeet RandhawaRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Isabel Castro AlvarezRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Angela Young-BrinnCharles R. Drew University of Medicine and Science, Los Angeles, CA, USA.
Constance L Kizzie-GillettLillie's Circle of Care, Streamwood, IL, USA.
Dawn RosiniUniversity of Florida Shands Hospital, Gainesville, FL, USA.
Eric D IsaacsDepartment of Emergency Medicine, University of California San Francisco, San Francisco, CA, USA.
Ernest HopkinsThe Phoenix Group Foundation, Atlanta, GA, USA.
Garrett K ChanHealthImpact, Oakland, CA, USA.
Juanita Booker-VaughnsCharles R. Drew University of Medicine and Science, Los Angeles, CA, USA.
Margaret MaguireCambia Health Solutions, Portland, OR, USA.
Martha NavarroCharles R. Drew University of Medicine and Science, Los Angeles, CA, USA.
Neha Reddy PidatalaAmerican Cancer Society, Atlanta, GA, USA.
Patrick DunnAmerican Heart Association, Dallas, TX, USA.
Pluscedia WilliamsCharles R. Drew University of Medicine and Science, Los Angeles, CA, USA.
Robert GalvinThe Blackstone Group, New York, NY, USA.
Romilla BatraSenior Care Action Network (SCAN) Health Plan, Long Beach, CA, USA.
Sally WelshHospice and Palliative Nurses Association, Carnegie, PA, USA.
William VaughanPatient Advocacy, Fairfax, VA, USA.
Jean-Baptiste Bouillon-MinoisRonald O. Perelman Department of Emergency Medicine, New York University Grossman School of Medicine, 227 East 30th Street, New York, NY, 10016, USA.
Corita R GrudzenDivision of Supportive and Acute Care Services, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
New York University · USCharles R. Drew University of Medicine and Science · USAction Network · USAmerican Cancer Society · USAmerican Heart Association · USBlackstone (United States) · USCambia Health Solutions (United States) · USCleveland Clinic · USFlorida College · USHarbor–UCLA Medical Center · USHospice and Palliative Nurses Foundation · USMemorial Sloan Kettering Cancer Center · USPatient Advocate Foundation · USStony Brook School · USTibor Rubin VA Medical Center · USUniversity of California, San Francisco · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundInvolving patient and community stakeholders in clinical trials adds value by ensuring research prioritizes patient goals both in conduct of the study and application of the research. The use of stakeholder committees and their impact on the conduct of a multicenter clinical trial have been underreported clinically and academically. The aim of this study is to describe how Study Advisory Committee (SAC) recommendations were implemented throughout the Emergency Medicine Palliative Care Access (EMPallA) trial. EMPallA is a multi-center, pragmatic two-arm randomized controlled trial (RCT) comparing the effectiveness of nurse-led telephonic case management and specialty, outpatient palliative care of older adults with advanced illness.

methodsA SAC consisting of 18 individuals, including patients with palliative care experience, members of healthcare organizations, and payers was convened for the EMPallA trial. The SAC engaged in community-based participatory research and assisted in all aspects from study design to dissemination. The SAC met with the research team quarterly and annually from project inception to dissemination. Using meeting notes and recordings we completed a qualitative thematic analysis using an iterative process to develop themes and subthemes to summarize SAC recommendations throughout the project's duration.

resultsThe SAC convened 16 times between 2017 and 2020. Over the course of the project, the SAC provided 41 unique recommendations. Twenty-six of the 41 (63%) recommendations were adapted into formal Institutional Review Board (IRB) study modifications. Recommendations were coded into four major themes: Scientific, Pragmatic, Resource and Dissemination. A majority of the recommendations were related to either the Scientific (46%) or Pragmatic (29%) themes. Recommendations were not mutually exclusive across three study phases: Preparatory, execution and translational. A vast majority (94%) of the recommendations made were related to the execution phase. Major IRB study modifications were made based on their recommendations including data collection of novel dependent variables and expanding recruitment to Spanish-speaking patients.

conclusionsOur study provides an example of successful integration of a SAC in the conduct of a pragmatic, multi-center RCT. Future trials should engage with SACs in all study phases to ensure trials are relevant, inclusive, patient-focused, and attentive to gaps between health care and patient and family needs.

trial registrationClinicaltrials.gov Identifier: NCT03325985, 10/30/2017.

Indexed as

Palliative carePatient and public involvementResearch designStakeholder participationStudy Advisory Committee

Identifiers

PMID38263088
PMCPMC10807180
OpenAlexW4391135613

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.