Palliative Care Initiated in the Emergency Department: A Cluster Randomized Clinical Trial.
Grudzen CR, Siman N, Cuthel AM, Adeyemi O, Yamarik RL, Goldfeld KS, PRIM-ER Investigators, Abella BS, Bellolio F, Bourenane S, Brody AA, Cameron-Comasco L, Chodosh J, Cooper JJ, Deutsch AL, Elie MC, Elsayem A, Fernandez R, Fleischer-Black J, Gang M, Genes N, Goett R, Heaton H, Hill J, Horwitz L, Isaacs E, Jubanyik K, Lamba S, Lawrence K, Lin M, Loprinzi-Brauer C, Madsen T, Miller J, Modrek A, Otero R, Ouchi K, Richardson C, Richardson LD, Ryan M, Schoenfeld E, Shaw M, Shreves A, Southerland LT, Tan A, Uspal J, Venkat A, Walker L, Wittman I, Zimny E
- DOI
- 10.1001/jama.2024.23696
- Record issued
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-20
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/bcfdb028-0caa-441e-908c-66146859574c is authoritative.
How this rating was calculated
- ReportingEthical approvals partially met−0.25★
- ReportingData & code availability partially met−0.25★
- Statistics were not checked: no recomputable values were found in this text — no test statistic reported with its degrees of freedom, no effect estimate printed with both a 95% CI and a p-value, and no percentage printed with both its count and its denominator.
- No data or code availability links were detected to verify.
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
The paper presents a well-designed cluster randomized stepped-wedge trial with a clear rationale and appropriate statistical methods. The main weaknesses are missing explicit ethics approval and informed consent statements, an incomplete data sharing statement, and several minor reporting gaps (randomization details, power analysis, statistical software, limitations).
Both reviewers classified the study as interventional, and this was adopted. The evaluation covered the abstract and available methods/results sections; full-text details on ethics, randomization, and limitations were not available, which may affect the completeness of the assessment. The statistics verification component could not recompute any tests due to lack of test statistics/df, so statistical correctness is not fully verified.
Numerical inconsistencies
None foundValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
Checked — nothing surfaced.
Overstated conclusions
None foundConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
Checked — nothing surfaced.
3 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewers 1, 2The multicomponent intervention did not have an effect on hospital admission.The primary outcome analysis shows no significant difference, with adjusted OR crossing 1.Evidence: Adjusted OR 1.03 (95% CI 0.93-1.14) for hospital admission.
“adjusted odds ratio [OR], 1.03 [95% CI, 0.93 to 1.14]”
Results - supportedReviewers 1, 2The intervention did not affect subsequent health care use or survival.All secondary outcomes show no significant differences, with CIs crossing 1.Evidence: Adjusted ORs for ICU admission, ED revisits, hospice use, home health use, readmission, and death all have CIs including 1.
“There was no difference in the secondary outcomes before vs after the intervention.”
Results - supportedReviewer 1The intervention is a multicomponent primary palliative care intervention.The intervention components are clearly described.Evidence: Description of the four components in the Intervention section.
“A multicomponent intervention (the Primary Palliative Care for Emergency Medicine intervention) included (1) evidence-based multidisciplinary education; (2) simulation-based workshops on serious illness communication; (3) clinical decision support; and (4) audit and feedback for ED clinical staff.”
Intervention
Data authenticity concerns
None foundAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
Checked — nothing surfaced.
Reporting gaps
2 findings · worst mediumRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
- Data/code availability incompleteAssessed
- Ethics/consent reporting incompleteAssessed
The introduction and importance sections provide a logical rationale for initiating palliative care in the ED, referencing the opportunity and prior evidence. The objective is clearly stated. Limitations of prior research are implicitly addressed through the design of a large multicenter trial, though not explicitly detailed.
“The emergency department (ED) offers an opportunity to initiate palliative care for older adults with serious, life-limiting illness.”
“To assess the effect of a multicomponent intervention to initiate palliative care in the ED on hospital admission, subsequent health care use, and survival in older adults with serious, life-limiting illness.”
“The emergency department (ED) offers an opportunity to initiate palliative care for older adults with serious, life-limiting illness.”
“To assess the effect of a multicomponent intervention to initiate palliative care in the ED on hospital admission, subsequent health care use, and survival in older adults with serious, life-limiting illness.”
The study is a cluster randomized stepped-wedge trial, which is appropriate for evaluating a system-level intervention. Randomization method is implied by the cluster design, though the specific method is not detailed. Inclusion/exclusion criteria are clearly stated. Power analysis is not reported, but the large sample size (98,922 visits) likely provides adequate power. Blinding is not feasible for this type of intervention and is not mentioned, but this is acceptable for pragmatic trials.
“Cluster randomized, stepped-wedge, clinical trial”
“patients aged 66 years or older who visited 1 of 29 EDs across the US between May 1, 2018, and December 31, 2022, had 12 months of prior Medicare enrollment, and a Gagne comorbidity score greater than 6”
“Cluster randomized, stepped-wedge, clinical trial”
“patients aged 66 years or older who visited 1 of 29 EDs across the US between May 1, 2018, and December 31, 2022, had 12 months of prior Medicare enrollment, and a Gagne comorbidity score greater than 6”
The study reports age, sex, and race/ethnicity of participants. Health status is captured via Gagne comorbidity score. Species/strain and housing conditions are not applicable. Sex is reported for both sexes, so justification for single-sex is not needed.
“median age, 77 years [IQR, 71-84 years]; 50% were female; 13% were Black and 78% were White”
“median Gagne comorbidity score was 8 [IQR, 7-10]”
“median age, 77 years [IQR, 71-84 years]; 50% were female; 13% were Black and 78% were White; and the median Gagne comorbidity score was 8 [IQR, 7-10]”
The paper does not mention an IRB approval or informed consent. Although the trial is registered and funded by NIH, the absence of an ethics statement is a concern. The data sharing statement is referenced but not detailed.
“ClinicalTrials.gov Identifier: NCT03424109”
The intervention is a multicomponent educational and decision-support program, not a drug or device. No antibodies, cell lines, or reagents are used. Software tools are not described in detail, but the intervention includes clinical decision support, which may involve software, but it is not a key resource for replication.
“A multicomponent intervention (the Primary Palliative Care for Emergency Medicine intervention) included (1) evidence-based multidisciplinary education; (2) simulation-based workshops on serious illness communication; (3) clinical decision support; and (4) audit and feedback for ED clinical staff.”
“A multicomponent intervention (the Primary Palliative Care for Emergency Medicine intervention) included (1) evidence-based multidisciplinary education; (2) simulation-based workshops on serious illness communication; (3) clinical decision support; and (4) audit and feedback for ED clinical staff.”
The paper reports adjusted odds ratios with 95% confidence intervals for all outcomes, which is a complete way to report effect estimates. The statistical tests are not explicitly named, but the use of adjusted ORs implies logistic regression or similar. Assumptions are not discussed, but for large trials this is often acceptable. Data presentation includes rates and CIs, which is adequate.
“adjusted odds ratio [OR], 1.03 [95% CI, 0.93 to 1.14]”
“adjusted odds ratio [OR], 1.03 [95% CI, 0.93 to 1.14]”
The paper mentions a 'Data Sharing Statement: See .' but the actual statement is not included in the provided text. No repository deposit or accession numbers are given. Code sharing is not applicable as no custom code is described.
“Data Sharing Statement: See .”
“Data Sharing Statement: See .”
The trial registration number is provided. Methods are described in sufficient detail for replication. Limitations are not explicitly discussed in the provided text, but the discussion likely covers them. Conclusions are proportional to the results. Funding and conflicts are reported.
“ClinicalTrials.gov Identifier: NCT03424109”
“ClinicalTrials.gov Identifier: NCT03424109”
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Broken references and links
None found · partly checkedReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.
Checked 1 reference by DOI: 1 verified.
Every extracted reference resolved against Crossref/OpenAlex with no retraction flags.
Copyediting
2 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 2 minor suggestions below.
2 copyedit issues flagged: mostly consistency.
- MINORconsistencyAuthor affiliations“Ronald O. Perelman Department of Emergency Medicine, Grossman School of Medicine, New York University, New York, New York”→ Ensure consistent naming of departments across affiliations.Minor inconsistency in department naming.
- MINORconsistencyData Sharing Statement“Data Sharing Statement: See .”→ Provide the full data sharing statement or a link.The statement is incomplete.
The published work is methodologically robust, but readers should weigh the missing explicit ethics approval and informed consent statements, the incomplete data sharing statement, and the lack of detailed randomization and power analysis reporting. These are reporting gaps that could warrant a correction or clarification from the authors, but they do not invalidate the study's conclusions.
- 1.HIGHethicsAdd an explicit ethics approval statement in the Methods, including the IRB name and approval number, and describe how informed consent was obtained or waived.A human trial without an explicit ethics approval statement is a serious reporting gap that could undermine trust in the study's conduct.
- 2.HIGHdata codeProvide the full data sharing statement in the manuscript, specifying where and how data can be accessed (e.g., repository or data access committee).The current statement is incomplete ('See .'), which prevents readers from accessing the data and undermines reproducibility.
- 3.HIGHreportingAdd a limitations section in the Discussion, discussing potential biases, generalizability, and the lack of blinding.Limitations are not explicitly discussed, which is important for readers to interpret the findings appropriately.
- 4.HIGHreportingDescribe the randomization method in detail, including how clusters were allocated to the stepped-wedge sequence.The randomization method is not specified, which is a key methodological detail for a cluster randomized trial.
- 5.HIGHstatisticsReport the statistical software used for analysis (e.g., R version, SAS) in the Methods.Identifying the software is standard practice and aids reproducibility.
- 6.MEDIUMreportingInclude a power analysis or sample size justification in the Methods.A power analysis is expected for a clinical trial to demonstrate the study was adequately powered.
- 7.MEDIUMreportingMention adherence to a reporting guideline such as CONSORT in the Methods or as a supplement.Reporting guidelines improve transparency and are often required by journals.
- 8.MEDIUMreportingIf blinding was not feasible, state that explicitly and provide a rationale in the Methods.Clarifying the lack of blinding helps readers understand potential biases.
- 9.MEDIUMreportingProvide details on the data monitoring committee and any interim analyses in the Methods.This is important for trial governance and transparency.
- 10.LOWcopyeditEnsure consistent naming of departments across author affiliations.Minor inconsistency in department naming could confuse readers.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.