NCT06651645

Brief Summary

This study aims to perform a retrospective cohort study of administrative health data to understand how care delivery performance varies across US hospitals post-COVID-19 pandemic compared to the pre-pandemic performance. We also hope to identify which factors contribute to performance changes.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 29, 2025

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

October 18, 2024

Last Update Submit

April 28, 2025

Conditions

Keywords

In-hospital mortalityPost pandemic hospital performanceSurgeHospital recoveryHospital performance

Outcome Measures

Primary Outcomes (1)

  • Adjusted in-hospital mortality

    Our primary outcome will be based on a composite measure of in-hospital mortality or discharge to hospice as determined by discharge status code. The primary outcome will itself be expressed as a modified standardized mortality ration (mSMR) calculated as mean-shrunken number of observed deaths or discharge to hospice divided by the expected number of deaths or discharge to hospice for a center in that post-pandemic month assuming the effects of a typical center in the pre-pandemic era.

    During hospital admission

Secondary Outcomes (1)

  • Rates of potential inpatient complications (PICs)

    During hospital admission

Study Arms (3)

Pre-pandemic admissions

Patients admitted between January 1, 2018 - February 29, 2020 with one of the following five primary diagnoses of acute myocardial infarction, stroke, heart failure, pneumonia, and chronic obstructive pulmonary disease in alignment with the Centers for Medicare and Medicaid Service's (CMS's) condition-specific mortality measures reporting

Post-pandemic admissions

Patients admitted between May 1, 2022 and May 31, 2023 without a diagnosis for COVID-19 and with one of the following five primary diagnoses of acute myocardial infarction, stroke, heart failure, pneumonia, and chronic obstructive pulmonary disease in alignment with the Centers for Medicare and Medicaid Service's (CMS's) condition-specific mortality measures reporting.

Other: COVID-19 Surge

Pandemic admissions

Patients admitted between March 1, 2020 and April 30, 2022 without a diagnosis for COVID-19 and with one of the following five primary diagnoses of acute myocardial infarction, stroke, heart failure, pneumonia, and chronic obstructive pulmonary disease in alignment with the Centers for Medicare and Medicaid Service's (CMS's) condition-specific mortality measures reporting

Other: COVID-19 Surge

Interventions

Impact of COVID-19 pandemic on hospital care delivery

Pandemic admissionsPost-pandemic admissions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult inpatients admitted to a hospital represented with the PINC-AI hospital database.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health

Bethesda, Maryland, 20892, United States

Location

Study Officials

  • Maniraj Neupane, MD, Ph.D.

    Grand Island Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tenure Track Investigator

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 22, 2024

Study Start

July 30, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

April 29, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations