Pre- vs Post-Pandemic Risk-adjusted Survival Rates in the US Hospitals

April 28, 2025 updated by: Sameer Kadri, M.D., National Institutes of Health Clinical Center (CC)

Pre- vs Post-COVID-19 Pandemic Risk-adjusted Survival Rates in the US Hospitals: Retrospective Cohort Study of Hospital Performance

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

The study cohort will include one random encounter per patient for all adult (age ≥18years) encounters. All inpatients with the Premier healthcare database (PINC-AI) and those patients who were admitted under observation status and expired in the hospital or those who presented acutely to the emergency department and died in the emergency department will be considered as inpatients for the purpose of this study as per prior precedence in including such patients.

All pediatric inpatients, skilled nursing facilities inpatients, long term acute care inpatients, rehabilitation facility inpatients, psychiatric inpatients, hospice inpatients, chemical dependency unit inpatients and deceased organ donor inpatients are excluded after applying encounter level exclusion criteria from this inpatient cohort. Application of this encounter level exclusion will also preferentially exclude any children hospitals, skilled nursing facilities, acute long term care facilities, psychiatry hospitals, inpatient hospices and chemical dependency units.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Impact of COVID-19 pandemic on hospital care delivery
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
Impact of COVID-19 pandemic on hospital care delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted in-hospital mortality
Time Frame: During hospital admission
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of potential inpatient complications (PICs)
Time Frame: During hospital admission
PICs are complications developed during the hospital stay which may reflect the performance changes post pandemic due to circumstances observed during the pandemic. List of PICs will be curated as has been done previously using Premier Healthcare Database as reported in Korvink et al. Med Care, 2023. For each of the patient, we will calculate the cumulative number of PICs developed during their inpatient stay, which would be a sum of individual counts of PICs out of the list of 74 total possible PICs. Eventually, observed and expected rate of PICs normalized to the length of stay will be calculated with analysis restricted to within hospitals after adjusting for patient level covariates. Subsequently, risk factor model will include hospital level factors to assess association of these factors to aggregate rates of PICs in the cohort to identify factors associated with better or poor performance post pandemic
During hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maniraj Neupane, MD, Ph.D., Grand Island Regional Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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