In-hospital MortalityNCT06651645
Pre- vs Post-Pandemic Risk-adjusted Survival Rates in the US Hospitals
An observational study of In-hospital Mortality and Non-COVID Deaths, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-hospital Mortality, Non-COVID Deaths, Surge
- What is being tested?
- COVID-19 Surge
- How many people
- 30,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult inpatients admitted to a hospital represented with the PINC-AI hospital database.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health
Bethesda, Maryland, 20892
About this study
Official title: 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.
- Conditions
- In-hospital Mortality, Non-COVID Deaths, Surge
- Being tested
- COVID-19 Surge
- Keywords
- In-hospital mortality, Post pandemic hospital performance, Surge, Hospital recovery, Hospital performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 SurgeOther
Impact of COVID-19 pandemic on hospital care delivery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: COVID-19 Surge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During hospital admission
Secondary outcomes (1)
Rates of potential inpatient complications (PICs)
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
Measured: During hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start30 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-hospital MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Sameer Kadri, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Maniraj Neupane, MD, Ph.D., Principal investigator, Grand Island Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651645
- Sponsor's protocol ID
- BD022390
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- vs Post-COVID-19 Pandemic Risk-adjusted Survival Rates in the US Hospitals: Retrospective Cohort Study of Hospital Performance
- ClinicalTrials.gov ID
- NCT06651645
- Acronym / sponsor ID
- BD022390
- Conditions
- In-hospital Mortality, Non-COVID Deaths, Surge
- Keywords
- In-hospital mortality, Post pandemic hospital performance, Surge, Hospital recovery, Hospital performance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000,000 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: COVID-19 SurgePatients 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. |
| Pandemic admissions | – | Other: COVID-19 SurgePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients admitted to a hospital represented with the PINC-AI hospital database.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 SurgeImpact of COVID-19 pandemic on hospital care delivery | Other | Pandemic admissions, Post-pandemic admissions |
Primary outcome
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.
1 secondary outcome
Rates of potential inpatient complications (PICs)
Time frame: During hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maniraj Neupane, MD, Ph.D. principal investigator
Grand Island Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-hospital Mortality and Non-COVID Deaths, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted in-hospital mortality (time frame: During hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.