Economic BurdenNCT04482205
Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures
An observational study of Economic Burden, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Covid-19 has adversely impacted the health care organizations by over burdening with Covid patients and suspending the elective surgeries and clinics A single center retrospective study was conducted to quantify losses due to postponement of elective surgeries and extra cost for procurement of PPEs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Economic Burden
- How many people
- 840 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Mar 2020to 31 May 2020
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients admitted for operative intervention of fractures management and elective procedures for tumour, degenerative disease, sport related injuries
Who may be able to join
- All the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020.
Who cannot join
- Patients presenting with other bone morbidities that did not require surgical interventions including rickets, osteomalacia, osteogenesis imperfecta, marble bone disease (osteopetrosis), Paget disease of bone, and fibrous dysplasia, patients with incomplete medical records were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures in Musculoskeletal Service Line of a Tertiary Care Hospital
Covid-19 has adversely impacted the health care organizations by over burdening with Covid patients and suspending the elective surgeries and clinics A single center retrospective study was conducted to quantify losses due to postponement of elective surgeries and extra cost for procurement of PPEs. The secondary objective was to see the effect of Covid -19 on the total costs of inpatient care during Covid era.
Read the detailed description
Covid-19 has impacted adversely the economy of Pakistan that has already poor and challenged socioeconomic conditions This is a single hospital retrospective cross sectional study conducted to quantify losses due postponement of elective surgeries and procurement of PPEs and see the effect of Covid -19 on the total costs of inpatient care during Covid era.
We included all the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020. We divided this period into two halves; the first half was from January first to March 15 named as PreCovid Era and second half was from March 16, to May 31, 2020, termed as Covid Era. The total number of trauma procedures and elective procedures were compared in both eras. We compared six procedures each from upper and lower limit for cost analysis and length of stay. We also analyzed the extra cost for procurement of PPEs.
- Conditions
- Economic Burden
- Keywords
- economic burden, covid-19 pandemic
- Medical subject headings
- Financial Stress, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| precovid group | those who were operated from fJanuary first to March 15 | |
| covid | those operated from March 16, to May 31, 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of Covid -19 on the total costs of inpatient care
the effect of Covid -19 on the total costs of inpatient care during Covid era
Measured: 5 months
Secondary outcomes (1)
drop in the collective revenue generated in covid era
to quantify drop in the collective revenue generated in covid era
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start16 Mar 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Economic BurdenStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shah fahad, Aga Khan University
- Investigators
- Pervaiz Hashmi, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482205
- Sponsor's protocol ID
- akupde
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures in Musculoskeletal Service Line of a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT04482205
- Acronym / sponsor ID
- akupde
- Conditions
- Economic Burden
- Keywords
- economic burden, covid-19 pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 22 Jul 2020 (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.
Covid-19 has adversely impacted the health care organizations by over burdening with Covid patients and suspending the elective surgeries and clinics A single center retrospective study was conducted to quantify losses due to postponement of elective surgeries and extra cost for procurement of PPEs. The secondary objective was to see the effect of Covid -19 on the total costs of inpatient care during Covid era.
Detailed description
Covid-19 has impacted adversely the economy of Pakistan that has already poor and challenged socioeconomic conditions This is a single hospital retrospective cross sectional study conducted to quantify losses due postponement of elective surgeries and procurement of PPEs and see the effect of Covid -19 on the total costs of inpatient care during Covid era.
We included all the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020. We divided this period into two halves; the first half was from January first to March 15 named as PreCovid Era and second half was from March 16, to May 31, 2020, termed as Covid Era. The total number of trauma procedures and elective procedures were compared in both eras. We compared six procedures each from upper and lower limit for cost analysis and length of stay. We also analyzed the extra cost for procurement of PPEs.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| precovid group | – | –those who were operated from fJanuary first to March 15 |
| covid | – | –those operated from March 16, to May 31, 2020 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients admitted for operative intervention of fractures management and elective procedures for tumour, degenerative disease, sport related injuries
Key inclusion criteria (1 listed)
- All the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020.
Key exclusion criteria (1 listed)
- Patients presenting with other bone morbidities that did not require surgical interventions including rickets, osteomalacia, osteogenesis imperfecta, marble bone disease (osteopetrosis), Paget disease of bone, and fibrous dysplasia, patients with incomplete medical records were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the effect of Covid -19 on the total costs of inpatient care
Time frame: 5 months
the effect of Covid -19 on the total costs of inpatient care during Covid era
1 secondary outcome
drop in the collective revenue generated in covid era
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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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.
Pervaiz Hashmi, FCPS principal investigator
Aga Khan University
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 Economic Burden, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 22 Jul 2020. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the effect of Covid -19 on the total costs of inpatient care (time frame: 5 months). 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 22 Jul 2020.