Overnight Intensive RecoveryNCT04717089
Extended Post Anaesthetic Care in PACU During COVID-19: Multi-perspective Value-based Analysis
An observational study of Overnight Intensive Recovery and Postoperative Care, run by Tuen Mun Hospital at 1 site in Hong Kong.
Trial summary
To evaluate the value-based effectiveness of the implementation of TMH Extended post anaesthetic care in PACU during COVID-19 pandemics by an institutional matched case-control and quantitative survey study Two ordinary recovery beds were converted to an overnight intensive recovery ("Extended post-anesthetic care in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overnight Intensive Recovery, Postoperative Care
- What is being tested?
- overnight intensive recovery / extended post anaesthetic care in PACU
- How many people
- 299 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Feb 2020to 30 Jun 2021
- 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: o The operation periods of TMH Extended post anesthetic care in PACU during COVID-19 and therefore the number of cases included in this study was largely bound by the administrative decision of hospital management based on the ICU bed pressure during COVID-19 situations. All patients being admitted to TMH Extended post anesthetic care in PACU during the three periods of service activation amid COVID-19 pandemics, i.e. from 10 February 2020 to 26 April 2020, from 27 July 2020 to 13 September 2020, from 14 December 2020 to 28 February 2021 were included in this audit. To increase the statistical power above 0.8, a control-to-case ratio of 5 will be adopted for case matching based on the assumption of having the correlation coefficient greater than 0.2 or the prevalence of exposure in the control group less than 0.15.
Who may be able to join
- o Postoperative patients admitted to TMH Extended post anesthetic care in PACU during COVID-19 pandemics
Who cannot join
- Patients awaiting ICU admission in the ordinary recovery room
- Patients requiring level 3 intensive care on arrival at the recovery room
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Rapid Conversion of Ordinary Recovery Beds to an Overnight Intensive Recovery (OIR) to Alleviate the High Pressure on Postoperative Intensive Care Demands During COVID-19 Pandemics in a Local Tertiary Hospital: a Multi-perspective Value-based Analysis
To evaluate the value-based effectiveness of the implementation of TMH Extended post anaesthetic care in PACU during COVID-19 pandemics by an institutional matched case-control and quantitative survey study Two ordinary recovery beds were converted to an overnight intensive recovery ("Extended post-anesthetic care in PACU") within the operating theatre complex of Tuen Mun Hospital during COVID-19 pandemics, in an attempt to free the ICU bed and resources from postoperative patients. This study was designed to evaluate the efficacy and staff perceptions towards the abrupt implementation of TMH extended post-anesthetic care in PACU by mobilization of the existing OT resources to cope with the COVID-19 emergency situations. The value-based analysis would look into the implementation effectiveness in twofold: 1) the clinical efficacy using a case-control audit on clinical outcomes and 2) the staff acceptance by means of the staff attitudes survey. Hopefully, this would provide a multi-perspective evaluation of the implementation strategies and aid planning of new services in the future.
Read the detailed description
2 parts are included in this study
The Matched Case-Control study, with the aim of analyzing the clinical efficacy of TMH Extended post-anesthetic care in PACU during COVID-19 in a value-based healthcare model. We included all postoperative patients admitted in TMH Extended post-anesthetic care in PACU during COVID epidemics, excluding patients awaiting ICU in the ordinary recovery room or patients requiring level 3 intensive care on arrival in the recovery room. Three activation periods of 水xtended post-anesthetic care in PACU service (10 Feb - 26 Apr 2020 / 27 Jul - 13 Sep 2020 / 14 Dec 2020 - 28 Feb 2021), and performed case matching with the postoperative patient with similar clinical characteristics entering intensive care unit directly in recent 10 years, with each case matched with specifically 5 control. We evaluate the value-based health care efficacy, including the amount of healthcare expenditure based on bed occupancy and manpower, rate of elective discharge to intensive care unit from extended post-anesthetic care in PACU, rate of unanticipated intensive care admission within 48hrs upon discharge to the general ward, and length of hospital stay, and the total number of ICU bed spared.
The staff attitude survey, with the aim to investigate the staff perception towards the implementation of TMH extended post-anesthetic care in PACU during COVID-19 pandemics based on the Technology Acceptance Model in healthcare. We designed a questionnaire based on Technology Acceptance Model, and distributed it to medical and nursing staff involved in extended post anaesthetic care in PACU service, and evaluate the perceived usefulness, perceived ease of use, social influence of subjective norm, and perceived behavioral control of facilitating condition. A differential analysis would be conducted for the evaluation.
- Conditions
- Overnight Intensive Recovery, Postoperative Care
- Being tested
- overnight intensive recovery / extended post anaesthetic care in PACU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overnight intensive recovery / extended post anaesthetic care in PACUOther
From January 2020, during COVID-19 first pandemics in Hong Kong, a bundle of interim measures was implemented with the joint efforts of the Department of Anaesthesia and Operating Theatre Services (A\&OT) and Intensive Care Unit (ICU), and two ordinary recovery beds were converted into extended post anesthetic care in PACU (ExRR), based on the concept of overnight intensive recovery (OIR) to provide level 2 intensive care to patients undergoing major or ultra-major operations or having multiple comorbidities warranted intensive care in the immediately postoperative periods. This was conducted over 3 pandemic waves in Hong Kong.
| Study group | Role | What they receive |
|---|---|---|
| postoperative patients admitted to TMH extended post anaesthetic care in PACU | Exclusion criteria:
* Patients awaiting ICU admission in the ordinary recovery room
* Patients requiring level 3 intensive care on arrival at the recovery room Receives: Other: overnight intensive recovery / extended post anaesthetic care in PACU | |
| Postoperative patient admitted to ICU with case matched | Inclusion criteria: o Based on case matched with the extended post anaesthetic care in PACU |
What is being measured
The primary outcome is the main question the study is designed to answer.
total number of ICU bed days spared
Measured: during study period, up to 1 year
Secondary outcomes (4)
amount of healthcare expenditures based on bed occupancy and manpower
Measured: during study period, up to 1 year
number of unanticipated intensive care unit admission within 48 hours upon discharge to general ward
Measured: 48 hour
rate of elective discharge to the intensive care unit
Measured: After extended post anaesthetic care in PACU service by case. Up to 24 hour
length of hospital stays
Measured: during admission or patient death, typically up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start10 Feb 2020
- Primary completion28 Feb 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overnight Intensive RecoveryStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Collaborators
- Anaesthesia & Operation Theatre Service, Tuen Mun Hospital, Hong Kong, Intensive Care Unit, Tuen Mun Hospital, Hong Kong
- Responsible party
- Principal investigator, Lau Hon Wai, Tuen Mun Hospital
- Investigators
- Carmen Lam, Study director, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717089
- Sponsor's protocol ID
- TMH-ExRR-001
- Status last verified
- Jun 2023
- First submitted
- 19 Jan 2021
- Last updated
- 28 Jun 2023
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rapid Conversion of Ordinary Recovery Beds to an Overnight Intensive Recovery (OIR) to Alleviate the High Pressure on Postoperative Intensive Care Demands During COVID-19 Pandemics in a Local Tertiary Hospital: a Multi-perspective Value-based Analysis
- ClinicalTrials.gov ID
- NCT04717089
- Acronym / sponsor ID
- TMH-ExRR-001
- Conditions
- Overnight Intensive Recovery, Postoperative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Collaborators
- Anaesthesia & Operation Theatre Service, Tuen Mun Hospital, Hong Kong, Intensive Care Unit, Tuen Mun Hospital, Hong Kong
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Jan 2021 (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.
To evaluate the value-based effectiveness of the implementation of TMH Extended post anaesthetic care in PACU during COVID-19 pandemics by an institutional matched case-control and quantitative survey study Two ordinary recovery beds were converted to an overnight intensive recovery ("Extended post-anesthetic care in PACU") within the operating theatre complex of Tuen Mun Hospital during COVID-19 pandemics, in an attempt to free the ICU bed and resources from postoperative patients. This study was designed to evaluate the efficacy and staff perceptions towards the abrupt implementation of TMH extended post-anesthetic care in PACU by mobilization of the existing OT resources to cope with the COVID-19 emergency situations. The value-based analysis would look into the implementation effectiveness in twofold: 1) the clinical efficacy using a case-control audit on clinical outcomes and 2) the staff acceptance by means of the staff attitudes survey. Hopefully, this would provide a multi-perspective evaluation of the implementation strategies and aid planning of new services in the future.
Detailed description
2 parts are included in this study
The Matched Case-Control study, with the aim of analyzing the clinical efficacy of TMH Extended post-anesthetic care in PACU during COVID-19 in a value-based healthcare model. We included all postoperative patients admitted in TMH Extended post-anesthetic care in PACU during COVID epidemics, excluding patients awaiting ICU in the ordinary recovery room or patients requiring level 3 intensive care on arrival in the recovery room. Three activation periods of 水xtended post-anesthetic care in PACU service (10 Feb - 26 Apr 2020 / 27 Jul - 13 Sep 2020 / 14 Dec 2020 - 28 Feb 2021), and performed case matching with the postoperative patient with similar clinical characteristics entering intensive care unit directly in recent 10 years, with each case matched with specifically 5 control. We evaluate the value-based health care efficacy, including the amount of healthcare expenditure based on bed occupancy and manpower, rate of elective discharge to intensive care unit from extended post-anesthetic care in PACU, rate of unanticipated intensive care admission within 48hrs upon discharge to the general ward, and length of hospital stay, and the total number of ICU bed spared.
The staff attitude survey, with the aim to investigate the staff perception towards the implementation of TMH extended post-anesthetic care in PACU during COVID-19 pandemics based on the Technology Acceptance Model in healthcare. We designed a questionnaire based on Technology Acceptance Model, and distributed it to medical and nursing staff involved in extended post anaesthetic care in PACU service, and evaluate the perceived usefulness, perceived ease of use, social influence of subjective norm, and perceived behavioral control of facilitating condition. A differential analysis would be conducted for the evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative patients admitted to TMH extended post anaesthetic care in PACU | – | Other: overnight intensive recovery / extended post anaesthetic care in PACUExclusion criteria: * Patients awaiting ICU admission in the ordinary recovery room * Patients requiring level 3 intensive care on arrival at the recovery room |
| Postoperative patient admitted to ICU with case matched | – | –Inclusion criteria: o Based on case matched with the extended post anaesthetic care in PACU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- o The operation periods of TMH Extended post anesthetic care in PACU during COVID-19 and therefore the number of cases included in this study was largely bound by the administrative decision of hospital management based on the ICU bed pressure during COVID-19 situations. All patients being admitted to TMH Extended post anesthetic care in PACU during the three periods of service activation amid COVID-19 pandemics, i.e. from 10 February 2020 to 26 April 2020, from 27 July 2020 to 13 September 2020, from 14 December 2020 to 28 February 2021 were included in this audit. To increase the statistical power above 0.8, a control-to-case ratio of 5 will be adopted for case matching based on the assumption of having the correlation coefficient greater than 0.2 or the prevalence of exposure in the control group less than 0.15.
Key inclusion criteria (1 listed)
- o Postoperative patients admitted to TMH Extended post anesthetic care in PACU during COVID-19 pandemics
Key exclusion criteria (2 listed)
- Patients awaiting ICU admission in the ordinary recovery room
- Patients requiring level 3 intensive care on arrival at the recovery room
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 |
|---|---|---|
| overnight intensive recovery / extended post anaesthetic care in PACUFrom January 2020, during COVID-19 first pandemics in Hong Kong, a bundle of interim measures was implemented with the joint efforts of the Department of Anaesthesia and Operating Theatre Services (A\&OT) and Intensive Care Unit (ICU), and two ordinary recovery beds were converted into extended post anesthetic care in PACU (ExRR), based on the concept of overnight intensive recovery (OIR) to provide level 2 intensive care to patients undergoing major or ultra-major operations or having multiple comorbidities warranted intensive care in the immediately postoperative periods. This was conducted over 3 pandemic waves in Hong Kong. | Other | postoperative patients admitted to TMH extended post anaesthetic care in PACU |
Primary outcome
total number of ICU bed days spared
Time frame: during study period, up to 1 year
4 secondary outcomes
amount of healthcare expenditures based on bed occupancy and manpower
Time frame: during study period, up to 1 year
number of unanticipated intensive care unit admission within 48 hours upon discharge to general ward
Time frame: 48 hour
rate of elective discharge to the intensive care unit
Time frame: After extended post anaesthetic care in PACU service by case. Up to 24 hour
length of hospital stays
Time frame: during admission or patient death, typically up to 1 month
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 28 Jun 2023.
- Individual participant dataSharing planned: No
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.
Carmen Lam study director
Tuen Mun Hospital
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 Overnight Intensive Recovery and Postoperative Care, run by Tuen Mun Hospital at 1 site in Hong Kong.
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 2 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 28 Jun 2023. 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 Hong Kong. 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?
total number of ICU bed days spared (time frame: during study period, up to 1 year). 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 28 Jun 2023.