- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04386733
Same-day Cardiac Surgery Cancellation
Cardiac Surgery Cancellation at a Large UK Centre and Patient Satisfaction Survey - Quality Improvement Study
Study Overview
Status
Conditions
Detailed Description
This prospective audit was performed over a 7-month period (August - March 2018). A quality improvement team, consisting of two clinical research fellows and a consultant cardiothoracic surgeon, reviewed all the cancellations. The research is reported in line with the Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines.
Adult patients undergoing elective and urgent cardiac surgery were included in our study. Those who underwent emergency or non-cardiac procedures and patients under the age of 18 were excluded. Patients were identified on a weekly basis from theatre registers and printed operating lists. Same day surgery cancellations were defined as any postponement of patients' operation once listed for surgery.
Electronic hospital records were reviewed, and the following information was recorded for all patients: demographics; scheduled surgery date; euroSCORE II and its components; admission type (elective/urgent in-house/transfer patient); date of pre-operative anaesthetic review. Additionally, reasons for cancellation, timing of cancellation (pre-operative/during anaesthesia/intraoperative) and outcomes were recorded. Outcomes included: time from cancellation to performed operation; hospital stay post-cancellation and mortality. Patients were divided into cancelled (C) and non-cancelled (NC) groups for analysis.
The reasons for cancellation were categorized into: lack of ITU beds and nurses; patient medically unfit; scheduling error; patient-related issues; emergency intervened; procedure no longer needed; lack of perfusionist; incomplete investigations; surgeon unavailable; transfer issue; theatre staff shortage; electrical system failure; new intra-operative TOE findings. Patient-related issues included failure to stop medication and treatment refusal. Scheduling errors included overrunning cases, overbooking of the operating room, late operation start and IT errors.
The investigators further assessed the impact of cancellations on patient satisfaction and wellbeing. Patients completed a questionnaire by telephone at 3 months after discharge to allow time to reflect. Questionnaire data assessed adherence to Association of Anaesthetists of Great Britain and Ireland Theatre Efficiency guidance, including healthcare professional informing patients; time offered for explanation; patient understanding and satisfaction as well as perception of being kept nil by mouth (NBM) longer than necessary. (Figure 1) This questionnaire has previously been used by Wasim et al. to assess patient experience following cancelled orthopaedic surgery. A pilot study was conducted to trial the its' validity.
All data was entered into a Microsoft Excel spreadsheet. Statistical analysis consisted of determination of the mean and range for continuous data and percentage quantification for the categorical data. Statistical significance was established using chi-squared test and two-sided unpaired student t-test with p values <0.05 considered significant. The study was approved by the St Bartholomew's Trust Ethics and Quality Improvement Committee. As this was a quality improvement project and information collected did not include personal identifiers, individual consents were not required.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom
- St Bartholomew's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients who were scheduled for elective or urgent cardiac surgery
Exclusion Criteria:
- patients under the age of 18 or scheduled for an emergency cardiac surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cancelled
all adult patients whose surgery was cancelled on the day of the planned procedure
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the investigators observed how many patients had their surgeries cancelled and analysed the reasons of these cancellations
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|
Non-cancelled
all adult patients whose surgery was not cancelled on the day of the planned procedure
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the investigators observed how many patients had their surgeries cancelled and analysed the reasons of these cancellations
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of cancelled cardiac surgery assessed by number of cancellations
Time Frame: immediately after the cancellation of the same-day surgery
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frequency and reason for same-day cancellations
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immediately after the cancellation of the same-day surgery
|
|
Reasons for cancellation of cardiac surgery
Time Frame: immediately after the cancellation of the same-day surgery
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reasons for cancelled cardiac surgeries were checked in patients notes and recorded
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immediately after the cancellation of the same-day surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient's satisfaction and reaction to the cancellation assessed by the Patient Satisfaction Questionnaire
Time Frame: throughout study completion, an average of 3 months
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evaluation of patient's reactions to cancellations
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throughout study completion, an average of 3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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