Clinical trial NCT04366167: Patient Recovery From Heart Surgery During the Covid-19 Pandemic
Official title: An Observational Cohort Study to Explore Patient Outcome From Heart Surgery During the Covid-19 Pandemic (CardiacCovid)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
COVID
Keywords: cardiac surgery
patient reported outcomes
COVID
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Queen Mary University of London
First posted: 2020-04-28
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac surgery during the COVID-19 pandemic

Brief summary: This study will describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will include mortality, morbidity, health-related quality of life, event-specific distress and depression.

Detailed description: The overall aim of this study is to describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will include mortality, morbidity, health-related quality of life, event-specific distress and depression.

All adult patients having cardiac surgery during the pandemic at St Bartholomew's Hospital will be approached to join this study. As of the end of March this is this is approximately 20 operations a week. Questionnaires will be administered at five time points alongside a review of clinical notes.

Appropriate descriptive and summative statistics will be used to analyse outcomes. If sample size is adequate, possible associations/effect of the impact of the covid-19 pandemic on each of the recovery parameters included in the study will be determined. The differences in outcomes between those with and without covid-19 may also be analysed if the sample size is adequate. Bias and loss to follow-up in observational cohort studies has been considered.

Eligibility criteria: Inclusion Criteria:

* Undergoing cardiac surgery during the Covid-19 pandemic (end date as yet unknown but inferred when elective surgery is reinstated)
* Discharge from hospital where operation was performed is being planned
* Able and willing to give informed consent

Exclusion Criteria:

* Unable or unwilling to give written informed consent. This includes patients who are being transferred to another hospital and are considered too vulnerable or unwell to be approached (based on clinical judgement of the clinical care team)
* Unable or unwilling to give and/or complete the questionnaires
* Inability to understand written and/or verbal English

Primary outcomes:
measure: Change in Impact of Events scores
timeFrame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
Secondary outcomes:
measure: Survival
timeFrame: Up to 1 year post surgery
measure: Morbidity
timeFrame: Up to 1 year post surgery
measure: Change in Health-related quality of life scores
timeFrame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
measure: Change in Depression scores
timeFrame: Baseline, 1 week after discharge, 6 weeks (+/- 2 weeks) post surgery, 6 months (+/- 2 weeks) post surgery, 1 year (+/- 2 weeks) post surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: St. Bartholomew's Hospital
name: Julie Sanders, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanders J, Bueser T, Beaumont E, Dodd M, Murray SE, Owens G, Berry A, Hyde E, Clayton T, Oo AY. The impact of the COVID-19 pandemic on recovery from cardiac surgery: 1-year outcomes. Eur J Cardiovasc Nurs. 2023 Jul 19;22(5):516-528. doi: 10.1093/eurjcn/zvac083.