Clinical trial NCT05602298: The Quality of Recovery-15 Survey After Cardiac Surgery
Official title: The Validity of the Quality of Recovery Score 15 Following Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Disease
Surgery
Surgery-Complications
Cardiac Valve Disease
Cardiac Complication
Cardiac Event
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing inpatient or outpatient cardiac surgery at St. Paul's Hospital

Brief summary: Patient reported outcomes are becoming increasingly recognized as an important metric to determine efficacy of interventions following recovery after cardiac surgery. Quality of Recovery 15 survey is a tool that attempts to measure patients' recovery across several different domains (i.e physical, emotional and social). This tool has been validated extensively in the post operative patient population, but these studies contained only small numbers of cardiac surgery patients. This population faces unique challenges to recovery such as a longer duration of mechanical ventilation, ICU and hospital LOS, delirium, significant pain in the first 24-48 hours and post operative arrhythmias. This study aims to validate the QoR 15 in this population exclusively to determine if it is feasible, valid, reliable and responsive in this unique population.

Detailed description: The QoR-15 will be administered at three time points, verbally to the patient by a standardized script. The time points are at baseline QoR-15 (t=0) at time of enrollment in the PAC, surgical daycare or surgical ward, post extubation day 1 (t=2), and post extubation day 2 (t=3) and 12 weeks following surgery. Concurrently, patients will also be asked to rate their overall postoperative recovery using an 100-mm visual analogue scale (VAS), from "poor recovery" to "excellent recovery". A subset of patients will also be asked to repeat the QoR 15 questionnaire 30-60 min later to measure repeatability. Duration to complete each QoR-15 will be recorded.

Baseline demographic information (sex, age, ethnicity, comorbidities such as smoking status, lung disease, history of MI, hypertension, heart failure, renal failure, NYHA class) will be collected at time of enrollment. Intraoperative data (type of surgical procedure, duration of procedure, duration of cardiopulmonary bypass and aortic cross clamp time), Cardiac Surgery Intensive Care Unit (CSICU) LoS, duration of mechanical ventilation, and hospital LoS will be collected following patient discharge from hospital.

Post operative complications will be assessed using the Clavien-Dindo Classification, which is a 5 scale classification system, ranking complications on severity, depending on therapy required. Days alive and at home to Day 30 (DAH 30) (10) is a quantifiable and patient centred outcome that may be used as a proxy for a patient's recovery after surgery. This will be collected from chart review at 30 days following surgery and will be used as a metric to assess construct validity.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing cardiac surgery (outpatient or inpatient surgery)

Exclusion Criteria:

* At baseline patient screening:

  1. Patients who have severe cognitive impairment (score of 1 or 2) measured through the use of the three minute screening tool, Mini-Cog 26
  2. Patient has limited ability to complete assessment at baseline
  3. Unable to read/speak English
  4. Significant hearing impairments
  5. Critical state before surgery with high probability of death within 24 hours
* After cardiac surgery, patients will be removed from further data collection if:

  1. They require a tracheostomy or 5 days of ventilation

Primary outcomes:
measure: Feasibility of the QoR 15 (1.1)
timeFrame: Aug 4, 2022 to Jan 1, 2023
measure: Feasibility of the QoR 15 (1.2)
timeFrame: Aug 4, 2022 to Jan 1, 2023
measure: Feasibility of the QoR 15 (1.3)
timeFrame: Aug 4, 2022 to Jan 1, 2023
measure: Feasibility of the QoR 15 (1.4)
timeFrame: Aug 4, 2022 to Feb 1, 2023
measure: Validity (2.1)
timeFrame: Aug 4, 2022 to Feb 1, 2023
measure: Validity (2.2)
timeFrame: Aug 4, 2022 to Feb 1, 2023
measure: Validity (2.3)
timeFrame: Aug 4, 2022 to Feb 1, 2023
measure: Reliability (3.1)
timeFrame: Aug 4, 2022 to Feb 1, 2023
measure: Reliability (3.2)
timeFrame: Aug 4, 2022 to Feb 1, 2023
measure: Reliability (3.3)
timeFrame: Aug 4, 2022 to Feb 1, 2023
measure: Reliability (3.4)
timeFrame: July 18. 2022 to Jan 1, 2023
measure: Responsiveness (4.1)
timeFrame: July 18. 2022 to Jan 1, 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Alana Flexman
role: STUDY_DIRECTOR
References:
citation: Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
citation: Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
citation: Myles PS, Myles DB, Galagher W, Chew C, MacDonald N, Dennis A. Minimal Clinically Important Difference for Three Quality of Recovery Scales. Anesthesiology. 2016 Jul;125(1):39-45. doi: 10.1097/ALN.0000000000001158.
citation: Campfort M, Cayla C, Lasocki S, Rineau E, Leger M. Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. J Clin Anesth. 2022 Jun;78:110638. doi: 10.1016/j.jclinane.2021.110638. Epub 2022 Jan 13.