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The Quality of Recovery-15 Survey After Cardiac Surgery

University of British Columbia logo

University of British Columbia

Status

Enrolling

Conditions

Surgery-Complications
Cardiac Disease
Surgery
Cardiac Complication
Cardiac Event
Cardiac Valve Disease

Treatments

Other: Quality of Recovery 15 survey

Study type

Observational

Funder types

Other

Identifiers

NCT05602298
H22-01459

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Nicola Edwards; Terri Sun

Data sourced from clinicaltrials.gov

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