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The Quality of Recovery-15 Survey After Cardiac Surgery

The Validity of the Quality of Recovery Score 15 Following Cardiac Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05602298
Enrollment
160
Registered
2022-11-02
Start date
2022-08-04
Completion date
2023-05-01
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERQuality of Recovery 15 survey

QOR 15 is a patient reported outcomes measure (PROM) tool used as a global measure of patient recovery after surgery and anesthesia. It uses fifteen questions to assess various domains of patient health: pain, physical comfort, physical independence, psychological support, and emotional state.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reliability (3.1)Aug 4, 2022 to Feb 1, 2023Internal consistency - averaged correlation between each item with QoR15
Reliability (3.2)Aug 4, 2022 to Feb 1, 202315-25 patients will be asked to repeat a second time 30-60min later and their QoR 15 score compared
Reliability (3.3)Aug 4, 2022 to Feb 1, 2023Inter-item correlation matrix
Reliability (3.4)July 18. 2022 to Jan 1, 2023Interdimensional and item total dimension correlation
Feasibility of the QoR 15 (1.1)Aug 4, 2022 to Jan 1, 2023Response rate (Percentage of questionnaires completed at each time point)
Feasibility of the QoR 15 (1.2)Aug 4, 2022 to Jan 1, 2023Proportion of questions completed independently without help/clarification by research assistant (Percentage)
Feasibility of the QoR 15 (1.3)Aug 4, 2022 to Jan 1, 2023Proportion of questions completed/answered (Percentage)
Feasibility of the QoR 15 (1.4)Aug 4, 2022 to Feb 1, 2023Time taken to complete the questionnaire (median +/- IQR)
Validity (2.1)Aug 4, 2022 to Feb 1, 2023Correlation between QoR 15 compared with VAS global rating of health using 100mm scale (Pearson correlation coefficient)
Validity (2.2)Aug 4, 2022 to Feb 1, 2023Correlation with NRS pain score (Pearson correlation coefficient)
Validity (2.3)Aug 4, 2022 to Feb 1, 2023Association between QoR 15 with age, gender, duration of surgery, duration of ICU stay, duration of hospital stay, opioid consumption, surgical complications and DAH 30 will be assessed using multivariable linear regression
Responsiveness (4.1)July 18. 2022 to Jan 1, 2023Cohen effect size (avg change scores from pretest to post tes, divided by SD at baseline Standardised response mean (change scores divided by SD of change scores)

Countries

Canada

Contacts

Primary ContactTerri Sun
terri.sun@gmail.com6047797817
Backup ContactNicola Edwards
nedwards@providencehealth.bc.ca604-682-2344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026