The Quality of Recovery-15 Survey After Cardiac Surgery

NCT05602298 | Unknown

• 1 other identifier: H22-01459
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (12)

• Feasibility of the QoR 15 (1.1)

  Response rate (Percentage of questionnaires completed at each time point)

  Aug 4, 2022 to Jan 1, 2023

• Feasibility of the QoR 15 (1.2)

  Proportion of questions completed independently without help/clarification by research assistant (Percentage)

  Aug 4, 2022 to Jan 1, 2023

• Feasibility of the QoR 15 (1.3)

  Proportion of questions completed/answered (Percentage)

  Aug 4, 2022 to Jan 1, 2023

• Feasibility of the QoR 15 (1.4)

  Time taken to complete the questionnaire (median +/- IQR)

  Aug 4, 2022 to Feb 1, 2023

• Validity (2.1)

  Correlation between QoR 15 compared with VAS global rating of health using 100mm scale (Pearson correlation coefficient)

  Aug 4, 2022 to Feb 1, 2023

• Validity (2.2)

  Correlation with NRS pain score (Pearson correlation coefficient)

  Aug 4, 2022 to Feb 1, 2023

• Validity (2.3)

  Association 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

  Aug 4, 2022 to Feb 1, 2023

• Reliability (3.1)

  Internal consistency - averaged correlation between each item with QoR15

  Aug 4, 2022 to Feb 1, 2023

• Reliability (3.2)

  15-25 patients will be asked to repeat a second time 30-60min later and their QoR 15 score compared

  Aug 4, 2022 to Feb 1, 2023

• Reliability (3.3)

  Inter-item correlation matrix

  Aug 4, 2022 to Feb 1, 2023

• Reliability (3.4)

  Interdimensional and item total dimension correlation

  July 18. 2022 to Jan 1, 2023

• Responsiveness (4.1)

  Cohen 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)

  July 18. 2022 to Jan 1, 2023

Interventions

Quality of Recovery 15 survey OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing inpatient or outpatient cardiac surgery at St. Paul's Hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Related Publications (4)

• 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.

  PMID: 23411725 BACKGROUND

• 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.

  PMID: 35430086 BACKGROUND

• 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.

  PMID: 27159009 BACKGROUND

• 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.

  PMID: 35033845 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Heart Valve Diseases; Cardiovascular Diseases

Study Officials

• Alana Flexman

  University of British Columbia

  STUDY DIRECTOR

Central Study Contacts

Terri Sun

CONTACT

6047797817; terri.sun@gmail.com

Nicola Edwards

CONTACT

604-682-2344; nedwards@providencehealth.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: November 2, 2022
• Study Start: August 4, 2022
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)