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Cardiac DiseaseNCT05602298

The Quality of Recovery-15 Survey After Cardiac Surgery

An observational study of Cardiac Disease and Surgery, run by University of British Columbia at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cardiac Disease, Surgery, Surgery-Complications
What is being tested?
Quality of Recovery 15 survey
How many people
160 participants
Where
1 siteCanada
Study dates
4 Aug 2022to 1 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Terri Sun contact

6047797817

terri.sun@gmail.com

Nicola Edwards contact

604-682-2344 ext. 62115

nedwards@providencehealth.bc.ca

Canada1 site, 1 recruiting

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Nicola Edwards, MHA, 604-861-9024, nedwards@providencehealth.bc.ca

    Terri Sun, MD

    Recruiting

Other trials in Canada

About this study

Official title: The Validity of the Quality of Recovery Score 15 Following Cardiac Surgery

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.

Read the 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.

Being tested
Quality of Recovery 15 survey
Medical subject headings
Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality of Recovery 15 surveyOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the QoR 15 (1.1)

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

    Measured: Aug 4, 2022 to Jan 1, 2023

  2. Feasibility of the QoR 15 (1.2)

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

    Measured: Aug 4, 2022 to Jan 1, 2023

  3. Feasibility of the QoR 15 (1.3)

    Proportion of questions completed/answered (Percentage)

    Measured: Aug 4, 2022 to Jan 1, 2023

  4. Feasibility of the QoR 15 (1.4)

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

    Measured: Aug 4, 2022 to Feb 1, 2023

  5. Validity (2.1)

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

    Measured: Aug 4, 2022 to Feb 1, 2023

  6. Validity (2.2)

    Correlation with NRS pain score (Pearson correlation coefficient)

    Measured: Aug 4, 2022 to Feb 1, 2023

  7. 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

    Measured: Aug 4, 2022 to Feb 1, 2023

  8. Reliability (3.1)

    Internal consistency - averaged correlation between each item with QoR15

    Measured: Aug 4, 2022 to Feb 1, 2023

  9. Reliability (3.2)

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

    Measured: Aug 4, 2022 to Feb 1, 2023

  10. Reliability (3.3)

    Inter-item correlation matrix

    Measured: Aug 4, 2022 to Feb 1, 2023

  11. Reliability (3.4)

    Interdimensional and item total dimension correlation

    Measured: July 18. 2022 to Jan 1, 2023

  12. 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)

    Measured: July 18. 2022 to Jan 1, 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2022
  2. Study start4 Aug 2022
  3. Primary completion1 Feb 2023 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05602298
Sponsor's protocol ID
H22-01459
Status last verified
Oct 2022
First submitted
11 Jul 2022
Last updated
2 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23411725

  • 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.

    PubMed 35430086

  • 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.

    PubMed 27159009

  • 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.

    PubMed 35033845

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Disease and Surgery, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Terri Sun (6047797817, terri.sun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the QoR 15 (1.1) (time frame: Aug 4, 2022 to Jan 1, 2023). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05602298, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

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