Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05602298

Conditions

Cardiac Disease

Surgery

Surgery-Complications

Cardiac Valve Disease

Cardiac Complication

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Quality of Recovery 15 survey

Study Details

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

Study ID

NCT05602298

Start date

Aug 4, 2022

Status verified date

Oct, 2022

Completion date

May 1, 2023

Anticipated

Primary completion date

Feb 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Interventions

Quality 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.

Primary outcome measure

  • Feasibility of the QoR 15 (1.1) [ Time Frame: Aug 4, 2022 to Jan 1, 2023 ]
  • Feasibility of the QoR 15 (1.2) [ Time Frame: Aug 4, 2022 to Jan 1, 2023 ]
  • Feasibility of the QoR 15 (1.3) [ Time Frame: Aug 4, 2022 to Jan 1, 2023 ]
  • Feasibility of the QoR 15 (1.4) [ Time Frame: Aug 4, 2022 to Feb 1, 2023 ]
  • Validity (2.1) [ Time Frame: Aug 4, 2022 to Feb 1, 2023 ]
  • Validity (2.2) [ Time Frame: Aug 4, 2022 to Feb 1, 2023 ]
  • Validity (2.3) [ Time Frame: Aug 4, 2022 to Feb 1, 2023 ]
  • Reliability (3.1) [ Time Frame: Aug 4, 2022 to Feb 1, 2023 ]
  • Reliability (3.2) [ Time Frame: Aug 4, 2022 to Feb 1, 2023 ]
  • Reliability (3.3) [ Time Frame: Aug 4, 2022 to Feb 1, 2023 ]
  • Reliability (3.4) [ Time Frame: July 18. 2022 to Jan 1, 2023 ]
  • Responsiveness (4.1) [ Time Frame: July 18. 2022 to Jan 1, 2023 ]

Central Contacts and Locations

Central contacts

Terri Sun

6047797817terri.sun@gmail.com

Nicola Edwards

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

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Nicola Edwards, MHA

604-861-9024nedwards@providencehealth.bc.ca

Principal Investigator:

Terri Sun, MD

More Information

Sponsor

University of British Columbia

Last update posted

Nov 2, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-11-02.