Quality of Life After Cardiac Surgery (QUACS)

During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery. Heart operations often improve survival and quality of life (QoL), but that is not true for all patients. Regarding survival, clinicians can measure the risk to life from having a heart operation and the risk to life from not quite precisely, but clinicians have little idea about the impact of heart operations on QoL, which is the outcome that patients care about most. Clinicians are unable to provide patients with robust information on how an operation will affect their QoL. This study will provide this information by analysing the data from patient questionnaires immediately before and after the procedure and monthly thereafter for 12 months.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Coronary Artery Bypass Graft; Mitral Valve Disease; Tricuspid Valve Disease; Aorta Disease
• Intervention / Treatment: Procedure: Cardiac Surgery

Detailed Description

The Sponsor shall use existing questionnaires to measure QoL in patients having major heart surgery. QoL will be measured before the operation and monthly afterwards for 12 months in order to answer the following questions:

1. How does having heart surgery affect the QoL immediately after the operation?
2. How long does it take patients to return to the same quality of life they had before the surgery?
3. How long does it take patients to regain any loss of quality of life due to the operation? Does quality of life improve thereafter?
4. What proportion of patients will achieve a net benefit in QoL?
5. Are there features that can predict who will benefit in terms of QoL and who will not? The Sponsor will use the data to develop an electronic calculator to enable quick and robust evaluation of the impact of heart surgery on the QoL of individuals. Patients will then be able to give truly informed consent and to decide if they wish have surgery based on a full knowledge of both surgical risk and the potential impact on QoL.

• Study Type: Observational
• Enrollment (Estimated): 8004

Contacts and Locations

• Study Contact: Name: Christine Mills; Phone Number: 01223 639710; Email: christine.mills@nhs.net
• Study Contact Backup: Name: Phil Noyes; Phone Number: 01223 639159; Email: p.noyes@nhs.net

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
      • Recruiting
      • Royal Papworth Hospital
      • Contact: Jamie Pack; Phone Number: 01223 639623; Email: Jamie.Pack@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adults able to understand the patient information sheet written in English.

Description

Inclusion Criteria:

• EuroSCORE II ≥ 3% or EuroSCORE logistic of ≥ 6%
• Patients undergoing routine/ urgent cardiac surgery
• Patients must have the ability to provide informed consent

Exclusion Criteria:

• Patients undergoing salvage or emergency operations

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life using Questionnaire EQ-5D	Conduct questionnaire EQ-5D to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life using Questionnaire SF-12	Conduct questionnaire SF-12 to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.	12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life using Questionnaire LOT	Conduct questionnaire LOT to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.	12 months
Change in Quality of Life using Questionnaire PANAS	Conduct questionnaire PANAS to assess Quality of Life Change post major cardiac surgery procedure. These questionnaires ask patients to assess their levels of pain, mobility, anxiety and depression to give an overall Quality of Life Measure.	12 months

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Investigators: Study Director: Samer Nashef, Chief Investigator Royal Papworth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: P02500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data is not to be shared with researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No