Individualised Follow-up After Valve Surgery

Surgery Clinical Trial

— INVOLVE  

Official title:

Individualised Follow-up After Valve Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053778
• Other study ID #: 222
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: June 2, 2018

Study information

• Verified date: July 2018
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effect of an intervention consisting of early, individualised outpatient follow-up after heart valve surgery on unplanned readmissions and death within 180-days after discharge.

Furthermore, Health economics and health-related quality of life will be investigated.

Description:

The incidence of valvular heart disease is estimated to exceed 42 million people worldwide. In Denmark 1700 patients undergo heart valve surgery every year and the number is increasing due to an ageing population. The most common heart valve diseases is aortic stenosis, followed by mitral regurgitation and aortic regurgitation, whereas only few patients are treated in Denmark for mitral stenosis and primary tricuspid valve and pulmonic valve diseases.

Heart valve surgery can be a lifesaving procedure for patients with severe symptomatic heart valve disease, but complications after heart valve surgery are common and readmissions frequent with rates exceeding 40% in Denmark. Most frequent causes for readmission, includes new onset atrial fibrillation, pleural and pericardial effusions, infections and acute heart failure. These causes can potentially be detected by careful outpatient follow-up in order to avoid unplanned readmission, and improve mental, physical and social health outcomes. A recent Danish study demonstrated that 56% of surgical heart valve patients were readmitted within a year and readmission was associated with low psychical and mental PROs. PROs' include validated patient health status surveys that allow quantification of critical patient-centered outcomes. Further previous studies have suggested an association between PROs and prolonged hospital stay, morbidity and mortality in cardiac patients. Knowledge about PROs can potentially be used to identify patients that especially may benefit from intensified follow-up after heart valve surgery.

Existing guidelines recommend that patients following valve surgery are reviewed on a regular basis by a cardiologist with special knowledge about heart valve diseases. A recent European study demonstrate though, a gap between the existing guidelines and clinical practice. A plausible way to improving the postoperative care could be to introduce a multidisciplinary heart valve clinic (HVC), where specialized nurses educates the patients while intervening and supporting the patients after surgery in collaboration with cardiologist and surgeons. This has proven efficient in improving outcomes such as, mortality, readmission and quality of life in patients with heart failure.3 A multidisciplinary teamwork can provide a timely access to a clinical review of the patient and simultaneously look for signs and symptoms of valve dysfunction.18 Although, previous studies have described the HVCs. Although, previous studies have described the HVCs, the effect gained from HVC compared to usual care on readmission, mortality, cost-utility and patient-reported outcomes have not yet systematically been investigated.

The aim for this study is firstly to describe PROs after heart valve surgery, incorporate the knowledge into a structured intervention, and secondly to evaluate a HVC and its association to PRO's, readmission, mortality and cost-utility.

The study consist of two parts,

• Matched cohort study comparing HVC to a historical control group to evaluate the effect of the HVC on readmission, mortality and HRQoL.

• A health economic analysis of effect of the HVC compared to a historical control Group.

The intervention and collection of clinical data: Introducing a HVC to gain knowledge of its effect on readmission, mortality and health economics.

Preoperative: Clinical data regarding the patient will be gathered at admission including calculated Euroscore II, pulmonary function measured with spirometry, status on nutrition, smoking and alcohol consumption, BMI, electrocardiography (ECG), and most recent echocardiography. Furthermore, the patients' frailty status will be assessed with a gait speed test the day before surgery and will be used in the risk model.

Postoperative: Before discharge a trained cardiac nurse will perform a screening for pleural and pericardial effusion, volume overload, risk for atrial fibrillation and repeat frailty assessment. Before discharge the patients' medication will be evaluated and adapted according to their clinical status, and the patients will be educated in warning signs after surgery. The surgical status will be evaluated before discharge. Based on these data and the PROs the patients' follow-up will be individualized.

Follow-up: The specific follow-up will be planed according to the patients' status where patients considered at high risk of being readmitted based on the clinical evaluation at discharge (e.g. atrial fibrillation) will have a more intensive follow-up. The focus of the follow-up will be a status on the patients' physical condition regarding; weight, pain and shortness of breath in combination with the areas of the PROs from study I. Consideration on further follow-up will be made depending on the condition of the patient.

After 1 month all patients will be seen in the HVC where ECG and echocardiography will be performed. At each visit the patient will be educated and informed regarding the disease and illnesses, which should lead to a better understanding and self-management of care in the post-operative period. The aim of the education is to give the patient the insight to promptly identify and report the symptoms and signs for progression of their valve disease or dysfunction of their prosthetic or repaired valve. The patient education thereby also aims to improve the patients' wellbeing and psychological condition by an increase of the feeling of security and by preventing poor physical outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1414
• Est. completion date: June 2, 2018
• Est. primary completion date: June 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient having Heart Valve Surgery at Odense University Hospital, Denmark

Exclusion Criteria:

Related Conditions & MeSH terms

• Heart Valve Diseases
• Readmission
• Surgery

Intervention

Other:
• Early follow-up
Early follow-up until 4 weeks after discharge

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of readmission	Reduction of readmission. a controlled prospective intervention trial comparing readmission rates and all-cause mortality in patients undergoing individualized follow-up with a historical control Group. A propensity matching will be performed	Up to two years
Secondary	Differences in costs between the two groups	Health economics as measured by differences in the two groups. Further more a cost-utility analysis of cost and quality of life. The cost utility analysis is measured with a questionnaire	Up to three years
Secondary	Quality of Life and associations with readmission	Symptoms of health related quality of life measured with a questionnaire	Up to three years
Secondary	The effect of a Heart valve Clinic on patient-reported outcomes	Symptoms of disease specific quality of life measured with a questionnaire	Up to three years
Secondary	Frailty status after Heart valve surgery	Measuring of frailty status at discharge and associations to other outcomes	Up to two years