The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial

Aortic Valve Disease Clinical Trial

— AVRre  

Official title:

The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522663
• Other study ID #: AVRre
• Status: Completed
• Phase: N/A
• First received: August 11, 2015
• Last updated: March 8, 2018
• Start date: August 20, 2015
• Est. completion date: March 1, 2018

Study information

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

Clinical Trial Summary

Aortic Valve Replacement (AVR) surgery for aortic valve disease continues to increase in numbers. With better surgical techniques and equipment, also older patients can be operated on, resulting in an growth of the older population. AVR is characterized by high rates of hospital readmissions, resulting in suboptimal care planning and higher health care costs. Hence, it is important to develop strategies to reduce hospital readmissions following AVR. The purpose if this study is to develop and test the efficacy of a 24/7-phone support in the reduction of readmissions after AVR treatment. Secondary outcomes are a reduced level of anxiety, less depressive symptoms and a better health related quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treatment with AVR (biological or mechanical) single, AVR (b or m)+aortocoronary bypass, AVR (b or m)+supra coronary tube graft

• Can understand, speak and write native Language (norwegian), and be able to fill in the questionnaires

• Can be contacted by phone after discharge from hospital

Exclusion criteria:

• Patients who have been admitted to intensive care for more than 24 hours

• Patients who have complications related to surgery e.g. cerebral insult with significant impact on cognitive functions after surgery

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Other:
• 24/7-telephone support
ICU nurses answer the calls from treated AVR patients during the first month after discharge, and use an evidence-based information manual to answer questions from the patients.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Bergesen foundation, Norwegian Extra Foundation for Health and Rehabilitation, Raagholt Foundation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced readmissions	Will use data from the national patient registry: Norway Patient Registry (NPR) and data from patient journals to measure the readmission rates. Main measure will be readmission rate 30 days after discharge for Aortic Valve Replacement (AVR).	1 year follow-up
Secondary	Reduced anxiety	Will use Hospital Anxiety and Depression Scale (HADS) for measuring outcome on anxiety. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR	1 year follow-up
Secondary	Reduced depression	Will use Hospital Anxiety and Depression Scale (HADS) for measuring outcome on depression. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR.	1 year follow-up
Secondary	Increased health related quality of life	Will use EQ-5D-3L questionnaire from The EuroQol Group to measure health related quality of life. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR	1 year follow-up
Secondary	Reduced costs	Will use data from the national patient registry: Norway Patient Registry, data from the patients journals and data from The Norwegian Health Economics Administration (HELFO). Cost-utility analysis to compare intervention group with the control group.	1 year follow-up