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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Other: 24/7-telephone support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Today, no post-discharge telephone support is offered as standard care from the hospital. | |
| Experimental: Intervention group<br>Experimental group is offered 24/7-telephone support during the first 1 month post-discharge, and patients are actively called at day 2 and day 9 day after discharge. | Other: 24/7-telephone support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telephone support, discharge management, readmission, aortic valve replacement