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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02522663
Acronym
AVRre
Enrollment
288
Registered
2015-08-13
Start date
2015-08-20
Completion date
2018-03-01
Last updated
2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease

Keywords

telephone support, discharge management, readmission, aortic valve replacement

Brief 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.

Interventions

OTHER24/7-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.

Sponsors

The Bergesen Foundation
CollaboratorOTHER
Raagholt Foundation
CollaboratorUNKNOWN
Norwegian Extra Foundation for Health and Rehabilitation
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reduced readmissions1 year follow-upWill 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).

Secondary

MeasureTime frameDescription
Reduced anxiety1 year follow-upWill 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
Reduced depression1 year follow-upWill 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.
Increased health related quality of life1 year follow-upWill 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
Reduced costs1 year follow-upWill 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026