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

NCT ID: NCT02522663

Last Updated: 2018-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-20

Study Completion Date

2018-03-01

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.

Detailed Description

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Conditions

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Aortic Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care

Today, no post-discharge telephone support is offered as standard care from the hospital.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type EXPERIMENTAL

24/7-telephone support

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Bergesen Foundation

OTHER

Sponsor Role collaborator

Raagholt Foundation

UNKNOWN

Sponsor Role collaborator

Norwegian Extra Foundation for Health and Rehabilitation

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stein Ove Danielsen

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stein O Danielsen

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Danielsen SO, Moons P, Leegaard M, Solheim S, Tonnessen T, Lie I. Facilitators of and barriers to reducing thirty-day readmissions and improving patient-reported outcomes after surgical aortic valve replacement: a process evaluation of the AVRre trial. BMC Health Serv Res. 2020 Mar 27;20(1):256. doi: 10.1186/s12913-020-05125-5.

Reference Type DERIVED
PMID: 32220252 (View on PubMed)

Danielsen SO, Moons P, Sandvik L, Leegaard M, Solheim S, Tonnessen T, Lie I. Impact of telephone follow-up and 24/7 hotline on 30-day readmission rates following aortic valve replacement -A randomized controlled trial. Int J Cardiol. 2020 Feb 1;300:66-72. doi: 10.1016/j.ijcard.2019.07.087. Epub 2019 Jul 30.

Reference Type DERIVED
PMID: 31387822 (View on PubMed)

Lie I, Danielsen SO, Tonnessen T, Solheim S, Leegaard M, Sandvik L, Wisloff T, Vangen J, Rosstad TH, Moons P. Determining the impact of 24/7 phone support on hospital readmissions after aortic valve replacement surgery (the AVRre study): study protocol for a randomised controlled trial. Trials. 2017 May 30;18(1):246. doi: 10.1186/s13063-017-1971-y.

Reference Type DERIVED
PMID: 28693599 (View on PubMed)

Other Identifiers

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AVRre

Identifier Type: -

Identifier Source: org_study_id

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