Clinical trial NCT02522663: The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial
Official title: The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: telephone support
discharge management
readmission
aortic valve replacement
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Bergesen Foundation
name: Raagholt Foundation
name: Norwegian Extra Foundation for Health and Rehabilitation
First posted: 2015-08-13
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduced readmissions
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Reduced anxiety
timeFrame: 1 year follow-up
measure: Reduced depression
timeFrame: 1 year follow-up
measure: Increased health related quality of life
timeFrame: 1 year follow-up
measure: Reduced costs
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Stein O Danielsen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.