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

Abstract Background Patients undergoing surgical aortic valve replacement (sAVR) have high rates of 30-day readmissions. They also report a low health-related quality of life (HRQOL) and elevated anxiety and depression. The aim of the AVRre study is to determine the efficacy and cost of a 24/7 phone...

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Main Authors: Irene Lie, Stein Ove Danielsen, Theis Tønnessen, Svein Solheim, Marit Leegaard, Leiv Sandvik, Torbjørn Wisløff, Jonny Vangen, Tor Henning Røsstad, Philip Moons
Format: Article
Language:English
Published: BMC 2017-05-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-017-1971-y
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author Irene Lie
Stein Ove Danielsen
Theis Tønnessen
Svein Solheim
Marit Leegaard
Leiv Sandvik
Torbjørn Wisløff
Jonny Vangen
Tor Henning Røsstad
Philip Moons
author_facet Irene Lie
Stein Ove Danielsen
Theis Tønnessen
Svein Solheim
Marit Leegaard
Leiv Sandvik
Torbjørn Wisløff
Jonny Vangen
Tor Henning Røsstad
Philip Moons
author_sort Irene Lie
collection DOAJ
description Abstract Background Patients undergoing surgical aortic valve replacement (sAVR) have high rates of 30-day readmissions. They also report a low health-related quality of life (HRQOL) and elevated anxiety and depression. The aim of the AVRre study is to determine the efficacy and cost of a 24/7 phone-support intervention in reducing post-discharge readmissions after sAVR. The nature of the support is to help patients better understand and self-manage non-urgent symptoms at home. Methods/design AVRre is a prospective, randomised controlled study comprising 30 days of continuous phone-support intervention and then intermittent follow-up for the first 12 months. Phone call data from and to patients are evaluated qualitatively; thus, the study has a mixed-method design. Two hundred and eighty-six patients, aged >18 years, scheduled for a sAVR — singly or in combination with another procedure — are recruited from locations in southeast Norway. Patients are randomly assigned to the intervention group, who are purposively phone-called individually 2 and 9 days after discharge and offered on-demand 24/7 (around-the-clock) telephone support for 30 days post-discharge. The primary outcome variable is the number of 30-day hospital readmissions. Secondary outcomes are anxiety and depression symptoms, as measured by the Hospital Anxiety and Depression Scale, HRQOL and quality-adjusted life years, measured by the EuroQol (EQ-5D). Intervention and hospital readmission (diagnosis-related groups (DRGs)/length of stay) for the first year after initial discharge from hospital are used for a cost-utility analysis. Standard parametric and non-parametric tests are used for evaluations over time. Analysis of covariance is used to control for possible differences at baseline. Narratives from phone calls are transcribed verbatim and analysed using systematic text condensation. Discussion A complex ‘around-the-clock’ intervention within a university hospital-based setting could be an effective strategy to reduce the high readmission rates to hospital after sAVR. Furthermore, the AVRre 24/7 phone-support manual can be adapted to other high-risk surgery populations with high readmission rates. Trial registration ClinicalTrials.gov, NCT02522663 . Registered on 11 August 2015.
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spelling doaj.art-65bda9624b184bf58b0b3a0056972fda2022-12-21T23:30:36ZengBMCTrials1745-62152017-05-011811910.1186/s13063-017-1971-yDetermining the impact of 24/7 phone support on hospital readmissions after aortic valve replacement surgery (the AVRre study): study protocol for a randomised controlled trialIrene Lie0Stein Ove Danielsen1Theis Tønnessen2Svein Solheim3Marit Leegaard4Leiv Sandvik5Torbjørn Wisløff6Jonny Vangen7Tor Henning Røsstad8Philip Moons9Centre for Patient-centered Heart and Lung research, Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University HospitalCentre for Patient-centered Heart and Lung research, Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University HospitalDepartment of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University HospitalDepartment of Cardiology, Division of Medicine, Oslo University HospitalDepartment of Nursing and Health Promotion, Faculty of Health Sciences, Oslo and Akershus University College of Applied SciencesOslo Centre for Biostatistics and Epidemiology (OCBE), Oslo University HospitalDepartment of Infectious Disease Epidemiology and Modelling, Norwegian Institute of Public HealthDepartment of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University HospitalDepartment of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University HospitalKU Leuven Department of Public Health and Primary Care, KU Leuven – University of LeuvenAbstract Background Patients undergoing surgical aortic valve replacement (sAVR) have high rates of 30-day readmissions. They also report a low health-related quality of life (HRQOL) and elevated anxiety and depression. The aim of the AVRre study is to determine the efficacy and cost of a 24/7 phone-support intervention in reducing post-discharge readmissions after sAVR. The nature of the support is to help patients better understand and self-manage non-urgent symptoms at home. Methods/design AVRre is a prospective, randomised controlled study comprising 30 days of continuous phone-support intervention and then intermittent follow-up for the first 12 months. Phone call data from and to patients are evaluated qualitatively; thus, the study has a mixed-method design. Two hundred and eighty-six patients, aged >18 years, scheduled for a sAVR — singly or in combination with another procedure — are recruited from locations in southeast Norway. Patients are randomly assigned to the intervention group, who are purposively phone-called individually 2 and 9 days after discharge and offered on-demand 24/7 (around-the-clock) telephone support for 30 days post-discharge. The primary outcome variable is the number of 30-day hospital readmissions. Secondary outcomes are anxiety and depression symptoms, as measured by the Hospital Anxiety and Depression Scale, HRQOL and quality-adjusted life years, measured by the EuroQol (EQ-5D). Intervention and hospital readmission (diagnosis-related groups (DRGs)/length of stay) for the first year after initial discharge from hospital are used for a cost-utility analysis. Standard parametric and non-parametric tests are used for evaluations over time. Analysis of covariance is used to control for possible differences at baseline. Narratives from phone calls are transcribed verbatim and analysed using systematic text condensation. Discussion A complex ‘around-the-clock’ intervention within a university hospital-based setting could be an effective strategy to reduce the high readmission rates to hospital after sAVR. Furthermore, the AVRre 24/7 phone-support manual can be adapted to other high-risk surgery populations with high readmission rates. Trial registration ClinicalTrials.gov, NCT02522663 . Registered on 11 August 2015.http://link.springer.com/article/10.1186/s13063-017-1971-yThoracic surgeryPatient readmissionClinical trial
spellingShingle Irene Lie
Stein Ove Danielsen
Theis Tønnessen
Svein Solheim
Marit Leegaard
Leiv Sandvik
Torbjørn Wisløff
Jonny Vangen
Tor Henning Røsstad
Philip Moons
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
Thoracic surgery
Patient readmission
Clinical trial
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Thoracic surgery
Patient readmission
Clinical trial
url http://link.springer.com/article/10.1186/s13063-017-1971-y
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