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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.

Identifieur interne : 000B01 ( Main/Corpus ); précédent : 000B00; suivant : 000B02

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.

Auteurs : Irene Lie ; Stein Ove Danielsen ; Theis T Nnessen ; Svein Solheim ; Marit Leegaard ; Leiv Sandvik ; Torbj Rn Wisl Ff ; Jonny Vangen ; Tor Henning R Sstad ; Philip Moons

Source :

RBID : pubmed:28693599

English descriptors

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.


DOI: 10.1186/s13063-017-1971-y
PubMed: 28693599
PubMed Central: PMC6389149

Links to Exploration step

pubmed:28693599

Le document en format XML

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<term>Anxiety (etiology)</term>
<term>Anxiety (psychology)</term>
<term>Aortic Valve (surgery)</term>
<term>Aortic Valve Stenosis (diagnosis)</term>
<term>Aortic Valve Stenosis (surgery)</term>
<term>Cost-Benefit Analysis (MeSH)</term>
<term>Depression (etiology)</term>
<term>Depression (psychology)</term>
<term>Health Care Costs (MeSH)</term>
<term>Heart Valve Prosthesis Implantation (adverse effects)</term>
<term>Heart Valve Prosthesis Implantation (economics)</term>
<term>Hospitals, University (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Norway (MeSH)</term>
<term>Patient Readmission (economics)</term>
<term>Postoperative Care (economics)</term>
<term>Postoperative Care (methods)</term>
<term>Prospective Studies (MeSH)</term>
<term>Quality of Life (MeSH)</term>
<term>Research Design (MeSH)</term>
<term>Severity of Illness Index (MeSH)</term>
<term>Telephone (economics)</term>
<term>Time Factors (MeSH)</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en">
<term>Heart Valve Prosthesis Implantation</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en">
<term>Aortic Valve Stenosis</term>
</keywords>
<keywords scheme="MESH" qualifier="economics" xml:lang="en">
<term>Heart Valve Prosthesis Implantation</term>
<term>Patient Readmission</term>
<term>Postoperative Care</term>
<term>Telephone</term>
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<term>Anxiety</term>
<term>Depression</term>
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<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Postoperative Care</term>
</keywords>
<keywords scheme="MESH" qualifier="psychology" xml:lang="en">
<term>Anxiety</term>
<term>Depression</term>
</keywords>
<keywords scheme="MESH" qualifier="surgery" xml:lang="en">
<term>Aortic Valve</term>
<term>Aortic Valve Stenosis</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Cost-Benefit Analysis</term>
<term>Health Care Costs</term>
<term>Hospitals, University</term>
<term>Humans</term>
<term>Norway</term>
<term>Prospective Studies</term>
<term>Quality of Life</term>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>BACKGROUND</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS/DESIGN</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>DISCUSSION</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>TRIAL REGISTRATION</b>
</p>
<p>ClinicalTrials.gov, NCT02522663 . Registered on 11 August 2015.</p>
</div>
</front>
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<AbstractText Label="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.</AbstractText>
<AbstractText Label="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.</AbstractText>
<AbstractText Label="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.</AbstractText>
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<Affiliation>Centre for Patient-centered Heart and Lung research, Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Building 63, Ullevål, Oslo, Pb 4956, Nydalen, 0424, Norway. Irene.lie@ous-hf.no.</Affiliation>
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<LastName>Danielsen</LastName>
<ForeName>Stein Ove</ForeName>
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<Affiliation>Centre for Patient-centered Heart and Lung research, Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Building 63, Ullevål, Oslo, Pb 4956, Nydalen, 0424, Norway.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>KU Leuven Department of Public Health and Primary Care, KU Leuven - University of Leuven, Leuven, Belgium.</Affiliation>
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<Affiliation>Department of Cardiology, Division of Medicine, Oslo University Hospital, Ullevål, Oslo, Norway.</Affiliation>
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<Affiliation>Department of Infectious Disease Epidemiology and Modelling, Norwegian Institute of Public Health, Oslo, Norway.</Affiliation>
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<AffiliationInfo>
<Affiliation>Department of Health Management and Health Economics, University of Oslo, Oslo, Norway.</Affiliation>
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<Affiliation>Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Ullevål, Oslo, Norway.</Affiliation>
</AffiliationInfo>
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<Affiliation>Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Ullevål, Oslo, Norway.</Affiliation>
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<Affiliation>KU Leuven Department of Public Health and Primary Care, KU Leuven - University of Leuven, Leuven, Belgium.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden.</Affiliation>
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<QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName>
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