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

Irene Lie, Stein Ove Danielsen, Theis Tønnessen, Svein Solheim, Marit Leegaard, Leiv Sandvik, Torbjørn Wisløff, Jonny Vangen, Tor Henning Røsstad, Philip Moons, Irene Lie, Stein Ove Danielsen, Theis Tønnessen, Svein Solheim, Marit Leegaard, Leiv Sandvik, Torbjørn Wisløff, Jonny Vangen, Tor Henning Røsstad, Philip Moons

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.

Keywords: Clinical trial; Patient readmission; Thoracic surgery.

Figures

Fig. 1
Fig. 1
Patient flow and data collection chart
Fig. 2
Fig. 2
SPIRIT schedule of enrolment, interventions and assessments for the AVRre study

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