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

Primary Purpose

Aortic Valve Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
24/7-telephone support
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disease focused on measuring telephone support, discharge management, readmission, aortic valve replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Intervention group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Reduced readmissions
Will use data from the national patient registry: Norway Patient Registry (NPR) and data from patient journals to measure the readmission rates. Main measure will be readmission rate 30 days after discharge for Aortic Valve Replacement (AVR).

Secondary Outcome Measures

Reduced anxiety
Will use Hospital Anxiety and Depression Scale (HADS) for measuring outcome on anxiety. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR
Reduced depression
Will use Hospital Anxiety and Depression Scale (HADS) for measuring outcome on depression. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR.
Increased health related quality of life
Will use EQ-5D-3L questionnaire from The EuroQol Group to measure health related quality of life. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR
Reduced costs
Will use data from the national patient registry: Norway Patient Registry, data from the patients journals and data from The Norwegian Health Economics Administration (HELFO). Cost-utility analysis to compare intervention group with the control group.

Full Information

First Posted
August 11, 2015
Last Updated
March 8, 2018
Sponsor
Oslo University Hospital
Collaborators
The Bergesen Foundation, Raagholt Foundation, Norwegian Extra Foundation for Health and Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT02522663
Brief Title
The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial
Acronym
AVRre
Official Title
The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 20, 2015 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
The Bergesen Foundation, Raagholt Foundation, Norwegian Extra Foundation for Health and Rehabilitation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
Keywords
telephone support, discharge management, readmission, aortic valve replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Today, no post-discharge telephone support is offered as standard care from the hospital.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
24/7-telephone support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduced readmissions
Description
Will use data from the national patient registry: Norway Patient Registry (NPR) and data from patient journals to measure the readmission rates. Main measure will be readmission rate 30 days after discharge for Aortic Valve Replacement (AVR).
Time Frame
1 year follow-up
Secondary Outcome Measure Information:
Title
Reduced anxiety
Description
Will use Hospital Anxiety and Depression Scale (HADS) for measuring outcome on anxiety. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR
Time Frame
1 year follow-up
Title
Reduced depression
Description
Will use Hospital Anxiety and Depression Scale (HADS) for measuring outcome on depression. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR.
Time Frame
1 year follow-up
Title
Increased health related quality of life
Description
Will use EQ-5D-3L questionnaire from The EuroQol Group to measure health related quality of life. Measure times: T0: Before AVR, T1: 1 month after AVR, T2: 3 months after AVR, T4: 6 months after AVR, T5: 1 year after AVR
Time Frame
1 year follow-up
Title
Reduced costs
Description
Will use data from the national patient registry: Norway Patient Registry, data from the patients journals and data from The Norwegian Health Economics Administration (HELFO). Cost-utility analysis to compare intervention group with the control group.
Time Frame
1 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stein O Danielsen
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32220252
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.
Results Reference
derived
PubMed Identifier
31387822
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.
Results Reference
derived
PubMed Identifier
28693599
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.
Results Reference
derived

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

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