Aortic Valve DiseaseAVRreNCT02522663
The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial
A study testing 24/7-telephone support in people with Aortic Valve Disease, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- 24/7-telephone support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteNorway
- Study dates
- 20 Aug 2015to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aortic Valve Disease
- Being tested
- 24/7-telephone support
- Keywords
- telephone support, discharge management, readmission, aortic valve replacement
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24/7-telephone supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Today, no post-discharge telephone support is offered as standard care from the hospital. |
| Intervention group | Experimental | 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. Receives: Other: 24/7-telephone support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year follow-up
Secondary outcomes (4)
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
Measured: 1 year follow-up
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.
Measured: 1 year follow-up
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
Measured: 1 year follow-up
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.
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start20 Aug 2015
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Bergesen Foundation, Raagholt Foundation, Norwegian Extra Foundation for Health and Rehabilitation
- Responsible party
- Principal investigator, Stein Ove Danielsen, Oslo University Hospital
- Investigators
- Stein O Danielsen, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522663
- Sponsor's protocol ID
- AVRre
- Acronym
- AVRre
- Status last verified
- Mar 2018
- First submitted
- 11 Aug 2015
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32220252Danielsen 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.
PubMed 31387822Lie 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.
PubMed 28693599
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02522663
- Acronym / sponsor ID
- AVRre / AVRre
- Conditions
- Aortic Valve Disease
- Keywords
- telephone support, discharge management, readmission, aortic valve replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Bergesen Foundation, Raagholt Foundation, Norwegian Extra Foundation for Health and Rehabilitation
- Study start
- 20 Aug 2015 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Today, no post-discharge telephone support is offered as standard care from the hospital. |
| Intervention group | Experimental | Other: 24/7-telephone supportExperimental 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24/7-telephone supportICU 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. | Other | Intervention group |
Primary outcome
Reduced readmissions
Time frame: 1 year follow-up
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).
4 secondary outcomes
Reduced anxiety
Time frame: 1 year follow-up
Reduced depression
Time frame: 1 year follow-up
Increased health related quality of life
Time frame: 1 year follow-up
Reduced costs
Time frame: 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Derived from this study: PubMed 32220252Danielsen 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.
- Derived from this study: PubMed 31387822Danielsen 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.
- Derived from this study: PubMed 28693599Lie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stein O Danielsen principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24/7-telephone support in people with Aortic Valve Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced readmissions (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02522663, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.