Valvular Heart DiseaseSTAR-NurseNCT04301648
Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain.
A study testing STAR Nurse and Common Practice in people with Valvular Heart Disease and Nurse's Role, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The hypothesis is that patients with structural heart disease who are treated by STructural heARt nurses obtain better results in indicators of quality of care, compared with the usual practice (or not assisted) by this type of new interventional cardiology's nursing role. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease, Nurse's Role, Competence
- What is being tested?
- STAR Nurse and Common Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 1 Jul 2022
- 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
- Adult patients (>18 years) who have been or will undergo any procedure of structural heart disease in the hemodynamic and interventional cardiology unit of the Hospital de la Santa Creu i Sant Pau.
- Patients who accept to participate in the study.
Who cannot join
- Patients with cognitive impairment, mental disability or other serious difficulty communicating.
- Patients with insufficient fluency of the main languages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain. STAR Nurse Project.
The hypothesis is that patients with structural heart disease who are treated by STructural heARt nurses obtain better results in indicators of quality of care, compared with the usual practice (or not assisted) by this type of new interventional cardiology's nursing role.
Read the detailed description
Valvular disease is the future epidemic structural heart disease of developed countries. To slow or alter the course of the disease, cardiac valve repair or replacement is necessary. Transcatheter treatment has become a safe alternative to surgery. The United States and Canada developed the TAVI (Transcather Aortic Valve Implantation) program and TAVI Nurse is strongly supported by scientific societies as a key leadership role in the aortic stenosis care process. This nursing role is not implemented in Spain.
The objective of this study is to develop a new nursing role in interventional cardiology, similar to TAVI Nurse but including all the structural heart diseases, through conceptual definition and competencies, and evaluate its impact on the quality of care after of its implementation.
The new nursing role of a hemodynamics and interventional cardiology unit in Spain will be based on the model existing in other countries.
This study consists of three phases:
Phase I) Integrative review to explore and identify the definition and competencies of TAVI Nurse or another similar figure outside Spain, as well as identify quality of care indicators.
Phase II) The competences of these nurses will be contextualized in Spain, and indicators of quality of care will be defined through the consensus of experts using a Delphi methodology.
Phase III) Quasi-experimental pre / post study to assess the quality of care, through the indicators developed, of the implementation of the new nursing role.
- Conditions
- Valvular Heart Disease, Nurse's Role, Competence, Cardiac Disease
- Being tested
- STAR Nurse, Common Practice
- Keywords
- Quality of Health Care/organization & administration, Advanced Practice Nursing/trends, Quality Improvement/organization & administration, Quality of Health Care/standards, Professional Role, Structural Heart Disease, Nurse's Role, Valvular Heart Disease, Nurse's Competences
- Medical subject headings
- Heart Valve Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR NurseOther
This intervention will consist in that the nurse who is in the hemodynamic nurse's office will do the STAR Nurse's tasks and competences.
Although the intervention will be detailed through phase 1 (integrative review) and 2 (Delphy methodology).
It is expected that the main STAR nurse's competencies and tasks in the nurse's office will be:
- To guarantee a comprehensive evaluation and appropriate triage to candidates for an interventional procedure of structural heart disease, coordinating the request for complementary tests and previous visits.
- Make education to the patient and family.
- Make communication bridge with cardiologists.
- Establish specific patient-centered care processes.
- Promote continuity of care after discharge, follow up after discharge, and reevaluate quality of life and fragility.
Common PracticeOther
Common practice will consist in that the nurse who is in the hemodynamic nurse's office will do her usual task that is exclusively health education.
| Study group | Role | What they receive |
|---|---|---|
| Common Practice | Active comparator | Patients included in the phase before will receive common practice. Receives: Other: Common Practice |
| STAR Nurse | Experimental | Patients included in the phase after will receive care by a STAR Nurse. Receives: Other: STAR Nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural Quality Indicators
Structural quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's structural quality indicators could be some like:
- Percutaneous/transcatheter treatment waiting time (days). Data will be collected by medical history review.
Measured: 30 days
Process Quality Indicators
Process quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's process quality indicators could be some like:
- Evaluation of procedural risk (points). The Society of Thoracic Surgery (STS) risk score will be used.
The classification of the results is:
- Less than or equal to 2 points means low surgical risk.
- From 3 to 5 points means intermediate surgical risk.
- Upper than or equal to 6 means high surgical risk.
Measured: 30 days
Outcome Quality Indicators
Outcome quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's outcome quality indicators could be some like:
- Mortality after Percutaneous/transcatheter treatment for any medical cause (days). Data will be collected by medical history review.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Nov 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental design study, pre-post intervention type.
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301648
- Sponsor's protocol ID
- IIBSP-STA-2019-123
- Acronym
- STAR-Nurse
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain. STAR Nurse Project.
- ClinicalTrials.gov ID
- NCT04301648
- Acronym / sponsor ID
- STAR-Nurse / IIBSP-STA-2019-123
- Conditions
- Valvular Heart Disease, Nurse's Role, Competence, Cardiac Disease
- Keywords
- Quality of Health Care/organization & administration, Advanced Practice Nursing/trends, Quality Improvement/organization & administration, Quality of Health Care/standards, Professional Role, Structural Heart Disease, Nurse's Role, Valvular Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 10 Mar 2020 (actual)
- 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.
The hypothesis is that patients with structural heart disease who are treated by STructural heARt nurses obtain better results in indicators of quality of care, compared with the usual practice (or not assisted) by this type of new interventional cardiology's nursing role.
Detailed description
Valvular disease is the future epidemic structural heart disease of developed countries. To slow or alter the course of the disease, cardiac valve repair or replacement is necessary. Transcatheter treatment has become a safe alternative to surgery. The United States and Canada developed the TAVI (Transcather Aortic Valve Implantation) program and TAVI Nurse is strongly supported by scientific societies as a key leadership role in the aortic stenosis care process. This nursing role is not implemented in Spain.
The objective of this study is to develop a new nursing role in interventional cardiology, similar to TAVI Nurse but including all the structural heart diseases, through conceptual definition and competencies, and evaluate its impact on the quality of care after of its implementation.
The new nursing role of a hemodynamics and interventional cardiology unit in Spain will be based on the model existing in other countries.
This study consists of three phases:
Phase I) Integrative review to explore and identify the definition and competencies of TAVI Nurse or another similar figure outside Spain, as well as identify quality of care indicators.
Phase II) The competences of these nurses will be contextualized in Spain, and indicators of quality of care will be defined through the consensus of experts using a Delphi methodology.
Phase III) Quasi-experimental pre / post study to assess the quality of care, through the indicators developed, of the implementation of the new nursing role.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental design study, pre-post intervention type.
| Arm | Type | Receives |
|---|---|---|
| Common Practice | Active comparator | Other: Common PracticePatients included in the phase before will receive common practice. |
| STAR Nurse | Experimental | Other: STAR NursePatients included in the phase after will receive care by a STAR Nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (>18 years) who have been or will undergo any procedure of structural heart disease in the hemodynamic and interventional cardiology unit of the Hospital de la Santa Creu i Sant Pau.
- Patients who accept to participate in the study.
Key exclusion criteria (2 listed)
- Patients with cognitive impairment, mental disability or other serious difficulty communicating.
- Patients with insufficient fluency of the main languages.
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 |
|---|---|---|
| STAR NurseThis intervention will consist in that the nurse who is in the hemodynamic nurse's office will do the STAR Nurse's tasks and competences. Although the intervention will be detailed through phase 1 (integrative review) and 2 (Delphy methodology). It is expected that the main STAR nurse's competencies and tasks in the nurse's office will be: 1. To guarantee a comprehensive evaluation and appropriate triage to candidates for an interventional procedure of structural heart disease, coordinating the request for complementary tests and previous visits. 2. Make education to the patient and family. 3. Make communication bridge with cardiologists. 4. Establish specific patient-centered care processes. 5. Promote continuity of care after discharge, follow up after discharge, and reevaluate quality of life and fragility. | Other | STAR Nurse |
| Common PracticeCommon practice will consist in that the nurse who is in the hemodynamic nurse's office will do her usual task that is exclusively health education. | Other | Common Practice |
Primary outcome
Structural Quality Indicators
Time frame: 30 days
Structural quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's structural quality indicators could be some like: - Percutaneous/transcatheter treatment waiting time (days). Data will be collected by medical history review.
Process Quality Indicators
Time frame: 30 days
Process quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's process quality indicators could be some like: - Evaluation of procedural risk (points). The Society of Thoracic Surgery (STS) risk score will be used. The classification of the results is: * Less than or equal to 2 points means low surgical risk. * From 3 to 5 points means intermediate surgical risk. * Upper than or equal to 6 means high surgical risk.
Outcome Quality Indicators
Time frame: 30 days
Outcome quality indicators developed through phase 1 (Integrative Review) and phase 2 (Delphi Methodology) results. However, it is expected that the main STAR nurse's outcome quality indicators could be some like: - Mortality after Percutaneous/transcatheter treatment for any medical cause (days). Data will be collected by medical history review.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR Nurse and Common Practice in people with Valvular Heart Disease and Nurse's Role, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ADRIAN MARQUEZ LOPEZ (+342919000 ext. 7926, amarquez@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural Quality Indicators (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2020.