Heart FailureNCT02921607
Development of Scalable New Model(s) Focused on Care Co-ordination and Care Provision for Medically Complex, Co-morbid Chronic Disease Patient Segments Focusing on Heart Failure
An observational study of Heart Failure, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The goal is to define a set of clinical pathways for heart failure patients, reflecting the period from prior to admission to the post-discharge period following hospitalisation, under the current system that exists at the two clinical sites [as mentioned previously, the main site is at St Vincent's University… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Observational group
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Jul 2018
- Phase
- Observational
- 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
Study population: Patients with acute decompensated heart failure
Who may be able to join
- Patients aged 18 years and above.
- With or without an established community diagnosis of heart failure.
- Admitted to the hospital through the Emergency Department or directly to the cardiology wards, for management of a primary problem/complaint of Acute Decompensated Heart Failure.
- Able and willing to provide written, informed consent.
Who cannot join
- Patients who present with primary non-heart failure presentation who may/may not have a secondary problem with heart failure, or stable heart failure not contributing to the present illness will be excluded.
- Also excluded will be those who cannot provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
The goal is to define a set of clinical pathways for heart failure patients, reflecting the period from prior to admission to the post-discharge period following hospitalisation, under the current system that exists at the two clinical sites [as mentioned previously, the main site is at St Vincent's University Hospital in Dublin, but to ensure generalizability the project team will also carry out similar work Portsmouth Hospital, United Kingdom]. These pathways have been drawn up using the experience of the clinical investigators, using an interactive workshop approach and a pilot study.
- Pre-Admission Pathway
- Emergency Department Pathway
- In-Hospital management Pathway
- Pre-discharge Pathway
- Post-Discharge Pathway
During identification of these pathways, the research team identified the settings/personnel that require study to more fully comprehend the methods, strengths and weaknesses of the present processes. Study activities are focused on two aspects of the patient journey, immediately before discharge and three months post discharge during the outpatient phase.
Read the detailed description
Heart failure is a significant public health issue with a prevalence of over 2%, and is among the leading causes of hospital admission worldwide, particularly in those over-65 years. Patients with heart failure frequently require acute hospitalisation and are at increased risk of mortality (more than half of heart failure patients will die within five years of initial diagnosis, American Heart Association). The high hospital admission rate and readmission reduce quality of life and significantly drive up the costs of health care provision for these patients. Moreover, there is a high variability in the reported readmission rates across institutions and countries, indicating that the structure of health care delivery is variable and of significant importance to outcome in this population. This study sets out to investigate the most clinically effective and cost- efficient method of delivering care to patients with heart failure focusing on the phase immediately before hospital admission, the hospital stay and the immediate discharge period, through analysis of the current standards of practice in both Ireland and the United Kingdom.
- Conditions
- Heart Failure
- Being tested
- Observational group
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational groupOther
Participants will be asked to complete a questionnaire prior to discharge and 3 months later to follow up
| Study group | Role | What they receive |
|---|---|---|
| Observational | One group - all participants will be completing questionnaires and will be followed up with three months post discharge. Receives: Other: Observational group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient/carer questionnaire
to determine the extent to which the patient's day to day life is affected by heart failure. Also to determine the carer's level of involvement as a care giver and their opinion of the treatment/pathway
Measured: Baseline data and three month post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- ResMed, Boston Scientific Corporation, Cardiomark
- Responsible party
- Sponsor
- Investigators
- Paul Kalra, Study director, Portsmouth Hospitals NHS TrustKen McDonald, Study chair, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921607
- Sponsor's protocol ID
- PHT/2016/16
- Status last verified
- Aug 2018
- First submitted
- 21 Sep 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Participant data will be shared in an anonymized form as part of a larger database and in a collaborative fashion.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Scalable New Model(s) Focused on Care Co-ordination and Care Provision for Medically Complex, Co-morbid Chronic Disease Patient Segments Focusing on Heart Failure
- ClinicalTrials.gov ID
- NCT02921607
- Acronym / sponsor ID
- PHT/2016/16
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- ResMed, Boston Scientific Corporation, Cardiomark
- Study start
- Sep 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 3 Oct 2016 (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.
The goal is to define a set of clinical pathways for heart failure patients, reflecting the period from prior to admission to the post-discharge period following hospitalisation, under the current system that exists at the two clinical sites [as mentioned previously, the main site is at St Vincent's University Hospital in Dublin, but to ensure generalizability the project team will also carry out similar work Portsmouth Hospital, United Kingdom]. These pathways have been drawn up using the experience of the clinical investigators, using an interactive workshop approach and a pilot study.
- Pre-Admission Pathway
- Emergency Department Pathway
- In-Hospital management Pathway
- Pre-discharge Pathway
- Post-Discharge Pathway
During identification of these pathways, the research team identified the settings/personnel that require study to more fully comprehend the methods, strengths and weaknesses of the present processes. Study activities are focused on two aspects of the patient journey, immediately before discharge and three months post discharge during the outpatient phase.
Detailed description
Heart failure is a significant public health issue with a prevalence of over 2%, and is among the leading causes of hospital admission worldwide, particularly in those over-65 years. Patients with heart failure frequently require acute hospitalisation and are at increased risk of mortality (more than half of heart failure patients will die within five years of initial diagnosis, American Heart Association). The high hospital admission rate and readmission reduce quality of life and significantly drive up the costs of health care provision for these patients. Moreover, there is a high variability in the reported readmission rates across institutions and countries, indicating that the structure of health care delivery is variable and of significant importance to outcome in this population. This study sets out to investigate the most clinically effective and cost- efficient method of delivering care to patients with heart failure focusing on the phase immediately before hospital admission, the hospital stay and the immediate discharge period, through analysis of the current standards of practice in both Ireland and the United Kingdom.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Observational groupOne group - all participants will be completing questionnaires and will be followed up with three months post discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute decompensated heart failure
Key inclusion criteria (4 listed)
- Patients aged 18 years and above.
- With or without an established community diagnosis of heart failure.
- Admitted to the hospital through the Emergency Department or directly to the cardiology wards, for management of a primary problem/complaint of Acute Decompensated Heart Failure.
- Able and willing to provide written, informed consent.
Key exclusion criteria (2 listed)
- Patients who present with primary non-heart failure presentation who may/may not have a secondary problem with heart failure, or stable heart failure not contributing to the present illness will be excluded.
- Also excluded will be those who cannot provide informed consent.
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 |
|---|---|---|
| Observational groupParticipants will be asked to complete a questionnaire prior to discharge and 3 months later to follow up | Other | Observational |
Primary outcome
Change in patient/carer questionnaire
Time frame: Baseline data and three month post discharge
to determine the extent to which the patient's day to day life is affected by heart failure. Also to determine the carer's level of involvement as a care giver and their opinion of the treatment/pathway
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 31 Aug 2018.
- Individual participant dataSharing planned: Yes. Participant data will be shared in an anonymized form as part of a larger database and in a collaborative fashion.
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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.
Paul Kalra study director
Portsmouth Hospitals NHS Trust
Ken McDonald study chair
St Vincent's University Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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 4 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 31 Aug 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 United Kingdom. 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?
Change in patient/carer questionnaire (time frame: Baseline data and three month post discharge). 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 31 Aug 2018.