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

NCT ID: NCT02921607

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-07-31

Brief Summary

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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.

1. Pre-Admission Pathway
2. Emergency Department Pathway
3. In-Hospital management Pathway
4. Pre-discharge Pathway
5. 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

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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

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Observational

One group - all participants will be completing questionnaires and will be followed up with three months post discharge.

Observational group

Intervention Type OTHER

Participants will be asked to complete a questionnaire prior to discharge and 3 months later to follow up

Interventions

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Observational group

Participants will be asked to complete a questionnaire prior to discharge and 3 months later to follow up

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Cardiomark

UNKNOWN

Sponsor Role collaborator

Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Kalra

Role: STUDY_DIRECTOR

Portsmouth Hospitals NHS Trust

Ken McDonald

Role: STUDY_CHAIR

St Vincent's University Hospital

Locations

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Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PHT/2016/16

Identifier Type: -

Identifier Source: org_study_id

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