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OpenTrials
Completed

NCT Number: NCT02921607

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational Group

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Collaborators

  • Boston Scientific Corporation
  • Cardiomark
  • ResMed

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2016
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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