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

NCT02921607 | Completed

• 1 other identifier: PHT/2016/16
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 \[as mentioned previously, the main site is at St Vincent's University Hospital in Dublin, but to ensure generalizability the project team will also carry out similar work Portsmouth Hospital, United Kingdom\]. These pathways have been drawn up using the experience of the clinical investigators, using an interactive workshop approach and a pilot study.

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline data and three month post discharge

Study Arms (1)

Observational

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

Other: Observational group

Interventions

Observational group OTHER

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

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute decompensated heart failure

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• ResMed: collaborator
• Boston Scientific Corporation: collaborator
• Cardiomark: collaborator

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Paul Kalra

  Portsmouth Hospitals NHS Trust

  STUDY DIRECTOR

• Ken McDonald

  St Vincent's University Hospital, Ireland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: October 3, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)