Skip to main content
Clinical Trials/NCT01450644
NCT01450644
Unknown
Phase 2

A Fast-track Randomised Controlled Trial to Evaluate a Hospital2Home Palliative Care Service for Patients With Advanced Progressive Idiopathic Fibrotic Interstitial Lung Disease

Royal Marsden NHS Foundation Trust2 sites in 1 country52 target enrollmentOctober 2011
ConditionsLung Disease

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Lung Disease
Sponsor
Royal Marsden NHS Foundation Trust
Enrollment
52
Locations
2
Primary Endpoint
Change in POS scores from week 4 to baseline for each group
Last Updated
14 years ago

Overview

Brief Summary

The investigators hypothesise that H2H will result in improved symptom control and quality of life and may be more cost-effective than standard best practice.

Interstitial Lung Disease (ILD) is a lung condition characterised by progressive scarring - known as fibrosis. This is especially seen in patients with idiopathic pulmonary fibrosis (IPF). There around 2,000 new patients diagnosed in the UK every year with a similar number of deaths.

Fibrotic-ILD causes breathing to slowly deteriorate and as there is no cure, an estimated two-thirds of patients die within five years of diagnosis. Patients suffer from many symptoms including shortness of breath, cough, low mood and fatigue which are currently being poorly managed. In addition, these patients suffer a poor health related quality of life whilst dying from their disease.

In the later stages of their disease, these patients often end up in hospital (see appendix 1a) when there is no proven or effective treatment. Many die there despite wishing to be looked after and die at home. These patients rarely receive palliative care which may help to improve their symptoms, quality of life, address end of life planning needs and prevent hospital admission. The Hospital2Home case conference conducted in the patient's home (or place of their choice) aims to address this. At the case conference involving the patient, their carers, a specialist nurse, and all the community health professionals, a care plan specific to the patient will be developed. Each health professional will be aware of their responsibility and duties. The investigators will look at whether this results in better symptom control and better quality of life for the patient and their carer. The investigators will also examine whether this prevents emergency hospital admission and allows patients to die in their preferred place. The investigators will compare patients who receive the service immediately with those who receive it after a delay.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
January 2013
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients i)Clinical diagnosis of PIF-ILD and a 30% survival at 1 year according to the validated prognostic tool developed by Professor Wells.(Appendix 5)
  • ii) Aged 18 years or over
  • iii) Any patient who does not meet any of the exclusion criteria
  • Carers i) The informal caregivers of patients specified above, who can be significant others, relatives, friends or neighbours
  • ii) Aged 18 years or over
  • iii) Any carer who does not meet the exclusion criteria
  • Health professional Primary health professional in contact with patient able to give consent

Exclusion Criteria

  • Patients/informal caregiver i) Any patient/ informal caregiver unable to give informed consent
  • ii) Any patient/informal caregiver less than 18 years of age
  • iii) Participants who are unable to understand/speak English
  • iv) Participants who are remaining as an inpatient in the hospital or being transferred to another inpatient facility (eg hospice unit, for terminal care)
  • v) Participants whose prognosis is less than 1 week or judged too unwell by the research team to take part in serial interviews

Outcomes

Primary Outcomes

Change in POS scores from week 4 to baseline for each group

Time Frame: 15 months

POS scores evaluate symptoms and palliative concerns using the Palliative Care Outcome Scale (POS). This comprises eight questions on anxiety, patient and informal caregiver concerns, and practical needs, each rated 0-4. This scoring system will ensure that there is some ongoing data available if the patient becomes unwell and is no longer able to complete the study.

Secondary Outcomes

  • comparison of the patient and informal caregiver POS in this study to see how inter-changeable/reliable the 2 assessments are(15 months)

Study Sites (2)

Loading locations...

Similar Trials