Evaluation of the Hospital2Home Palliative Care Service for Patients With Advanced Progressive Lung Disease

Lung Disease Clinical Trial

— H2H-ILD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01450644
• Other study ID #: CCR3669
• Status: Recruiting
• Phase: Phase 2
• First received: October 7, 2011
• Last updated: December 7, 2011
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: December 2011
• Source: Royal Marsden NHS Foundation Trust
• Contact: Dr Sabrina Bajwah
• Phone: 02078082761
• Email: sabrina.bajwah[@]kcl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• The Hospital2Home Service
This intervention is a new multiprofessional, patient case conference that is organised for people nearing the end-of-life. Evidenced based guidelines for the management of the physical, psychological, spiritual and end of life-planning needs for these patients will be used in the H2H case conference. A case conference will be organised in their home (or place of their choice). The patient, informal caregiver, H2H CNS, GP, district nurse, social worker and community palliative care nurse are invited to attend. Current and anticipated care needs are discussed, and an action plan is agreed allocating a responsible health care professional for each item. During the case conference, individualised care plans will be made. This is then communicated with local services, primary and specialist teams resulting in streamlining of transfer of data and codifying responsibility for the patient, hospital and community care professionals.

Locations

Country	Name	City	State
United Kingdom	The Royal Brompton NHS Foundation Trust	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in POS scores from week 4 to baseline for each group	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.	15 months	No
Secondary	comparison of the patient and informal caregiver POS in this study to see how inter-changeable/reliable the 2 assessments are	At each interview, service use questions will be asked which will record the frequency and types of health/social services received in order that an accurate evaluation of cost of care per patient can be made. In addition semi-structured qualitative interviews will be conducted with patients, informal caregivers and health professionals. Prompts will include views of the case conference, the guidelines and what level of input was needed after the case conference. A record will be made of when and where the patient dies.	15 months	No