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

NCT01450644 | Unknown Phase 2 DMC

• 1 other identifier: CCR3669
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Disease

Keywords

Advanced; Progressive; Idiopathic Fibrotic Interstitial Lung Disease; Palliative Care; Randomised; Controlled

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  15 months

Study Arms (2)

Fast track

OTHER

If patients are randomised to fast-track, their information will be passed to the H2H nurse to organise a case conference within one week of discharge.

Other: The Hospital2Home Service

Waiting list

OTHER

If patients are in the control arm, they will continue to receive Standard Best Practice (SBP) and their data will be held by the researcher until after the second interview (4 weeks). After this time, they will be contacted by the H2H nurse to receive the intervention and will be interviewed and followed up as for the fast track group.

Other: The Hospital2Home Service

Interventions

The Hospital2Home Service OTHER

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.

Fast track; Waiting list

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Carers i) The informal caregivers of patients specified above, who can be significant others, relatives, friends or neighbours
• ii) Aged 18 years or over
• Health professional Primary health professional in contact with patient able to give consent
• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (2)

The Royal Marsden NHS Foundation Trust

London, London, SW3 6JJ, United Kingdom

RECRUITING

The Royal Brompton NHS Foundation Trust

London, London, SW3 6NP, United Kingdom

RECRUITING

Related Publications (1)

• Bajwah S, Ross JR, Wells AU, Mohammed K, Oyebode C, Birring SS, Patel AS, Koffman J, Higginson IJ, Riley J. Palliative care for patients with advanced fibrotic lung disease: a randomised controlled phase II and feasibility trial of a community case conference intervention. Thorax. 2015 Sep;70(9):830-9. doi: 10.1136/thoraxjnl-2014-206583. Epub 2015 Jun 23.

  PMID: 26103995 DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Dr Julia Riley

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Sabrina Bajwah

CONTACT

02078082761; sabrina.bajwah@kcl.ac.uk

Jenna C Frizell, MSc

CONTACT

02078082005; jenna.frizell@rmh.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

GB (2)