Trial record 13 of 1175 for:    Open Studies | "Hospitals"

Evaluation of the Hospital2Home Palliative Care Service for Patients With Advanced Progressive Lung Disease (H2H-ILD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01450644
First received: October 7, 2011
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Lung Disease
Other: The Hospital2Home Service
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • Change in POS scores from week 4 to baseline for each group [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • comparison of the patient and informal caregiver POS in this study to see how inter-changeable/reliable the 2 assessments are [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 52
Study Start Date: October 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fast track
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
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.
Waiting list
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450644

Contacts
Contact: Dr Sabrina Bajwah 02078082761 ext 2761 sabrina.bajwah@kcl.ac.uk
Contact: Jenna C Frizell, MSc 02078082005 ext 4648 jenna.frizell@rmh.nhs.uk

Locations
United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Contact: Jenna C Frizell, MSc    02078082005 ext 4648    jenna.frizell@rmh.nhs.uk   
Principal Investigator: Dr Julia Riley         
The Royal Brompton NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6NP
Contact: Jenna C Frizell, MSc    02078082005 ext 4648    jenna.frizell@rmh.nhs.uk   
Principal Investigator: Dr Julia Riley         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Dr Julia Riley The Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01450644     History of Changes
Other Study ID Numbers: CCR3669
Study First Received: October 7, 2011
Last Updated: December 7, 2011
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
Advanced
Progressive
Idiopathic Fibrotic Interstitial Lung Disease
Palliative Care
Randomised
Controlled

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014