Lung DiseasePhase 2H2H-ILDNCT01450644
Evaluation of the Hospital2Home Palliative Care Service for Patients With Advanced Progressive Lung Disease
A Phase 2 study testing The Hospital2Home Service in people with Lung Disease, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Disease
- What is being tested?
- The Hospital2Home Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2011to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Aged 18 years or over
- 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
- Aged 18 years or over
- Any carer who does not meet the exclusion criteria
- Health professional Primary health professional in contact with patient able to give consent
Who cannot join
- Patients/informal caregiver i) Any patient/ informal caregiver unable to give informed consent
- Any patient/informal caregiver less than 18 years of age
- Participants who are unable to understand/speak English
- Participants who are remaining as an inpatient in the hospital or being transferred to another inpatient facility (eg hospice unit, for terminal care)
- Participants whose prognosis is less than 1 week or judged too unwell by the research team to take part in serial interviews
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
London, London, SW3 6JJ
Jenna C Frizell, MSc, 02078082005 ext. 4648, jenna.frizell@rmh.nhs.uk
Dr Julia Riley
- Recruiting
The Royal Brompton NHS Foundation Trust
London, London, SW3 6NP
Jenna C Frizell, MSc, 02078082005 ext. 4648, jenna.frizell@rmh.nhs.uk
Dr Julia Riley
About this study
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
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.
Read more
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
- Being tested
- The Hospital2Home Service
- Keywords
- Advanced, Progressive, Idiopathic Fibrotic Interstitial Lung Disease, Palliative Care, Randomised, Controlled
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Hospital2Home ServiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: The Hospital2Home Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Julia Riley, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450644
- Sponsor's protocol ID
- CCR3669
- Acronym
- H2H-ILD
- Status last verified
- Dec 2011
- First submitted
- 7 Oct 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26103995
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01450644
- Acronym / sponsor ID
- H2H-ILD / CCR3669
- Conditions
- Lung Disease
- Keywords
- Advanced, Progressive, Idiopathic Fibrotic Interstitial Lung Disease, Palliative Care, Randomised, Controlled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast track | Other | Other: The Hospital2Home ServiceIf 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. |
| Waiting list | Other | Other: The Hospital2Home ServiceIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- Aged 18 years or over
- 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
- Aged 18 years or over
Key exclusion criteria (5 listed)
- Patients/informal caregiver i) Any patient/ informal caregiver unable to give informed consent
- Any patient/informal caregiver less than 18 years of age
- Participants who are unable to understand/speak English
- Participants who are remaining as an inpatient in the hospital or being transferred to another inpatient facility (eg hospice unit, for terminal care)
- Participants whose prognosis is less than 1 week or judged too unwell by the research team to take part in serial interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Hospital2Home ServiceThis 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. | Other | Fast track, Waiting list |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
- Derived from this study: PubMed 26103995Bajwah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Julia Riley principal investigator
Royal Marsden NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The Hospital2Home Service in people with Lung Disease, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Sabrina Bajwah (02078082761 ext. 2761, sabrina.bajwah@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in POS scores from week 4 to baseline for each group (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.