Palliative CarePiPCARNCT04894162
Participating in Palliative Care Research
A study testing Questionnaire in people with Palliative Care and Terminal Illness, run by Northumbria Healthcare NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
This research seeks the views of patients who are admitted to hospices and specialist palliative care units (SPCUs) regarding whether they would consider being involved in different types of clinical research. This is a questionnaire based study of inpatients in the North East of England. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Terminal Illness, Hospice Care
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Jul 2021to 30 Jun 2022
- Phase
- Interventional
- 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
- Inpatient on a specialist palliative care unit
- Admitted in the study period.
- Over 18 years of age
- Willing to participate
- Able to complete the questionnaire (with or without support) during their admission
Who cannot join
- Lack of capacity to consent to involvement in the study
- Clinical team consider the offer of participation may cause distress or burden
- Patients not under the care of the specialist palliative care team e.g. medical borders (this exclusion criteria is only relevant to the specialist palliative care units attached to hospitals and not the hospice)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Wansbeck General Hospital
Ashington, NE639JJ
St Oswald's Hospice
Newcastle, NE31EE
North Tyneside General Hospital
North Shields, NE298NH
About this study
This research seeks the views of patients who are admitted to hospices and specialist palliative care units (SPCUs) regarding whether they would consider being involved in different types of clinical research. This is a questionnaire based study of inpatients in the North East of England.
The results will be used to inform healthcare professionals about the research which patients may or may not be interested in, as well as enabling future research design to be supportive of patient preferences.
Read more
Many of the interventions used within specialist palliative care lack a strong evidence base with guidelines often based on a mixture of expert opinion, anecdotal evidence or extrapolated from research in other patient groups rather than robust clinical research. Previous studies have highlighted multiple potential barriers to expanding research within the palliative care setting. Barriers include a lack of funding compared to other medical specialties and a lack of institutional capacity.
An ongoing barrier to research in this field is that the nature of the population makes patient recruitment to research challenging. This may be associated with professionals in palliative care being reluctant to ask patients if they would want to be involved in research as they feel that it would be inappropriate to potentially burden patients who are very unwell with research which is unlikely to change the disease outcome for the individual. However, many recognise that it is important to understand what patients themselves think about the potential to take part in clinical research.
Our main research question will help us to ascertain whether patients admitted under Palliative Medicine in our region would welcome the opportunity to be involved in clinical research. Previous studies have been at a single site with small numbers of patients, whereas our research will aim to recruit a larger number of patients and will be a multi-centre study involving a range of inpatient settings including an independent hospice, two National Health Service (NHS) Palliative Care Units. These centres are across the north-east region (Northumbria and Newcastle) and accept admissions from a mixture of affluent and less affluent areas. It will also involve patients with both malignant and non-malignant disease. Previous studies have not surveyed patients that were described as "too unwell", therefore as a secondary outcome we will be recording how well patients are functionally (by recording performance status- AKPS) to examine if those patients who are most unwell would still want to be involved in research. There is a gap in current knowledge of whether those patients with advanced disease and close to end of life would still find it rewarding to have the opportunity to be involved in research of some sort and whether it is fair to exclude them from being offered opportunities to be involved based on their advanced disease status.
Read the detailed description
Research Question: Do patients who are cared for in specialist inpatient units in the North East of England want to take part in in research? If not, why not?
- Is there a difference in desire to participate in research between patients with malignant and non malignant disease?
- Is there a difference in desire to participate in research for patients with lower functional status?
- Is there a difference in desire to participate in research for those closer or further away from death?
From the start date of the study all consecutive admissions to the hospice or specialist palliative care units will be offered the opportunity to take part in the research study within 72 hours of their admission if they have capacity and they are under the care of the specialist palliative care team.
The opportunity to take part will be offered by a designated member of the of the multi-professional team with training in capacity assessment. This will occur at three designated times during the week to ensure both minimal disruption to patient care provision and that patients are given the opportunity to participate within 72 hours of their admission. Whilst the researchers appreciate only recruiting three times a week may miss patients with a very short length of stay it is felt that the risk of this is outweighed by reducing disruption to patient care and facilitating participation across multiple sites.
Patients will be provided with information using a patient information leaflet. This leaflet will make it clear that the decision to take part will have no impact on their usual care, and they are able to withdraw at any point in the future. The leaflet can either be read by the patient or read to the patient depending on the presence of any difficulties with reading (incl. literacy level, visual impairment and fatigue).
If the patient wishes to participate, they will be asked to sign a consent form and then given the research questionnaire to complete.
The questionnaire will be placed in a sealed envelope will be given back to a member of the healthcare team, or deposited in a collection box situated at a (manned) front desk or reception area.
Once completed consent forms and research questionnaires are received, the data will be transferred by the research team on each site to an on-site database. At this point, demographic details will be added on to the database to include age, gender, postcode, performance status and main diagnosis. The patient's NHS number will be included on the database, in order to be able to assess the patient outcome following completion of the questionnaire after 3 and 6 months. This enables the important question regarding whether the desire to participate in research changes with a shorter prognosis.
Completed research questionnaires will be gathered three times a week and stored in a locked drawer of a locked office on each research site. No patient identifiable information will be transferred between sites.
Consecutive research questionnaires for all eligible patients will be gathered. A minimum sample size of 100 patients will be recruited so that we would have a minimum ratio of events to predictor variables (age and sex) of 10, allowing us to perform meaningful analysis and minimise the risk of overfitting and type II error inflation.
Demographic data regarding the patient's underlying condition and functional status will be collected contemporaneously.
Outcome data regarding the patient's location of care will be collected at 3 and 6 months.
- Conditions
- Palliative Care, Terminal Illness, Hospice Care
- Being tested
- Questionnaire
- Keywords
- research preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Consecutive, eligible inpatients in a participating specialist palliative care unit will be invited to participate in the research: those who wish to participate will complete a research questionnaire about research preferences.
| Study group | Role | What they receive |
|---|---|---|
| Sequential recruitment of all inpatients | Other | Consecutive, eligible inpatients in a participating specialist palliative care unit will be invited to participate in the research: those who wish to participate will complete a questionnaire about research preferences.
This is not part of standard care and results do not contribute to usual care - thus is an 'interventional' study. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients admitted consecutively to specialist palliative care inpatient units in the North east of England who wish to participate in research - binary Yes/No outcome.
Questionnaire study of consecutively admitted inpatients in specialist palliative care inpatient units.
Measured: 6 months
Secondary outcomes (3)
Proportion of patients who express a desire to participate in research who have malignant (vs non-malignant) disease.
Details of diagnosis (malignant or non-malignant) will be gathered to determine whether there is a difference between those with cancer and those with non-malignant disease, in relation to their preferences for research participation.
Measured: 6 months
Proportion of patients who express a desire to participate in research who have an Australia-modified Karnofsky Performance Scale (AKPS) of ≥70%, between 40% and 60% and ≤30% respectively.
Data regarding functional status (using the Australia-modified Karnofsky Performance Scale) will be gathered to determine whether there is a difference between those with higher or lower functional scores, in relation to their preferences for research participation.
Measured: 6 months
Proportion of patients who express a desire to participate in research who survive ≤1 week, ≤ 2weeks, ≤3 weeks, ≤4weeks, between 4-6 weeks, between 6-8 weeks, between 8-12 weeks, between 3-6 months and >6 months from completion of questionnaire.
Outcome data (regarding living at home, in care home, in hospital or death) will be gathered after 3 and 6 months following completion of the questionnaire, to determine whether there is a difference between those who have a shorter or longer prognosis, and their desire to participate in research.
Measured: 18 months from first patient recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Research questionnaire for all patients sequentially admitted to a specialist palliative care inpatient unit - 2 NHS inpatient units and 1 independent hospice. This is not part of standard care and data does not contribute to usual care. As such this is 'interventional' research.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria Healthcare NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peta Heslop, Study director, Northumbria Healthcare NHS FT - Head of R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894162
- Sponsor's protocol ID
- NHCT0230
- Acronym
- PiPCAR
- Status last verified
- Apr 2022
- First submitted
- 18 Feb 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Identifiable data will be kept on-site and not shared between organisations.
Publications
Higginson IJ. Research challenges in palliative and end of life care. BMJ Support Palliat Care. 2016 Mar;6(1):2-4. doi: 10.1136/bmjspcare-2015-001091. No abstract available.
PubMed 26893386Lunder U, Sauter S, Furst CJ. Evidence-based palliative care: beliefs and evidence for changing practice. Palliat Med. 2004 May;18(4):265-6. doi: 10.1191/0269216304pm900ed. No abstract available.
PubMed 15198115Chen EK, Riffin C, Reid MC, Adelman R, Warmington M, Mehta SS, Pillemer K. Why is high-quality research on palliative care so hard to do? Barriers to improved research from a survey of palliative care researchers. J Palliat Med. 2014 Jul;17(7):782-7. doi: 10.1089/jpm.2013.0589. Epub 2014 Jun 2.
PubMed 24885960Terry W, Olson LG, Ravenscroft P, Wilss L, Boulton-Lewis G. Hospice patients' views on research in palliative care. Intern Med J. 2006 Jul;36(7):406-13. doi: 10.1111/j.1445-5994.2006.01078.x.
PubMed 16780445White C, Hardy J. What do palliative care patients and their relatives think about research in palliative care?-a systematic review. Support Care Cancer. 2010 Aug;18(8):905-11. doi: 10.1007/s00520-009-0724-1. Epub 2009 Aug 25.
PubMed 19705165Ross C, Cornbleet M. Attitudes of patients and staff to research in a specialist palliative care unit. Palliat Med. 2003 Sep;17(6):491-7. doi: 10.1191/0269216303pm785oa.
PubMed 14526881Henderson M, Addington-Hall JM, Hotopf M. The willingness of palliative care patients to participate in research. J Pain Symptom Manage. 2005 Feb;29(2):116-8. doi: 10.1016/j.jpainsymman.2004.12.001. No abstract available.
PubMed 15733802White CD, Hardy JR, Gilshenan KS, Charles MA, Pinkerton CR. Randomised controlled trials of palliative care - a survey of the views of advanced cancer patients and their relatives. Eur J Cancer. 2008 Sep;44(13):1820-8. doi: 10.1016/j.ejca.2008.05.003. Epub 2008 Jun 10.
PubMed 18550360Downing A, Morris EJ, Corrigan N, Sebag-Montefiore D, Finan PJ, Thomas JD, Chapman M, Hamilton R, Campbell H, Cameron D, Kaplan R, Parmar M, Stephens R, Seymour M, Gregory W, Selby P. High hospital research participation and improved colorectal cancer survival outcomes: a population-based study. Gut. 2017 Jan;66(1):89-96. doi: 10.1136/gutjnl-2015-311308. Epub 2016 Oct 19.
PubMed 27797935
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participating in Palliative Care Research
- ClinicalTrials.gov ID
- NCT04894162
- Acronym / sponsor ID
- PiPCAR / NHCT0230
- Conditions
- Palliative Care, Terminal Illness, Hospice Care
- Keywords
- research preferences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Northumbria Healthcare NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 May 2021 (actual)
- 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.
This research seeks the views of patients who are admitted to hospices and specialist palliative care units (SPCUs) regarding whether they would consider being involved in different types of clinical research. This is a questionnaire based study of inpatients in the North East of England.
The results will be used to inform healthcare professionals about the research which patients may or may not be interested in, as well as enabling future research design to be supportive of patient preferences.
Many of the interventions used within specialist palliative care lack a strong evidence base with guidelines often based on a mixture of expert opinion, anecdotal evidence or extrapolated from research in other patient groups rather than robust clinical research. Previous studies have highlighted multiple potential barriers to expanding research within the palliative care setting. Barriers include a lack of funding compared to other medical specialties and a lack of institutional capacity.
An ongoing barrier to research in this field is that the nature of the population makes patient recruitment to research challenging. This may be associated with professionals in palliative care being reluctant to ask patients if they would want to be involved in research as they feel that it would be inappropriate to potentially burden patients who are very unwell with research which is unlikely to change the disease outcome for the individual. However, many recognise that it is important to understand what patients themselves think about the potential to take part in clinical research.
Our main research question will help us to ascertain whether patients admitted under Palliative Medicine in our region would welcome the opportunity to be involved in clinical research. Previous studies have been at a single site with small numbers of patients, whereas our research will aim to recruit a larger number of patients and will be a multi-centre study involving a range of inpatient settings including an independent hospice, two National Health Service (NHS) Palliative Care Units. These centres are across the north-east region (Northumbria and Newcastle) and accept admissions from a mixture of affluent and less affluent areas. It will also involve patients with both malignant and non-malignant disease. Previous studies have not surveyed patients that were described as "too unwell", therefore as a secondary outcome we will be recording how well patients are functionally (by recording performance status- AKPS) to examine if those patients who are most unwell would still want to be involved in research. There is a gap in current knowledge of whether those patients with advanced disease and close to end of life would still find it rewarding to have the opportunity to be involved in research of some sort and whether it is fair to exclude them from being offered opportunities to be involved based on their advanced disease status.
Detailed description
Research Question: Do patients who are cared for in specialist inpatient units in the North East of England want to take part in in research? If not, why not?
- Is there a difference in desire to participate in research between patients with malignant and non malignant disease?
- Is there a difference in desire to participate in research for patients with lower functional status?
- Is there a difference in desire to participate in research for those closer or further away from death?
From the start date of the study all consecutive admissions to the hospice or specialist palliative care units will be offered the opportunity to take part in the research study within 72 hours of their admission if they have capacity and they are under the care of the specialist palliative care team.
The opportunity to take part will be offered by a designated member of the of the multi-professional team with training in capacity assessment. This will occur at three designated times during the week to ensure both minimal disruption to patient care provision and that patients are given the opportunity to participate within 72 hours of their admission. Whilst the researchers appreciate only recruiting three times a week may miss patients with a very short length of stay it is felt that the risk of this is outweighed by reducing disruption to patient care and facilitating participation across multiple sites.
Patients will be provided with information using a patient information leaflet. This leaflet will make it clear that the decision to take part will have no impact on their usual care, and they are able to withdraw at any point in the future. The leaflet can either be read by the patient or read to the patient depending on the presence of any difficulties with reading (incl. literacy level, visual impairment and fatigue).
If the patient wishes to participate, they will be asked to sign a consent form and then given the research questionnaire to complete.
The questionnaire will be placed in a sealed envelope will be given back to a member of the healthcare team, or deposited in a collection box situated at a (manned) front desk or reception area.
Once completed consent forms and research questionnaires are received, the data will be transferred by the research team on each site to an on-site database. At this point, demographic details will be added on to the database to include age, gender, postcode, performance status and main diagnosis. The patient's NHS number will be included on the database, in order to be able to assess the patient outcome following completion of the questionnaire after 3 and 6 months. This enables the important question regarding whether the desire to participate in research changes with a shorter prognosis.
Completed research questionnaires will be gathered three times a week and stored in a locked drawer of a locked office on each research site. No patient identifiable information will be transferred between sites.
Consecutive research questionnaires for all eligible patients will be gathered. A minimum sample size of 100 patients will be recruited so that we would have a minimum ratio of events to predictor variables (age and sex) of 10, allowing us to perform meaningful analysis and minimise the risk of overfitting and type II error inflation.
Demographic data regarding the patient's underlying condition and functional status will be collected contemporaneously.
Outcome data regarding the patient's location of care will be collected at 3 and 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Research questionnaire for all patients sequentially admitted to a specialist palliative care inpatient unit - 2 NHS inpatient units and 1 independent hospice. This is not part of standard care and data does not contribute to usual care. As such this is 'interventional' research.
| Arm | Type | Receives |
|---|---|---|
| Sequential recruitment of all inpatients | Other | Other: QuestionnaireConsecutive, eligible inpatients in a participating specialist palliative care unit will be invited to participate in the research: those who wish to participate will complete a questionnaire about research preferences. This is not part of standard care and results do not contribute to usual care - thus is an 'interventional' study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatient on a specialist palliative care unit
- Admitted in the study period.
- Over 18 years of age
- Willing to participate
- Able to complete the questionnaire (with or without support) during their admission
Key exclusion criteria (3 listed)
- Lack of capacity to consent to involvement in the study
- Clinical team consider the offer of participation may cause distress or burden
- Patients not under the care of the specialist palliative care team e.g. medical borders (this exclusion criteria is only relevant to the specialist palliative care units attached to hospitals and not the hospice)
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 |
|---|---|---|
| QuestionnaireConsecutive, eligible inpatients in a participating specialist palliative care unit will be invited to participate in the research: those who wish to participate will complete a research questionnaire about research preferences. | Other | Sequential recruitment of all inpatients |
Primary outcome
Proportion of patients admitted consecutively to specialist palliative care inpatient units in the North east of England who wish to participate in research - binary Yes/No outcome.
Time frame: 6 months
Questionnaire study of consecutively admitted inpatients in specialist palliative care inpatient units.
3 secondary outcomes
Proportion of patients who express a desire to participate in research who have malignant (vs non-malignant) disease.
Time frame: 6 months
Proportion of patients who express a desire to participate in research who have an Australia-modified Karnofsky Performance Scale (AKPS) of ≥70%, between 40% and 60% and ≤30% respectively.
Time frame: 6 months
Proportion of patients who express a desire to participate in research who survive ≤1 week, ≤ 2weeks, ≤3 weeks, ≤4weeks, between 4-6 weeks, between 6-8 weeks, between 8-12 weeks, between 3-6 months and >6 months from completion of questionnaire.
Time frame: 18 months from first patient recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Background: PubMed 26893386Higginson IJ. Research challenges in palliative and end of life care. BMJ Support Palliat Care. 2016 Mar;6(1):2-4. doi: 10.1136/bmjspcare-2015-001091. No abstract available.
- Background: PubMed 15198115Lunder U, Sauter S, Furst CJ. Evidence-based palliative care: beliefs and evidence for changing practice. Palliat Med. 2004 May;18(4):265-6. doi: 10.1191/0269216304pm900ed. No abstract available.
- Background: PubMed 24885960Chen EK, Riffin C, Reid MC, Adelman R, Warmington M, Mehta SS, Pillemer K. Why is high-quality research on palliative care so hard to do? Barriers to improved research from a survey of palliative care researchers. J Palliat Med. 2014 Jul;17(7):782-7. doi: 10.1089/jpm.2013.0589. Epub 2014 Jun 2.
- Background: PubMed 16780445Terry W, Olson LG, Ravenscroft P, Wilss L, Boulton-Lewis G. Hospice patients' views on research in palliative care. Intern Med J. 2006 Jul;36(7):406-13. doi: 10.1111/j.1445-5994.2006.01078.x.
- Background: PubMed 19705165White C, Hardy J. What do palliative care patients and their relatives think about research in palliative care?-a systematic review. Support Care Cancer. 2010 Aug;18(8):905-11. doi: 10.1007/s00520-009-0724-1. Epub 2009 Aug 25.
- Background: PubMed 14526881Ross C, Cornbleet M. Attitudes of patients and staff to research in a specialist palliative care unit. Palliat Med. 2003 Sep;17(6):491-7. doi: 10.1191/0269216303pm785oa.
- Background: PubMed 15733802Henderson M, Addington-Hall JM, Hotopf M. The willingness of palliative care patients to participate in research. J Pain Symptom Manage. 2005 Feb;29(2):116-8. doi: 10.1016/j.jpainsymman.2004.12.001. No abstract available.
- Background: PubMed 18550360White CD, Hardy JR, Gilshenan KS, Charles MA, Pinkerton CR. Randomised controlled trials of palliative care - a survey of the views of advanced cancer patients and their relatives. Eur J Cancer. 2008 Sep;44(13):1820-8. doi: 10.1016/j.ejca.2008.05.003. Epub 2008 Jun 10.
- Background: PubMed 27797935Downing A, Morris EJ, Corrigan N, Sebag-Montefiore D, Finan PJ, Thomas JD, Chapman M, Hamilton R, Campbell H, Cameron D, Kaplan R, Parmar M, Stephens R, Seymour M, Gregory W, Selby P. High hospital research participation and improved colorectal cancer survival outcomes: a population-based study. Gut. 2017 Jan;66(1):89-96. doi: 10.1136/gutjnl-2015-311308. Epub 2016 Oct 19.
- Individual participant dataSharing planned: No. Identifiable data will be kept on-site and not shared between organisations.
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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.
Peta Heslop study director
Northumbria Healthcare NHS FT - Head of R&D
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Palliative Care and Terminal Illness, run by Northumbria Healthcare NHS Foundation Trust at 3 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients admitted consecutively to specialist palliative care inpatient units in the North east of England who wish to participate in research - binary Yes/No outcome. (time frame: 6 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 NCT04894162, which also lists 9 linked publications.
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 25 Oct 2022.