Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2021-07-01
2022-06-30
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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NA
SEQUENTIAL
This is not part of standard care and data does not contribute to usual care. As such this is 'interventional' research.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Sequential recruitment of all inpatients
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.
Questionnaire
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.
Interventions
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Questionnaire
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Clinical team consider the offer of participation may cause distress or burden
18 Years
ALL
No
Sponsors
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Northumbria Healthcare NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Peta Heslop
Role: STUDY_DIRECTOR
Northumbria Healthcare NHS FT - Head of R&D
Locations
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Wansbeck General Hospital
Ashington, , United Kingdom
St Oswald's Hospice
Newcastle, , United Kingdom
North Tyneside General Hospital
North Shields, , United Kingdom
Countries
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References
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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.
Lunder 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.
Chen 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.
Terry 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.
White 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.
Ross 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.
Henderson 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.
White 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.
Downing 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.
Other Identifiers
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NHCT0230
Identifier Type: -
Identifier Source: org_study_id
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