Participating in Palliative Care Research

NCT04894162 | Completed

• 1 other identifier: NHCT0230
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Palliative Care; Terminal Illness; Hospice Care

Keywords

research preferences

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Proportion of patients who express a desire to participate in research who have malignant (vs non-malignant) disease.

  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.

  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.

  18 months from first patient recruitment

Study Arms (1)

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.

Other: Questionnaire

Interventions

Questionnaire 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 research questionnaire about research preferences.

Sequential recruitment of all inpatients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Lack of capacity to consent to involvement in the study
• Clinical team consider the offer of participation may cause distress or burden

Sponsors & Collaborators

• Northumbria Healthcare NHS Foundation Trust: lead

Study Sites (3)

Wansbeck General Hospital

Ashington, NE639JJ, United Kingdom

Location

St Oswald's Hospice

Newcastle, NE31EE, United Kingdom

Location

North Tyneside General Hospital

North Shields, NE298NH, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 26893386 BACKGROUND

• 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.

  PMID: 15198115 BACKGROUND

• 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.

  PMID: 24885960 BACKGROUND

• 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.

  PMID: 16780445 BACKGROUND

• 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.

  PMID: 19705165 BACKGROUND

• 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.

  PMID: 14526881 BACKGROUND

• 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.

  PMID: 15733802 BACKGROUND

• 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.

  PMID: 18550360 BACKGROUND

• 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.

  PMID: 27797935 BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Peta Heslop

  Northumbria Healthcare NHS FT - Head of R&D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: May 20, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)