Participating in Palliative Care Research (PiPCAR)

October 24, 2022 updated by: Northumbria Healthcare NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ashington, United Kingdom, NE639JJ
        • Wansbeck General Hospital
      • Newcastle, United Kingdom, NE31EE
        • St Oswald's Hospice
      • North Shields, United Kingdom, NE298NH
        • North Tyneside General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who express a desire to participate in research who have malignant (vs non-malignant) disease.
Time Frame: 6 months
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.
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
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.
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
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.
18 months from first patient recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria Healthcare NHS Foundation Trust

Investigators

  • Study Director: Peta Heslop, Northumbria Healthcare NHS FT - Head of R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

May 16, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NHCT0230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Identifiable data will be kept on-site and not shared between organisations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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