Participating in Palliative Care Research

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.

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.

Eligibility Criteria:
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)