Clinical trial NCT04678310: iLIVE Volunteer Study
Official title: iLIVE Project: Live Well, Die Well. A Nested Volunteer Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Terminal Illness
Keywords: Dying
Palliative Care
Volunteers
End-of-Life-Care
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2020-12-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be any patient who is admitted to a participating hospital, and who meets the inclusion criteria for the study.

All patients will have an advanced, incurable illness from which they will not be cured, and will have been assessed by their clinical team as being in the last month of life.

Brief summary: The aim of this study is to develop and evaluate the implementation of an international volunteer training programme to support patients dying in the hospital setting and their families. It has the following objectives:

1. Explore the experience and perceptions of the international hospital palliative and end of life care volunteer programme, including care delivery, from the perspectives of:

   * Patients and their family members who receive the service
   * Volunteers who deliver the service
   * Health care professionals caring for patients who receive the service
2. Assess the implementation and impact of a hospital volunteer service for dying patients

Detailed description: An excess of 5 million people die in the EU each year, with 77% of deaths resulting from chronic disease and illness. Of these 4 million deaths, many people will have died in pain or symptomatic distress, died alone, and/or died without structured health or social care for the patient and/or their family. Volunteer support represents an important and necessary community resource to enhance the experience of living at the end of life, and dying, however, a Cochrane review in 2015 concluded: "research is needed on the impact of training and support for palliative care volunteers on patients, their families, volunteers and palliative care services". Palliative care volunteer services are relatively uncommon and empirical evidence of the usefulness of such services in the hospital setting remains scarce.

An EU H2020 funded study, iLIVE, will address this concern. The iLIVE Volunteer Study, one of 8 workpackages within the iLIVE project, has developed an international hospital palliative care volunteer training programme, to support the implementation of palliative care volunteer services within five hospitals in five countries. The study will evaluate the implementation, use and experience of the iLIVE Volunteer Service across the five countries, embedded within the current iLIVE Cohort Study (ClinicalTrials.giv reference number: NCT04271085).

Aim/Rationale:

The aim of this study is to develop and evaluate the implementation of an international volunteer training programme to support patients dying in the hospital setting and their families.

Objectives:

1. Explore the experience and perceptions of the international hospital palliative and end of life care volunteer programme, including care delivery, from the perspectives of:

   1. Patients and their family members who receive the service
   2. Volunteers who deliver the service
   3. Health care professionals caring for patients who receive the service
2. Assess the implementation and impact of a hospital volunteer service for dying patients

Eligibility criteria: Inclusion Criteria:

* Patient is \>18 years old;
* The patient has already been recruited to the iLIVE Cohort Study (fulfilling the eligibility criteria);
* The physician or clinical team estimates the patient's life expectancy to be one month or less, based on a modified version of the 'Surprise Question' "Would you be surprised if this patient would die within one month?"
* The physician or clinical team agrees that the patient is eligible for involvement of the hospital palliative care volunteer service.

Exclusion Criteria:

* Patient is \<18 years old;
* The patient has not already been recruited to the iLIVE Cohort Study and does not fulfil the eligibility criteria;
* The physician or clinical team does not estimate the patient's life expectancy to be one month or less, based on a modified version of the 'Surprise Question' "Would you be surprised if this patient would die within one month?"
* The physician or clinical team do not agree that the patient is eligible for involvement of the hospital palliative care volunteer service.

Primary outcomes:
measure: Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).
timeFrame: Baseline (recruitment)
measure: Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).
timeFrame: Follow-up 1 (7 days [+/- 2 days] following support from volunteer service)
measure: Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).
timeFrame: Follow-up 2 (1 month following recruitment)
measure: Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).
timeFrame: Baseline (recruitment)
measure: Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).
timeFrame: Follow-up 1 (7 days [+/- 2 days] following support from volunteer service)
measure: Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).
timeFrame: Follow-up 2 (1 month following recruitment)
Secondary outcomes:
measure: Distress Thermometer (single measure questionnaire)
timeFrame: Follow-up 1 (7 days [+/- 2 days] following support from volunteer service); follow-up 2 (1 month following recruitment)
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Liverpool
name: John E Ellershaw
role: PRINCIPAL_INVESTIGATOR
References: