iLIVE Volunteer Study

NCT04678310 | Completed

• 1 other identifier: UoL001538 iLIVE Volunteer
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Terminal Illness

Keywords

Dying; Palliative Care; Volunteers; End-of-Life-Care

Outcome Measures

Primary Outcomes (6)

• Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).

  The EQ-5D-5L is made up of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on 5 levels, using a 1-digit number: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. The digits for the 5 dimensions are then combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.

  Baseline (recruitment)

• Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).

  The EQ-5D-5L is made up of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on 5 levels, using a 1-digit number: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. The digits for the 5 dimensions are then combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.

  Follow-up 1 (7 days [+/- 2 days] following support from volunteer service)

• Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).

  The EQ-5D-5L is made up of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on 5 levels, using a 1-digit number: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. The digits for the 5 dimensions are then combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.

  Follow-up 2 (1 month following recruitment)

• Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).

  ICECAP-SCM is a self-completion questionnaire developed to evaluate quality of life in palliative and supportive care. The ICECAP-SCM comprises 7 attributes: Having a say; Being with people who care about you; Physical suffering; Emotional suffering; Dignity; Being supported; Being prepared. Each dimension is scored on 4 levels ranging from: 4 = full capability; 1 = no capability. Higher scores indicate a better outcome.

  Baseline (recruitment)

• Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).

  ICECAP-SCM is a self-completion questionnaire developed to evaluate quality of life in palliative and supportive care. The ICECAP-SCM comprises 7 attributes: Having a say; Being with people who care about you; Physical suffering; Emotional suffering; Dignity; Being supported; Being prepared. Each dimension is scored on 4 levels ranging from: 4 = full capability; 1 = no capability. Higher scores indicate a better outcome.

  Follow-up 1 (7 days [+/- 2 days] following support from volunteer service)

• Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).

  ICECAP-SCM is a self-completion questionnaire developed to evaluate quality of life in palliative and supportive care. The ICECAP-SCM comprises 7 attributes: Having a say; Being with people who care about you; Physical suffering; Emotional suffering; Dignity; Being supported; Being prepared. Each dimension is scored on 4 levels ranging from: 4 = full capability; 1 = no capability. Higher scores indicate a better outcome.

  Follow-up 2 (1 month following recruitment)

Secondary Outcomes (1)

• Distress Thermometer (single measure questionnaire)

  Follow-up 1 (7 days [+/- 2 days] following support from volunteer service); follow-up 2 (1 month following recruitment)

Study Arms (2)

Intervention Group

A patient will be assessed as 'eligible' for participation in the iLIVE Volunteer Study if they have an advanced, incurable illness that is unlikely to be cured, and they have been assessed by their clinical team as being in the last month of life. If patients meet this criteria, they will be offered support from the hospital palliative and end of life care volunteer service (developed for this study). Patients who agree to support will be recruited to the 'Intervention Group'.

Other: Support from the hospital palliative and end of life care volunteer service (developed for this study).

Case Control Comparison Group

If a patient is 'eligible' to receive support from the hospital palliative and end of life care volunteer service (see 'Intervention Group'), but declines involvement, they will be approached for inclusion in the study, as part of the 'Case Control Comparison' group for comparative analysis to assess the 'impact' of the volunteer service.

Interventions

Support from the hospital palliative and end of life care volunteer service (developed for this study). OTHER

Hospital palliative and end of life care volunteer service: a volunteer service to provide support to patients dying in the hospital and their families. The volunteer service has been designed to provide presence and companionship to dying patients at the end of life, and their families.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liverpool: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

Location

Related Publications (1)

• Yildiz B, van der Heide A, Bakan M, Iversen GS, Haugen DF, McGlinchey T, Smeding R, Ellershaw J, Fischer C, Simon J, Vibora-Martin E, Ruiz-Torreras I, Goossensen A; iLIVE consortium. Facilitators and barriers of implementing end-of-life care volunteering in a hospital in five European countries: the iLIVE study. BMC Palliat Care. 2024 Apr 2;23(1):88. doi: 10.1186/s12904-024-01423-5.

  PMID: 38561727 DERIVED

Study Officials

• John E Ellershaw

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 21, 2020
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)