Clinical trial NCT04900103: Evaluation of Implementation of ITV-Pal Program
Official title: Evaluation of Implementation Process of Tech-Volunteer Program in Palliative Care: ITV-Pal Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Keywords: Palliative Care
Volunteering
New technologies
Lead sponsor: Cudeca Hospice Foundation
Sponsor class: OTHER
Collaborators: name: La Caixa Foundation
First posted: 2021-05-25
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: How can offer support to patients and families through a volunteer caring program based on new technologies? The aim of this study is to implement and evaluate a volunteer training programme in the use of new technologies: ITV-Pal Programme to support patients facing a life-threatening illness and their families.

It will created two groups of volunteers, one group will follow the CUDECA standard training program, the other will follow the proposed intervention, ITV-Pal programme. Volunteers will be allocated randomly to each group. Second stage will consist in the implementation of the direct support to patients and families through the volunteers.

The expectation is that ITV-Pal volunteers trained will be able to increase general welfare of patients and families they care for. To test it, the quality of life of patients, families and volunteers, the quality of the dying process, and identify how new technology supports volunteer end of life care will be measure.

Detailed description: The inclusion of volunteers to the Team in the care of the patient and the family is continually increasing. The requests for volunteers by the Medical Care Teams have been increasing year after year by 5%, reaching about 75 requests received in 2019. 85% of these requests are assigned a volunteer and the 15% who are not assigned is because the volunteer does not have the required profile which responds to the patient's needs. These statistics show, on the one hand, the important and irreplaceable work that volunteers offer in social support to the patient and this is perceived both by the patient and their family who decide to have it, and also by the Care Team that is aware of the benefits of "non-professional" care, which also humanises palliative care. On the other hand, the volunteer is increasingly present in our society and this is positive, so that more people offer their collaboration and this in turn "normalises" their role in palliative care.

Although volunteers contribute millions of hours of work, the review of bibliography found no sufficiently robust studies to merit inclusion, and even less when associating PC volunteering and NT. As more research is needed on the impact of training and support for palliative care volunteers, this study intends to study the state of art of technophilia and technophobia among patients, relatives, volunteers and healthcare professionals in PC, and according to the results, implement and evaluate a volunteer training programme in the use of new technology to support patients dying at home and their relatives.

The best approach to evaluate the implementation process of complex intervention is the combination of quantitative and qualitative methods. Basic quantitative measures of implementation may be combined with in-depth qualitative data to provide detailed understandings of intervention functioning on a small scale. Use quantitative methods to measure key process variables and allow testing of pre-hypothesised mechanisms of impact and contextual moderators. Use qualitative methods to capture emerging changes in implementation, experiences of the intervention and unanticipated or complex causal pathways, and to generate new theory.

Quantitative approach:

* Pragmatic cluster randomized clinical trial to test the efficacy (the unit of randomization is the volunteer and the unit of analysis is the patient/relative).
* Before-after design for satisfaction of volunteers and HPC with the intervention and its implementation to test the effectiveness.
* Cost-utility study from the perspective of the funder with a time horizon of one year. A detailed cost analysis including costs for the adaptation of volunteer standard course to ITVPal Programme as well as the recruitment and training costs of the volunteers will be performed.

Qualitative approach: interviews (individuals and groupal) with HPC, volunteers and with key informants of patients/relatives to test at the beginning the need and usefulness of NT, and also during the implementation process to test changes and experiences.

Eligibility criteria: Inclusion Criteria:

Patients/relatives:

* Over 18 years; PC patients and relatives eligible for volunteer support according to the PC team assessment.
* Acceptance to participate in the study by signing the Informed Consent.

PC Volunteers:

- Acceptance to participate in the study by signing the Informed Consent.

Exclusion criteria

- No acceptance to participate in the study by signing the Informed Consent.

Primary outcomes:
measure: Distress thermometer
timeFrame: Through study completion, an average of 3 months
measure: ICECAP-SCM
timeFrame: Through study completion, an average of 15 days
Secondary outcomes:
measure: EuroQoL 5D-5L
timeFrame: Baseline, 15 and 30 days after inclusion.
measure: Satisfaction Volunteer Programme
timeFrame: Through study completion, an average of 12 months
measure: Service Improvement Metrics: fidelity
timeFrame: Through study completion, an average of 12 months
measure: Service Improvement Metrics: dose
timeFrame: Through study completion, an average of 12 months
measure: Service Improvement Metrics: reach
timeFrame: Through study completion, an average of 12 months
measure: Heath resource use
timeFrame: Through study completion, an average of 12 months
Other outcomes:
measure: PHTech questionnaire
timeFrame: Through study completion, an average of 3 months
measure: Volunteer Motivation (VFI)
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Educational level
timeFrame: Baseline
Locations:
city: Benalmádena
country: Spain
facility: Fundación CUDECA
state: Málaga
Study officials:
References: