Clinical trial NCT06526637: User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate).
Official title: User Testing of the Palliate Intervention, Supporting Lay Carers to Prepare and Administer Anticipatory Medications to Loved Ones at Home at the End of Life.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End of Life
Support, Family
Keywords: Palliative Care
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Oak Foundation
First posted: 2024-07-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will use direct observational methods in a workshop setting. Participants will be randomised to receive one of three Palliate training and material versions. Randomisation will be completed ahead of study commencement using a random number generator to allow the researcher time to prepare and set up the selected training information and materials. Randomisation will be conducted in blocks of three to ensure an even number randomised to each of the study arms (intervention version 1,2 and 3).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the acceptability, safety and efficiency of the Palliate intervention.

The Palliate intervention is a nurse-led process that includes training and documentation materials to support lay carers in administering top up medications to loved ones at the end of life at home. The Palliate intervention was designed based on the CARiAD\* intervention using user testing and has been successfully piloted and rolled out in Central and North West London National Health Service (NHS) Foundation Trust.

\*CARer-ADministration of as-needed sub-cutaneous medication for breakthrough symptoms in homebased dying patients.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 years or older and able to communicate in English.

Exclusion Criteria:

* Individuals aged less than 18 years old and/or unable to communicate in English.

Primary outcomes:
measure: Acceptability
timeFrame: Through study completion per participant (≤ 5 weeks)
Secondary outcomes:
measure: Usability
timeFrame: Through study completion per participant (≤ 5 weeks)
measure: Incidence of error
timeFrame: Through study completion per participant (≤ 5 weeks)
measure: Efficiency
timeFrame: Through study completion per participant (≤ 5 weeks)
measure: Factors contributing to error, potential errors and acceptability of the intervention
timeFrame: Through study completion per participant (≤ 5 weeks)
measure: Learnability/ Retained learning
timeFrame: Through study completion per participant (≤ 5 weeks)
measure: Actual and perceived barriers and opportunities from the participants regarding the use of the Palliate intervention
timeFrame: Through study completion per participant (≤ 5 weeks)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: Leila Shepherd, PhD
role: PRINCIPAL_INVESTIGATOR
References: