User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate).
NCT Number: NCT06526637
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: End of Life|Support, Family
Interventions: OTHER: Paper Package|OTHER: V1 + Preparation Sheet|OTHER: V2 + Video Training
Sponsor: Imperial College London
Collaborators: Oak Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-05
Locations: Imperial College London, London, United Kingdom

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.

Primary Outcome Measures: Acceptability, Participant scores of acceptability of the intervention as per the responses on the Theoretical Framework of Acceptability (TFA) questionnaire. Free text or verbal responses noted when completing the questionnaire will be thematically analysed as informed by the TFA.

The TFA questionnaire is an eight-item questionnaire. Raw total scores range from 8 (the worst possible score) to 40 (the best possible score)., Through study completion per participant (≤ 5 weeks)
Secondary Outcome Measures: Usability, Participant scores of usability as per the System Usability Scale (SUS) questionnaire.

The SUS is a ten-item attitude Likert scale giving a global view of subjective assessments of usability. Scores range from 0 (the worst possible score) to 100 (the best possible score)., Through study completion per participant (≤ 5 weeks)|Incidence of error, Medication Error will be defined as any of the following - Wrong medication

Wrong dose - if \>10% deviation from the prescribed dose.

Wrong indication - was the selected medication and dose correct for the symptoms presented.

Administration error - incorrect process of administration

Documentation error - failure to document or incorrect documentation.

(Wrong patient- n/a, Wrong route- n/a, Wrong concentration- n/a, Wrong diluent- n/a), Through study completion per participant (≤ 5 weeks)|Efficiency, Time taken to prepare and administer each medication. This will be defined as - Start = the moment the participant begins reading the scenario Finish = the moment the medication has been administered Time for documentation will also be recorded., Through study completion per participant (≤ 5 weeks)|Factors contributing to error, potential errors and acceptability of the intervention, Hierarchical Task Analysis - The workflow of reading the scenario, through to preparation, administration and documentation of the medications will be micro-analysed and mapped. Medication events that are found to be erroneous, take longer than anticipated or deem to be problematic by the participant or researcher/s will be analysed against the workflow map to identify which step in the process was the likely cause of the issue., Through study completion per participant (≤ 5 weeks)|Learnability/ Retained learning, Differences in the incidence of error and time to complete task between a, each medication preparation and administration and b, between the first and second visit., Through study completion per participant (≤ 5 weeks)|Actual and perceived barriers and opportunities from the participants regarding the use of the Palliate intervention, Guided by the theoretical framework of acceptability- Short semi-structure interviewers following participation in the user testing. And/or completion of a questionnaire with a combination of open and closed questions., Through study completion per participant (≤ 5 weeks)