User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate).

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.

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.

Study Overview

• Status: Completed
• Conditions: End of Life; Support, Family
• Intervention / Treatment: Other: V1 + Preparation Sheet; Other: Paper Package; Other: V2 + Video Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Version 1 of Palliate; Participants will be randomised to receive this version of Palliate training and materials.	Other: Paper Package; Paper based (as per current practice at Central and North West London (CNWL) NHS Foundation Trust) version of Palliate.
Experimental: Version 2 of Palliate; Participants will be randomised to receive this version of Palliate training and materials.	Other: V1 + Preparation Sheet; Paper based version of Palliate plus a preparation sheet, that provides visual cues as to what equipment is required for the preparation and administration of the medications.
Experimental: Version 3 of Palliate; Participants will be randomised to receive this version of Palliate training and materials.	Other: V2 + Video Training; Hybrid - paper based materials, preparation sheet, and video instructions available via an interactive portable document format (PDF) version of the training materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Oak Foundation
• Investigators: Principal Investigator: Leila Shepherd, PhD, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Palliative Care
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death; myotrophin
• Other Study ID Numbers: OFIL-20-279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No