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

Not Applicable

Not yet recruiting

• Conditions: End of Life; Support, Family
• Interventions: Other: V2 + Video Training; Other: Paper Package; Other: V1 + Preparation Sheet

• Registration Number: NCT06526637
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2025-03
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Version 3 of Palliate	V2 + Video Training	Participants will be randomised to receive this version of Palliate training and materials.
Version 1 of Palliate	Paper Package	Participants will be randomised to receive this version of Palliate training and materials.
Version 2 of Palliate	V1 + Preparation Sheet	Participants will be randomised to receive this version of Palliate training and materials.

Primary Outcome Measures

Name	Time	Method
Acceptability	Through study completion per participant (≤ 5 weeks)	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).

Secondary Outcome Measures

Name	Time	Method
Efficiency	Through study completion per participant (≤ 5 weeks)	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.
Actual and perceived barriers and opportunities from the participants regarding the use of the Palliate intervention	Through study completion per participant (≤ 5 weeks)	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.
Learnability/ Retained learning	Through study completion per participant (≤ 5 weeks)	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.
Usability	Through study completion per participant (≤ 5 weeks)	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).
Factors contributing to error, potential errors and acceptability of the intervention	Through study completion per participant (≤ 5 weeks)	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.
Incidence of error	Through study completion per participant (≤ 5 weeks)	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)

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom