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Clinical Trials/NCT05133700
NCT05133700
Enrolling By Invitation
Not Applicable

Use and Opinions' Concerning Medicines Related Errors, Monitoring and Audit Tools Used to Assess Medicines Optimisation Within Care Homes in England

University of Central Lancashire1 site in 1 country152 target enrollmentStarted: March 23, 2022Last updated:

Overview

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
152
Locations
1
Primary Endpoint
Barriers and facilitators: qualitative semi-structured individual interviews

Overview

Brief Summary

To describe the barriers and facilitators experienced by residents, health and social care staff, commissioners and regulators when managing medicines within care homes.

Detailed Description

The prescribing of medicines is the most frequent health intervention in England. The administration or omission of medicines is not without risk and incidents involving medicines occur. The frequency of prescribing medicines increases with age and frailty. People living in care homes (with and without nursing) are generally older and more frail than similar groups in the community. Therefore, care homes and their staff need to be proficient and safe when administering medicines.

However, an under investigated area of prescribed medicines is the views of people living in care homes, health and social care staff, commissioners and regulator about managing medicines in care homes.

During the study a series of semi-structured interviews and focus groups will be undertaken. These focus groups will be held with people living in care homes (with and without nursing). Further interviews and focus groups will be held with health and social care staff, commissioners and regulators.

Care homes will be invited to provide copies of their current medicines monitoring tool. In addition, services supporting care homes including community pharmacies will also be invited to provide copies of their current medicines monitoring tools.

Analysis of conversations and monitoring tools made available to the study team will be undertaken and compared to published literature including grey literature.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • within pre-agreed areas,
  • registered with the regulator (CQC) for the regulated activities of Residential Care (with or without nursing) that have consented to participate.
  • Theses care homes will also be registered for one or more of the following specialisms:
  • dementia,
  • mental health conditions,
  • physical disabilities,
  • sensory impairments,
  • caring for adults under 65 years
  • caring for adults over 65 years.
  • Residents who have capacity and an adequate understanding of written and verbal English to consent and participate of participating care homes.

Exclusion Criteria

  • Care homes registered with the regulator (CQC)
  • outside of the pre-agreed areas.
  • Care homes registered with the regulator (CQC)
  • within the pre-agreed areas for the regulated activities of Residential Care (with or without nursing) that are also registered for the specialism of supporting younger people.
  • Residents of participating care homes judged by staff to lack capacity, an adequate understanding of written and verbal English to consent and participate, too unwell or might find it distressing.
  • Staff in participating care homes who lack an adequate understanding of written and verbal English to consent and participate.

Outcomes

Primary Outcomes

Barriers and facilitators: qualitative semi-structured individual interviews

Time Frame: 0 to 9 months

Transcribed interviews will be coded and then emerging themes from the data identified and developed. A constant comparison method of analysis will be used. The presence or lack of consensus and reinforcement on certain topics will also be observed.

Similarities and differences: current medicines monitoring tools

Time Frame: 9 to 12 months

Current medicines monitoring tools will be coded and then emerging themes from the data identified and developed. A constant comparison method of analysis will be used. The presence or lack of consensus and reinforcement on certain topics will also be observed.

Qualitative comparative analysis

Time Frame: 9 to 12 months

Themes and topics that emerged from the interviews, focus groups and current medicines monitoring tools will be compared and contrasted with each other and the evidence identified from a separate scoping review.

Barriers and facilitators: qualitative semi-structured focus groups

Time Frame: 0 to 9 months

Transcribed focus groups will be coded and then emerging themes from the data identified and developed. A constant comparison method of analysis will be used. The presence or lack of consensus and reinforcement on certain topics will also be observed.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Malcolm Irons

Principal Investigator

University of Central Lancashire

Study Sites (1)

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