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Enrolling by Invitation

NCT Number: NCT05133700

Use and Opinions of Care Home Medicines Audit Tools

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Central Lancashire

Preston, Lancashire, PR1 2HE, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Care homes
  • 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.
  • Care home staff, including registered managers who have an adequate understanding of written and verbal English to consent and participate of participating care homes.
  • Visiting health and social care staff who support care homes in the study locality.
  • Commissioner and regulatory staff with oversight of care homes in the study locality.
  • Medicines monitoring tools used by participating
  • care homes,
  • community pharmacies supporting the participating care homes
  • commissioners and regulators with oversight of care homes in the study locality.

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.

Treatment and study plan

Interview or focus group discussion

Other

There is no intervention. This is a qualitative piece of work only

Review of submitted medicines audit tools

Other

There is no intervention. This is a qualitative piece of work only

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Central Lancashire

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2021
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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