Use and Opinions of Care Home Medicines Audit Tools

NCT ID: NCT05133700

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2025-12-31

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.

Conditions

Medication Systems; Quality Improvement

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Qualitative interviews and focus group

Qualitative semi-structured individual interviews and focus groups to be held with people living in care homes (with and without nursing), health and social care staff supporting these people, commissioners and regulators.

Interview or focus group discussion

Intervention Type: OTHER

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

Qualitative medicines monitoring tools

Submission of current medicines monitoring tools by care homes and services supporting care homes including community pharmacies.

Review of submitted medicines audit tools

Intervention Type: OTHER

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

Interventions

Interview or focus group discussion

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

Intervention Type: OTHER

Review of submitted medicines audit tools

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Residents who have capacity and an adequate understanding of written and verbal English to consent and participate of participating care homes.

3. Care home staff, including registered managers who have an adequate understanding of written and verbal English to consent and participate of participating care homes.

4. Visiting health and social care staff who support care homes in the study locality.

5. Commissioner and regulatory staff with oversight of care homes in the study locality.

6. 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

1. Care homes registered with the regulator (CQC)

• outside of the pre-agreed areas.

2. 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.

3. 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.

4. Staff in participating care homes who lack an adequate understanding of written and verbal English to consent and participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Central Lancashire

OTHER

Sponsor Role: lead

Responsible Party

Malcolm Irons

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malcolm W Irons

Role: PRINCIPAL_INVESTIGATOR

University of Central Lancashire

Locations

University of Central Lancashire

Preston, Lancashire, United Kingdom

Countries

United Kingdom

Other Identifiers

280907

Identifier Type: OTHER

Identifier Source: secondary_id

21/IEC08/0015

Identifier Type: OTHER

Identifier Source: secondary_id

HEALTH 0228CA

Identifier Type: -

Identifier Source: org_study_id