Use and Opinions of Care Home Medicines Audit Tools

Quality Improvement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05133700
• Other study ID #: HEALTH 0228CA
• Secondary ID: 28090721/IEC08/0
• Status: Enrolling by invitation
• Start date: March 23, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: University of Central Lancashire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 152
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medication Systems
• Quality Improvement

Intervention

Other:
• Interview or focus group discussion
There is no intervention. This is a qualitative piece of work only
• Review of submitted medicines audit tools
There is no intervention. This is a qualitative piece of work only

Locations

Country	Name	City	State
United Kingdom	University of Central Lancashire	Preston	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barriers and facilitators: qualitative semi-structured individual interviews	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.	0 to 9 months
Primary	Barriers and facilitators: qualitative semi-structured focus groups	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.	0 to 9 months
Primary	Similarities and differences: current medicines monitoring tools	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.	9 to 12 months
Primary	Qualitative comparative analysis	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.	9 to 12 months