Use and Opinions of Care Home Medicines Audit Tools

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality Improvement; Medication Systems
• Intervention / Treatment: Other: Interview or focus group discussion; Other: Review of submitted medicines audit tools

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 Type: Observational
• Enrollment (Estimated): 152

Contacts and Locations

Study Locations

• United Kingdom
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR1 2HE
      • University of Central Lancashire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Three geographical areas of England in different NHS regions

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Interview or focus group discussion; 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.	Other: Review of submitted medicines audit tools; There is no intervention. This is a qualitative piece of work only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Central Lancashire
• Investigators: Principal Investigator: Malcolm W Irons, University of Central Lancashire

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Qualitative; Residential Facilities
• Other Study ID Numbers: HEALTH 0228CA; 280907 (Other Identifier: NHS Health Research Authority); 21/IEC08/0015 (Other Identifier: Social Care Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No