Use and Opinions of Care Home Medicines Audit Tools

NCT05133700 | Enrolling By Invitation

• 3 other identifiers: HEALTH 0228CA28090721/IEC08/0015
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Systems; Quality Improvement

Keywords

Residential Facilities; Qualitative

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

Interview or focus group discussion OTHER

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

Qualitative interviews and focus group

Review of submitted medicines audit tools OTHER

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

Qualitative medicines monitoring tools

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three geographical areas of England in different NHS regions

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Lancashire: lead

Study Sites (1)

University of Central Lancashire

Preston, Lancashire, PR1 2HE, United Kingdom

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Malcolm W Irons

  University of Central Lancashire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 24, 2021
• Study Start: March 23, 2022
• Primary Completion: January 19, 2025
• Study Completion: December 31, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)