Use and Opinions of Care Home Medicines Audit Tools

Sponsor
University of Central Lancashire (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05133700
Collaborator
(none)
152
1
7.3
20.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
152 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Use and Opinions' Concerning Medicines Related Errors, Monitoring and Audit Tools Used to Assess Medicines Optimisation Within Care Homes in England
Actual Study Start Date :
Mar 23, 2022
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Barriers and facilitators: qualitative semi-structured individual interviews [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

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

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

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

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

  5. 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.
  1. 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.
  1. 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.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Central Lancashire Preston Lancashire United Kingdom PR1 2HE

Sponsors and Collaborators

  • University of Central Lancashire

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Malcolm Irons, Principal Investigator, University of Central Lancashire
ClinicalTrials.gov Identifier:
NCT05133700
Other Study ID Numbers:
  • HEALTH 0228CA
  • 280907
  • 21/IEC08/0015
First Posted:
Nov 24, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Malcolm Irons, Principal Investigator, University of Central Lancashire

Study Results

No Results Posted as of Apr 6, 2022