Clinical trial NCT05133700: Use and Opinions of Care Home Medicines Audit Tools
Official title: Use and Opinions' Concerning Medicines Related Errors, Monitoring and Audit Tools Used to Assess Medicines Optimisation Within Care Homes in England
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Medication Systems
Quality Improvement
Keywords: Residential Facilities
Qualitative
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three geographical areas of England in different NHS regions

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.

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.

Primary outcomes:
measure: Barriers and facilitators: qualitative semi-structured individual interviews
timeFrame: 0 to 9 months
measure: Barriers and facilitators: qualitative semi-structured focus groups
timeFrame: 0 to 9 months
measure: Similarities and differences: current medicines monitoring tools
timeFrame: 9 to 12 months
measure: Qualitative comparative analysis
timeFrame: 9 to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancashire
Study officials:
affiliation: University of Central Lancashire
name: Malcolm W Irons
role: PRINCIPAL_INVESTIGATOR
References: