Medication SystemsNCT05133700
Use and Opinions of Care Home Medicines Audit Tools
An observational study of Medication Systems and Quality Improvement, run by University of Central Lancashire at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Systems, Quality Improvement
- What is being tested?
- Interview or focus group discussion and Review of submitted medicines audit tools
- How many people
- 152 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Three geographical areas of England in different NHS regions
Who may be able to join
- 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,
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- 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
- care homes,
- community pharmacies supporting the participating care homes
- commissioners and regulators with oversight of care homes in the study locality.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Central Lancashire
Preston, Lancashire, PR1 2HE
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication Systems, Quality Improvement
- Being tested
- Interview or focus group discussion, Review of submitted medicines audit tools
- Keywords
- Residential Facilities, Qualitative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview or focus group discussionOther
There is no intervention. This is a qualitative piece of work only
Review of submitted medicines audit toolsOther
There is no intervention. This is a qualitative piece of work only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Review of submitted medicines audit tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start23 Mar 2022
- Primary completion19 Jan 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication SystemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malcolm Irons, University of Central Lancashire
- Investigators
- Malcolm W Irons, Principal investigator, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133700
- Sponsor's protocol ID
- HEALTH 0228CA
- Other IDs
- 280907, 21/IEC08/0015
- Status last verified
- Jan 2025
- First submitted
- 15 Oct 2021
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Opinions' Concerning Medicines Related Errors, Monitoring and Audit Tools Used to Assess Medicines Optimisation Within Care Homes in England
- ClinicalTrials.gov ID
- NCT05133700
- Acronym / sponsor ID
- HEALTH 0228CA
- Conditions
- Medication Systems, Quality Improvement
- Keywords
- Residential Facilities, Qualitative
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 19 Jan 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualitative interviews and focus group | – | Other: Interview or focus group discussionQualitative 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. |
| Qualitative medicines monitoring tools | – | Other: Review of submitted medicines audit toolsSubmission of current medicines monitoring tools by care homes and services supporting care homes including community pharmacies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Three geographical areas of England in different NHS regions
Key inclusion criteria (18 listed)
- Care homes
- 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.
Key exclusion criteria (6 listed)
- Care homes registered with the regulator (CQC)
- Care homes registered with the regulator (CQC)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview or focus group discussionThere is no intervention. This is a qualitative piece of work only | Other | Qualitative interviews and focus group |
| Review of submitted medicines audit toolsThere is no intervention. This is a qualitative piece of work only | Other | Qualitative medicines monitoring tools |
Primary outcome
Barriers and facilitators: qualitative semi-structured individual interviews
Time frame: 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.
Barriers and facilitators: qualitative semi-structured focus groups
Time frame: 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.
Similarities and differences: current medicines monitoring tools
Time frame: 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.
Qualitative comparative analysis
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malcolm W Irons principal investigator
University of Central Lancashire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Systems and Quality Improvement, run by University of Central Lancashire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers and facilitators: qualitative semi-structured individual interviews (time frame: 0 to 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.