Trial Outcomes & Findings for Nurse-led Medicines' Monitoring in Care Homes: a Process Evaluation (NCT NCT03110471)

Results Overview

ADRs (adverse drug reactions) (as listed in the British National Formulary and manufacturers' datasheets) where actions are taken to correct the problem.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

6 months

Results posted on

2020-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Observed Residents The administration of ADRe by nurses with 30 residents was observed in ten volunteer care homes in South West Wales, U.K. Five care homes were recruited to the study from our earlier randomised controlled trial \[24\], and five were newly recruited. All observed residents were receiving prescribed mental health medicines. The wider policy context was explored in 30 interviews with service users, including family members, nurse managers and strategic health care leads in South Wales	Service Providers pharmacists nurses strategic leads
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observed Residents n=30 Participants Administration of ADRe by nurses to 30 residents in care homes observed	Service Providers and Users Policy context explored in interviews with service users, nurse managers strategic leads	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=30 Participants	0 Participants	2 Participants n=30 Participants
Age, Categorical >=65 years	28 Participants n=30 Participants	0 Participants	28 Participants n=30 Participants
Age, Continuous	77.7 years STANDARD_DEVIATION 9.9 • n=30 Participants	—	77.7 years STANDARD_DEVIATION 9.9 • n=30 Participants
Sex: Female, Male Female	15 Participants n=30 Participants	—	15 Participants n=30 Participants
Sex: Female, Male Male	15 Participants n=30 Participants	—	15 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	30 participants n=30 Participants	—	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Observation of residents. Service providers and users were not observed: they gave interviews.

ADRs (adverse drug reactions) (as listed in the British National Formulary and manufacturers' datasheets) where actions are taken to correct the problem.

Outcome measures

Outcome measures
Measure	Whole Study - Observed Residents n=30 Participants Care home (long-stay) residents observed for adverse drug reactions.
Number of Participants With Adverse Drug Reactions (ADRs) Treated	30 Participants

SECONDARY outcome

Timeframe: up to 1 hour

Population: Observed resident/ care-giver interaction.

Assessed by researchers observing resident/ care-giver interaction.

Outcome measures

Outcome measures
Measure	Whole Study - Observed Residents n=30 Participants Care home (long-stay) residents observed for adverse drug reactions.
Time for ADRe Administration (Including Interruptions) in Minutes	27.7 minutes Standard Deviation 12.0

SECONDARY outcome

Timeframe: up to 1 hour

Population: Observed resident/ care-giver interaction.

Signs and symptoms of prescribed medicines as listed as undesirable effects in manufacturers' Summaries of Product Characteristics.

Outcome measures

Outcome measures
Measure	Whole Study - Observed Residents n=30 Participants Care home (long-stay) residents observed for adverse drug reactions.
Number of Problems Identified Per Resident	17.5 problems / resident Standard Deviation 7.1

SECONDARY outcome

Timeframe: up to 4 weeks

Population: Observed resident/ care-giver interaction.

Measures taken to alleviate signs and symptoms of prescribed medicines as listed as undesirable effects in manufacturers' Summaries of Product Characteristics.

Outcome measures

Outcome measures
Measure	Whole Study - Observed Residents n=30 Participants Care home (long-stay) residents observed for adverse drug reactions.
Number of Changes to Care by Nurses Identified Per Resident	2.3 care changes / resident Standard Deviation 1.6

SECONDARY outcome

Timeframe: up to 4 weeks

Population: Observed resident/ medicines charts reviewed in conjunction with the ADRe profile.

Recommendations to optimise prescription regimens. These included specific points to review or change.

Outcome measures

Outcome measures
Measure	Whole Study - Observed Residents n=30 Participants Care home (long-stay) residents observed for adverse drug reactions.
Number of Pharmacist Recommendations for Prescription Review Per Resident	3.8 recommended changes / resident Standard Deviation 2.1

SECONDARY outcome

Timeframe: up to 4 weeks

Population: Observed resident/ medicines charts reviewed.

Regimen entered into the BNF drug interactions checker, and number of interactions flagged up were used for this outcome measure.

Outcome measures

Outcome measures
Measure	Whole Study - Observed Residents n=30 Participants Care home (long-stay) residents observed for adverse drug reactions.
Number of Drug Interactions Per Resident	6.1 drug interactions / resident Standard Deviation 5.7

Adverse Events

Observed Residents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

sue jordan

swansea university

Phone: +44 (0) 1792 518541

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place