None listed
Conditions
Brief summary
This randomised controlled trial will assess a pharmacist led intervention to reduce medicine induced deterioration and adverse reactions. Medicine induced deterioration encompasses the spectrum of side effects that are frequently not recognised as medication related but are misattributed as geriatric syndromes, frailty or “changes due to aging”. The aim of the service is to enable early identification of signs and symptoms of medicine-induced deterioration so that worsening frailty and subsequent adverse events, such as injurious falls, fractures and delirium are prevented. In implementing the service, the pharmacist will use a suite of validated tools to assist in the detection of signs and symptoms of medicine-induced deterioration. The validated tools will encompass assessments to monitor changes in cognition, change in 24-hour movement behavior, including sleep, as well as grip strength. In addition, pharmacists will assess the potential for adverse medicine events via review of the resident care assessment record and through patient or carer reported changes in health since the medicine regimen was changed. The pharmacist service will be compared with usual care. The trial, involving 354 patients will take place in aged-care facilities in South Australia and Tasmania. The expected clinical outcome is a reduction in medication-induced deterioration, as measured by change in frailty score.
Interventions
The ‘intervention’ is a 12-month pharmacist led assessment of signs and symptoms of medicine-induced deterioration and adverse medicine events. The intervention group will receive a sessional pharmacist-led assessment which occurs every 8 weeks.
The service includes assessment for adverse medicine events and medicine-induced deterioration including assessment of cognition (using the Montreal Cognitive Assessment (MoCA)), 24-hour movement behaviour including sleep (Activinsights Bands, Activinsi
The ‘intervention’ is a 12-month pharmacist led assessment of signs and symptoms of medicine-induced deterioration and adverse medicine events. The intervention group will receive a sessional pharmacist-led assessment which occurs every 8 weeks. The service includes assessment for adverse medicine events and medicine-induced deterioration including assessment of cognition (using the Montreal Cognitive Assessment (MoCA)), 24-hour movement behaviour including sleep (Activinsights Bands, Activinsights Ltd, Cambridgeshire, UK fitted for one year), and hand grip strength (dynamometer, Jamar, Illinois, USA). During the visit, the pharmacists will review participant care records to identify any new illnesses or conditions present since the last assessment. The pharmacists will review the care record to identify any adverse events (e.g. falls, delirium events, bowel or urinary changes, weight loss) or any signs or symptoms noted in the care record that could be indicative of adverse events (e.g. changes in nutritional status, pain). The pharmacists will also access the medication chart to identify any medication changes that have occurred since the last visit. The pharmacist service also involves discussions with the participants and care staff to identify any concerns. The pharmacists will compare the results for the 24 hour movement behaviour, MoCA test, grip strength and weight with the most recent previous assessment and with baseline data to identify immediate and cumulative changes in each category. Where medicine-induced deterioration is detected in the intervention-group participants and considered serious, the pharmacists will contact the participants’ GPs to discuss the participants’ condition, fill out a report to the GP including recommended actions and follow-up with the GP and facility staff. The pharmacists will reassess the participant at the next sessional visit to determine if medicine-induced deterioration or adverse events have resolved.
Sponsors
Australian Government Department of Health Pharmacy Trial Program
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Receive services from an eligible aged-care facility; 2) Use four or more medicines at the time of recruitment or on more than one medicine one of which has anticholinergic or sedative properties.
Exclusion criteria
1) Persons with significant existing frailty burden, defined as a score of 0.40 or above using the Frailty Index; 2) Persons with moderate or severe dementia; 3) Persons receiving palliative care; 4) Persons receiving respite care; 5) Persons participating in another research project
Outcome results
None listed