Category
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Primary study
Registry of Trials»ANZCTR
Year
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2018
INTERVENTION: The ‘intervention’ is a 12‐month pharmacist led assessment of signs and symptoms of medicine‐induced deterioration and adverse medicine events. The assessment will occur subsequent to a change in the person’s medicine regimen, with persons eligible for a maximum of one assessment per month. In implementing the service, the pharmacist will use a suite of validated tools (Montreal Cognitive Assessment MoCA, activity tracker and dynamometer) 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. The validated tools will be administered by the pharmacists with each resident required to complete the tools only where there is a change in the medication regime. 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. A risk matrix will be developed specifically for this study. The risk matrix will be employed to assist pharmacists to determine the likelihood that medicine‐induced deterioration is present and whether the deterioration is likely to lead to harm. Medicine‐induced deterioration will be defined using the minimum clinically significant difference known for the validated tool. Where changes are greater than 20% (relative) above the minimum clinically significant difference, the potential for harms will be considered high. Where medicine‐induced deterioration is present and there is high risk of harm, a case conference with the resident's general practitioner will be scheduled. Where warranted, a medicine action plan will be developed and subsequently implemented by the pharmacist. The medicine action plan will include plans to continue, withhold, cease or change the medicine to another medicine with similar mechanism of action but with reduced risk of harm. Where the medicine action plan results in changes to the medication regimen, the pharmacist will reassess the resident to determine if medicine induced deterioration or adverse events have resolved. Since each participant is eligible for a maximum of one pharmacist service per month, and assessment would occur only subsequent to change in medicine, we anticipate that participants will be assessed a maximum of 12 times. This is based on the assumptions that: ‐ A participant has 6 medicine change per year which results in high risk of harm; ‐ All six action plans results in changes in medication regime, therefore requiring reassessment of the participant. To ensure adherence and fidelity to the trial, a study coordinator will oversee the scheduled monthly pharmacist service. CONDITION: Polypharmacy PRIMARY OUTCOME: Change in frailty level as assessed using the frailty index 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. SECONDARY OUTCOME: Change in 24 hour movement behaviour (light, moderate and vigorous intensity activity) as measured using GENEActiv activity tracker Change in 24 hour movement behaviour (sleep time) as measured using GENEActiv activity tracker Change in 24 hour movement behaviour (total activity time) as measured using GENEActiv activity tracker Change in cognitive function as measures using the Montreal Cognitive Assessment (MoCA) Change in percentage of robust, pre‐frail and frail individuals as measured using the frailty phenotype. The frailty phenotype comprises five criteria: unintentional weight loss, low grip strength, self‐rated exhaustion, low walking time and low physical activity. In the frailty phenotype, individuals are classified as frail if they meet three or more of the five criteria, and pre‐fail if they have one or two attributes. Individuals who meet none of the criteria are classified as robust. Change in quality of life as measured using EQ‐5D Change in weight as measured using a digital scale Changes in health resource use will be collected from resident care record. Data will be collected on intervention‐associated resource use (pharmacist, doctor, nursing and care staff time, changes in medication and non‐medication management) and resource use associated with any adverse events. Grip strength (dynamometer) Rate of adverse medicine events (such as falls, fractures, delirium, faecal impaction) via a review of the Resident Care Assessment Record
Epistemonikos ID: 069838510a17c36341d47b05811a470bb939da22
First added on: Aug 25, 2024