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Background: Anticholinergic burden (ACB) from medications has been associated with adverse outcomes in older adults. Aim: The aim was to conduct a non-randomized feasibility study of an intervention to reduce the anticholinergic burden in older patients (REGENERATE) to inform a subsequent definitive trial. Methods: The development and evaluation of an ACB reduction intervention was guided by the Medical Research Council framework. Findings from preliminary studies, two systematic reviews, and two qualitative studies informed the design of a mixed-method feasibility study. The study was conducted in one UK primary care site. The clinical pharmacist identified and invited potentially eligible patients, reviewed their medications, and made recommendations to reduce the ACB as needed. Patients completed surveys at baseline and 6 and 12 weeks post-intervention. A purposive sample of patients and healthcare professionals was interviewed.
The overall aim was to conduct a feasibility study of an intervention to reduce anticholinergic burden in patients, aged 65 years and over, delivered in primary and secondary care, to inform a future definitive randomised controlled trial
The primary care pharmacist undertook a refresher training session that provided information on the unwanted effects of ACB drugs, the ACoB scale and tools to support deprescribing, information on alternative drugs with lower ACB sores, and the study processes. This was delivered through video-recorded talks, which could be watched at a time convenient to the pharmacist. The pharmacist, who had full access to the medical record, including the diagnosis and medication history, reviewed the medication of each participating patient prior to agreeing on a time and date for a telephone consultation, during which the pharmacist discussed the need to deprescribe or switch a drug to reduce the ACB. The study pharmacist was an experienced, qualified independent prescriber. In line with the study protocol, they assessed the ACoB score, deprescribed and/or switched the drugs to an alternative, implemented the agreed change, updated the patient's medical record, and completed a pharmaceutical care plan (PCP). The patient was advised about any new medications that they had been prescribed and informed about potential side effects. No second consultation with the pharmacist or GP was routinely scheduled. Patients were asked to contact their pharmacist/clinician/GP if they had any subsequent changes in symptoms or were experiencing any unwanted side effects. The GP and the study team were then notified of any symptoms or medication changes by the pharmacist, who also updated the PCP. Patients were advised that in an emergency, they could contact the chief investigator (P.K.M.), a medical consultant in care of the elderly.
Primary care pharmacist
Inclusion Criteria - Patients who were: aged 65 years and over; able to provide informed consent; on one or more long-term drugs (prescribed for a minimum of 6 weeks) with ACB potential (Anticholinergic Cognitive Burden scale ≥3). Exclusion Criteria - Patients who: were without capacity to provide informed consent; had severe mental illness (such as diagnosis of severe anxiety, severe depression, severe dementia etc.); were terminally ill (life expectancy less than 6 months); in opinion of responsible clinician were not suitable; were taking part to another similar study
Pharmaceutical care plans; acceptability of intervention; Quality of life; medication changes; anticholinergic burden changes; adverse events. Qualitative interviews with patients were also undertaken to explore experiences of the intervention.
There was a response of 16/20; 14/16 attended the pharmacist-led consultation and completed the baseline questionnaire, and 13/14 completed both follow-up questionnaires. The sustainability of deprescribing was confirmed. The results suggest the potential of the intervention to reduce side effects from medications and improve quality of life (EQ-5D-5L). The interviews showed patients were happy with the study processes and the medication changes and were satisfied with the pharmacist's consultation.
The study showed a high response and retention rate, which might be due to good communication and a positive relationship between the primary care pharmacist and their patients, including the prior telephone conversation with the pharmacist before sending the invitation packs. Only one primary care pharmacist delivered the intervention in a single primary care setting, which was a strength as it could be assumed that the intervention was delivered consistently but also a limitation. Fidelity to the intervention was supported by training and a detailed standard operating procedure, although without observation, fidelity cannot be assumed.
Limitations were that findings from one pharmacist at one site might not be representative of the wider primary care pharmacist population, and likewise, the small sample size limited the generalizability. Virtual conduct of the interviews using the telephone meant that non-verbal communication from patients could not be included. A potential solution to this is the use of other platforms such as MS TEAMS or Zoom meetings to conduct the patient interviews if face-to-face interviews are not possible. Further, the interview with the doctor had to be replaced by a free text survey, which provided less rich information than an interactive interview. Another source of bias in our study sample was the exclusion of patients with severe mental illness.
Qualitative interviews with patients were also undertaken to explore experiences of the intervention.