Pharmacist-led Intervention for AF in Long-Term Care (PIVOTALL) Study Conducted in Liverpool and Sefton Council
The PIVOTALL study, also known as the Pharmacist-led Intervention for AF in Long-Term Care study, was a pilot and feasibility study conducted in care homes in Liverpool and Sefton, UK. The study aimed to assess the feasibility of a pharmacist-led intervention for residents with atrial fibrillation (AF) and to gather data on various outcomes.
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The study design followed a single-blinded, individually randomised approach, consistent with the consensus-agreed conceptual framework proposed for defining pilot and feasibility studies. It adhered to the Consolidated Standards of Reporting Trials (CONSORT) statement extension for pilot and feasibility studies. Ethical approval was obtained from Health and Care Research Wales and the Health Research Authority, and the study was registered with the International Standard Randomised Controlled Trial Number Registry.
Participants in the study were older residents (aged 65 years and above) of care homes with a diagnosis of AF. Exclusions included those receiving end-of-life care, non-English speakers, individuals with aphasia, and short-stay care home residents. Participants without capacity were eligible for inclusion if they had a Lasting Power of Attorney for Health and Welfare who could consent on their behalf.
Care homes registered with the Care Quality Commission in Liverpool and Sefton were approached to participate in the study. Recruitment was facilitated by a consultant geriatrician or medicines management pharmacists. General practices providing medical support to the care homes were also involved in the recruitment process.
Residents were randomised into two groups: the intervention group and the usual care group. The intervention group received a pharmacist-led medication review based on the ABC pathway framework for AF management. Adherence to the pathway was assessed before and after the medication review. Medication recommendations were made to the residents’ GPs for implementation.
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The primary outcome of the study was the feasibility of the intervention, including recruitment and retention rates, completion rates of questionnaires and assessments, and GP implementation of medication recommendations. Secondary outcomes included health events such as strokes, bleeding, mortality, hospital admissions, and falls.
Data collection took place at baseline and at six months follow-up. Various assessments and questionnaires were administered to gather information on quality of life, frailty, cognitive function, AF symptoms, stroke and bleeding risk, and dependency in activities of daily living.
The PIVOTALL study aimed to provide valuable insights into the feasibility of a pharmacist-led intervention for AF in long-term care settings. The findings will contribute to the development of future interventions and improve the management of AF in this population..
