Pharmacist-led intervention for older people with atrial fibrillation in long-term care (PIVOTALL study): a randomised pilot and feasibility study

Abstract

Background: Older care home residents are a vulnerable group of people with atrial fibrillation (AF) at high risk of adverse health events. The Atrial Fibrillation Better Care (ABC: Avoid stroke; Better symptom management; Cardiovascular and other comorbidity management) pathway is the gold-standard approach toward integrated AF care, and pharmacists are a potential resource with regards to its' implementation. The aim of this study was to determine the feasibility of pharmacist-led medicines optimisation in care home residents, based on the ABC pathway compared to usual care.

Methods: Individually randomised, prospective pilot and feasibility study of older (aged ≥ 65 years) care home residents with AF (ISRCTN14747952); residents randomised to ABC pathway optimised care versus usual care. The primary outcome was a description of study feasibility (resident and care home recruitment and retention). Secondary outcomes included the number and type of pharmacist medication recommendations and general practitioner (GP) implementation.

Results: Twenty-one residents were recruited and 11 (mean age [standard deviation] 85.0 [6.5] years, 63.6% female) were randomised to receive pharmacist-led medicines optimisation. Only 3/11 residents were adherent to all three components of the ABC pathway. Adherence was higher to 'A' (9/11 residents) and 'B' (9/11 residents) components compared to 'C' (3/11 residents). Four ABC-specific medicines recommendations were made for three residents, and two were implemented by residents' GPs. Overall ABC adherence rates did not change after pharmacist medication review, but adherence to 'A' increased (from 9/11 to 10/11 residents). Other ABC recommendations were inappropriate given residents' co-morbidities and risk of medication-related adverse effects.

Conclusions: The ABC pathway as a framework was feasible to implement for pharmacist medication review, but most residents' medications were already optimised. Low rates of adherence to guideline-recommended therapy were a result of active decisions not to treat after assessment of the net risk-benefit.

Keywords: Atrial fibrillation; Care homes; Feasibility study; Integrated care; Medication optimisation; Older people; Pharmacists.

Fig. 1

Flow diagram of care home recruitment. ^ainitial introduction to care home facilitated by Mersey Care NHS Foundation Trust medicines management pharmacists (n = 7), consultant geriatrician (n = 7), community matron (n = 3), general practice-based physician associate (n = 1), general practitioner (n = 1), care home manager of participating care home (n = 3). ^ball care homes that did not respond were contacted at least once more

Fig. 2

Flow diagram of participant recruitment. EMIS; Egton Medical Information Systems; LPA, Lasting Power of Attorney. ^aLPA for Health and Welfare. ^bdetails of study unknown

Fig. 3

Completion rate of resident self-report researcher-administered questionnaires and researcher-administered assessments at baseline and six months. AFEQT, Atrial Fibrillation Effect on Quality of Life; 6-CIT, 6-item Cognitive Impairment Test; EFS-AC, Edmonton Frail Scale – Acute Care; EQ-5D-5L, EuroQol-5-Dimensions-5-Levels questionnaire; mEHRA, modified European Heart Rhythm Association; VAS, visual analogue scale

Fig. 4

Adherence to the Atrial Fibrillation Better Care pathway and pharmacist recommendations in the event of non-adherence. AF, atrial fibrillation; ACEI, angiotensin converting enzyme inhibitor; AKI, acute kidney injury; BB, beta-blocker; BP, blood pressure; EHRA, European Heart Rhythm Association; ESRD, end stage renal disease; GI, gastrointestinal; HbA1c, glycated haemoglobin; HFpEF, heart failure with preserved ejection fraction (≥ 50%); HFrEF, heart failure with reduced ejection fraction (< 40%); HR, heart rate; LFTs, liver function tests; NOAC, non-vitamin K antagonist oral anticoagulant; OAC, oral anticoagulant; TTR, time in therapeutic range; VKA, vitamin K antagonist

Fig. 5

Number and type of all pharmacist medicines recommendations and implementation rates at six month follow-up. HbA1c, glycated haemoglobin; IR, immediate release; MR, modified release; NOAC, non-vitamin K antagonist oral anticoagulant; VKA, vitamin K antagonist. *two ABC-specific recommendations for one resident to (1) review diltiazem and bisoprolol in a resident with heart failure and then (2) review antihypertensive medications accordingly (readings > 140/85 mmHg), two non-ABC specific recommendations to rationalise bendroflumethiazide/perindopril in a resident with hypotension, and rationalise linagliptin in a diabetic resident with a HbA1c of 42 mmol/mol. **one ABC-specific recommendation to repeat HbA1c in a resident with documented history of type 2 diabetes but no record of blood glucose levels, HbA1c or prescription of antidiabetic medicines, one non-ABC specific recommendation to repeat HbA1c in a resident with type 2 diabetes who had gliclazide stopped with no repeat HbA1c. ***ABC-specific recommendation for a resident on warfarin with time in therapeutic range < 70%