Deprescribing anticholinergic and sedative drugs to reduce polypharmacy in frail older adults living in the community: a randomized controlled trial.

BACKGROUND: Polypharmacy is associated with poor outcomes in older adults. Targeted deprescribing of anticholinergic and sedative medications may improve health outcomes for frail older adults. Our pharmacist-led deprescribing intervention was a pragmatic two-arm randomized controlled trial stratified by frailty. We compared usual care (control) with the intervention of pharmacists providing deprescribing recommendations to general practitioners. METHODS: Community-based older adults (≥65 years) from two New Zealand district health boards were recruited following a standardized interRAI needs assessment. The Drug Burden Index (DBI) was used to quantify use of sedative and anticholinergic medications for each participant. The trial was stratified into low, medium, and high frailty. We hypothesized that the intervention would increase the proportion of participants with a reduction in DBI ≥ 0.5 within six months. RESULTS: Of 363 participants, 21 (12.7%) in the control group and 21 (12.2%) in the intervention group had a reduction in DBI ≥ 0.5. The difference in the proportion of -0.4% (95%CI: -7.9% to 7.0%) provided no evidence of efficacy for the intervention. Similarly, there was no evidence to suggest the effectiveness of this intervention for participants of any frailty level. CONCLUSIONS: Our pharmacist-led medication review of frail older participants did not reduce the anticholinergic/sedative load within six months. Covid-19 lockdown measures required modification of the intervention. Subgroup analyses pre- and post-lockdown showed no impact on outcomes. Reviewing this and other deprescribing trials through the lens of implementation science may aid an understanding of the contextual determinants preventing or enabling successful deprescribing implementation strategies.

Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial.

INTRODUCTION: Sleep-time blood pressure correlates more strongly with adverse cardiovascular events than does daytime blood pressure. The BedMed trial evaluates whether bedtime antihypertensive administration, as compared with conventional morning use, reduces major adverse cardiovascular events. METHODS AND ANALYSIS: DesignProspective randomised, open-label, blinded end-point trial.ParticipantsHypertensive primary care patients using blood pressure lowering medication and free from glaucoma.SettingCommunity primary care providers in 5 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba and Ontario) are mailing invitations to their eligible patients. Social media campaigns (Google, Facebook) are additionally running in the same provinces.InterventionConsenting participants are allocated via central randomisation to bedtime vs morning use of all antihypertensives.Follow-up(1) Telephone or email questionnaire at 1 week, 6 weeks, 6 months and every 6 months thereafter, and (2) accessing linked governmental healthcare databases tracking hospital and community medical services.Primary outcomeComposite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure.Secondary outcomesEach primary outcome element on its own, all-cause hospitalisation or emergency department visit, long-term care admission, non-vertebral fracture, new glaucoma diagnosis, 18-month cognitive decline from baseline (via Short Blessed Test).Select other outcomesSelf-reported nocturia burden at 6 weeks and 6 months (no, minor or major burden), 1-year self-reported overall health score (EQ-5D-5L), self-reported falls, total cost of care (acute and community over study duration) and mean sleep-time systolic blood pressure after 6 months (via 24-hour monitor in a subset of 302 sequential participants).Primary outcome analysisCox proportional hazards survival analysis.Sample sizeThe trial will continue until a projected 254 primary outcome events have occurred.Current statusEnrolment ongoing (3227 randomised to date). ETHICS AND DISSEMINATION: BedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02990663.

HOW TO TREAT: COVID-19 in primary care

Other key aspects of monitoring include: * A clinician who knows the patient and has access to their regular health records, evidence-based resources to guide monitoring, and a template for systematic monitoring and recording. * A systematic approach to ensure no one falls through the cracks, and a clinic-wide team approach so all staff understand the system and their roles in it. * Patient access to a pulse oximeter;where risk indicates need;and information for patients on illness course, red flags, safety net systems and self-management strategies. * Understanding of local access to support for basic needs (food, shelter, communication). Monitoring Beyond initial set-up and triage for current red flags, there are four main aspects to monitoring patients with COVID-19 in primary care: risk assessment and determining monitoring frequency;assessment of current symptoms and change from previous;assessment of current vital signs and oxygen saturation, and changes in these from recent;hydration and assessment for red flags indicating the patient should be transferred to hospital for further assessment. If not transferred, such patients should be monitored as high risk: * is socially isolated (lives alone, unable to connect with others through technology, little to no social network) * lacks caregiver support, if needed (including a safe environment for care of children) * is unable to maintain hydration (diarrhoea, vomiting, cognitive impairment, poor fluid intake) * has food or financial insecurity * receives home-care support * has challenges with health literacy or ability to understand treatment recommendations or isolation expectations * is unable to self-manage. Other important goals of monitoring are to reassure patients who do not need hospital-level care and to provide education on illness course, safety net instructions, advice on symptom management and attention to mental health impacts of a positive diagnosis (a positive diagnosis is anxiety-provoking for anyone, and particularly for those who are aware they are at greater risk).