Protocol for a non-randomised pilot and feasibility study evaluating a multicomponent intervention to simplify medication regimens for people receiving community-based home care services

Abstract

IntroductionManaging medication regimens is one of the most complex and burdensome tasks performed by older people, and can be prone to errors. People living with dementia may require medication administration assistance from formal and informal caregivers. Simplified medication regimens maintain the same therapeutic intent, but have less complex instructions and administration schedules. This protocol paper outlines a study to determine the feasibility of a multicomponent intervention to simplify medication regimens for people receiving community-based home care services.Methods and analysisThis is a non-randomised pilot and feasibility study. Research nurses will recruit 50 people receiving community-based home care services. All participants will receive the intervention from a clinical pharmacist, who will undertake medication reconciliation, assess each participant’s capacity to self-manage their medication regimen and apply a structured tool to identify opportunities for medication simplification. The pharmacist will communicate recommendations regarding medication simplification to registered nurses at the community-based home care provider organisation. The primary outcome will be a description of study feasibility (recruitment and retention rates, protocol adherence and stakeholder acceptability). Secondary outcomes include the change in number of medication administration times per day, medication adherence, quality of life, participant satisfaction, medication incidents, falls and healthcare utilisation at 4 months.Ethics and disseminationEthical approval was obtained from the Monash University Human Research Ethics Committee and the community-based home care provider organisation’s ethical review panel. Research findings will be disseminated to consumers and caregivers, health professionals, researchers and healthcare providers through the National Health and Medical Research Council Cognitive Decline Partnership Centre and through conference presentations, lay summaries and peer-reviewed publications. This study will enable an improved understanding of medication management and administration among people receiving community-based home care services. This study will inform the decision to proceed with a randomised controlled trial to assess the effect of this intervention.Trial registration numberACTRN12618001130257; Pre-results.

<p>Simplifying Medication Regimens for People Receiving Community-Based Home Care Services: Outcomes of a Non-Randomized Pilot and Feasibility Study</p>

“…The study was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001130257) and the protocol was published. 24 Participants were older recipients of home care services delivered through government-funded packages that subsidize providers to deliver services that meet an individual's care needs. 25,26 The home care services included Commonwealth Home Support Programme services or Home Care Packages.…”

“…The full list of primary and secondary study objectives are outlined in the published study protocol. 24…”

The Role of Pharmacists in Home Health Care: A Study Set in a Regional Hospital in Taipei City

“…Therefore, it is crucial to single out these variables for discussion and include them in relevant databases in the future. In addition to the assessments on patients' medication-related problems and instructions and recommendations for self-care, a Japanese study 23 mentioned that an increasing number of pharmacists have expressed their desire to acquire the skills for conducting physical assessments. This would grant them a more thorough understanding of a patient's condition, this would lead to new insights for home care pharmacists in the future.…”

Protocol for a non-randomised feasibility study evaluating a codesigned patient safety guide in primary care

“…A purposeful sample of around six practice staff covering different staff groups will be interviewed to seek feedback about the workshop and the acceptability of the patient safety guide, its functionality, format and design, as well as to understand the facilitators and barriers to using the PSG-PC in everyday practice. 37 Participants will be given the information sheet at least 24 hours before the interviews and will provide written consent to take part before the interview begins. Any questions about participation will be answered by the research team at any time.…”

“…36 As this is a feasibility study, a formal sample size calculation is not required. 37 We will aim to recruit 120 patients across both phases (to complete questionnaires and 30 patients sampled within this for interviews). Sixteen healthcare professionals across phase 1 and phase 2 will be recruited for interviews.…”