Reducing Medical Admissions into Hospital through Optimising Medicines (REMAIN HOME) Study: protocol for a stepped-wedge, cluster-randomised trial

Abstract

IntroductionA model of general practitioner (GP) and pharmacist collaboration in primary care may be an effective strategy to reduce medication-related problems and provide better support to patients after discharge. The aim of this study is to investigate whether a model of structured pharmacist and GP care reduces hospital readmissions in high-risk patients.Methods and analysisThis protocol details a stepped-wedge, cluster-randomised trial that will recruit participants over 9 months with a 12-month follow-up. There will be 14 clusters each representing a different general practice medical centre. A total of 2240 participants will be recruited from hospital who attend an enrolled medical centre, take five or more long-term medicines or whose reason for admission was related to heart failure or chronic obstructive pulmonary disease.The intervention is a multifaceted service, involving a pharmacist integrated into a medical centre to assist patients after hospitalisation. Participants will meet with the practice pharmacist and their GP after discharge to review and reconcile their medicines and discuss changes made in hospital. The pharmacist will follow-up with the participant and liaise with other health professionals involved in the participant’s care. The control will be usual care, which usually involves a patient self-organising a visit to their GP after hospital discharge.The primary outcome is the rate of unplanned, all-cause hospital readmissions over 12 months, which will be analysed using a mixed effects Poisson regression model with a random effect for cluster and a fixed effect to account for any temporal trend. A cost analysis will be undertaken to compare the healthcare costs associated with the intervention to those of usual care.Ethics and disseminationThe study has received ethical approval (HREC/16/QRBW/410). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders.Trial registration numberACTRN12616001627448

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

“…There will be no pharmacist in the medical centre during the control phase. Medication liaison in the form of a discharge medication record may be provided to patients on discharge from hospital and may be included in the hospital discharge summary to the GP.” 47 …”

“…Example 4 (Transition period) —“A 1-month transition phase is included where the medical centre is not considered as being in control or intervention and does not contribute to analysis. This transition period allows for the time it takes to embed the intervention into a medical centre.” 47 …”

“…This will be done through collection of routine data from the hospital and medical centre. Demographics and reason for admission at enrolment and subsequent admissions in the 12-month follow-up will be collected through participant hospital records…Medical centre records will be used to identify whether a discharge treatment plan was received and the timeliness and number of GP visits during the 12-month follow-up period for each participant.” 47 …”

Effects of the “Living well with COPD” intervention in primary care: a comparative study

“…It is particularly important to develop strategies to reduce the burden of COPD in the early phase; i.e. early diagnosis [10] and collaborative management [11] in primary care. Most previous randomised trials were either hospital-based or enrolled patients with diverse degrees of severity, and considered a wide range of approaches.…”

Looking for a chronic care model in COPD patients

“…Therefore, it seems that the general practice in primary care settings represents a critical field of application for the CCM in order to reduce the impact on chronic respiratory patients in terms of both clinical burden and healthcare utilisation [11], even in the early phase of the disease. A major issue in this setting is thus represented by undiagnosed COPD patients, who would not benefit from the opportunity given by a CCM.…”