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

ABSTRACT: INTRODUCTION:A 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 ANALYSIS:This 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 DISSEMINATION:The 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 NUMBER:ACTRN12616001627448.

SUBMITTER: Foot H

PROVIDER: S-EPMC5719661 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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

Foot Holly H Freeman Christopher C Hemming Karla K Scott Ian I Coombes Ian D ID Williams Ian D ID Connelly Luke L Whitty Jennifer A JA Sturman Nancy N Kirsa Sue S Nicholson Caroline C Russell Grant G Kirkpatrick Carl C Cottrell Neil N

BMJ open 20170413 4

<h4>Introduction</h4>A 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.<h4>Methods and analysis</h4>This protocol details a stepped-wedge, cluster-randomised trial that will recruit participants over ...[more]

PMID: 28408545

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Project description:BackgroundSkilled nursing facility (SNF) patients and their caregivers who transition to home experience complications and frequently return to acute care. We tested the efficacy of the Connect-Home transitional care intervention on patient and caregiver preparedness for care at home, and other patient and caregiver-reported outcomes.MethodsWe used a stepped wedge, cluster-randomized trial design to test the intervention against standard discharge planning (control). The setting was six SNFs and six home health offices in one agency. Participants were 327 dyads of patients discharged from SNF to home and their caregivers; 11.1% of dyads in the control condition and 81.2% in the intervention condition were enrolled after onset of COVID-19. Patients were 63.9% female and mean age was 76.5 years. Caregivers were 73.7% female and mean age was 59.5 years. The Connect-Home intervention includes tools, training, and technical assistance to deliver transitional care in SNFs and patients' homes. Primary outcomes measured at 7 days included patient and caregiver measures of preparedness for care at home, the Care Transitions Measure-15 (patient) and the Preparedness for Caregiving Scale (caregiver). Secondary outcomes measured at 30 and 60 days included the McGill Quality of Life Questionnaire, Life Space Assessment, Zarit Caregiver Burden Scale, Distress Thermometer, and self-reported number of patient days in the ED or hospital in 30 and 60 days following SNF discharge.ResultsThe intervention was not associated with improvement in patient or caregiver outcomes in the planned analyses. Post-hoc analyses that distinguished between pre- and post-pandemic effects suggest the intervention may be associated with increased patient preparedness for discharge and decreased number of acute care days.ConclusionsConnect-Home transitional care did not improve outcomes in the planned statistical analysis. Post-hoc findings accounting for COVID-19 impact suggest SNF transitional care has potential to increase patient preparedness and decrease return to acute care.

Project description:BackgroundContinuity of care, in particular personal continuity, is a core principle of general practice and is associated with many benefits such as a better patient-provider relationship and lower mortality. However, personal continuity is under pressure due to changes in society and healthcare. This affects older patients more than younger patients. As the number of older patients will double the coming decades, an intervention to optimise personal continuity for this group is highly warranted.MethodsFollowing the UK Medical Research Council framework for complex Interventions, we will develop and evaluate an intervention to optimise personal continuity for older patients in general practice. In phase 0, we will perform a literature study to provide the theoretical basis for the intervention. In phase I we will define the components of the intervention by performing surveys and focus groups among patients, general practitioners, practice assistants and practice nurses, concluded by a Delphi study among members of our group. In phase II, we will test and finalise the intervention with input from a pilot study in two general practices. In phase III, we will perform a stepped wedge cluster randomised pragmatic trial. The primary outcome measure is continuity of care from the patients' perspective, measured by the Nijmegen Continuity Questionnaire. Secondary outcome measures are level of implementation, barriers and facilitators for implementation, acceptability and feasibility of the intervention. In phase IV, we will establish the conditions for large-scale implementation.DiscussionThis is the first study to investigate an intervention for improving personal continuity for older patients in general practice. If proven effective, our intervention will enable General practitioners to improve the quality of care for their increasing population of older patients. The pragmatic design of the study will enable evaluation in real-life conditions, facilitating future implementation.Trial registration numberNetherlands Trial Register, trial NL8132 . Registered 2 November 2019.

Project description:BackgroundPeople with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines' monitoring.DesignPragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines' monitoring versus usual care.SettingFive UK private sector care homes.Participants41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine.InterventionNurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step.OutcomesProblems addressed and changes in medicines prescribed.Data collection and analysisInformation was collected from participants' notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site.ResultsFive of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57-4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78-8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80-235.90] and 5.12 [1.45-18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15-17.22).ConclusionThe WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse effects of prescribed medicines.Trial registrationISRCTN 48133332.

Project description:BackgroundSkilled nursing facility (SNF) patients are medically complex with multiple, advanced chronic conditions. They are dependent on caregivers and have experienced recent acute illnesses. Among SNF patients, the rate of mortality or acute care use is over 50% within 90 days of discharge, yet these patients and their caregivers often do not receive the quality of transitional care that prepares them to manage serious illnesses at home.MethodsThe study will test the efficacy of Connect-Home, a successfully piloted transitional care intervention targeting seriously ill SNF patients discharged to home and their caregivers. The study setting will be SNFs in North Carolina, USA, and, following discharge, in patients' home. Using a stepped wedge cluster randomized trial design, six SNFs will transition at randomly assigned intervals from standard discharge planning to the Connect-Home intervention. The SNFs will contribute data for patients (N = 360) and their caregivers (N = 360), during both the standard discharge planning and Connect-Home time periods. Connect-Home is a two-step intervention: (a) SNF staff create an individualized Transition Plan of Care to manage the patient's illness at home; and (b) a Connect-Home Activation RN visits the patient's home to implement the written Transition Plan of Care. A key feature of the trial includes training of the SNF and Home Care Agency staff to complete the transition plan rather than using study interventionists. The primary outcomes will be patient preparedness for discharge and caregiver preparedness for caregiving role. With the proposed sample and using a two-sided test at the 5% significance level, we have 80% power to detect a 18% increase in the patient's preparedness for discharge score. We will employ linear mixed models to compare observations between intervention and usual care periods to assess primary outcomes. Secondary outcomes include (a) patients' quality of life, functional status, and days of acute care use and (b) caregivers' burden and distress.DiscussionStudy results will determine the efficacy of an intervention using existing clinical staff to (a) improve transitional care for seriously ill SNF patients and their caregivers, (b) prevent avoidable days of acute care use in a population with persistent risks from chronic conditions, and (c) advance the science of transitional care within end-of-life and palliative care trajectories of SNF patients and their caregivers. While this study protocol was being implemented, the COVID-19 pandemic occurred and this protocol was revised to mitigate COVID-related risks of patients, their caregivers, SNF staff, and the study team. Thus, this paper includes additional material describing these modifications.Trial registrationClinicalTrials.gov NCT03810534 . Registered on January 18, 2019.

Project description:BackgroundUnplanned nursing home (NH) transfers are burdensome for residents and costly for health systems. Innovative nurse-led models of care focusing on improving in-house geriatric expertise are needed to decrease unplanned transfers. The aim was to test the clinical effectiveness of a comprehensive, contextually adapted geriatric nurse-led model of care (INTERCARE) in reducing unplanned transfers from NHs to hospitals.MethodsA multicenter nonrandomized stepped-wedge design within a hybrid type-2 effectiveness-implementation study was implemented in 11 NHs in German-speaking Switzerland. The first NH enrolled in June 2018 and the last in November 2019. The study lasted 18 months, with a baseline period of 3 months for each NH. Inclusion criteria were 60 or more long-term care beds and 0.8 or more hospitalizations per 1'000 resident care days. Nine hundred and forty two long-term NH residents were included between June 2018 and January 2020 with informed consent. Short-term residents were excluded. The primary outcome was unplanned hospitalizations. A fully anonymized dataset of overall transfers of all NH residents served as validation. Analysis was performed with segmented mixed regression modeling.ResultsThree hundred and three unplanned and 64 planned hospitalizations occurred. During the baseline period, unplanned transfers increased over time (β1 = 0.52), after which the trend significantly changed by a similar but opposite amount (β2 = -0.52; p = 0.0001), resulting in a flattening of the average transfer rate throughout the postimplementation period (β1 + β2 ≈ 0). Controlling for age, gender, and cognitive performance did not affect these trends. The validation set showed a similar flattening trend.ConclusionA complex intervention with six evidence-based components demonstrated effectiveness in significantly reducing unplanned transfers of NH residents to hospitals. INTERCARE's success was driven by registered nurses in expanded roles and the use of tools for clinical decision-making.

Project description:BACKGROUND:Cluster randomised trials with unequal sized clusters often have lower precision than with clusters of equal size. To allow for this, sample sizes are inflated by a modified version of the design effect for clustering. These inflation factors are valid under the assumption that randomisation is stratified by cluster size. We investigate the impact of unequal cluster size when that constraint is relaxed, with particular focus on the stepped-wedge cluster randomised trial, where this is more difficult to achieve. METHODS:Assuming a multi-level mixed effect model with exchangeable correlation structure for a cross-sectional design, we use simulation methods to compare the precision for a trial with clusters of unequal size to a trial with clusters of equal size (relative efficiency). For a range of scenarios we illustrate the impact of various design features (the cluster-mean correlation - a function of the intracluster correlation and the cluster size, the number of clusters, number of randomisation sequences) on the average and distribution of the relative efficiency. RESULTS:Simulations confirm that the average reduction in precision, due to varying cluster sizes, is smaller in a stepped-wedge trial compared to the parallel trial. However, the variance of the distribution of the relative efficiency is large; and is larger under the stepped-wedge design compared to the parallel design. This can result in large variations in actual power, depending on the allocation of clusters to sequences. Designs with larger variations in cluster sizes, smaller number of clusters and studies with smaller cluster-mean correlations (smaller cluster sizes or smaller intra-cluster correlation) are particularly at risk. CONCLUSION:The actual realised power in a stepped-wedge trial might be substantially higher or lower than that estimated. This is particularly important when there are a small number of clusters or the variability in cluster sizes is large. Constraining the randomisation on cluster size, where feasible, might mitigate this effect.

Project description:BackgroundDenmark has inferior cancer survival rates compared with many European countries. The main reason for this is suggested to be late diagnosis at advanced cancer stages. Cancer diagnostic work-up begins in general practice in 85% of all cancer cases. Thus, general practitioners (GPs) play a key role in the diagnostic process. The latest Danish Cancer Plan included continuing medical education (CME) on early cancer diagnosis in general practice to improve early diagnosis. This dual aims of this protocol are, first, to describe the conceptualisation, operationalisation and implementation of the CME and, second, to describe the study design and outcomes chosen to evaluate the effects of the CME.Methods/designThe intervention is a CME in early cancer diagnosis targeting individual GPs. It was developed by a step-wise approach. Barriers for early cancer diagnosis at GP level were identified systematically and analysed using the behaviour system involving capability, opportunity and motivation described by Michie et al. The study will be designed as a geographical cluster randomised stepped wedge study. The study population counts 836 GPs from 417 general practices in the Central Denmark Region, geographically divided into eight clusters. GPs from each cluster will be invited to a CME meeting at a certain date three weeks apart. The primary outcomes will be primary care interval and GP referral rate on cancer suspicion. Data will be obtained from national registries, GP-completed forms on patients referred to cancer fast-track pathways and GP-completed online questionnaires before and after the intervention.DiscussionTo our knowledge, this will be the first study to measure the effect of a theory-based CME in early cancer diagnosis at three levels: GP knowledge and attitude, GP activity and patient outcomes. The achieved knowledge will contribute to the understanding of whether and how general practice's ability to perform cancer diagnosis may be improved.Trial registrationRegistered as NCT02069470 on ClinicalTrials.gov.

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

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

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