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Nursing home team-care deprescribing study: a stepped-wedge randomised controlled trial protocol.

ABSTRACT: INTRODUCTION:An ageing population has become an urgent concern for Asia in recent times. In nursing homes, polypharmacy has also become a compounding issue. Deprescribing practice is an evidence-based strategy to provide a better outcome in this group of patients; however, its implementation in nursing homes is often challenging, and prospective outcome data on deprescribing practice in the elderly is lacking. Our study assesses the implementation of team-care deprescribing to understand the benefits of this practice in geriatric setting and to explore the factors affecting deprescribing practice. METHODS AND ANALYSIS:This multicentre prospective study consists of a prestudy interview questionnaire, and a preintervention and postintervention study to be conducted in the nursing home setting on residents at least 65 years old and on five or more medications. We will employ a cluster randomised stepped-wedge interventional design, based on a five-step (reviewing, checking, discussion, communication and documentation) team-care deprescribing practice coupled with the use of a deprescribing guide (consisting of Beers and STOPP criteria, as well as drug interaction checking), to assess the health and pharmacoeconomic outcome in nursing homes' practice. Primary outcome measures of the intervention will consist of fall risks using a fall risk assessment tool. Other outcomes assessed include fall rates, pill burden including number of pills per day, number of doses per day and number of medications prescribed. Cost-related measures will include the use of cost-benefit analysis, which is calculated from the medication cost savings from deprescribing. For the prestudy interview questionnaire, findings will be analysed qualitatively using thematic analysis. ETHICS AND DISSEMINATION:This study is approved by the Domain Specific Review Board of National Healthcare Group, Singapore (2016/00422) and Monash University Human Research Ethics Committee (2016-1430-7791). The study findings shall be disseminated in international conferences and peer-reviewed publications. The study is registered with ClinicalTrials.gov (NCT02863341), Pre-results.

SUBMITTER: Kua CH

PROVIDER: S-EPMC5623346 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Nursing home team-care deprescribing study: a stepped-wedge randomised controlled trial protocol.

Kua Chong-Han CH Yeo Cindy Ying Ying CYY Char Cheryl Wai Teng CWT Tan Cheryl Wei Yan CWY Tan Poh Ching PC Mak Vivienne Sl VS Lee Shaun Wen Huey SWH Leong Ian Yi-Onn IY

BMJ open 20170509 5

<h4>Introduction</h4>An ageing population has become an urgent concern for Asia in recent times. In nursing homes, polypharmacy has also become a compounding issue. Deprescribing practice is an evidence-based strategy to provide a better outcome in this group of patients; however, its implementation in nursing homes is often challenging, and prospective outcome data on deprescribing practice in the elderly is lacking. Our study assesses the implementation of team-care deprescribing to understand ...[more]

PMID: 28490560

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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: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:INTRODUCTION:Current guidelines recommend tailored interventions to optimise knee osteoarthritis (OA) management. However, models of care still have a 'one size fits all' approach, which is suboptimal as it ignores patient heterogeneity. This study aims to compare a stepped care strategy with standard care for overweight and obese persons with medial tibiofemoral OA. METHODS AND ANALYSIS:Participants will be randomised into two groups (85 each). The intervention will receive a diet and exercise programme for 18 weeks in the first step of the study. Disease remission will then be assessed using the Patient Acceptable Symptom State (PASS). PASS is defined as the highest level of symptom beyond which patients consider themselves well and takes into account pain intensity, patient's global assessment of disease activity and degree of functional impairment. In the second step, participants in remission will continue with diet and exercise. If remission is not achieved, participants will be assigned in a hierarchical order to cognitive behavioural therapy, knee brace or muscle strengthening for 12 weeks. The intervention will be decided based on their clinical presentation for symptoms of depression and varus malalignment. Participants without depression or varus malalignment will undertake a muscle strengthening programme. The control group will receive educational material related to OA management. Main inclusion criteria are age ?50 years, radiographic medial tibiofemoral OA, body mass index (BMI) ?28?kg/m2, knee pain ?40 (Visual Analogue Scale, 0-100), PASS (0-100) >32 for pain and global assessment, and 31 for functional impairment. Outcomes will be measured at 20-week and 32-week visits. The primary outcome is disease remission at 32 weeks. Other outcomes include functional mobility; patient-reported outcomes; BMI; waist-hip ratio; quadriceps strength; symptoms of depression, anxiety and stress; and knee range of motion. The analysis will be performed according to the intention-to-treat principle. ETHICS AND DISSEMINATION:The local ethics committee approved this protocol (HREC/14/HAWKE/381). Dissemination will occur through presentations at international conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ACTRN12615000227594.

Project description:IntroductionAntimicrobial resistance is a growing global health threat, driven by increasing inappropriate use of antimicrobials. High prevalence of unnecessary use of antimicrobials in residential aged care facilities (RACFs) has driven demand for the development and implementation of antimicrobial stewardship (AMS) programmes. The Stepped-wedge Trial to increase antibiotic Appropriateness in Residential aged care facilities and model Transmission of antimicrobial resistance (START) will implement and evaluate the impact of a nurse-led AMS programme on antimicrobial use in 12 RACFs.Methods and analysisThe START trial will implement and evaluate a nurse-led AMS programme via a stepped-wedge cluster randomised controlled trial design in 12 RACFs over 16 months. The AMS programme will incorporate education, aged care-specific treatment guidelines, documentation forms, and audit and feedback strategies that will target aged care staff, general practitioners, pharmacists, and residents and their families. The intervention will primarily focus on urinary tract infections, lower respiratory tract infections, and skin and soft tissue infections. RACFs will transition from control to intervention phases in random order, two at a time, every 2 months, with a 2-month transition, wash-in period. The primary outcome is the cumulative proportion of residents within each facility prescribed an antibiotic during each month and total days of antibiotic use per 1000 occupied bed days. Secondary outcomes include the number of courses of systemic antimicrobial therapy, antimicrobial appropriateness, antimicrobial resistant organisms, Clostridioides difficile infection, change in antimicrobial susceptibility profiles, hospitalisations and all-cause mortality. Analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationEthics approval has been granted by the Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/591). Research findings will be disseminated through peer-reviewed publications, conferences and summarised reports provided to participating RACFs.Trial registration numberNCT03941509.

Project description:INTRODUCTION:Prevention of overweight and obesity in childhood is a priority because of associated acute and chronic conditions in childhood and later in life, which place significant burden on health systems. Evidence suggests prevention should engage a range of actions and actors and target multiple levels. The Whole of Systems Trial Of Prevention Strategies for childhood obesity (WHO STOPS) will evaluate the outcomes of a novel systems-based intervention that aims to engage whole communities in a locally led multifaceted response. This paper describes the planned economic evaluation of WHO STOPS and examines the methodological challenges for economic evaluation of a complex systems-based intervention. METHODS AND ANALYSIS:Economic evaluation alongside a stepped-wedge cluster randomised controlled trial in regional and rural communities in Victoria, Australia. Cost-effectiveness and cost-utility analyses will provide estimates of the incremental cost (in $A) per body mass index unit saved and quality adjusted life year gained. A Markov cohort model will be employed to estimate healthcare cost savings and benefits over the life course of children. The dollar value of community resources harnessed for the community-led response will be estimated. Probabilistic uncertainty analyses will be undertaken to test sensitivity of results to plausible variations in all trial-based and modelled variables. WHO STOPS will also be assessed against other implementation considerations (such as sustainability and acceptability to communities and other stakeholders). ETHICS AND DISSEMINATION:The trial is registered by the Australian New Zealand Clinical Trials Registry (ACTRN12616000980437). Full ethics clearances have been received for all methods described below: Deakin University's Human Research Ethics Committee 2014-279, Deakin University's Human Ethics Advisory Group-Health (HEAG-H) HEAG-H 194_2014, HEAG-H 17 2015, HEAG-H 155_2014, HEAG-H 197_2016, HEAG-H 118_2017, the Victorian Department of Education and Training 2015_002622 and the Catholic Archdiocese of Ballarat. Trial findings (including economic evaluation) will be published in peer-reviewed journals and presented at international conferences. Collected data and analyses will be made available in accordance with journal policies and study ethics approvals. Results will be presented to relevant government authorities with an interest in cost-effectiveness of these types of interventions. TRIAL REGISTRATION NUMBER:ACTRN12616000980437; Pre-results.

Project description:IntroductionMost potential kidney transplant donors in the UK are aged over 60 years, yet increasing donor age is associated with poorer graft survival and function. Urgent preimplantation kidney biopsy can identify chronic injury, and may aid selection of better 'quality' kidneys from this group. However, the impact of biopsy on transplant numbers remains unproven. The PreImplantation Trial of Histopathology In renal Allografts (PITHIA) study will assess whether the introduction of a national, 24 hours, digital histopathology service increases the number, and improves outcomes, of kidneys transplanted in the UK from older deceased donors.Methods and analysisPITHIA is an open, multicentre, stepped-wedge cluster randomised study, involving all UK adult kidney transplant centres. At 4-monthly intervals, a group of 4-5 randomly selected clusters (transplant centres) will be given access to remote, urgent, digital histopathology (total intervention period, 24 months). The trial has two primary end points: it is powered for an 11% increase in the proportion of primary kidney offers from deceased donors aged over 60 years that are transplanted, and a 6 mL/min increase in the estimated glomerular filtration rate of recipients at 12 months post-transplant. This would equate to an additional 120 kidney transplants performed in the UK annually. Trial outcome data will be collected centrally via the UK Transplant Registry held by NHS Blood and Transplant (NHSBT) and will be analysed using mixed effects models allowing for clustering within centres and adjusting for secular trends. An accompanying economic evaluation will estimate the cost-effectiveness of the service to the National Health Service.Ethics and disseminationThe study has been given favourable ethical opinion by the Cambridge South Research Ethics Committee and is approved by the Health Research Authority. We will present our findings at key transplant meetings, publish results within 4 years of the trial commencing and support volunteers at renal patient groups to disseminate the trial outcome.Trial registration numberISRCTN11708741; Pre-results.

Project description:BackgroundMalawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes.MethodsWe will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model.DiscussionThis study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.Trial registrationClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021.

Project description: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.

Dataset Information

Nursing home team-care deprescribing study: a stepped-wedge randomised controlled trial protocol.

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Nursing home team-care deprescribing study: a stepped-wedge randomised controlled trial protocol.

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