Project description:ObjectivesThe Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Our aim was to describe procedures that were implemented to optimize participant retention; report retention yields by age, sex, clinical site, and follow-up time; provide reasons for study withdrawals; and highlight the successes and lessons learned from the STRIDE retention efforts.DesignPragmatic cluster randomized trial.SettingA total of 86 primary care practices within 10 US healthcare systems.ParticipantsA total of 5451 community-living persons, 70 years of age or older, at high risk for serious fall injuries.MeasurementsStudy outcomes were collected every 4 months by a central call center. Reconsent was required to extend follow-up beyond the originally planned 36 months.ResultsOver a median follow-up of 3.2 years (interquartile range = 2.8-3.7 y), 439 (8.1%) participants died and 600 (11.0%) withdrew their consent or did not reconsent to extend follow-up beyond 36 months, yielding rates (per 100 person-years) of deaths and withdrawals of 2.6 and 3.6, respectively. The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site. The most common reasons for withdrawal were illness and unable to contact for reconsent at 36 months. Completion of the follow-up interviews was greater than 93% at each time point. Most participants completed all (71.8%) or all but one (9.2%) of the follow-up interviews. The most common reason for not completing a follow-up interview was unable to contact, with rates ranging from 2.8% at 40 months to 4.6% at 20 months.ConclusionCompletion of the thrice-yearly follow-up interviews in STRIDE was high, and retention of participants over 44 months exceeded the original projections. The procedures used in STRIDE, together with lessons learned, should assist other investigators who are planning or conducting large pragmatic trials of vulnerable older persons. J Am Geriatr Soc 68:1242-1249, 2020.

Project description:ObjectivesTo examine whether primary care outreach facilitation improves the quality of care for general practice patients from refugee backgrounds.DesignPragmatic, cluster randomised controlled trial, with stepped wedge allocation to early or late intervention groups.Setting, participants31 general practices in three metropolitan areas of Sydney and Melbourne with high levels of refugee resettlement, November 2017 - August 2019.InterventionTrained facilitators made three visits to practices over six months, using structured action plans to help practice teams optimise routines of refugee care.Major outcome measureChange in proportion of patients from refugee backgrounds with documented health assessments (Medicare billing). Secondary outcomes were refugee status recording, interpreter use, and clinician-perceived difficulty in referring patients to appropriate dental, social, settlement, and mental health services.ResultsOur sample comprised 14 633 patients. The intervention was associated with an increase in the proportion of patients with Medicare-billed health assessments during the preceding six months, from 19.1% (95% CI, 18.6-19.5%) to 27.3% (95% CI, 26.7-27.9%; odds ratio, 1.88; 95% CI, 1.42-2.50). The impact of the intervention was greater in smaller practices, practices with larger proportions of patients from refugee backgrounds, recent training in refugee health care, or higher baseline provision of health assessments for such patients. There was no impact on refugee status recording, interpreter use increased modestly, and reported difficulties in refugee-specific referrals to social, settlement and dental services were reduced.ConclusionsLow intensity practice facilitation may improve some aspects of primary care for people from refugee backgrounds. Facilitators employed by local health services could support integrated approaches to enhancing the quality of primary care for this vulnerable population.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618001970235 (retrospective).

Project description:BackgroundAustralia is one of many nations struggling with the challenges of delivering quality primary health care (PHC) to increasing numbers of refugees. The OPTIMISE project represents a collaboration between 12 organisations to generate a model of integrated refugee PHC suitable for uptake throughout Australia. This paper describes the methodology of one component; an outreach practice facilitation intervention, directed towards improving the quality of PHC received by refugees in Australian general practices.MethodsOur mixed methods study will use a cluster stepped wedge randomised controlled trial design set in 3 urban regions of high refugee resettlement in Australia. The intervention was build upon regional partnerships of policy advisors, clinicians, academics and health service managers. Following a regional needs assessment, the partnerships reached consensus on four core areas for intervention in general practice (GP): recording of refugee status; using interpreters; conducting comprehensive health assessments; and referring to refugee specialised services. Refugee health staff trained in outreach practice facilitation techniques will work with GP clinics to modify practice routines relating to the four core areas. 36 general practice clinics with no prior involvement in a refugee health focused practice facilitation will be randomly allocated into early and late intervention groups. The primary outcome will be changes in number of claims for Medical Benefit Service reimbursed comprehensive health assessments among patients identified as being from a refugee background. Changes in practice performance for this and 3 secondary outcomes will be evaluated using multilevel mixed effects models. Baseline data collection will comprise (i) pre-intervention provider survey; (ii) two surveys documenting each practices' structure and approaches to delivery of care to refugees. De-identified medical record data will be collected at baseline, at the end of the intervention and 6 and 12 months following completion.DiscussionOPTIMISE will test whether a regionally oriented practice facilitation initiative can improve the quality of PHC delivered to refugees. Findings have the potential to influence policy and practice in broader primary care settings.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618001970235 , 05/12/2018, Retrospectively registered. Protocol Version 1, 21/08/2017.

Project description:BACKGROUND: Summary measures of health that combine mortality and morbidity into a single indicator are being estimated in the Canadian context for approximately 200 diseases and conditions. To manage the large amount of data and calculations for this many diseases, we have developed a structured workbook system with easy to use tools. We expect this system will be attractive to researchers from other countries or regions of Canada who are interested in estimating the health-adjusted life years (HALYs) lost to premature mortality and year-equivalents lost to reduced functioning, as well as population attributable fractions (PAFs) associated with risk factors. This paper describes the workbook system using cancers as an example, and includes the entire system as a free, downloadable package. METHODS: The workbook system was developed in Excel and runs on a personal computer. It is a database system that stores data on population structure, mortality, incidence, distributions of cases entering a multitude of health states, durations of time spent in health states, preference scores that weight for severity, life table estimates of life expectancies, and risk factor prevalence and relative risks. The tools are Excel files with embedded macro programs. The main tool generates workbooks that estimate HALY, one per disease, by copying data from the database into a pre-defined template. Other tools summarize the HALY results across diseases for easy analysis. RESULTS: The downloadable zip file contains the database files initialized with Canadian data for cancers, the tools, templates and workbooks that estimate PAF and a user guide. The workbooks that estimate HALY are generated from the system at a rate of approximately one minute per disease. The resulting workbooks are self-contained and can be used directly to explore the details of a particular disease. Results can be discounted at different rates through simple parameter modification. CONCLUSION: The structured workbook approach offers researchers an efficient, easy to use, and easy to understand set of tools for estimating HALY and PAF summary measures for their country or region of interest.

Project description:BackgroundConservative surgery followed by breast and nodal irradiation is the standard loco-regional early breast cancer (BC) treatment for patients with four or more involved lymph nodes. However, the treatment strategy when fewer nodes are involved remains unclear, especially when lymphadenectomy has not been performed. Sensitive nodal status assessment molecular techniques as the One-Step Nucleic Acid Amplification (OSNA) assay can contribute to the definition and standardization of the treatment strategy. Therefore, the OPTIMAL study aims to demonstrate the feasibility of incidental irradiation of axillary nodes in patients with early-stage BC and limited involvement of the SLN.MethodsBC patients who underwent conservative surgery and whose SLN total tumour load assessed with OSNA ranged between 250-15,000 copies/µL will be eligible. Patients will be randomized to receive irradiation on the breast, tumour bed, axillary and supraclavicular lymph node areas (intentional arm) or only on the breast and tumour bed (incidental arm). All areas, including the internal mammary chain, will be contoured. The mean, median, D5% and D95% doses received in all volumes will be calculated. The primary endpoint is the non-inferiority of the incidental irradiation of axillary nodes compared to the intentional irradiation in terms of 5-year disease free survival. Secondary endpoints comprise the comparison of acute and chronic toxicity and loco-regional and distant disease recurrence rates.DiscussionStandardizing the treatment and diagnosis of BC patients with few nodes affected is crucial due to the lack of consensus. Hence, the quantitative score for the metastatic burden of SLN provided by OSNA can contribute by improving the discrimination of which BC patients with limited nodal involvement can benefit from incidental radiation as an adjuvant treatment strategy.Trial registrationClinicalTrial.gov, NCT02335957; https://clinicaltrials.gov/ct2/show/NCT02335957.

Project description:IntroductionLong COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, presents major threats to individual and public health across countries, affecting over 1.5 million people in the UK alone. Evidence-based interventions are urgently required and an integrated care pathway approach in pragmatic trials, which include investigations, treatments and rehabilitation for LC, could provide scalable and generalisable solutions at pace.Methods and analysisThis is a pragmatic, multi-centre, cluster-randomised clinical trial of two components of an integrated care pathway (Coverscan™, a multi-organ MRI, and Living with COVID Recovery™, a digitally enabled rehabilitation platform) with a nested, Phase III, open label, platform randomised drug trial in individuals with LC. Cluster randomisation is at level of primary care networks so that integrated care pathway interventions are delivered as "standard of care" in that area. The drug trial randomisation is at individual level and initial arms are rivaroxaban, colchicine, famotidine/loratadine, compared with no drugs, with potential to add in further drug arms. The trial is being carried out in 6-10 LC clinics in the UK and is evaluating the effectiveness of a pathway of care for adults with LC in reducing fatigue and other physical, psychological and functional outcomes at 3 months. The trial also includes an economic evaluation which will be described separately.Ethics and disseminationThe protocol was reviewed by South Central-Berkshire Research Ethics Committee (reference: 21/SC/0416). All participating sites obtained local approvals prior to recruitment. Coverscan™ has UK certification (UKCA 752965). All participants will provide written consent to take part in the trial. The first participant was recruited in July 2022 and interim/final results will be disseminated in 2023, in a plan co-developed with public and patient representatives. The results will be presented at national and international conferences, published in peer reviewed medical journals, and shared via media (mainstream and social) and patient support organisations.Trial registration numberISRCTN10665760.

Dataset Information

The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization.

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