There are 10 million older adults (65+) with osteoporosis in the United States of America contributing to over 2 million fragility fractures annually that result in disability, nursing home placement, and mortality. Older adults with lower limb fractures receive acute care and surgery in hospital and are discharged within 3-5 days to a skilled nursing facility (SNF) for rehabilitation where care is highly heterogenous. Length of stay in SNF can be 3-12 weeks and offers the ideal setting for initiating evidence-based interventions across the clinical care team and allowing for targeted education for the patient and family. The investigators propose to introduce OsteoPorotic fracTure preventION System (OPTIONS), an integrated multi-modal intervention, with clinical decision support (CDS), for providers, patients, and care partners, to improve uptake of tailored exercise, healthy nutrition, and bone-enhancing medications. The investigators focus on those who were community-dwelling at the time of fracture entering SNFs for rehabilitation and their transitions back to the community. CDS is needed to quickly and easily guide clinicians to the most effective strategies for an individual patient and engage patients and their caregivers in decision-making to ensure that the evidence-based interventions are routinely implemented and sustained in clinical practice within the SNF and across transitions in the community.
The investigators will partner with PointClickCare, a large cloud-based healthcare software provider and with SNFs across the United States to conduct a matched pair cluster randomized controlled trial (SNF as unit of randomization) across 32 SNFs. The purpose of this project is to determine the effectiveness of OPTIONS to improve function and quality of life by increasing uptake and adherence of 3 evidence-based clinical interventions: functional exercises, nutrition, and bone-enhancing medications. The investigators will compare outcomes from 776 older patients with access to OPTIONS in 16 SNFs versus enhanced usual care (n=776 patients in 16 SNFs) in the year after lower limb fracture across transitions of care from SNF to community-based care. The OPTIONS intervention and implementation will be informed by the OPTIONS study's stakeholder community which consists of patients, caregivers, professional and para-professional providers, and professional organizations.
It is critical to use both effectiveness and implementation science aims to maximize rigor in testing OPTIONS' effectiveness and in developing and testing the implementation protocol to produce a widely reproducible product. To ensure successful implementation in a large number of complex care environments (SNF/Community), the investigators will first use the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) implementation science framework to develop an OPTIONS implementation toolkit during a pilot implementation phase using semi-structured interviews with key stakeholders (SNF staff, patients, and care partners). Based on this qualitative feedback, the investigators will refine the implementation protocol and toolkit for conducting the cluster randomized trial. The investigators will also use RE-AIM to refine the OPTIONS implementation toolkit at the end of the trial with additional qualitative interviews to facilitate widespread dissemination of the OPTIONS intervention.
The study's specific aims are:
Outcome Aim: Evaluate the effectiveness of OPTIONS versus enhanced usual care for improving function and quality of life (primary outcomes) by increasing uptake and adherence of 3 evidence-based clinical interventions: functional exercise, nutrition, and bone-enhancing medications, across SNF and community care transitions in the first year after lower limb fracture. Secondary and tertiary outcomes include self-reported falls and fractures, mortality (secondary outcomes); measures of adherence to the trimodal interventions in the year after lower limb fracture, and primary care follow-up rates after discharge from SNF (tertiary outcomes).
Implementation Aim: Evaluate the effectiveness of the OPTIONS implementation process and adherence during SNF and community care transitions, during the pilot phase and at trial completion, using content analysis of qualitative data from key stakeholders. The investigators will produce an implementation toolkit to facilitate spread beyond project sites that will include tools to address the following: 1) Process evaluation including implementation progress and identification of processes that worked well or need adjustment. 2) Readiness for Implementation checklist. 3) Classification of adoption success using a rating system that will allow future sites to redress ongoing issues after the initial implementation period.
This study will provide reliable evidence about the effectiveness of OPTIONS that could be widely disseminated to other SNFs providing rehabilitative care and community-based programs to ensure that tailored prevention recommendations and prescriptions are evidence-based and consistent with patients' needs and preferences.
