Clinical trial NCT06731608: OsteoPorotic FracTure PreventION System (OPTIONS) Research Study
Official title: Effectiveness of an Multi-Modal Intervention for Transitions of Care After Lower Limb Fracture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoporosis
Lower Limb Fracture
Keywords: Osteoporosis
Lower Limb Fracture
Post-fracture Care
Fracture Prevention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
name: Hebrew SeniorLife
name: University of Florida
name: Patient-Centered Outcomes Research Institute
First posted: 2024-12-12
Enrollment: 1553
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A matched-pair cluster randomized controlled trial (RCT) design
Primary purpose: PREVENTION

Brief summary: Osteoporosis is a disease that weakens bones so the bones may break easily. The risk for osteoporosis increases with age in both women and men. Osteoporosis affects 10 million older adults in the US. Osteoporosis is a common cause of broken bones in the hips and legs. Broken bones can lead to disability, nursing home placement, and death. Because of the dire consequences, a broken hip or leg is one of the most dreaded injuries for older adults. Many studies confirm that a simple regimen of exercise, healthy diet and bone-strengthening medications can improve overall recovery after a broken hip or leg. This regimen can prevent a person from becoming disabled, having future fractures, and even prevent death.

Many older adults have surgery in a hospital after breaking a hip or leg. Then older adults go to a skilled nursing facility (SNF) for rehabilitation. Care in SNFs varies greatly. Some patients do not receive the regimen that the investigators know is most beneficial to improve bone health and recovery. Even patients who get exercise, healthy diet, and bone-strengthening medication in the SNF, may not continue with the regimen once patients go home. Therefore, the investigators want to implement and test OsteoPorotic fracTure preventION System (OPTIONS). OPTIONS is a program that will integrate the regimen into the care that is provided in SNFs and after discharge to the community. OPTONS will provide information about exercise, diet, and bone-strengthening medication. OPTIONS will provide doctors, clinical staff, patients, and care partners with the information these stakeholders need to carry out the best-practice regimen.

The investigators are partnering with PointClickCare, a large cloud-based healthcare software provider, with SNFs and community care sites across the US. The investigators will include 32 SNFs from different US areas. The investigators will flip a coin to assign SNFs to the intervention (OPTIONS) or the control arm (enhanced usual care) of the study. Enhanced usual care is the care that is typically provided in SNFs after a fracture and adding information about a publicly available fall prevention toolkit. The investigators are using an "implementation science" approach that requires the investigators to get input from the OPTIONS study's vast stakeholder community throughout the study. The OPTIONS study's stakeholders include patients, care partners, clinicians, and professional organizations.

The research question is, can using OPTIONS in SNFs and in the community after discharge improve physical function and quality of life in older people in the year after a hip or leg fracture? The investigators are measuring patient-reported outcomes. The investigators will include 1553 patients across the 32 facilities. The investigators have selected outcomes that are important to patients. Specifically, the investigators are measuring patient-reported function and quality of life. The investigators are also measuring patient-reported falls and fractures. The investigators will track the number of patients who die during the study. This study's hypothesis is that patients who receive OPTIONS will report better physical function (i.e., can walk and take better care of themselves) than those who receive enhanced usual care. The investigators also hypothesize that patients that receive OPTIONS will report a better quality of life than those who receive enhanced usual care.

This study will provide sound data about the effectiveness of OPTIONS. OPTIONS could then be spread to other SNFs and community-based programs. This would ensure that all older people receive the right care after a hip or leg fracture.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 65 and over
* Admitted to a participating SNF
* Expected to be discharged back to the community

Exclusion Criteria:

* Not English or Spanish-speaking
* Do not have access to a working phone
* In hospice care or terminal condition (not expected to live at least 4 months)
* Severe cognitive impairment (Minimum Data Set 3.0 Cognitive Function Scale (MDS-COGS) score \> 5: 0, 1 represents cognitively intact-mild impairment, 2, 3, 4 represents mild-moderate impairment, 5, 6, 7, 8 represents moderate-severe impairment)

Primary outcomes:
measure: Patient-reported function
timeFrame: Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)
measure: Patient-reported quality of life
timeFrame: Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)
Secondary outcomes:
measure: Number of patients with Falls
timeFrame: Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)
measure: Patient Reported Falls Efficacy
timeFrame: Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)
measure: Number of patients with Fractures
timeFrame: Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)
measure: Care Partner Reported Mortality Rate
timeFrame: Six months and twelve months post-SNF discharge (two-time points)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore, Department of Epidemiology and Public Health, Division of Gerontology
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: University of Maryland, Baltimore
name: Denise Orwig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Patricia Dykes, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: