OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608 | Recruiting DMC

• 2 other identifiers: 2024P002736OFP-2021C3-24922
• Study Type: interventional
• Target: 1,344
• Locations: 1 country
• Sites: 2

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.

Conditions

Lower Limb Fracture; Osteoporosis

Keywords

Osteoporosis; Lower Limb Fracture; Post-fracture Care; Fracture Prevention

Outcome Measures

Primary Outcomes (2)

• Patient-reported function

  Daily Activity Scale of the Activity Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (Low Function): The AM-PAC measures a patient's functional ability to perform daily activities, with higher scores indicating greater independence (raw scores range from 6 to 24).

  Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)

• Patient-reported quality of life

  Euroqol-5-Dimension Questionnaire-3-Level (EQ-5D-3L): The EQ-5D-3L measures health-related quality of life (Mobility, Self-care, Usual activities, Pain or discomfort, and Anxiety or depression). The best possible health state is represented by score of 1, and the worst possible health state is less than 0.

  Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)

Secondary Outcomes (7)

• Number of patients with Falls

  Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)

• Patient Reported Falls Efficacy

  Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)

• Number of patients with Fractures

  Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)

• Care Partner Reported Mortality Rate

  Six months and twelve months post-SNF discharge (two-time points)

• Function-Mobility

  Discharge from a SNF within four weeks and at six months and twelve months post-SNF discharge (three-time points)

Study Arms (2)

OPTIONS intervention

EXPERIMENTAL

OPTIONS is a multimodal intervention approach that includes providing clinical decision support (CDS) for healthcare providers, patients, and their caregivers focused on exercise, nutrition, and bone-enhancing medications using CDS in SNFs that use the same electronic health record system (PointClickCare).

Behavioral: OPTIONS

Enhanced Usual Care

ACTIVE COMPARATOR

Enhanced usual care includes access to the STEADI (Stopping Elderly Accidents, Deaths, and Injuries) toolkit, a fall prevention program from the CDC.

Behavioral: Enhanced usual care

Interventions

OPTIONS BEHAVIORAL

OPTIONS is a multimodal intervention approach that includes providing clinical decision support (CDS) for healthcare providers, patients, and their caregivers focused on exercise, nutrition, and bone-enhancing medications using CDS in SNFs that use the same electronic health record system (PointClickCare).

OPTIONS intervention

Enhanced usual care BEHAVIORAL

Enhanced usual care includes access to the STEADI (Stopping Elderly Accidents, Deaths, and Injuries) toolkit, a fall prevention program from the CDC.

Enhanced Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years old
• Community-dwelling at the time of fracture
• Admission to a participating SNF for rehabilitation following a lower limb fragility fracture, including pelvic fractures
• Expected discharge to the community (home or assisted living)

You may not qualify if:

• Not English or Spanish speaker
• Admission Brief Interview for Mental Status (BIMS) score 0-7
• SNF length of stay \< 7 days
• Regular access to a working telephone or other communication device
• Receiving hospice or end-of-life care

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Maryland, Baltimore: collaborator
• Hebrew SeniorLife: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• University of Arkansas: collaborator
• Emory University: collaborator

Study Sites (2)

University of Maryland, Baltimore, Department of Epidemiology and Public Health, Division of Gerontology

Baltimore, Maryland, 21201, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Denise Orwig, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Patricia Dykes, RN, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Dykes, RN, PhD

CONTACT

617-850-5748; pdykes@bwh.harvard.edu

Kumiko Schnock, RN,PhD

CONTACT

617-525-6651; kschnock@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The OsteoPorotic fracTure preventION System (OPTIONS) intervention is a facility-level initiative for Skilled Nursing Facilities (SNFs) and 21 SNF sites will receive the OPTIONS intervention, while 21 SNF sites will serve as a comparator group, receiving enhanced usual care with the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) Toolkit.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Model Details: A matched-pair cluster randomized controlled trial (RCT) design

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 12, 2024
• Study Start: January 16, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)