Study Title: OPTIONS (OsteoPorotic fracTure preventION System) Study: Effectiveness of a multi-modal intervention for transitions of care after lower limb fracture
Principal Investigators (PIs):
Patricia Dykes, PhD, MA, RN, Brigham and Women’s Hospital, Boston MA
Denise Orwig, PhD, University of Maryland School of Medicine, Baltimore, MD
Why
Why are we doing this study?
Many older adults have a leg or hip fracture like you that is often due to weakening of the bones or osteoporosis. We want to hear how people are doing after being discharged from a skilled nursing facility. This will help us to find ways to improve the ability to do daily activities and quality of life in older people in the year after a hip or leg fracture. We want to see if two different care plans offered in the skilled nursing facility improve the ability to do daily activities and quality of life in older people in the year after a hip or leg fracture. There are 32 skilled nursing facilities across the US and half the facilities (16) focused on fall prevention [STEADI group] and the other half (16) focused on strengthening bones [OPTIONS group]. The skilled nursing facilities were matched in pairs and each facility was randomly assigned (like flipping a coin) to one of the two groups. This study will provide useful knowledge for skilled nursing facilities providing rehabilitative care and community-based programs to help improve recovery after a hip or leg fracture.
Who
Who is included in this study?
This study will include 1553 people who had a hip or leg fracture and received rehabilitation in a skilled nursing facility.
What
What does the study involve?
All study activities will take place remotely which means that there will be no in-person contact with the study team and contact will be by telephone or other communication devices, if available.
Participation involves 3 telephone calls answering questions about your recovery lasting 45 minutes (the initial call within 4 weeks of SNF discharge and again at 6 and 12 months).
Benefits and Risks
What are the benefits?
There are no direct benefits to you for participating in this research project. This study may help improve recovery for other older adults who experience a hip or leg fracture.
What are the risks?
There is a small risk that the confidentiality regarding your personal information may be breached from research data. There is also a small risk that your privacy may be breached. To minimize these two risks, all information provided during the study will be treated as strictly confidential. All personal information will be kept private. When you enroll in the study, you will be assigned a unique research number. All information about you will be filed under the research number. Electronic data will be password-protected, and access will be restricted to investigators and study staff. All research staff receive training on how to protect participants’ privacy and personal information.
Sponsor
Who is sponsoring this research?
This research is being sponsored by the Patient-Centered Outcomes Research Institute (PCORI).