Why are we doing this study?

Many older adults, like you, have a leg or hip fracture that is often due to weakening of the bones or osteoporosis. 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. The study is being conducted in 32 skilled nursing facilities across the US and half the facilities (16) focused on fall prevention [STEADI OPTIONS group] and the other half (16) focused on strengthening bones [OPTIONS Study group]. 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 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 does your participation in the study involve?

We are asking you to take part in the OPTIONS (OsteoPorotic fracTure preventION System) Research Study led by Dr. Patricia Dykes at Brigham and Women’s Hospital (BWH) and Dr. Denise Orwig at the University of Maryland School of Medicine.  

Your decision to participate in this study is voluntary. You have the right to choose not to take part in this study or to withdraw from the study at any time.

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 health, how you take care of yourself and how you do daily tasks lasting 45 minutes per call (the initial call within 4 weeks of SNF discharge and again at 6 and 12 months later).

The research staff will compare your medical records with Medicare information to confirm if you've had an injury from a fall or other event that affects your healthcare needs during the year after leaving the skilled nursing facility.

Payment to Participants

You will receive up to $50 in gift cards for your time.

• $25 e-gift card after completing the initial assessment
• $25 e-gift card after completing the 12-month assessment

Who is sponsoring this research?

This research is being sponsored by the Patient-Centered Outcomes Research Institute (PCORI), a non-profit organization that funds research to help patients and their caregivers make informed health decisions.

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?

Although there are no highly sensitive questions, you might feel embarrassed about answering questions about your health and feelings. However, you can refuse to answer certain questions, or you may decide to stop the interview at any time.

There are small risks that your personal information and/or privacy could be breached.  To minimize these 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 and your name will not be used.  Electronic data will be protected with a password, and access will be restricted to study investigators and staff.  All research staff and investigators receive training on how to protect participants' privacy and confidentiality.  

Privacy:

The information you share with us is private. The law requires us to protect the privacy of any health or other information obtained for research. During this study, we will only share information with researchers conducting the study. We share your health information only when we must, for example for quality control and public health purposes. We require anyone who receives your information from us to protect your privacy.

If you would like more information about our privacy policy, I can provide you with more in writing or online.

[For privacy questions, contact the UMSOM Privacy Official (410-706-0337) about your rights and protections under privacy rules.]

What are the alternatives to participation?

You do not have to participate in this research study. Whether or not you decide to take part in this study will not affect your healthcare nor will your decision harm your relationship with your doctors.

How can I contact someone for more information?

Please feel free to contact us with any questions, comments, or concerns. If you do not wish to participate and do not want us to contact you in the future, please let us know. You can contact us

• by phone (Dr. Denise Orwig at 410-706-8951 or by cell phone after 5:00 pm EST or on weekends at 410-456-0442)
• email (dorwig@som.umaryland.edu) or
• postal mail (OPTIONS Study, Dr. Denise Orwig, Department of Epidemiology and Public Health, Division of Gerontology, 660 West Redwood Street, Suite 200, Baltimore, MD 21201)

The Mass General Brigham Institutional Review Board (IRB) and the University of Maryland Institutional Review Board (IRB) have reviewed and approved this study and the way we will collect information.

If you would like to speak to someone not involved in this research about your rights as a research subject, or any concerns or complaints you may have about the research, contact the Mass General Brigham IRB at (857) 282-1900.