OPTIONS Program for Osteoporosis

(OPTIONS Trial)

Recruiting at 1 trial location

Overseen By Patricia Dykes, RN, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Non-English/Spanish, No phone, Hospice, Severe cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3-12 weeks

1553 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on adding a regimen of exercise, healthy diet, and bone-strengthening medications.

How does the OPTIONS treatment for osteoporosis differ from other treatments?

The OPTIONS treatment for osteoporosis is unique because it focuses on preventing fractures by engaging patients and clinicians in shared decision-making, which is different from traditional methods that primarily rely on bone density measurements and medication. This approach emphasizes personalized care and considers individual risk factors, potentially leading to more effective prevention strategies. ^{1 2 3 4 5}

What data supports the effectiveness of the OPTIONS treatment for osteoporosis?

The research highlights that osteoporosis management has improved with new technologies and treatments, including decision support tools that help identify patients at high risk of fractures. Effective prevention and treatment strategies involve lifestyle changes, adequate calcium and vitamin D intake, and medications like bisphosphonates and denosumab, which are part of current osteoporosis management practices. ^{1 6 7 8 9}

Who Is on the Research Team?

Denise Orwig, PhD

Principal Investigator

University of Maryland, Baltimore

Patricia Dykes, RN, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for older adults who have osteoporosis and have suffered a broken hip or leg. It aims to improve their recovery by testing a program called OPTIONS, which integrates exercise, diet, and bone-strengthening medication into post-fracture care in skilled nursing facilities (SNFs) and after discharge.

Inclusion Criteria

Admitted to a participating SNF

Expected to be discharged back to the community

I am 65 years old or older.

Exclusion Criteria

Do not have access to a working phone

Not in hospice care or no terminal condition (not expected to live at least 4 months)

No 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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the OPTIONS intervention or enhanced usual care in SNFs for rehabilitation

3-12 weeks

In-person visits at SNFs

Follow-up

Participants are monitored for safety and effectiveness after discharge from SNF

12 months

Follow-up assessments at discharge, 6 months, and 12 months post-SNF discharge

Implementation

Implementation of the OPTIONS intervention toolkit and evaluation of adherence during SNF and community care transitions

Pilot phase and trial completion

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced usual care
• OsteoPorotic FracTure PreventION System (OPTIONS)

Trial Overview The study compares the effectiveness of the OPTIONS program with enhanced usual care in SNFs. Enhanced usual care includes standard post-fracture treatment plus information on fall prevention. The goal is to see if OPTIONS can improve physical function and quality of life after discharge.

How Is the Trial Designed?

Group I: OPTIONS intervention Experimental Treatment 1 Intervention

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).

Group II: Enhanced Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Hebrew SeniorLife

Collaborator

Trials

52

Recruited

273,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Preventing osteoporosis-related fractures, especially hip fractures, is crucial as they significantly reduce quality of life and have a high mortality rate, particularly in older adults, with a 51% mortality rate within a year for nonagenarians after a hip fracture.

Effective prevention strategies should start in childhood to build peak bone mass and promote a healthy lifestyle, while also addressing modifiable risk factors like falls, to reduce the increasing prevalence of osteoporotic fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors and prevention of osteoporosis-related fractures. Dontas, IA., Yiannakopoulos, CK.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Endocrine Conditions in Older Adults: Osteoporosis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Osteoporosis update: effective prevention and treatment. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Development and validation of an osteoporosis treatment questionnaire (OSTREQ) evaluating physicians' criteria in the choice of treatment. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of treatment strategies and thresholds for optimizing fracture prevention in Canada: a simulation analysis. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Can we prevent fractures? [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

Strategies for prevention and treatment of osteoporosis at the primary, secondary, and tertiary level in Leuven, Belgium. [2005]

8. United States pubmed.ncbi.nlm.nih.gov

Decreasing the incidence of osteoporosis-related injuries through diet and exercise. [2018]

9. Greece pubmed.ncbi.nlm.nih.gov

Risk factors and prevention of osteoporosis-related fractures. [2022]