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Behavioural Intervention

OPTIONS Program for Osteoporosis (OPTIONS Trial)

N/A

Waitlist Available

Led By Denise Orwig, PhD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 65 and over

Be older than 65 years old

Must not have

Not English or Spanish-speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months and twelve months post-snf discharge (two-time points)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to improve recovery and prevent future fractures in older adults who have broken a hip or leg. The researchers will implement a program called OsteoPorotic fracTure preventION System (

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on implementing an integrated regimen of exercise, healthy diet, and medications rather than testing new drugs, side effects are not the primary concern but may include typical risks associated with any new exercise or dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ discharge from a snf within four weeks and at six months and twelve months post-snf discharge (three-time points)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~discharge from a snf within four weeks and at six months and twelve months post-snf discharge (three-time points)

This trial's timeline: 3 weeks for screening, Varies for treatment, and discharge from a snf within four weeks and at six months and twelve months post-snf discharge (three-time points) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-reported function

Patient-reported quality of life

Secondary study objectives

Care Partner Reported Mortality Rate

Number of patients with Falls

Number of patients with Fractures

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OPTIONS interventionExperimental Treatment1 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 CareActive Control1 Intervention

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

0 / 2Eligibility criteria met