Injury Prevention Care Models for Osteoporosis
(PRISM Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byCathleen S Colon-Emeric, MD, MHS

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone. The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders. The main questions this study aims to answer are: * Which of the three models is more effective in preventing falls with fractures? * What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling. * What are the differences in osteoporosis treatment and medication burden? The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services. 42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team. This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol.

Eligibility Criteria

This trial is for individuals aged 65 or older who are in skilled nursing facilities (SNFs) after being hospitalized for a fracture. It aims to prevent further injuries by optimizing medications and care.

Inclusion Criteria

I was admitted to a skilled nursing facility after a hospital stay for a fracture.

I am 65 years old or older.

Participant Groups

The study compares three care models: Deprescribing Care Model (reducing fall-related meds), Bone Health Service Model (osteoporosis management), and Injury Prevention Service Model (combines both). The effectiveness of preventing falls with fractures is measured.

3Treatment groups

Active Control

Group I: Injury Prevention Service ModelActive Control1 Intervention

In this pragmatic, cluster randomized crossover trial 42 Skilled Nursing Facilities (SNF) will each receive 6 months of each care model in random sequence. All patients with OP fracture admitted to the SNF within the intervention time period will receive the full designated care model, even if their stay in the SNF extends into the next intervention period.

Group II: Deprescribing Care ModelActive Control1 Intervention

Group III: Bone Heath Service ModelActive Control1 Intervention