Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications

Summary

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.

Conditions

• Accidental Falls/Prevention and Control
• Osteoporosis

Interventions

OTHER

Deprescribing Care Model

The Deprescribing Care Model is designed to deprescribe fall related medications (FRIDs)

OTHER

Bone Health Service Model

The Bone Health Service Model is designed to provide osteoporosis evaluation and management

OTHER

Injury Prevention Service Model

The Injury Prevention Service Model provides both the Deprescribing Care Model and the Bone Health Service Model.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Hebrew SeniorLife

  collaborator OTHER

• Brown University

  collaborator OTHER

• The American Health Care Association

  collaborator UNKNOWN

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Cathleen S Colon-Emeric, MD, MHS · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-30

Primary Completion

2028-07-01

Completion

2028-07-01

Countries

• United States

Study Locations