Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications

Conditions

• Accidental Falls/Prevention and Control
• Osteoporosis

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Deprescribing Care Model — OTHER
  The Deprescribing Care Model is designed to deprescribe fall related medications (FRIDs)
• Bone Health Service Model — OTHER
  The Bone Health Service Model is designed to provide osteoporosis evaluation and management
• Injury Prevention Service Model — OTHER
  The Injury Prevention Service Model provides both the Deprescribing Care Model and the Bone Health Service Model.

Study Details

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.

Key Dates

Start date

Sep 30, 2024

Status verified

Jan 2026

Primary completion

Jul 1, 2028

Completion

Jul 1, 2028

Study Design

Enrollment

3,780 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Arms

• Active Comparator: Deprescribing Care Model
  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.
• Active Comparator: Bone Heath Service Model
  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.
• Active Comparator: Injury Prevention Service Model
  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.

Primary Outcome Measure

Injurious falls [ Time Frame: Up to 3 years ]

Locations (2)

Find similar trials in Boston, MA

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