An interventional study of Deprescribing Care Model and Bone Health Service Model in Accidental Falls/Prevention and Control and Osteoporosis, sponsored by Duke University. Enrolling by invitation at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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:
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.
After hospitalization for fracture, approximately 60% of older adults receive post-acute care in Skilled Nursing Facilities (SNFs), but fewer than 20% of these individuals receive medication optimization, which is evidence-based care known to prevent additional injurious falls, fractures, and mortality. Therefore, there is an opportunity to substantially improve care and patient outcomes in this setting. The purpose of this study is to determine the comparative efficacy of a Deprescribing Care Model designed to deprescribe fall related medications (FRIDs), a Bone Heath Service Model designed to provide osteoporosis evaluation and management, or an Injury Prevention Service Model offering both services. 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. 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.
Our Specific aims are to:
Study Design: In the Comparative Effectiveness Aim (Aim 1), we will conduct a pragmatic, cluster randomized crossover trial in 42 SNFs comparing the effectiveness of a Bone Health Service Model, a Deprescribing Care Model, or an Injury Prevention Service Model, all delivered remotely by a post-fracture nurse consultant supported by an interprofessional team. Every SNF will receive 6 months of each care model in random sequence. Follow-up for delivery of the care models will begin on the date that the first eligible patient from the facility is included in the study. All patients with osteoporotic (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. One primary post-fracture nurse consultant will be assigned to each facility for the life of the study. To prevent contamination between models, the nurse consultant will double check the care model assigned before every patient/proxy encounter. Medication utilization (measured using EHR data) will be assessed at discharge and 90 days after SNF admission date, and Patient Reported Outcomes (PROs) (measured via survey) will be assessed at 90 days after SNF admission date, regardless of whether they have discharged home or remain in the SNF. We will therefore be able to compare the effectiveness of the models on important PROs, osteoporosis treatment rates, and FRID medication burden. Patients will be followed for injurious falls and fractures using administrative data and self-report during post-fracture nurse consultant calls until the end of the study period (up to 3 years, mean 2 years) censoring at death.
In the Overall Effectiveness Aim, we will compare rates of injurious falls and fractures for patients treated with the Deprescribing Care Model, Bone Health Service Model, or Injury Prevention Service Model to patients treated in 168 matched concurrent control SNFs, identified through the Long Term Care Data Cooperative. No new data will be collected for this aim.
In the Implementation Evaluation Aim, we will identify facility characteristics associated with high levels of intervention implementation. This aim will require the collection of surveys from facility leadership.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 3,780 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
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.
Other: 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.
Other: Bone Health 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.
Other: Injury Prevention Service Model
The Deprescribing Care Model is designed to deprescribe fall related medications (FRIDs)
The Bone Health Service Model is designed to provide osteoporosis evaluation and management
The Injury Prevention Service Model provides both the Deprescribing Care Model and the Bone Health Service Model.
Injurious falls
Composite outcome of unique claims for emergency department, urgent care, or hospital visit for injurious fall or any fracture during follow-up (up to 3 years) (ICD 10 codes); to ensure complete ascertainment for participants with Medicare Advantage, researchers will also collect via self-report/proxy report at telephone calls 1, 3, 6, 12, 18 months, and 24 months following discharge from the SNF.
Time frame: Up to 3 years
Number of patients who initiate treatment for osteoporosis
Osteoporosis treatment (process outcome)
Time frame: 1 day of discharge from SNF and one year
Medication Possession Ratio during follow-up, as measured by EHR and Medicare claims
Osteoporosis treatment adherence (process outcome)
Time frame: Up to 3 years
Number of patients who had deprescribing ordered
Fall-risk increasing drug (FRID) use (process outcome)
Time frame: 1 day of discharge from SNF and 90 days after SNF admission date
Modified Drug Burden Index during follow-up, as measured by EHR and Medicare claims
Fall-risk increasing drug (FRID) use (process outcome)
Time frame: Up to 3 years
Patient medication side effect burden, measured via Living with Medicines Questionnaire (LMQ3).
The LMQ3 is a validated self-report questionnaire. Medication side effect burden is measured via composite scores ranging from: No burden at all (41-73); Minimal burden (74-106); Moderate burden (107-139); High burden (140-172); and Extremely high burden (173-205), as well as a visual analog scale with scores ranging from: no burden at all (0.0- 2.0); minimal burden (2.1 -4.0); moderate (4.1-5.9); high burden (6.0-7.9); extremely high burden (8.0-10.0).
Time frame: 90 days after SNF admission date
Patient falls self-efficacy (i.e. fear of falling), measured via Falls Efficacy Scale
The Falls Efficacy Scale is a validated self-report questionnaire. Scores range from 10-100. A total score of greater than 70 indicates that the person has a fear of falling.
Time frame: 90 days after SNF admission date
Patient pain, measured via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form
The Pain Interference Short Form is a validated self-report questionnaire. Each item on the measure is rated on a 5-point scale (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; and 5=very much) with a range in score from 6 to 30 with higher scores indicating a greater degree of pain interference.
Time frame: 90 days after SNF admission date
Patient depression, measured via Patient Health Questionnaire survey (PHQ-8)
The PHQ-8 is a validated questionnaire for assessing the severity of depression symptoms.The score for each item is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of: not at all, several days, more than half the days, and nearly every day, respectively. Total score for the 8 items ranges from 0 to 24. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Time frame: 90 days after SNF admission date
Patient anxiety, measured via PROMIS anxiety short form survey
The PROMIS anxiety short form survey is a validated self-report questionnaire. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.
Time frame: 90 days after SNF admission date
Patient sleep, measured via PROMIS sleep disturbance short form
The PROMIS sleep disturbance short form is a validated self-report questionnaire. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time frame: 90 days after SNF admission date
Plan to share: No
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