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Accidental Falls/Prevention and ControlPRISMNCT06304428

Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications

A study testing Deprescribing Care Model, Bone Health Service Model and Injury Prevention Service Model in people with Accidental Falls/Prevention and Control and Osteoporosis, run by Duke University at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Deprescribing Care Model, Bone Health Service Model and Injury Prevention Service Model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,780 participants
Where
2 sitesUnited States
Study dates
30 Sep 2024to 1 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Aged 65 years or greater
  • Admitted to an enrolled SNF after hospitalized fracture
  • Completion of a medication optimization plan

Who cannot join

  • Non-osteoporotic fracture (e.g. facial, digital, skull, at site of tumor or infection)
  • Eligible for Hospice or palliative care
  • Patient discharged or died prior to completion of a medication optimization plan

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites
  • Marcus Institute for Aging Research, Hebrew SeniorLife

    Boston, Massachusetts, 02131

  • Duke University School of Medicine

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Read more

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.

Read the detailed description

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:

  1. Conduct a randomized cluster crossover trial in fracture patients comparing the effectiveness of the Deprescribing Care Model, Bone Health Service Model, or Injury Prevention Service Model in 42 SNFs, with each SNF receiving 6 months of each intervention in random sequence. We will test for clinically important differences in patient-centered outcomes (living with medicines survey, PHQ-8 depression scale, anxiety, sleep, and pain scales) at 90 days and implementation measures osteoporosis prescriptions, drug burden) at the time of discharge.
  2. Compare the effectiveness of the Deprescribing Care Model, Bone Health Service Model, or Injury Prevention Service Model on subsequent injurious fall and fractures for patients treated within the 42 randomized SNFs with those in 168 matched concurrent control SNFs. We will use data from the National Institute on Aging-funded Long-Term Care Data Cooperative which includes Minimum Data Set (MDS), Electronic Health Record (EHR), and Medicare (CMS) claims. To address decisional dilemmas, we will examine differences in efficacy by baseline estimated life expectancy and cognitive status.
  3. Identify SNF characteristics associated with measures of effective model implementation. We hypothesize that organizational factors captured by SNF staff responses to surveys capturing organizational readiness for change will explain additional variance in implementation measures beyond factors known to be associated with care quality (staff turnover rates, for profit-status, region, case mix, and proportion of patients from racial and ethnic minority groups).

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.

Being tested
Deprescribing Care Model, Bone Health Service Model, Injury Prevention Service Model
Keywords
Osteoporosis, Deprescribing, Falls, Skilled Nursing Facilities
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deprescribing Care ModelOther

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

  • Bone Health Service ModelOther

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

  • Injury Prevention Service ModelOther

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

Study groups in NCT06304428
Study groupRoleWhat they receive
Deprescribing Care ModelActive comparatorIn 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.
Receives: Other: Deprescribing Care Model
Bone Heath Service ModelActive comparatorIn 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.
Receives: Other: Bone Health Service Model
Injury Prevention Service ModelActive comparatorIn 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.
Receives: Other: Injury Prevention Service Model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 years

Secondary outcomes (10)
  1. Number of patients who initiate treatment for osteoporosis

    Osteoporosis treatment (process outcome)

    Measured: 1 day of discharge from SNF and one year

  2. Medication Possession Ratio during follow-up, as measured by EHR and Medicare claims

    Osteoporosis treatment adherence (process outcome)

    Measured: Up to 3 years

  3. Number of patients who had deprescribing ordered

    Fall-risk increasing drug (FRID) use (process outcome)

    Measured: 1 day of discharge from SNF and 90 days after SNF admission date

  4. Modified Drug Burden Index during follow-up, as measured by EHR and Medicare claims

    Fall-risk increasing drug (FRID) use (process outcome)

    Measured: Up to 3 years

  5. 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).

    Measured: 90 days after SNF admission date

  6. 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.

    Measured: 90 days after SNF admission date

  7. 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.

    Measured: 90 days after SNF admission date

  8. 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.

    Measured: 90 days after SNF admission date

  9. 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.

    Measured: 90 days after SNF admission date

  10. 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.

    Measured: 90 days after SNF admission date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start30 Sep 2024
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
3,780 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06304428
Sponsor's protocol ID
Pro00114580
Acronym
PRISM
Status last verified
Jan 2026
First submitted
5 Mar 2024
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Berry SD, Toles M, Travison TG, McConnell ES, Zullo AR, Little MO, Gwyther L, McDermott C, Lee R, Cary M, Syme M, Kissam S, Hecker E, MacLean KG, Colon-Emeric C. PReventing Injury in Skilled nursing facilities through optimizing Medications (PRISM), a protocol for a cluster randomized trial to reduce injurious falls in post-acute care. Trials. 2025 Sep 26;26(1):367. doi: 10.1186/s13063-025-09122-z.

    PubMed 41013714

Questions about this trial

What is this clinical trial studying?

A study testing Deprescribing Care Model, Bone Health Service Model and Injury Prevention Service Model in people with Accidental Falls/Prevention and Control and Osteoporosis, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Injurious falls (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06304428, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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