Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304428
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISM
Brief 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 ClinicalTrialsgov record represents the Comparative Effectiveness Aim of the protocol
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 ClinicalTrialsgov record represents the Comparative Effectiveness Aim of the protocol
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 100 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 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 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 100 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
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 100 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 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 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 100 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None