The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

Osteoporosis Clinical Trial

Official title:

The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947722
• Other study ID #: 13622
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: McMaster University
• Contact: Lauren Kane, MSc
• Phone: 905-521-2100
• Email: kanela[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hip fractures occur nearly twice as often for older adults residing in long-term care as they do in older adults of a similar age still living in other settings. Hip fractures are the leading cause of hospitalization and often result in loss of independence, problems with walking and sometimes death. To address this problem the PREVENT (Person-centered Routine Fracture PrEVENTion in LTC) program was designed for use in long-term care homes. PREVENT uses a tool ("fracture risk calculator") based on a residents electronic health record to capture who is most at risk of fracture due to osteoporosis and falls. The program then trains the health care team including doctors, pharmacists and nurses on the latest recommendations on how to best assist residents and their families in making treatment decisions. The healthcare teams are also given tools that help them stay on track such as templates for ordering medications, strategies to reduce falls and fractures and making care plans. The study will examine if this program is effective for decreasing hip fractures by assigning some homes to receive the PREVENT program (intervention group) and some homes to usual care (control group) and comparing the results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3060
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Both profit and non-profit long-term care homes in Ontario and Alberta.
• Homes must have a minimum of 70 occupied beds to participate; there is no maximum home size for participation.
• For both control and intervention homes, resident eligibility (and study cohorts) will be determined via the RAI-MDS 2.0 database.

Exclusion Criteria:

• Residents identified as having end-stage disease, who are comatose, receiving hospice or respite care and who have an expected short stay (90 days or less).

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Fractures, Hip
• Hip Fractures
• Osteoporosis

Intervention

Behavioral:
• PREVENT Program
A standardized PREVENT educational program will be offered to each intervention LTC home and health-care staff. The curricula includes video modules with fracture-prevention care recommendations and an orientation to the Fracture Prevention Toolkit. Using the Fracture Risk Scale (i.e., a clinical decision support tool embedded in the RAI-MDS 2.0), the LTC team will identify residents at high-risk for fracture and will implement the fracture prevention recommendations into care plans on an individual resident basis.

Locations

Country	Name	City	State
Canada	McMaster University - St. Peter's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hip-fractures	Data extracted from the Discharge Abstract Database (DAD) and National Ambulatory Care Reporting System (NACRS). Scored as occurred: yes, no.	One year
Secondary	Number of non-hip fractures (wrist, spine, pelvis, humerus)	Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.	One year
Secondary	Number of hospital transfers (emergency department and admissions)	Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.	One year
Secondary	Number of deaths	Data extracted from the DAD and NACRS datasets. Scored as occurred: yes, no.	One year
Secondary	Change in number of falls	Assessed by the Minimum Data Set (MDS) (standardized assessment) 2.0. Scored as occurred: yes, no and number of falls.	Baseline, 3, 6, 9 and 12 months
Secondary	Change in level of pain	Assessed by the MDS 2.0 Pain Scale. Scored on a scale from 0-4 where higher scores indicate more severe pain.	Baseline, 3, 6, 9 and 12 months
Secondary	Change in mobility	Assessed by the MDS 2.0 Activities of Daily Living (ADL) Hierarchy Scale. Scored on a scale from 0-6 where higher scores indicate more impairment in ADL performance.	Baseline, 3, 6, 9 and 12 months
Secondary	Change in responsive behaviours	Assessed by the MDS 2.0 Aggressive Behaviour Scale. Scored on a scale from 0-12 where higher scores indicate greater frequency and diversity of aggressive behaviour.	Baseline, 3, 6, 9 and 12 months
Secondary	Change in health related quality of life	Assessed by the MDS 2.0 Health Status Index. Scored on a scale from 0-1 where a score of 1 indicates full health.	Baseline, 3, 6, 9 and 12 months
Secondary	Change in medications and supplements	Data extracted from the pharmacy database. Recorded as number of LTC residents receiving osteoporosis medication, calcium and vitamin D supplements.	Baseline, 3, 6, 9 and 12 months