The iCARE Study: Education Modules for Fracture Prevention

Osteoporosis Clinical Trial

— iCARE  

Official title:

The iCARE Study: An Integrated Collection of Education Modules on Fall and Fracture Prevention for Healthcare Providers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05445336
• Other study ID #: 14463
• Status: Completed
• Start date: July 30, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: December 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A large proportion of older adults living in long term care homes are frail and have osteoporosis. With age, there is a gradual and progressive decline in bone quality and quantity and an increase in frailty, which is associated with increased fracture risk. Additionally, fractures pose a significant burden to the health and quality of life of long term care residents and contribute to high healthcare costs. Despite the high prevalence of osteoporosis, falls, and fractures in long term care, the management of osteoporosis is not optimal among long term care residents at risk of fracture. The aim of this study is to co-design a service provision (i.e., PREVENT - Person-centred Routine Fracture PreEVENTion) with healthcare providers in long term care and to determine the feasibility of implementing PREVENT in long term care settings.

Description:

Fractures pose a significant burden on health, quality of life, and mortality of older adults in long term care (LTC) and contribute to high health care costs. PREVENT (Person-centred Routine Fracture PreEVENTion) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture. The purpose of the iCARE study is to create a fall and fracture educational program (i.e., PREVENT) for LTC healthcare providers to deliver routine assessments for the management and treatment of osteoporosis. The benefit of such a guide may help to reduce the devastating impact of fractures in older adults residing in LTC homes. The aim of this pilot study is to: 1) determine feasibility and 2) adaptations through facilitators and barriers. Before a larger trial can be implemented to determine the effectiveness of the PREVENT Program in practice, the iCARE study seeks to determine the feasibility of implementing PREVENT in practice and identify strategies to tailor the program to the individual long term care home and care team through design thinking solutions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Organizational Level Inclusion Criteria:

Five long LTC homes in Ontario that

• Have a minimum of 70 residents

• Are publicly owned and private for-profit and private not-for-profit homes in both urban and rural sites

Individual Level Inclusion Criteria:

• At least one internal champion

• Five Professional Advisory Committee (PAC) care teams from five long term care homes in Ontario that provide osteoporosis care to residents.

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Chronic Disease
• Fracture
• Fractures, Bone
• Frailty
• Multiple Chronic Conditions
• Osteoporosis

Intervention

Behavioral:
• PREVENT Program
PREVENT (Person-centred Routine Fracture PreEVENTion) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture.

Locations

Country	Name	City	State
Canada	GERAS Centre for Aging Research	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Institutes of Health Research (CIHR)	Hamilton Health Sciences Corporation, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Recruitment Rate	Number of long term care homes (LTCs) in Ontario recruited within two months. Criteria for success: recruit 5 LTC homes in Ontario within 2 months	2 months
Primary	Feasibility - LTC home readiness and capacity	Determine long term care home readiness and capacity to participate in the iCARE study based on a Readiness Checklist Survey. Criteria for success: at least 75% of homes approached are ready and have the capacity to participate in the study	1 month
Primary	Feasibility - Length of time to complete PREVENT Program	Length of time for participants to implement the PREVENT Program	4 months
Primary	Feasibility - Logistics of linking data (Yes/No format)	Determine the logistics of linking MDS 2.0 data with pharmaceutical database data at the resident level. This will be assessed by a "yes" or "no" (i.e., Feasible - Yes vs. Feasible - No)	4 months
Primary	Fidelity of delivering the PREVENT program	Determine the fidelity of delivering the PREVENT program. Criteria for success: = 80% on the fidelity checklist.	4-6 months
Primary	Feasibility - Number of Questions Completed	The number of questions answered by the participants for each questionnaire. Criteria for success is 80% of questions are completed.	4 months
Secondary	Changes in Prescribing Habits	To determine if appropriate prescribing habits change after the educational session. The criteria for success is a 10% improvement in prescribing habits. This will be measured by the number of prescriptions per number of residents at high risk of fracture pre- vs. post-intervention.	4-6 months
Secondary	Adaptations to PREVENT Program	To determine adaptations to the PREVENT program by facilitating two 1.5-hour focus group sessions (semi-structured interviews) with the leadership team to 1) discuss facilitators of and barriers to implementing the PREVENT program and 2) make necessary changes to the PREVENT program/educational material catered to the individual LTC home.	4-6 months