Clinical trial NCT05445336: The iCARE Study: Education Modules for Fracture Prevention
Official title: The iCARE Study: An Integrated Collection of Education Modules on Fall and Fracture Prevention for Healthcare Providers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Frailty
Chronic Conditions, Multiple
Fracture
Keywords: Frailty
Service Provision
Education
Knowledge Translation
Knowledge Mobilization
Osteoporosis
Fracture Prevention
Long Term Care
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Hamilton Health Sciences Corporation
First posted: 2022-07-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Care planning in long term care is a collaborative effort between the resident, the long term care healthcare provider, and the resident's family/caregiver. An internal champion will be identified to represent several long term care homes and who will help identify the five Professional Advisory Committees care teams who are the end-users of the PREVENT program. The Professional Advisory Committee may consist of a Director of Care/Nursing Director, Medical Director, Clinical Consultant Pharmacist, and other participating members who may include dietitians, rehabilitation staff, nurses, physicians, and personal support workers.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility - Recruitment Rate
timeFrame: 2 months
measure: Feasibility - LTC home readiness and capacity
timeFrame: 1 month
measure: Feasibility - Length of time to complete PREVENT Program
timeFrame: 4 months
measure: Feasibility - Logistics of linking data (Yes/No format)
timeFrame: 4 months
measure: Fidelity of delivering the PREVENT program
timeFrame: 4-6 months
measure: Feasibility - Number of Questions Completed
timeFrame: 4 months
Secondary outcomes:
measure: Changes in Prescribing Habits
timeFrame: 4-6 months
measure: Adaptations to PREVENT Program
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: GERAS Centre for Aging Research
state: Ontario
Study officials:
affiliation: McMaster University
name: Alexandra Papaioannou, MD, MSc, FRCP(c), FACP
role: PRINCIPAL_INVESTIGATOR
References: