The iCARE Study: Education Modules for Fracture Prevention

NCT05445336 | Completed

• 1 other identifier: 14463
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Frailty; Chronic Conditions, Multiple; Fracture

Keywords

Frailty; Service Provision; Education; Knowledge Translation; Knowledge Mobilization; Osteoporosis; Fracture Prevention; Long Term Care

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Feasibility - Length of time to complete PREVENT Program

  Length of time for participants to implement the PREVENT Program

  4 months

• 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

• 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

• 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 Outcomes (2)

• Changes in Prescribing Habits

  4-6 months

• Adaptations to PREVENT Program

  4-6 months

Study Arms (3)

Internal Champion & LTC Leadership Team #1 from Site #1

The internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice.

Behavioral: PREVENT Program

Internal Champion & LTC Leadership Team #2 from Site #2

The internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice.

Behavioral: PREVENT Program

Internal Champion & LTC Leadership Team #3 from Site #3

The internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice.

Behavioral: PREVENT Program

Interventions

PREVENT Program BEHAVIORAL

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.

Internal Champion & LTC Leadership Team #1 from Site #1; Internal Champion & LTC Leadership Team #2 from Site #2; Internal Champion & LTC Leadership Team #3 from Site #3

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

GERAS Centre for Aging Research

Hamilton, Ontario, N3T 5M1, Canada

Location

MeSH Terms

Conditions

Osteoporosis; Frailty; Multiple Chronic Conditions; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Wounds and Injuries

Study Officials

• Alexandra Papaioannou, MD, MSc, FRCP(c), FACP

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director and Clinician Scientist, GERAS Centre for Aging Research

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: July 6, 2022
• Study Start: July 30, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: July 1, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)