The iCARE Study: Education Modules for Fracture Prevention

Sponsor

Canadian Institutes of Health Research (CIHR) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05445336

Collaborator

McMaster University (Other), Revera Inc. (Other), Schlegel Villages (Other), Hamilton Health Sciences Corporation (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Frailty Chronic Conditions, Multiple Fracture	Behavioral: PREVENT Program

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Internal Champion & Professional Advisory Committee (PAC) Team #1 from Site #1 The internal champion and PAC 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 PAC team. The 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 PAC 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 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 & Professional Advisory Committee (PAC) Team #2 from Site #2 The internal champion and PAC 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 PAC team. The 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 PAC 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 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 & Professional Advisory Committee (PAC) Team #3 from Site #3 The internal champion and PAC 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 PAC team. The 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 PAC 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 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.

Arm

Intervention/Treatment

Internal Champion & Professional Advisory Committee (PAC) Team #1 from Site #1

The internal champion and PAC 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 PAC team. The 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 PAC 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

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 & Professional Advisory Committee (PAC) Team #2 from Site #2

Behavioral: PREVENT Program

Internal Champion & Professional Advisory Committee (PAC) Team #3 from Site #3

Behavioral: PREVENT Program

Outcome Measures

Primary Outcome Measures

Feasibility - Recruitment Rate [2 months]
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
Feasibility - LTC home readiness and capacity [1 month]
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
Feasibility - Length of time to complete PREVENT Program [4 months]
Length of time for participants to implement the PREVENT Program
Feasibility - Logistics of linking data (Yes/No format) [4 months]
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)
Fidelity of delivering the PREVENT program [4-6 months]
Determine the fidelity of delivering the PREVENT program. Criteria for success: ≥ 80% on the fidelity checklist.
Feasibility - Number of Questions Completed [4 months]
The number of questions answered by the participants for each questionnaire. Criteria for success is 80% of questions are completed.

Secondary Outcome Measures

Changes in Prescribing Habits [4-6 months]
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.
Adaptations to PREVENT Program [4-6 months]
To determine adaptations to the PREVENT program by facilitating two 1.5-hour focus group sessions (semi-structured interviews) with the PAC 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.