Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study
2 other identifiers
observational
70
0 countries
N/A
Brief Summary
University Health Network (UHN), working together with local primary care practitioners, patients, and community healthcare services is developing a Diabetic Foot Care and Limb Preservation Care pathway. Our goal is to improve foot care for individuals living with diabetes. This study is using a method called developmental evaluation to help map out the system and to provide information in real-time so that the pathway can be adapted and respond to what is learned. The investigators are going to explore different factors (facilitators and barriers) and processes, which help or hinder the development, implementation, and adoption of the pathway. The investigators are also going to find out about the patient and provider's experiences with diabetic foot care, wound care, limb preservation, and amputation. Finally, the study team is going to look at value-based health care for the diabetic foot care pathways and document healthcare resource utilization, costs, and outcomes. The study team will conduct interviews of stakeholders, including patient representatives, and will examine the participation and engagement in the pathway, identifying barriers and facilitators of the process. Once the pathway has started, the study team will look at the way the care is delivered and satisfaction through surveys to patients and practitioners. The study team will also ask about patients' quality of life and their ability to manage diabetes. The study will aim to answer three key questions: What is happening? Why is it happening? and, What are reasonable prospects, and tools for change? The entire study is anticipated to take 3 years to complete.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedJuly 18, 2022
July 1, 2022
2.6 years
June 30, 2022
July 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Facilitators and Barriers
Key factors related to system readiness and implementation of the Diabetes Foot Care and Limb Preservation pathway
9 months
Secondary Outcomes (2)
Experience with Care
Duration of evaluation
Value-Based Healthcare
Duration of evaluation
Study Arms (3)
Patients and Informal Care Givers
Individuals living with diabetes who are receiving or have received care through the Diabetes Foot Care and Limb Preservation Pathway at various stages of the care pathway including screening \& prevention, wound care treatment, surgery and monitoring.
Healthcare Providers
Medical, Nursing, and other allied healthcare providers including chiropodists, physiotherapists, occupational therapists, social workers, and nutritionists.
Stakeholders
Individuals external and internal involved in clinical care, continuity of care, and policy-making including but not limited to senior hospital leadership, decision support, and researchers and policy decision-makers.
Interventions
Examine the participation and engagement in the Diabetic Foot Care and Limb Preservation Pathway design and implementation; identifying barriers and facilitators of the process
Eligibility Criteria
Individuals from the Greater Toronto Area (GTA) that are involved with the Diabetes Foot Care and Limb Preservation Pathway through UHN either as patients and their caregivers, healthcare providers, or stakeholders.
You may qualify if:
- Patients and Informal Caregivers:
- Diabetes (Type 1 and Type 2) receiving care within the Diabetes Foot Care and Limb Preservation Pathway
- Outpatient or inpatient care setting
- Non-Patient Participants:
- Healthcare providers providing care
- Stakeholders supporting the clinical pathway development through University Health Network.
- In the early phases of the project a broader audience who may not be involved in the explicit design, outside of those that are designing the program, and may include external and internal stakeholders involved in clinical care, continuity of care, policy decision-making, patients, and caregivers.
You may not qualify if:
- \- Not able to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valeria E. Rac, MD, PhD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2022
First Posted
July 6, 2022
Study Start
July 15, 2022
Primary Completion
February 28, 2025
Study Completion
March 31, 2025
Last Updated
July 18, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share