An observational study in Diabetic Foot, Lower Limb Wound and Diabetes, sponsored by University Health Network, Toronto. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by University Health Network, Toronto · Observational
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.
This study is a mixed-methods developmental evaluation study whose objectives are to:
The developmental evaluation will consist of an initial component. Further quantitative and qualitative measures will be incorporated into the developmental evaluation as the Diabetic Foot Care and Limb Preservation Pathway develops.
1. Pathway Design \& Implementation Case Study This qualitative research component will be completed through ethnographic fieldwork and the conduct of semi-structured interviews of stakeholders, including patient representatives, and will examine the participation and engagement in the Diabetic Foot Care and Limb Preservation Pathway design and implementation, identifying barriers and facilitators of the process. The study team will interview and observe three types of participants: patients and informal caregivers; healthcare providers including program service providers; stakeholders including hospital leadership and policy decision-makers. The research team will also attend meetings and collect and review documents and materials circulated as a part of the pathway development. In addition, social network analysis (SNA) may also be conducted as a part of this component to examine the interaction between stakeholders as well as the organizational dynamics and the fidelity of the intervention.
This study will be conducted in both the community and hospital settings at the University Health Network at Toronto General Hospital, Toronto Western Hospital, The Michener Institute of Education, Toronto Western Hospital Family Health Team (FHT) South Riverdale Community Health Centre, Primary Care Practices participating in the Seamless Care for Optimizing Patient Experience (SCOPE) and will be supported Nurse Navigators and by an Integrated Comprehensive Care (ICC) and associated homecare services.
1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 190 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients and Informal Caregivers:
Non-Patient Participants:
Exclusion Criteria:
- Not able to provide consent
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.
Other: Open-Ended Semi-Structured Interview
Medical, Nursing, and other allied healthcare providers including chiropodists, physiotherapists, occupational therapists, social workers, and nutritionists.
Other: Open-Ended Semi-Structured Interview
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.
Other: Open-Ended Semi-Structured Interview
Examine the participation and engagement in the Diabetic Foot Care and Limb Preservation Pathway design and implementation; identifying barriers and facilitators of the process
Facilitators and Barriers
Key factors related to system readiness and implementation of the Diabetes Foot Care and Limb Preservation pathway
Time frame: 9 months
Experience with Care
Experiences with diabetic foot care, wound care, limb preservation and amputation at UHN and the primary care settings and patient-level outcomes
Time frame: Duration of evaluation
Value-Based Healthcare
Potential of implementing value-based health care diabetic foot care pathways and document healthcare resource utilization, costs and outcomes.
Time frame: Duration of evaluation
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2022; primary completion for Feb 2025, 31 months later.
Of 63 non-industry observational studies under Diabetic Foot, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 117. This study's planned 31 months is close to that.
Counting every sponsor, half of 83 studies reached it within 28 months; a quarter within 13 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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