Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Diabetic Foot; Amputation; Lower Limb Wound
• Intervention / Treatment: Other: Open-Ended Semi-Structured Interview

Detailed Description

This study is a mixed-methods developmental evaluation study whose objectives are to:

1. Explore different factors (facilitators and barriers) and processes, which facilitate or impede the development, implementation, and adoption of Diabetes Foot Care and Limb Preservation Pathways using a multi-level framework.
2. Examine the patient and provider experiences with diabetic foot care, wound care, limb preservation, and amputation at UHN and the primary care settings and patient-level outcomes.

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.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: James M. Bowen, BScPhm, MSc; Phone Number: 416-634-8799; Email: jim.bowen@uhn.ca
• Study Contact Backup: Name: Sonia Meerai, MSW; Phone Number: 416-634-8806; Email: sonia.meerai@uhnresearch.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

- Not able to provide consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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
Healthcare Providers; Medical, Nursing, and other allied healthcare providers including chiropodists, physiotherapists, occupational therapists, social workers, and nutritionists.	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
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facilitators and Barriers	Key factors related to system readiness and implementation of the Diabetes Foot Care and Limb Preservation pathway	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Duration of evaluation

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Valeria E. Rac, MD, PhD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2022
• Primary Completion (Anticipated): February 28, 2025
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Developmental Evaluation; Care Pathway; Mixed-Methods Study
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: 21-6156; PHSTE202201 (Other Identifier: Program for Health System and Technology Evaluation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No