Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study

Diabetes Clinical Trial

Official title:

Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05446337
• Other study ID #: 21-6156
• Secondary ID: PHSTE202201
• Status: Not yet recruiting
• Start date: July 15, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: July 2022
• Source: University Health Network, Toronto
• Contact: James M. Bowen, BScPhm, MSc
• Phone: 416-634-8799
• Email: jim.bowen[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: March 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Diabetes
• Diabetic Foot
• Lower Limb Wound

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facilitators and Barriers	Key factors related to system readiness and implementation of the Diabetes Foot Care and Limb Preservation pathway	9 months
Secondary	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
Secondary	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