Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study

NCT ID: NCT05446337

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2025-03-31

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.

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.

Conditions

Diabetic Foot; Lower Limb Wound; Diabetes; Amputation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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.

Open-Ended Semi-Structured Interview

Intervention Type: OTHER

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.

Open-Ended Semi-Structured Interview

Intervention Type: OTHER

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.

Open-Ended Semi-Structured Interview

Intervention Type: OTHER

Examine the participation and engagement in the Diabetic Foot Care and Limb Preservation Pathway design and implementation; identifying barriers and facilitators of the process

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valeria E. Rac, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Central Contacts

James M. Bowen, BScPhm, MSc

Role: CONTACT

jim.bowen@uhn.ca

416-634-8799

Sonia Meerai, MSW

Role: CONTACT

sonia.meerai@uhnresearch.ca

416-634-8806

Other Identifiers

PHSTE202201

Identifier Type: OTHER

Identifier Source: secondary_id

21-6156

Identifier Type: -

Identifier Source: org_study_id