Clinical trial NCT05446337: Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study
Official title: Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot
Lower Limb Wound
Diabetes
Amputation
Keywords: Developmental Evaluation
Care Pathway
Mixed-Methods Study
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Facilitators and Barriers
timeFrame: 9 months
Secondary outcomes:
measure: Experience with Care
timeFrame: Duration of evaluation
measure: Value-Based Healthcare
timeFrame: Duration of evaluation
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Valeria E. Rac, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: