VOIES-D-ql - Qualitative Study on Experiences of Diabetes Care Delivery and Planning

Diabete Type 2 Clinical Trial

— VOIES-D-ql  

Official title:

VOIES-D-ql (Visualization for the Optimization of Interactions and Experiences in Healthcare Services in Diabetes Care)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04217902
• Other study ID #: 69HCL19_0897
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: March 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Population aging and the increase in incidence and prevalence of potentially disabling chronic conditions make health care more and more complex and costly. In this context, timelines are longer and adherence to care provision and health status are more variable - both within and between patients - and care is provided by different health care professionals, as well as services outside the health system, which may work at various levels of service integration. For diabetes, this is especially the case: patients at high risk for multimorbidity interact with multiple health care professionals, such as primary care physicians, diabetes specialists, nurses, nutritionists and therapeutic educators, with different perspectives to treatment. The patient is frequently the only link between the different health care professionals, and very often the main source of information regarding performed procedures, diagnoses and treatment decisions.

A current challenge facing all health care stakeholders, including policy makers, practitioners, businesses, and patients, is to coordinate the available services and integrate care ensuring safety, effectiveness, and comprehensiveness in relation to the needs of individual users across the lifespan. Routine collected data can provide key information to completely assess a patient's health status and thus help evaluating and deciding adapted steps in treatment to stabilize or improve clinical outcomes.

In France, the Dossier Medical Partagé (Shared Medical Record) represents an effort to centralize and improve accessibility, to patients and professionals alike, of medical information. This system is yet little adopted and there is the need for added value initiatives to exploit the tool's potential. In other countries, like the UK, the governmental unit NHSX develops public policies and good practices for the digital transformation of the NHS. In the United States, working groups like the Health Information Technology Working Group, in the National Institute of Diabetes and Digestive and Kidney Diseases, develop electronic care plans using Electronic Health Record data for chronic kidney disease patients. These initiatives, among others, show the necessity of simple, visual communication in order to build a comprehensive care delivery pathway to inform decision and further care planning, according to health goals set by shared decision-making.

This study aims to describe individual experiences of chronic care delivery of people living with diabetes and also from healthcare professionals working in diabetes care from 3 different domains: clinical (relevant clinical criteria necessary for the decision-making process, goal setting and planning), technological (tools used in routine practice and in patients' daily lives), and behavioural (behaviours and interactions that build the patient's pathway and strategies implemented by patients and professionals to help the decision-making process).

Locations of the study : Primary and secondary healthcare facilities and patient associations in Lyon and Grenoble areas

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

Inclusion Criteria:

Patient

• At least 18 years old

• Diagnosed with type 1 or type 2 diabetes according to HAS criteria and confirmed by and endocrinologist since at least one year

• Having had at least one consultation with a health care professional in the last 12 months

• Able to communicate in French

• Able to participate in an interview and not opposing to participate in the study

Professional

• Having at least one year of professional experience in diabetes care

• General practitioner, endocrinologist, diabetologist, intern, nurse, nutritionist or professional specialized in therapeutic education

Exclusion Criteria:

Patient

• Inability to communicate in French

• Institutionalized person

Professional

• Professional not having had at least one consultation with a person living with diabetes in the last 12 months

Related Conditions & MeSH terms

• Diabete Type 1
• Diabete Type 2
• Diabetes Mellitus, Type 2

Intervention

Other:
• Description of patients' experiences of diabetes care delivery and planning
Semi-directed interviews will be conducted with people living with type 1 or type 2 diabetes in person or by phone to assess and describe the care delivery pathway they have been through. Information on 3 domains will be assessed: clinical (information they consider essential for health care professionals to systematically have access to during consultations and other health-related interventions such as therapeutic education sessions), technological (what kind of digital services and technologies they use or are willing to use), and behavioural (the decision-making process and the key interactions that build the care delivery pathway).
• Description of health care professionals needs and experiences in diabetes care delivery and planning
Semi-directed interviews will be conducted with health care professionals working in diabetes care in person or by phone to assess and describe their needs and experiences in diabetes care. Information on 3 domains will be assessed: clinical (the information they consider to be essential to inform decisions in diabetes care, where and if they currently find that information and problems they might encounter), technological (which software they currently use and how data is input into clinical information systems), and behavioural (how care coordination is currently managed, how interactions with patients and other professionals are undertaken).

Locations

Country	Name	City	State
France	Laboratory HESPER EA 7425, University Claude Bernard Lyon 1	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of individual experiences of patients and health care professionals in diabetes care.	Socioeconomic status will be assessed, health literacy using the Brief Health Literacy Screening (BHLS), and a semi-directed interview will be undertaken with people living with type 1 or type 2 diabetes. The latter aims t obtain a description of their experiences concerning how their care delivery pathways were built over time, how health-related decisions are made individually and what data they consider health care professionals they interact with should systematically have access to (considering the 3 domains previously described). Health care professionals will also be interviewed regarding their experiences and needs in diabetes care, in the shared decision-making process and in establishing care coordination.	The moment of the interview (Day 0)