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

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ClinicalTrials.gov Identifier: NCT04217902
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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


Condition or disease Intervention/treatment
Diabete Type 1 Diabete Type 2 Other: Description of patients' experiences of diabetes care delivery and planning Other: Description of health care professionals needs and experiences in diabetes care delivery and planning

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Other
Time Perspective: Other
Official Title: VOIES-D-ql (Visualization for the Optimization of Interactions and Experiences in Healthcare Services in Diabetes Care)
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
People living with diabetes in Grenoble and Lyon areas
Eligible patients with type 1 or type 2 diabetes 1) during or after hospitalization for decompensation, ketoacidosis, or other emergency or elective interventions such as insulin pump installation, 2) followed in routine care in specialized diabetes services, 3) participating in patient associations.
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).

Health care professionals working in diabetes care in Grenoble
Health care professionals working with diabetes care in specialized services or ambulatory care.
Other: 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).




Primary Outcome Measures :
  1. Description of individual experiences of patients and health care professionals in diabetes care. [ Time Frame: The moment of the interview (Day 0) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People living with type 1 or type 2 diabetes recruited from Hospices Civils de Lyon or Centre Hospitalier Universitare Grenoble-Alpes, patient associations or online patient groups & HCPs
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217902


Contacts
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Contact: Alexandra DIMA, MD 4 26 68 82 41 ext +33 alexandra.dima@univ-lyon1.fr
Contact: Luiza SIQUEIRA DO PRADO, PhD 4 26 68 82 22 ext +33 luiza.siqueira-do-prado@univ-lyon1.fr

Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04217902    
Other Study ID Numbers: 69HCL19_0897
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Diabete Type 1
Diabete Type 2
Diabete Care
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases