Evaluation of the TRANSEND Program (EVATRANSEND)

Non-randomized Experimental Study Evaluating the Impact of Implantation of a New Organization in the Adult Sector Intended to Improve the Transition of Young People With Endocrine or Metabolic Diseases

"Transend" is a program designed to promote the transition of young patients with endocrine or metabolic diseases when they arrive in the adult sector at La Pitié-Salpétrière hospital. The main objective of the study is to compare the rate of patients lost to follow-up at 24 months after the transfer of pediatrics between the Transend group and the (historical) control group.

Study Overview

• Status: Completed
• Conditions: Pediatric Patient Transfer to Adult Service:Transition Program
• Intervention / Treatment: Behavioral: survey

Detailed Description

Adolescence and early adulthood represent important periods for young people suffering from chronic diseases. Several observational studies show needs not covered by care services at this period and significant lost to follow-up rates. "Transend" is a program designed to promote the transition of young patients with endocrine or metabolic diseases when they arrive in the adult sector at La Pitié-Salpétrière hospital (Paris, France). Since September 1, 2016, approximately 500 patients benefited from it.

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Chef du Service d'Endocrinologie et Médecine de le Reproduction, Hôpital de la Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 32 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Young patients with endocrine or metabolic diseases

Description

Inclusion Criteria:

• Patient aged 18 to 32
• Patient with endocrine or metabolic disease
• Patient who had a follow-up in a pediatric department for his endocrine or metabolic disease
• Patient transferred to the adult sector in the endocrinology, metabolism or nutrition department of Pitié-Salpêtrière
• Patient who had a first post-transfer consultation between January 1, 2015 and September 1, 2017
• Patient with a social security protection

Exclusion Criteria:

• Patient who transferred to another adult service before being followed at Pitié-Salpêtrière
• Patient who has expressed his opposition to participate in this research

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; Patients transferred to adult service according to the Transend transition program (between September 2016 and January 2018)	Behavioral: survey; Behavioral study of patients who are in the "Transend" Program (compliance in follow-up visits after transfert from pediatric to adult care in the 24 months)
Control group; Patients transferred to adult service without a transition program, in the same center, before the implementation of Transend (between January 2015 and September 2016)	Behavioral: survey; Behavioral study of patients who are in the "Transend" Program (compliance in follow-up visits after transfert from pediatric to adult care in the 24 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients lost to follow-up at 24 months post transfert	Defined by pathology as patients who have not been seen in a medical consultation since a time superior of the recommendation for his state of Heath at 24 months post-transfer and for whom no elements confirm a next consultation in the center nor a follow-up in another center	24 months post transfert

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of consultations not honored by the patient	Experimental group: patients transferred to adult service according to the Transend transition program (between September 2016 and January 2018) Control group: patients transferred to adult service without a transition program, in the same center, before the implementation of Traansend (between January 2015 and September 2016)	24 to 36 months post transfert
Relationship of trust between caregiver and patient	Score calculated by wake Forest scaleis a validated scale of 10 items for the evaluation of the different components of trust.including 3 items on loyalty, 3 items on competence, 1 item on honesty and 3 items on global trust. (short version) resulting from an evaluation anonymously made by patients	24 to 36 months post transfert
Time to first consultation in adult medicine	Experimental group: patients transferred to adult service according to the Transend transition program (between September 2016 and January 2018) Control group: patients transferred to adult service without a transition program, in the same center, before the implementation of Traansend (between January 2015 and September 2016)	24 to 36 months post transfert
Patient satisfaction	Satisfaction collected on a scale of 0 to 10 where 0 means the worst transfer imaginable resulting an anonymous assessment carried out by the Patients	24 to 36 months post transfet
Avoided care consumption and associated costs	Costs associated with hospital emergency room visits, home visit of SOS doctor, unplanned hospitalization	24 to 36 months post transfret
Compare the experience of the transition betmeen the two Groups	Frequency of feeling broken, continuity, need to contact the paediatrician, attention and perceived availability on the part of professionals on arrival in the adult hospital	24 to 36 months post transfret
Assess Transend's efficiency	Cost/incremental cost-effectiveness ratio in cost gained and cost per loss of view	24 to 36 months post transfret

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: TOURAINE Philippe, PU-PH, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2020
• Primary Completion (ACTUAL): October 10, 2020
• Study Completion (ACTUAL): October 10, 2020

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (ACTUAL): February 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: APHP190984; IDRCB 2019-A02243-54 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No