Out-of Pocket Payments in Patients With Lymphedema (Lymphorac2)

Out-of Pocket Payments in Patients With Primary Lymphedema in France and Inequities of Access to Healthcare

Primary lymphedema is a chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. The investigators aim was to analyze the distributive effects of OOPP for primary lymphedema patients in France.

A prospective, multicenter study will be conducted in France in 2015 on patients with primary lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. The investigators will combine concentration curves and concentration indices to assess the distributive effects.

Study Overview

• Status: Completed
• Conditions: Primary Lymphedema
• Intervention / Treatment: Other: Out of pocket payments in patients

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patients meeting the inclusion criteria will be included in each participating centre during the inclusion phase

Description

Inclusion criteria:

• Patient aged over six years, with primary lymphedema, regardless of the severity of the disease;
• Patient treated in one of the centres participating in the study;
• Patient (and her legal representative for minors) who gave her written consent [or did not refuse to participate, according to local Law];
• Patient with Internet access and an active email address.

Exclusion criteria:

• Patients with concomitant chronic venous insufficiency;
• Patient not covered by any health care insurance scheme;
• People protected under the law.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mean monthly out-of-pocket payment as assessed by an online self-questionnaire	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Gregoire MERCIER, MD, PHD, University Hospital, Montpellier

Publications and helpful links

General Publications

• Mercier G, Pastor J, Clement V, Rodts U, Moffat C, Quere I. Out-of-pocket payments, vertical equity and unmet medical needs in France: A national multicenter prospective study on lymphedema. PLoS One. 2019 May 8;14(5):e0216386. doi: 10.1371/journal.pone.0216386. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 9638

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
• product manufactured in and exported from the U.S.: No