- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04835012
Health and Health Care Utilization Effects of Medical Debt Forgiveness
28 avril 2026 mis à jour par: Wesley Yin, University of California, Los Angeles
The goal of this study is to estimate the direct, causal impact of medical debt on health care utilization, mental health, and wellbeing of patients.
The investigators will conduct a survey to measure the impact of the debt forgiveness on health care use, mental health, and wellbeing.
The survey will be administered to approximately 17,000 subjects of a recent medical financial intervention.
In that prior intervention, a non-profit charity, RIP Medical Debt, purchased and abolished medical debt for a randomly selected about 6,000 (out of the 17,000) individuals.
In this current protocol, the investigators will administer the survey, and will compare surveyed outcomes of subjects who received and did not receive the intervention.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This study will estimate the direct, causal impact of medical debt on health care utilization, mental health, and wellbeing of patients.
To do so, the investigators will administer a survey to approximately 17,000 subjects of a recent medical financial intervention.
In that intervention, a non-profit charity, RIP Medical Debt, purchased and abolished medical debt for a randomly selected about 6,000 (out of the 17,000) study subjects.
In this current protocol, the investigators will compare surveyed outcomes of subjects who received and did not receive the medical debt abolishment intervention.
Because debt abolishment was randomized, comparing surveyed outcomes of treated and control subjects in the cross-section will allow the study to estimate the causal impact of the medical debt abolishment.
The survey will measure the effects of medical debt on three sets of outcomes: (i) health care utilization, as measured by medical care visits, prescription drug utilization and adherence, and unmet need for medical care; (ii) mental health, as measured by validated screens for depression and anxiety; and (iii) subjective wellbeing, as measured by self-reported health, forgone consumption, and financial strain.
This study would be the first to provide a direct, causal connection between the rising personal debt associated with U.S. health care and the health outcomes of its recipients.
Type d'étude
Observationnel
Inscription (Réel)
15008
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
Los Angeles, California, États-Unis, 90095
- Wesley Yin
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
The study population is a probability sample drawn from population of individuals who owe medical debt held by FFAM, a debt collection agency.
La description
Inclusion Criteria:
- Individuals ages 18 and over who owed medical debt to FFAM, a debt collections agency
Exclusion Criteria:
- Excluded individuals who owed less than $500 in medical debt to FFAM
- Excluded individuals with missing social security numbers
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Treatment
Subjects in this "treatment" group had their medical debt forgiven by a non-profit charity, RIP Medical Debt.
This protocol will administer a survey to measure subjects' health care utilization, mental health, and subjective well-being.
|
A non-profit charity, RIP Medical Debt, bought and retired medical debt for individuals that were assigned to the treatment group.
|
|
Control
No intervention was given to subjects in this "control" group.
This protocol will administer a survey to measure subjects' health care utilization, mental health, and subjective well-being.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
8-item Patient Health Questionnaire (PHQ-8) Depression Scale
Délai: An average of 12 months after the intervention.
|
Scores on the 8-item Patient Health Questionnaire depression scale range from 0 to 24, with higher scores indicating greater severity of depression.
|
An average of 12 months after the intervention.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Received Needed Health Care
Délai: An average of 12 months after the intervention.
|
Binary response to: "If you needed medical care in the last 12 months, did you get ALL the medical care you needed?" (Health Care Utilization domain)
|
An average of 12 months after the intervention.
|
|
Received Needed Rx
Délai: An average of 12 months after the intervention.
|
Binary response to: "If you needed prescription medications in the last 12 months, did you get all the prescription medications you needed?" (Health Care Utilization domain)
|
An average of 12 months after the intervention.
|
|
7-item Generalized Anxiety Disorder (GAD7) Scale
Délai: An average of 12 months after the intervention.
|
Scores on the 7-item Generalized Anxiety Disorder Scale range from 0 to 21, with higher scores indicating greater severity of anxiety (Mental Health Domain).
|
An average of 12 months after the intervention.
|
|
Stress
Délai: An average of 12 months after the intervention.
|
Binary response to: "Stress means a situation in which a person feels tense, restless, nervous or anxious or is unable to sleep at night because his/her mind is troubled all the time.
Do you feel this kind of stress these days?"
(Mental Health Domain)
|
An average of 12 months after the intervention.
|
|
General Health
Délai: An average of 12 months after the intervention.
|
Response to: "In general, would you say your health is: Excellent, Very Good, Good, Fair, or Poor?" (General Health Domain)
|
An average of 12 months after the intervention.
|
|
Happiness
Délai: An average of 12 months after the intervention.
|
Response to: "Taken all together, how would you say things are these days - would you say that you are Very Happy, Pretty Happy, or Not Too Happy?" (Subjective Wellbeing Domain)
|
An average of 12 months after the intervention.
|
|
Problems paying other bills
Délai: An average of 12 months after the intervention.
|
Response to: "Besides medical bills, have you had problems paying other types of bills in the past 12 months?"
(Financial Stress Domain)
|
An average of 12 months after the intervention.
|
|
Changes in spending due to medical debt
Délai: An average of 12 months after the intervention.
|
Indexed response to: "As a result of medical bills have you cut back on spending in the past 12 months on i) basic necessities (like food, heat or housing, or other basic household items), ii) Big-ticket items (like cars, furniture, or appliances); iii) business investments?"
(Financial Stress Domain)
|
An average of 12 months after the intervention.
|
|
Changes in borrowing due to medical debt
Délai: An average of 12 months after the intervention.
|
Indexed response to: "As a result of medical bills, in the past 12 months, have you i) Increased your credit card debt, or charge card debt?
ii) Borrowed money from a payday lender?; iii) Borrowed from friends and family?; iv) Used up all or most of your savings?; v) Increased debt on other lines of credit?" (Financial Stress Domain)
|
An average of 12 months after the intervention.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Wesley Yin, PhD, University of California, Los Angeles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
9 novembre 2020
Achèvement primaire (Réel)
31 décembre 2021
Achèvement de l'étude (Réel)
31 décembre 2021
Dates d'inscription aux études
Première soumission
27 mars 2021
Première soumission répondant aux critères de contrôle qualité
4 avril 2021
Première publication (Réel)
8 avril 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 avril 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 avril 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB#20-001700
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
We will make de-identified and restricted data available to the research community through portals such as the publicly accessible Inter-University Consortium for Political and Social Research (hosted by the University of Michigan).
We will preserve the confidentiality of study participants and protect personal health information by stripping the data of personally identifying information and purging it of all personal health information, and any information that is sufficiently fine so that it could identify individuals.
We will follow standard protocols, such as converting specific dates to relative dates or date intervals, and aggregating small cells.
This will allow us to maximize the data available to researchers while strictly preserving confidentiality and privacy.
Délai de partage IPD
De-identified and confidential IPD will be made available by the on-line publication date of published research.
Critères d'accès au partage IPD
Access will be limited to researchers for non-commercial uses.
Users will also need to certify that no attempt will be made to re-identify participants from the de-identified data.
Type d'informations de prise en charge du partage d'IPD
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .