- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04835012
Health and Health Care Utilization Effects of Medical Debt Forgiveness
28 aprile 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
15008
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90095
- Wesley Yin
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Metodo di campionamento
Campione di probabilità
Popolazione di studio
The study population is a probability sample drawn from population of individuals who owe medical debt held by FFAM, a debt collection agency.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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.
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A non-profit charity, RIP Medical Debt, bought and retired medical debt for individuals that were assigned to the treatment group.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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8-item Patient Health Questionnaire (PHQ-8) Depression Scale
Lasso di tempo: An average of 12 months after the intervention.
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Scores on the 8-item Patient Health Questionnaire depression scale range from 0 to 24, with higher scores indicating greater severity of depression.
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An average of 12 months after the intervention.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Received Needed Health Care
Lasso di tempo: An average of 12 months after the intervention.
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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)
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An average of 12 months after the intervention.
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Received Needed Rx
Lasso di tempo: An average of 12 months after the intervention.
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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)
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An average of 12 months after the intervention.
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7-item Generalized Anxiety Disorder (GAD7) Scale
Lasso di tempo: An average of 12 months after the intervention.
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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).
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An average of 12 months after the intervention.
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Stress
Lasso di tempo: An average of 12 months after the intervention.
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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)
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An average of 12 months after the intervention.
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General Health
Lasso di tempo: An average of 12 months after the intervention.
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Response to: "In general, would you say your health is: Excellent, Very Good, Good, Fair, or Poor?" (General Health Domain)
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An average of 12 months after the intervention.
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Happiness
Lasso di tempo: An average of 12 months after the intervention.
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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)
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An average of 12 months after the intervention.
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Problems paying other bills
Lasso di tempo: An average of 12 months after the intervention.
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Response to: "Besides medical bills, have you had problems paying other types of bills in the past 12 months?"
(Financial Stress Domain)
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An average of 12 months after the intervention.
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Changes in spending due to medical debt
Lasso di tempo: An average of 12 months after the intervention.
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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)
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An average of 12 months after the intervention.
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Changes in borrowing due to medical debt
Lasso di tempo: An average of 12 months after the intervention.
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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)
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An average of 12 months after the intervention.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Wesley Yin, PhD, University of California, Los Angeles
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
9 novembre 2020
Completamento primario (Effettivo)
31 dicembre 2021
Completamento dello studio (Effettivo)
31 dicembre 2021
Date di iscrizione allo studio
Primo inviato
27 marzo 2021
Primo inviato che soddisfa i criteri di controllo qualità
4 aprile 2021
Primo Inserito (Effettivo)
8 aprile 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 aprile 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB#20-001700
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione IPD
De-identified and confidential IPD will be made available by the on-line publication date of published research.
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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