- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04835012
Health and Health Care Utilization Effects of Medical Debt Forgiveness
28. April 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
15008
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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California
-
Los Angeles, California, Vereinigte Staaten, 90095
- Wesley Yin
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
The study population is a probability sample drawn from population of individuals who owe medical debt held by FFAM, a debt collection agency.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
8-item Patient Health Questionnaire (PHQ-8) Depression Scale
Zeitfenster: 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.
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An average of 12 months after the intervention.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Received Needed Health Care
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
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An average of 12 months after the intervention.
|
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Happiness
Zeitfenster: 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)
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An average of 12 months after the intervention.
|
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Problems paying other bills
Zeitfenster: 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)
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An average of 12 months after the intervention.
|
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Changes in spending due to medical debt
Zeitfenster: 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)
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An average of 12 months after the intervention.
|
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Changes in borrowing due to medical debt
Zeitfenster: 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)
|
An average of 12 months after the intervention.
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Wesley Yin, PhD, University of California, Los Angeles
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
9. November 2020
Primärer Abschluss (Tatsächlich)
31. Dezember 2021
Studienabschluss (Tatsächlich)
31. Dezember 2021
Studienanmeldedaten
Zuerst eingereicht
27. März 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. April 2021
Zuerst gepostet (Tatsächlich)
8. April 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
30. April 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB#20-001700
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
De-identified and confidential IPD will be made available by the on-line publication date of published research.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- SAFT
- ICF
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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