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- Register voor klinische proeven in de VS.
- Klinische proef NCT04835012
Health and Health Care Utilization Effects of Medical Debt Forgiveness
16 april 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Verwacht)
17000
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Professor, PhD
- Telefoonnummer: (310) 206-3969
- E-mail: aorkin@research.ucla.edu
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90095
- Werving
- UCLA IRB
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Contact:
- Professor, PhD
- Telefoonnummer: 310-206-3969
- E-mail: aorkin@research.ucla.edu
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
The study population is a probability sample drawn from population of individuals who owe medical debt held by FFAM, a debt collection agency.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
8-item Patient Health Questionnaire (PHQ-8) Depression Scale
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Received Needed Health Care
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Wesley Yin, PhD, University of California, Los Angeles
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
9 november 2020
Primaire voltooiing (Verwacht)
1 november 2021
Studie voltooiing (Verwacht)
1 december 2023
Studieregistratiedata
Eerst ingediend
27 maart 2021
Eerst ingediend dat voldeed aan de QC-criteria
4 april 2021
Eerst geplaatst (Werkelijk)
8 april 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 april 2021
Laatste update ingediend die voldeed aan QC-criteria
16 april 2021
Laatst geverifieerd
1 april 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB#20-001700
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
De-identified and confidential IPD will be made available by the on-line publication date of published research.
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- SAP
- ICF
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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