- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04835012
Health and Health Care Utilization Effects of Medical Debt Forgiveness
28 de abril de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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 de estudio
De observación
Inscripción (Actual)
15008
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- Wesley Yin
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra de probabilidad
Población de estudio
The study population is a probability sample drawn from population of individuals who owe medical debt held by FFAM, a debt collection agency.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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8-item Patient Health Questionnaire (PHQ-8) Depression Scale
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Received Needed Health Care
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
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An average of 12 months after the intervention.
|
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General Health
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wesley Yin, PhD, University of California, Los Angeles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de noviembre de 2020
Finalización primaria (Actual)
31 de diciembre de 2021
Finalización del estudio (Actual)
31 de diciembre de 2021
Fechas de registro del estudio
Enviado por primera vez
27 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
4 de abril de 2021
Publicado por primera vez (Actual)
8 de abril de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de abril de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB#20-001700
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
De-identified and confidential IPD will be made available by the on-line publication date of published research.
Criterios de acceso compartido de 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 de información de apoyo para compartir IPD
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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