Health and Health Care Utilization Effects of Medical Debt Forgiveness

• ClinicalTrials.gov Identifier: NCT04835012
• Recruitment Status: Recruiting
• First Posted: April 8, 2021
• Last Update Posted: April 20, 2021
• Sponsor: University of California, Los Angeles
• Collaborators: Stanford University; National Opinion Research Center; Abdul Latif Jameel Poverty Action Lab; National Institutes of Health (NIH)
• Information provided by (Responsible Party): Wesley Yin, University of California, Los Angeles

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Health Care Utilization; Depression; Anxiety; Subjective Wellbeing	Other: Medical debt forgiveness

Detailed Description:

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 17000 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Health and Health Care Utilization Effects of Medical Debt Forgiveness
• Actual Study Start Date: November 9, 2020
• Estimated Primary Completion Date: November 2021
• Estimated Study Completion Date: December 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Other: Medical debt forgiveness; 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.

Outcome Measures

Primary Outcome Measures :

1. 8-item Patient Health Questionnaire (PHQ-8) Depression Scale [ Time Frame: 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.

Secondary Outcome Measures :

1. Received Needed Health Care [ Time Frame: 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)
2. Received Needed Rx [ Time Frame: 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)
3. 7-item Generalized Anxiety Disorder (GAD7) Scale [ Time Frame: 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).
4. Stress [ Time Frame: 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)
5. General Health [ Time Frame: 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)
6. Happiness [ Time Frame: 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)
7. Problems paying other bills [ Time Frame: 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)
8. Changes in spending due to medical debt [ Time Frame: 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)
9. Changes in borrowing due to medical debt [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

The study population is a probability sample drawn from population of individuals who owe medical debt held by FFAM, a debt collection agency.

Criteria

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

Contacts and Locations

Contacts

Contact: Professor, PhD; (310) 206-3969; aorkin@research.ucla.edu

Locations

United States, California

UCLA IRB; Recruiting

Los Angeles, California, United States, 90095

Contact: Professor, PhD 310-206-3969 aorkin@research.ucla.edu

Sponsors and Collaborators

University of California, Los Angeles

Stanford University

National Opinion Research Center

Abdul Latif Jameel Poverty Action Lab

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Wesley Yin, PhD; University of California, Los Angeles

More Information

• Responsible Party: Wesley Yin, Associate Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT04835012
• Other Study ID Numbers: IRB#20-001700
• First Posted: April 8, 2021
• Last Update Posted: April 20, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code
• Time Frame: De-identified and confidential IPD will be made available by the on-line publication date of published research.
• Access Criteria: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wesley Yin, University of California, Los Angeles:

Health Care Utilization; Mental Health; Depression; Anxiety; Subjective Wellbeing; Medical Debt

Additional relevant MeSH terms:

Depression; Behavioral Symptoms