Pilot Guaranteed Income Study, Philadelphia, April 2023

Study Overview
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Brief Summary
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The goal of this pilot clinical trial is to learn about the effects of a short-term unconditional cash transfer (UCT) in people living with poverty and chronic disease (either prediabetes/diabetes or hypertension). The main questions it aims to answer are: How feasible and acceptable is the intervention? How are key health behaviors and outcomes affected by the intervention? What are reasonable effect sizes to expect in a larger trial? Participants will complete surveys and health measurements at two timepoints 3 months apart. Half of the participants will be randomly assigned to the treatment where they will receive a UCT of $1000 over 4 months. Researchers will compare the treatment group to the control group to see if there are improvements in health risk factors directly related to insufficient resources (food and utility security, stress-levels, mental bandwidth), financial outcomes, and health behaviors.

Detailed Description
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Health behaviors are major, modifiable risk factors for the development and progression of chronic diseases, which account for a large proportion of all deaths in the US and contribute to disparities in premature mortality based on both income and race. There is substantial evidence, for example, that behaviors like smoking, physical inactivity, and unhealthy diet are associated with an increased risk of cardiovascular disease (CVD), as are modifiable factors such as blood pressure, cholesterol, body mass index, and fasting glucose. A growing body of research suggests that poverty may affect health behaviors through financial and psychological pathways. However, few studies have rigorously examined the effects of poverty alleviation interventions on health behaviors, particularly among individuals at high risk for CVD. Even fewer studies have examined potential psychological mechanisms by which anti-poverty interventions might influence health behavior. This pilot project will examine the effect of unconditional cash transfers, an economic intervention that is gaining traction among policymakers, on risk factors for CVD and other chronic diseases. The project will focus on low-income adults in Philadelphia who have at least one health risk factor for CVD (diabetes/pre-diabetes and/or hypertension) and examines whether short-term, unconditional cash transfer payments result in changes in objective and self-reported health outcomes. The second aim examines potential psychological mechanisms through which the cash transfer intervention may affect study participants' behavior, including mental health, psychosocial stress, bandwidth, and future orientation. The third aim uses qualitative methods to understand participants' experiences with this study. The project activities will include developing and testing the cash transfer intervention (Stage 1) as well as basic science analysis of mechanisms of change (Stage 0). Survey and measurement data will be collected from 100 participants at baseline and 3 month follow-up in a two-arm randomized controlled trial (50 in control, 50 in intervention). 16 participants will receive a blood pressure cuff to take home and send measurements weekly to assess the feasibility of at-home measurement (8 control, 8 intervention; half of each group will transmit wirelessly, the other half will not). 30 participants from the 3-month follow-up who are interested in doing an interview will provide additional qualitative data on their experience.

Official Title
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Philly Family Trust Study: A Pilot Randomized Controlled Trial of an Unconditional Cash Transfer to Improve Health Behaviors Among Adults With Chronic Diseases

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Cash Transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or greater Pennsylvania Medicaid enrollee At least one recent clinic visit at Penn Family Care (earliest six months before start of recruitment) Diagnosis of pre-diabetes/diabetes and/or hypertension Actively prescribed a medication for diabetes or hypertension Regular resident of the Philadelphia metro area without plans to leave in the next 6 months Exclusion Criteria: Does not meet all of the inclusion criteria Unable to provide consent Non-English speaker Cognitive impairment, per principal investigators' discretion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: At the end of the baseline assessment, participants will be randomized using a permuted block technique with block size of 4 to either usual care (Arm 1) or to the unconditional cash transfer intervention (Arm 2).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No intervention | |
| Experimental: Cash Transfer<br>Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. | Behavioral: Cash Transfer<br>* Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in food security category | Change from baseline in food security in the last 30 days as measured by the US Department of Agriculture food security scale. Outcome is 3 ordered categories: high or marginal food security, low food security, very low food security. | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in utility security category | Change from baseline in utility security in the last 3 months as measured by the Home Energy Insecurity scale. Outcome is 5 ordered categories: thriving, capable, stable, vulnerable, in-crisis. | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in financial well-being scale | Change from baseline in current financial well-being as measured by the Consumer Financial Protection Bureau Financial Well-Being 0-100 scale (higher scores are correlated to more well-being). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in perceived stress scale | Change from baseline in perceived stress in the last 30 days as measured by the Perceived Stress Scale (short form; 0-16, higher scores are correlated to more stress). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in state anxiety scale | Change from baseline in current anxiety as measured by the State Trait Anxiety Inventory (20-items reverse-coded and summed according to the manual, higher scores are correlated to more anxiety). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in mental bandwidth | Change from baseline in number of lapses in the Psychomotor Vigilance Task (more lapses indicate less mental bandwidth). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in health care expenditures on medications | Change from baseline in number of dollars spent out-of-pocket on medications in the past 30 days. | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in adherence to medication refills scale | Change from baseline in current adherence to refilling medications as measured by that subscale of the Adherence to Refills and Medications Scale (ARMS; 4-16, higher scores indicate lower adherence). | Assessed at 1-hour appointment at baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of emergency department visits | Change from baseline in number of emergency department visits in the prior 3 months as recorded in the Electronic Health Record. | Once all study appointments are completed, ED visit data will be collected through the Data Analytics Center for the 3-month period before baseline, and the 3-month period after baseline. | 
| Change in number of health care visits (non-emergency department) | Change from baseline in number of non-emergency department visits in the prior 3 months as recorded in the Electronic Health Record. | Once all study appointments are completed, number of health care visits(non-ED) data will be collected through the Data Analytics Center for the 3-month period before baseline, and the 3-month period after baseline. | 
| Change in cigarette dependence scale | Change from baseline in current cigarette dependence as measured by the Cigarette Dependence Scale (short version; 5-25, higher scores indicate more dependence). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in alcohol use scale | Change from baseline in current alcohol use as measured by the Alcohol Use Disorders Identification Test (0-12, higher scores indicate more use). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in all health care expenditures | Change from baseline in sum of dollars spent out-of-pocket on medications, office visits, and emergency room visits in the past 30 days. | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in time preference (patience) | Change from baseline on current patience which is a single item in the Preference Survey Module (0 completely unwilling to 10 completely willing to give up present benefits for future benefits, higher scores indicate future preference). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in time preference (behavioral task) | Change from baseline on current snack choice (binary: chose a more or a less healthy snack, choosing a healthy snack indicates future preference). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in psychological distress scale | Change from baseline in psychological distress in the past 30 days as measured by the Kessler Psychological Distress Scale (K6+, 6-30, higher scores indicate more distress). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in number of healthy days | Change from baseline in self-reported number of healthy days in the past 30 as measured by the CDC Health-Related Quality of Life Scale (0-30 days). | Assessed at 1-hour appointment at baseline and 3 months | 
| Change in adherence to taking medications scale | Change from baseline in current adherence to taking medications as measured by that subscale of the Adherence to Refills and Medications Scale (ARMS; 8-32, higher scores indicate lower adherence). | Assessed at 1-hour appointment at baseline and 3 months |