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Clinical Trial Summary

This is a study of conditional cash transfers (CCTs) to address social needs impacting the health of low-income patients in West Philadelphia who screen positive for financial strain, transportation needs, or food insecurity. Participants will be randomized to receive a CCT at enrollment. All participants will be interviewed at time of enrollment and again in 6 months to investigate if a CCT affected objective health outcomes, individual health goals, and self-rated perceptions of health.


Clinical Trial Description

This is a randomized trial of the effect of conditional cash transfers (CCTs) on West Philadelphia residents who are patients at two Division of General Internal Medicine primary care clinics located at 3701 Market Street. Currently, our practice administers social determinants of health (SDOH) screening questionnaires which are available to review as part of a patients electronic medical record. Eligible patients will have been flagged as having at least 1 of 3 social needs: financial resource strain, transportation needs, and food insecurity. From this pool, patients with Medicare and Medicaid insurance who live in low income neighborhoods in Philadelphia will be recruited. Eligible participants will be older than 18 years old with at least 1 chronic medical condition including obesity, diabetes, hypertension, chronic kidney disease, coronary artery disease, chronic lung disease, active smoker, and stroke. Eligible patients will be randomized to either the CCT arm or control. Verbal consent will be obtained from all participants allowing the study team to collect personal health information and conduct audio-recorded semi-structured patient interviews. Personal health information will include demographics, chronic medical conditions, weight, blood pressure, cigarettes per day, and last hemoglobin A1c. Utilization outcomes such as ED visits, hospital admissions, and primary care office visits using Epic will be recorded. This data will be collected in REDCap at the time of enrollment and at the end of the 6-month study period. Patient interviews will be conducted by a research assistant. The participants will have the option of conducting the interviews in-person using a private room within the primary care clinic or virtually using a secure telehealth platform. Translation services will be provided, if needed. The patient will first complete the Short Form-12 (SF-12) survey, a validated multidimensional generic measure of health-related quality of life. For interviews conducted in-person, a paper version of the SF-12 will be given to the patients and collected at the end of the interview. For interviews conducted virtually, the interviewer will orally present the SF-12 survey to the participant and record the answers in a paper format. The interviewer will then conduct an audio-recorded semi-structured enrollment interview exploring patient perceptions about the social need flagged in the SDOH screening questionnaire, how it impacts health, and asked to set a personal health goal to achieve over the next 6 months. Participants who were randomized to receive the CCT will be asked to use it towards the SDOH risk factor flagged by the social needs assessment. If the patient chooses to spend money on something not related to identified social need, there will be no punitive financial repercussions or payback required. The CCT will be given in the form of a pre-loaded electronic debit card like the Clincard. The study team will not review expenses of participants during or after the study is complete. Six months after the initial interview, all participants will again complete the SF-12 survey and the research assistant will conduct audio-recorded semi-structured exit interviews either in-person or virtually. These interviews will explore whether the patients achieved their health goal. Participants who received the CCT will be asked additional questions exploring whether the CCT helped achieve that goal. At the end of each interview, audio tapes will be sent for external transcription by a HIPAA compliant transcription service and then analyzed with the help of the research assistant working with the study team. ;


Study Design


NCT number NCT05201586
Study type Interventional
Source University of Pennsylvania
Contact Marguerite Balasta, MD
Phone 215-349-5200
Email [email protected]
Status Recruiting
Phase N/A
Start date November 1, 2021
Completion date September 30, 2022