Clinical trial NCT05201586: CCTs to Address Social Needs in a Primary Care Clinic
Official title: Conditional Cash Transfers to Address Social Determinants of Health and Social Needs in a Primary Care Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health-Related Behavior
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Eligible participants will be 18-89 years old of any gender
* At least 1 chronic medical condition including obesity, diabetes, hypertension, chronic kidney disease, coronary artery disease, chronic lung disease, active smoker, and stroke.
* Participants with Medicare and/or Medicaid insurance
* Home address falls within a West Philadelphia zip code (19104, 19131, 19139, 19143, 19151)

Exclusion Criteria:

* Adults 90 and older
* Patients who are unable to provide consent due to mental disability or illness
* Patients unable to participate in a verbal interview due to a physical or mental health condition will also be excluded

Primary outcomes:
measure: Themes in interview data
timeFrame: 6 months
Secondary outcomes:
measure: Short Form (SF)-12 survey
timeFrame: 6 months
measure: Objective health metrics - Blood pressure
timeFrame: 6 months
measure: Objective health metrics - Hemoglobin A1c
timeFrame: 6 months
measure: Objective health metrics - Cigarettes per day
timeFrame: 6 months
measure: Utilization data - Emergency department (ED) visits
timeFrame: 6 months
measure: Utilization data - Hospital admissions
timeFrame: 6 months
measure: Utilization data - Primary Care Office Visits
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: