CCTs to Address Social Needs in a Primary Care Clinic

NCT05201586 | Completed

• 1 other identifier: 849553
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Health-Related Behavior

Outcome Measures

Primary Outcomes (1)

• Themes in interview data

  The primary outcome is to identify main themes in the interview data of how social needs impact health and what effect CCTs may have have on patient perceptions of health. The audio recordings will be sent for external transcription by a HIPAA compliant transcription service. The transcriptions will be coded and analyzed in nVivo, a qualitative data management system. Content analyses will be used to discover the main themes in the interview data and then look at associations among the prevalence of themes and social needs within and between groups.

  6 months

Secondary Outcomes (7)

• Short Form (SF)-12 survey

  6 months

• Objective health metrics - Blood pressure

  6 months

• Objective health metrics - Hemoglobin A1c

  6 months

• Objective health metrics - Cigarettes per day

  6 months

• Utilization data - Emergency department (ED) visits

  6 months

Study Arms (2)

Conditional cash transfer

ACTIVE COMPARATOR

Investigators will randomize 15 patients into this intervention arm. All participants will undergo a semi-structured patient interview about how social needs impact health and self-perceptions of health at the time of enrollment and again in 6 months. All participants will receive a CCT after the first interview.

Other: Conditional Cash Transfer; Other: Semi-structured interviews

Control

ACTIVE COMPARATOR

Investigators will randomize 15 patients into this control arm. All participants will undergo a semi-structured patient interview about how social needs impact health and self-perceptions of health at the time of enrollment and again in 6 months.

Other: Semi-structured interviews

Interventions

Conditional Cash Transfer OTHER

CCTs will be given to participants in the form of a pre-loaded debit card.

Conditional cash transfer

Semi-structured interviews OTHER

Research team will conduct semi-structured interviews exploring how social determinants of health and social needs impact health. Participants will be asked to set a health goal. 6 months after the initial interview, the team will interview the patients again and evaluate whether that health goal was achieved.

Conditional cash transfer; Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: January 21, 2022
• Study Start: November 1, 2021
• Primary Completion: December 21, 2022
• Study Completion: June 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)