Health-Related BehaviorNCT05201586
CCTs to Address Social Needs in a Primary Care Clinic
A study testing Conditional Cash Transfer and Semi-structured interviews in people with Health-Related Behavior, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Health-Related Behavior
- What is being tested?
- Conditional Cash Transfer and Semi-structured interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Conditional Cash Transfers to Address Social Determinants of Health and Social Needs in a Primary Care Clinic
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.
Read the 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.
- Conditions
- Health-Related Behavior
- Being tested
- Conditional Cash Transfer, Semi-structured interviews
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditional Cash TransferOther
CCTs will be given to participants in the form of a pre-loaded debit card.
Semi-structured interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
Short Form (SF)-12 survey
Interviews will include administration of an SF-12 survey and a secondary outcome will look at differences in SF-12 answers between groups before and after intervention. The SF-12 is a validated health-related quality-of-life questionnaire consisting of twelve questions that assess patient's perceptions of physical and mental health. The SF-12 does not use a scoring scale; answers consist instead of "yes, no" or ratings of "not at all, a little bit, moderately, quite a bit, or extremely."
Measured: 6 months
Objective health metrics - Blood pressure
Most recent available blood pressure will be documented at the time of enrollment and again in 6 months. Changes to these clinical measures will be investigated between the control and intervention groups.
Measured: 6 months
Objective health metrics - Hemoglobin A1c
Most recent available diabetes number or Hemoglobin A1c will be documented at the time of enrollment and again in 6 months. Changes to these clinical measures will be investigated between the control and intervention groups.
Measured: 6 months
Objective health metrics - Cigarettes per day
If patient smokes, the number of cigarettes per day will be documented at the time of enrollment and again in 6 months. Changes to these clinical measures will be investigated between the control and intervention groups.
Measured: 6 months
Utilization data - Emergency department (ED) visits
The number of emergency department (ED) visits of each participant in the 6 months before enrollment and during the study period will be documented. Changes to these clinical measures will be investigated between the control and intervention groups.
Measured: 6 months
Utilization data - Hospital admissions
The number of hospital admissions of each participant in the 6 months before enrollment and during the study period will be documented. Changes to these clinical measures will be investigated between the control and intervention groups.
Measured: 6 months
Utilization data - Primary Care Office Visits
The number of primary care office visits of each participant in the 6 months before enrollment and during the study period will be documented. Changes to these clinical measures will be investigated between the control and intervention groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Nov 2021
- Primary completion21 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-Related BehaviorStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201586
- Sponsor's protocol ID
- 849553
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditional Cash Transfers to Address Social Determinants of Health and Social Needs in a Primary Care Clinic
- ClinicalTrials.gov ID
- NCT05201586
- Acronym / sponsor ID
- 849553
- Conditions
- Health-Related Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conditional cash transfer | Active comparator | Other: Conditional Cash Transfer, Other: Semi-structured interviewsInvestigators 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. |
| Control | Active comparator | Other: Semi-structured interviewsInvestigators 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditional Cash TransferCCTs will be given to participants in the form of a pre-loaded debit card. | Other | Conditional cash transfer |
| Semi-structured interviewsResearch 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. | Other | Conditional cash transfer, Control |
Primary outcome
Themes in interview data
Time frame: 6 months
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.
7 secondary outcomes
Short Form (SF)-12 survey
Time frame: 6 months
Objective health metrics - Blood pressure
Time frame: 6 months
Objective health metrics - Hemoglobin A1c
Time frame: 6 months
Objective health metrics - Cigarettes per day
Time frame: 6 months
Utilization data - Emergency department (ED) visits
Time frame: 6 months
Utilization data - Hospital admissions
Time frame: 6 months
Utilization data - Primary Care Office Visits
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Health-Related Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
RecruitingObservational study
Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia
CAR T-cell Therapy, Autoimmune Hemolytic Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conditional Cash Transfer and Semi-structured interviews in people with Health-Related Behavior, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Themes in interview data (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.