Primary Health CareNCT04491448
Acceptability of Social Risk Screening
An observational study of Primary Health Care, run by University of Pittsburgh at 1 site in United States.
Trial summary
Social risk screening asks patients to provide information on health-related social needs that are non-medical but affect health. These include housing stability, food security, reliable medical transportation, consistent utilities service (heat, light, water), and interpersonal safety. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Health Care
- What is being tested?
- Social needs screening
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 31 Aug 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for a routine physicals or new patient visits
Who may be able to join
- Aged 18+
- New patient or routine physical exam, GIMO clinic, Montefiore Hospital
Who cannot join
- Unable to provide verbal informed consent
- Unable to complete questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Acceptability of Social Risk Screening in Adult Primary Care
Social risk screening asks patients to provide information on health-related social needs that are non-medical but affect health. These include housing stability, food security, reliable medical transportation, consistent utilities service (heat, light, water), and interpersonal safety. This research will determine the acceptability of such screening in adult patients who attend a primary care clinic in-person or via a telemedicine visit, the level of social need in patients, and how to flag such information for care, planning, and follow up.
Read the detailed description
This study will evaluate the acceptability of social risk screening among adult patients seen in the General Internal Medicine Offices (GIMO) at Montefiore Hospital. The research will enroll patients using the resident clinic, which provides medical care to lower-income patients as well as other patients. The study will be limited to new patients or patients receiving routine follow-up care.
Acceptability will be assessed by (i) the proportion of patients completing the screen among those approached; (ii) the proportion of screening questions completed; and (iii) the proportion of patients willing to complete the screening over the phone (a) by interviewer or (b) on via website using Qualtrics.
The representativeness of the sample will be assessed by comparing the participant sample to aggregate clinic demographic characteristics and deidentified Epic EHR indicators using an honest broker.
The survey instrument is the CMS Accountable Care Communities instrument. It includes patient indicators (demography) and appraisals of care (e.g., trust) that will allow assessment of correlates of social need and acceptability of screening in the clinical setting.
- Conditions
- Primary Health Care
- Being tested
- Social needs screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social needs screeningBehavioural
Interview and referral for non-medical health-related social needs
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of social needs screening in medical encounter
Proportion reporting social needs relevant to medical care
Measured: One-time interview, 20-25 minutes
Secondary outcomes (1)
Effects of reported social needs on medical utilization and patient behavior
Reports of missed appointments and need for social work referrals
Measured: One-time interview, 20-25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start12 Aug 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Health CareStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven M. Albert, University of Pittsburgh
- Investigators
- Steven M Albert, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491448
- Sponsor's protocol ID
- STUDY20010212
- Status last verified
- Sep 2021
- First submitted
- 24 Jul 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made available to other researchers and students who approach the investigators and prepare detailed analytic plans. The Office of Sponsored Programs will review requests to share de-identified research data/materials to determine whether an agreement needs to be executed.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Social Risk Screening in Adult Primary Care
- ClinicalTrials.gov ID
- NCT04491448
- Acronym / sponsor ID
- STUDY20010212
- Conditions
- Primary Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 29 Jul 2020 (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.
Social risk screening asks patients to provide information on health-related social needs that are non-medical but affect health. These include housing stability, food security, reliable medical transportation, consistent utilities service (heat, light, water), and interpersonal safety. This research will determine the acceptability of such screening in adult patients who attend a primary care clinic in-person or via a telemedicine visit, the level of social need in patients, and how to flag such information for care, planning, and follow up.
Detailed description
This study will evaluate the acceptability of social risk screening among adult patients seen in the General Internal Medicine Offices (GIMO) at Montefiore Hospital. The research will enroll patients using the resident clinic, which provides medical care to lower-income patients as well as other patients. The study will be limited to new patients or patients receiving routine follow-up care.
Acceptability will be assessed by (i) the proportion of patients completing the screen among those approached; (ii) the proportion of screening questions completed; and (iii) the proportion of patients willing to complete the screening over the phone (a) by interviewer or (b) on via website using Qualtrics.
The representativeness of the sample will be assessed by comparing the participant sample to aggregate clinic demographic characteristics and deidentified Epic EHR indicators using an honest broker.
The survey instrument is the CMS Accountable Care Communities instrument. It includes patient indicators (demography) and appraisals of care (e.g., trust) that will allow assessment of correlates of social need and acceptability of screening in the clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for a routine physicals or new patient visits
Key inclusion criteria (2 listed)
- Aged 18+
- New patient or routine physical exam, GIMO clinic, Montefiore Hospital
Key exclusion criteria (2 listed)
- Unable to provide verbal informed consent
- Unable to complete questionnaire
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 |
|---|---|---|
| Social needs screeningInterview and referral for non-medical health-related social needs | Behavioural | – |
Primary outcome
Acceptability of social needs screening in medical encounter
Time frame: One-time interview, 20-25 minutes
Proportion reporting social needs relevant to medical care
1 secondary outcome
Effects of reported social needs on medical utilization and patient behavior
Time frame: One-time interview, 20-25 minutes
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 5 Sep 2021.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available to other researchers and students who approach the investigators and prepare detailed analytic plans. The Office of Sponsored Programs will review requests to share de-identified research data/materials to determine whether an agreement needs to be executed.
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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.
Steven M Albert, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Health Care, run by University of Pittsburgh 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 2 inclusion and 2 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 5 Sep 2021. 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?
Acceptability of social needs screening in medical encounter (time frame: One-time interview, 20-25 minutes). 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 5 Sep 2021.