- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491448
Acceptability of Social Risk Screening
Acceptability of Social Risk Screening in Adult Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18+
- New patient or routine physical exam, GIMO clinic, Montefiore Hospital
Exclusion Criteria:
- Unable to provide verbal informed consent
- Unable to complete questionnaire
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of social needs screening in medical encounter
Time Frame: One-time interview, 20-25 minutes
|
Proportion reporting social needs relevant to medical care
|
One-time interview, 20-25 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of reported social needs on medical utilization and patient behavior
Time Frame: One-time interview, 20-25 minutes
|
Reports of missed appointments and need for social work referrals
|
One-time interview, 20-25 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY20010212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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