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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04491448
Other study ID # STUDY20010212
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 12, 2020
Est. completion date August 31, 2021

Study information

Verified date September 2021
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 218
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Aged 18+ 2. New patient or routine physical exam, GIMO clinic, Montefiore Hospital Exclusion Criteria: 1. Unable to provide verbal informed consent 2. Unable to complete questionnaire

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social needs screening
Interview and referral for non-medical health-related social needs

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability of social needs screening in medical encounter Proportion reporting social needs relevant to medical care One-time interview, 20-25 minutes
Secondary Effects of reported social needs on medical utilization and patient behavior Reports of missed appointments and need for social work referrals One-time interview, 20-25 minutes
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