NCT04491448

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

August 12, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

July 24, 2020

Last Update Submit

September 3, 2021

Conditions

Primary Health Care

Outcome Measures

Primary Outcomes (1)

  • Acceptability of social needs screening in medical encounter

    Proportion reporting social needs relevant to medical care

    One-time interview, 20-25 minutes

Secondary Outcomes (1)

  • Effects of reported social needs on medical utilization and patient behavior

    One-time interview, 20-25 minutes

Interventions

Social needs screeningBEHAVIORAL

Interview and referral for non-medical health-related social needs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for a routine physicals or new patient visits

You may qualify if:

  • Aged 18+
  • New patient or routine physical exam, GIMO clinic, Montefiore Hospital

You may not qualify if:

  • Unable to provide verbal informed consent
  • Unable to complete questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Study Officials

  • Steven M Albert, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 29, 2020

Study Start

August 12, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
6 Months after study completion
Access Criteria
Contact PI

Locations

US(1)