Overview

This trial is active, not recruiting.

Conditions family's connection to community resources and public benefits, caregiver satisfaction and connectedness to clinic, child health care status
Treatments pediatric primary care intervention, pediatric urgent care intervention
Sponsor University of California, San Francisco
Start date October 2013
End date September 2015
Trial size 2250 participants
Trial identifier NCT01939704, 13-11628

Summary

It is increasingly clear that the environment in which a child lives, plays, and goes to school has a significant impact on their health. With the implementation of a Community to Clinic Linkage Program (CCLiP) in the SFGH Pediatrics Clinics, we will routinely address Social Determinants of Health when families present. We will randomize patients to receive either the CCLiP intervention or standard of care. We will evaluate programmatic outcome, health care utilization data and return on investment data. We hypothesize that by addressing the environmental and social factors that contribute to health within the setting of the medical home, we will be able to better connect families to community resources, enable more appropriate use of healthcare resources, improve health status, and enhance patient satisfaction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(No Intervention)
Baseline survey with a social needs assessment, health care status, health care satisfaction and health care utilization assessment and two telephone-based follow up surveys at 3 and 6 months.
(No Intervention)
Baseline survey with a social needs assessment, health care status, health care satisfaction and health care utilization assessment and two telephone-based follow up surveys at 3 and 6 months.
(Experimental)
Baseline survey that includes social needs assessment, health care status, health care satisfaction and health care utilization assessment; 30 minute on-site intervention, twice monthly follow-up phone calls for up to 3 months to help address social needs
pediatric primary care intervention
30 minute on-site intervention with biweekly follow up phone calls to address social needs and health care status.
(Experimental)
Baseline survey that includes social needs assessment, health care status, health care satisfaction and health care utilization assessment; 30 minute on-site intervention, twice monthly follow-up phone calls for up to 3 months to help address social needs
pediatric urgent care intervention
3 months of intervention protocol, including a 30 minute on-site intervention and twice monthly phone calls to address social needs and health care status.

Primary Outcomes

Measure
Family's connection to community resources and public benefits
time frame: up to 6 months post base-line

Secondary Outcomes

Measure
Child health care utilization
time frame: up to 6 months
Child health status
time frame: up to 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - English or Spanish Speaking - Parent/caregiver accompanying an SFGH Primary Care or Urgent Care Clinic patient 0-17 years old - Consenting adult over or equal to 18 years old Exclusion Criteria: - Non-English or non-Spanish speaking caregiver - Caregiver under age 18 - Caregiver accompanying patient is not familiar with the child's living situation - Family participated in study previously - Non-San Francisco resident - Foster child or child in clinic for a child protective clearance exam

Additional Information

Official title Community to Clinic Linkage Program at SFGH
Principal investigator Laura M Gottlieb, MD, MPH
Description We are proposing a 4-arm, 18 month randomized control clinical trial to address social determinants of health, improve health status and health care satisfaction, and change health care utilization patterns in the Pediatric Urgent Care and Primary Care Clinics at San Francisco General Hospital. We will compare our CCLiP protocol to standard of care in both the Pediatric Primary Care Clinic & Urgent Care. All arms (intervention and control) include a baseline survey including social needs assessment, health care status, health care satisfaction and health care utilization assessment; and two telephone-based follow up surveys at 3 and 6 months. Patients in the intervention arms (whether in urgent care or primary care) will receive a maximum of 3 months of intervention protocol which includes a 30 minute on-site intervention at time of enrollment in addition to twice monthly follow-up phone calls for up to 3 months to help address social needs. Patients in all arms will receive 3 and 6-month follow up surveys.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.