Community to Clinic Linkage Program at SFGH (CCLiP@SFGH)

December 16, 2019 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1809

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pediatric Primary Care Control
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: Pediatric Urgent Care Control
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: Pediatric Primary Care Intervention
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
Other: Pediatric Primary Care Intervention
30 minute on-site intervention with biweekly follow up phone calls to address social needs and health care status.
Experimental: Pediatric Urgent Care Intervention
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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family's connection to community resources and public benefits
Time Frame: up to 6 months post base-line
This will be assessed at 3 months and 6 months post-enrollment by phone administered questionnaires.
up to 6 months post base-line

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child health care utilization
Time Frame: up to 6 months
This will be assessed at 3 months and 6 months post-enrollment by phone administered questionnaires.
up to 6 months
Child health status
Time Frame: up to 6 months
This will be assessed at 3 months and 6 months post-enrollment by phone administered questionnaires.
up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver satisfaction with care/connectedness to clinical setting
Time Frame: up to 6 months
This will be assessed at 3 months and 6 months post-enrollment by phone administered questionnaires.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Laura M Gottlieb, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 6, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Actual)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 13-11628

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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