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

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ClinicalTrials.gov Identifier: NCT01939704
Recruitment Status : Active, not recruiting
First Posted : September 11, 2013
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Family's Connection to Community Resources and Public Benefits Caregiver Satisfaction and Connectedness to Clinic Child Health Care Status Other: Pediatric Primary Care Intervention Other: Pediatric Urgent Care Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Community to Clinic Linkage Program at SFGH
Study Start Date : October 2013
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939704


Locations
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United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Laura M Gottlieb, MD, MPH University of California, San Francisco

Publications:
Hanson M, Lawton E. Between a rock and a hard place: The prevalence and severity of unmet legal needs in the pediatric emergency department setting. Medical Legal Partnership for Children, 2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01939704     History of Changes
Other Study ID Numbers: 13-11628
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018