Community to Clinic Linkage Program at SFGH (CCLiP@SFGH)
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| ClinicalTrials.gov Identifier: NCT01939704 |
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Recruitment Status :
Completed
First Posted : September 11, 2013
Last Update Posted : December 18, 2019
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Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
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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 |
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 (Clinical Trial) |
| Actual Enrollment : | 1809 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 |
| Actual Study Completion Date : | October 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Children's Health
| Arm | Intervention/treatment |
|---|---|
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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.
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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.
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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
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Other: Pediatric Primary Care Intervention
30 minute on-site intervention with biweekly follow up phone calls to address social needs and health care status. |
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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
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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 :
- 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 :
- 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.
- 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:
- 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.
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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
| United States, California | |
| San Francisco General Hospital | |
| San Francisco, California, United States, 94110 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Laura M Gottlieb, MD, MPH | University of California, San Francisco |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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):
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01939704 |
| Other Study ID Numbers: |
13-11628 |
| First Posted: | September 11, 2013 Key Record Dates |
| Last Update Posted: | December 18, 2019 |
| Last Verified: | December 2019 |