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Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices (PROSWECARE)

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ClinicalTrials.gov Identifier: NCT02918435
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
Pediatric Research in Office Settings
Continuity Research Network
Boston University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Boston Medical Center

Brief Summary:
This research project is aimed to assess the implementation, effectiveness, and sustainability of a pediatric-based intervention aimed at reducing families' unmet material needs (food, housing, employment, childcare, household utilities, education) in pediatric practices throughout the United States.

Condition or disease Intervention/treatment Phase
Basic Unmet Material Needs Patient Satisfaction Receipt of Community Resources Provider Referrals Behavioral: WE CARE Not Applicable

Detailed Description:
The investigators prior work has focused on developing a pediatric primary care-based intervention, WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education), aimed at addressing poor families' material needs - food security, employment, parental education, housing stability, household heat, and childcare - by systematically screening for these needs and referring families to existing community-based services. To date, the investigators have tested WE CARE primarily in community health centers (CHCs); their randomized controlled trial (RCT) demonstrated WE CARE's efficacy on parental receipt of community-based resources. However, over 80% of low-income children receive care from providers in traditional pediatric practices (i.e. non-CHCs). The investigators therefore will conduct a large-scale, Hybrid Type 2 effectiveness-implementation trial in eighteen pediatric practices in the US. A stepped wedge study cluster RCT design will be used to implement WE CARE in all practices using two common strategies used to integrate systems-based interventions into primary care - a previously facilitated "on-site" strategy in which content experts provide training sessions and on-going consultation; and a self-directed "web-based" method modeled after the American Academy of Pediatrics' practice transformation strategy. The proposed study's specific aims are to: 1) demonstrate the non-inferiority of the self-directed, web-based strategy for implementing WE CARE, in comparison to the facilitated on-site strategy; 2) demonstrate WE CARE's effectiveness on increasing parental receipt of community resources; and 3) assess the sustainability of WE CARE in pediatric practices. The investigators hypothesize that WE CARE will have equivalent fidelity via the two strategies. Based on prior work, the investigators hypothesize that WE CARE will significantly increase parental receipt of community resources three months post-visit compared to usual care. The investigators also expect WE CARE to be sustained 1.5-, 2-, and 2.5-years post-implementation; they expect to gather data from over 2,700 chart reviews, 2,520 parent-child dyads, and 360 providers and office staff. This proposal has significant public health implications for the delivery of primary care to low-income children.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2520 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
No Intervention: Usual Care-Control
Participants in the usual care group will receive standard pediatric care.
Experimental: On-site WE CARE implementation arm
WE CARE will be implemented in the study site using a facilitated "on-site" strategy. 1. Participants will receive the WE CARE survey at health supervision visits; this survey will be used to identify unmet material needs. 2. Providers will be trained on WE CARE via an on-site team which will teach them how to review the survey and provide referrals (community resource information sheets) from a Family Resource Book located in each exam room.
Behavioral: WE CARE
The WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) survey consists of 12 questions used to identify six unmet material needs (education, employment, food security, housing, childcare, household utilities). It will be administered at health supervision visits during the WE CARE phase at each study site. The Family Resource Book will contain resource information sheets for each of these needs listing available community resources. A physician champion will conduct regular booster sessions every 4 months and train new providers should there be staff turnover.

Experimental: Self-directed web-based WE CARE implementation arm
WE CARE will be implemented in the study site using a web-based implementation strategy. 1. Participants will receive the WE CARE survey at health supervision visits; this survey will be used to identify unmet material needs. 2. Providers will be trained on WE CARE via web-based tools (e.g., web-based seminar) which will teach them how to review the survey and provide referrals (community resource information sheets) from a Family Resource Book located in each exam room
Behavioral: WE CARE
The WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) survey consists of 12 questions used to identify six unmet material needs (education, employment, food security, housing, childcare, household utilities). It will be administered at health supervision visits during the WE CARE phase at each study site. The Family Resource Book will contain resource information sheets for each of these needs listing available community resources. A physician champion will conduct regular booster sessions every 4 months and train new providers should there be staff turnover.




Primary Outcome Measures :
  1. Receipt of Community Resources [ Time Frame: 3 months post-index visit ]
    Effectiveness outcome of WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) on parental receipt of community resources

  2. Provider Referrals for Unmet Material Needs at Visit [ Time Frame: Baseline at Index visit ]
    Implementation outcome of WE CARE on provider referrals


Secondary Outcome Measures :
  1. WE CARE survey distribution [ Time Frame: 1.5-,2-,and 2.5- years post-implementation of WE CARE ]
    Sustainability of WE CARE- office staff outcome

  2. Appropriate referrals made by providers [ Time Frame: 1.5-,2-,and 2.5- years post-implementation of WE CARE ]
    Sustainability of WE CARE- provider outcome

  3. Patient satisfaction measured via the CAHPS Clinician and Group Survey (Child) [ Time Frame: 3 months post-index visit ]
    Parental assessment of satisfaction of pediatric care received

  4. Family centeredness measured via the National Survey of Children's Health (2016) [ Time Frame: 3 months post-index visit ]
    Parental assessment of family centeredness of pediatric care received

  5. Care coordination measured via the National Survey of Children's Health (2016) [ Time Frame: 3 months post-index visit ]
    Parental assessment of the care coordination of pediatric care received

  6. Acceptability of WE CARE measured via questionnaires [ Time Frame: Through study completion; baseline and 12-15 months into WE CARE phase at all sites ]
    Providers and Office staff acceptability views on WE CARE

  7. Whether Discussion of Unmet Needs (e.g., food insecurity) occurred at child's well-child care visit [ Time Frame: Baseline at index visit ]
    Measurement of whether discussion of unmet social needs occurred during pediatric visit

  8. Appropriateness of WE CARE measured via questionnaire [ Time Frame: Through study completion; baseline and 12-15 months into WE CARE phase at all sites ]
    Providers and Office staff appropriateness views on WE CARE



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents/legal guardians (aged at least 18 years) of children aged 2 months through 10 years whose child presents for a health supervision visit

Exclusion Criteria:

  • Foster parents, parents who speak neither English or Spanish, and previously enrolled parents

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): NCT02918435


Contacts
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Contact: Arvin Garg, MD, MPH 617-414-3817 arvin.garg@bmc.org
Contact: Michelle Pellicer, MPH 617- 414-5974 michelle.pellicer@bmc.org

Locations
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United States, Massachusetts
Arvin Garg Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Arvin Garg, MD         
Sponsors and Collaborators
Boston Medical Center
Pediatric Research in Office Settings
Continuity Research Network
Boston University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Arvin Garg, MD, MPH Boston Medical Center

Publications:
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02918435    
Other Study ID Numbers: H-35482
R01HD090191 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
WE CARE
Pediatric practices