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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 : Suspended (Currently suspended due to COVID-19 policies.)
First Posted : September 29, 2016
Last Update Posted : April 21, 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

Tracking Information
First Submitted Date  ICMJE September 26, 2016
First Posted Date  ICMJE September 29, 2016
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE October 7, 2019
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2019)
  • 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
  • Provider Referrals for Unmet Material Needs at Visit [ Time Frame: Baseline at Index visit ]
    Implementation outcome of WE CARE on provider referrals
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
  • Receipt of Community Resources [ Time Frame: 6-months post-index visit ]
    Effectiveness outcome of WE CARE on parental receipt of community resources
  • Provider Referrals for Unmet Material Needs at Visit [ Time Frame: Baseline at Index visit ]
    Implementation outcome of WE CARE on provider referrals
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
  • WE CARE survey distribution [ Time Frame: 1,2,and 3 years post-implementation of WE CARE ]
    Sustainability of WE CARE- office staff outcome
  • Appropriate referrals made by providers [ Time Frame: 1,2, and 3 years post-implementation of WE CARE ]
    Sustainability of WE CARE- provider outcome
  • Patient Satisfaction measured via CSQ-8 questionnaire [ Time Frame: 6 month post-index visit ]
  • Acceptability of WE CARE measured via questionnaires [ Time Frame: Through study completion; baseline and year 2 at all sites ]
    Providers and Office staff acceptability views on WE CARE
  • Whether Discussion of Unmet Needs (e.g., food insecurity) occurred at child's well-child care visit [ Time Frame: Baseline at index visit ]
  • Appropriateness of WE CARE measured via questionnaire [ Time Frame: Through study completion; baseline and year 2 at all sites ]
    Providers and Office staff appropriateness views on WE CARE
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices
Official Title  ICMJE Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Basic Unmet Material Needs
  • Patient Satisfaction
  • Receipt of Community Resources
  • Provider Referrals
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: WE CARE
  • 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
    Intervention: Behavioral: WE CARE
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 28, 2019)
2520
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2016)
11950
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02918435
Other Study ID Numbers  ICMJE H-35482
R01HD090191 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE
  • Pediatric Research in Office Settings
  • Continuity Research Network
  • Boston University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Arvin Garg, MD, MPH Boston Medical Center
PRS Account Boston Medical Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP