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Implementierung einer Intervention zur Adressierung sozialer Determinanten von Gesundheit in pädiatrischen Praxen (PROSWECARE)

5. November 2026 aktualisiert von: Arvin Garg, University of Massachusetts, Worcester

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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. Of note, due to the COVID-19 pandemic, the on-site strategy was changed to a "study team facilitated live webinar" implementation 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 parents, and 360 providers and office staff. This proposal has significant public health implications for the delivery of primary care to low-income children.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

2073

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02118
        • Boston Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Monate bis 10 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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
  • Providers and staff involved in the implementation component of the WE CARE intervention arm

Exclusion Criteria:

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Usual Care-Control

Participants in the usual care group will receive standard pediatric care.
Sonstiges: Usual Care

Standard pediatric care.
Experimental: Study team facilitated live webinar WE CARE implementation arm

WE CARE will be implemented in the study site using a facilitated "live webinar" 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 a live webinar facilitated by the study 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.
Verhalten: 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 pre-recorded webinar WE CARE implementation arm

WE CARE will be implemented in the study site using a pre-recoded webinar 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 self-directed pre-recorded webinar 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Receipt of Community Resources
Zeitfenster: 3 months post-index visit

Effectiveness outcome of WE CARE on caregiver receipt of community resources. This is measured by whether the caregiver of the child received new resources related to any of the listed domains as a result of a referral through the WE CARE program
3 months post-index visit
Provider Referrals for Unmet Material Needs Received at Visit
Zeitfenster: At the index visit

The number of provider referrals for unmet needs during a care visit for community resources that were self-reported by parent participants.
At the index visit

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sustainability of WE CARE--Survey Distribution
Zeitfenster: 6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice

Sustainability of WE CARE as measured by the number of surveys distributed across participating care practices.
6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice
Sustainability of WE CARE--Appropriate Referrals Made by Providers
Zeitfenster: 6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice

Sustainability of WE CARE as measured by the number of appropriate provider referrals to community resources for families who indicated that they wanted help with a need on a WE CARE screener.
6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice
Parental Assessment of Patient Satisfaction
Zeitfenster: At the index visit

Parental assessment of satisfaction of pediatric care received as measured by the Clinician and Group Survey.
At the index visit
Parental Assessment of Family Centeredness
Zeitfenster: At the index visit

Parental assessment of family centeredness of pediatric care received as measured by the National Survey of Children's Health (2016).
At the index visit
Parental Assessment of Care Coordination - Extra Help
Zeitfenster: 3-months post-index visit

Parental assessment of the care coordination of pediatric care received as measured via the National Survey of Children's Health (2016).

"During the past 3 months, have you felt that you could have used extra help arranging or coordinating your child's care among the different health care providers or services?"

Since this measure is recording the opinions of parents based on a question, the unit would be of participants who responded yes or no to the question above.
3-months post-index visit
Parental Assessment of Care Coordination - Amount of Help
Zeitfenster: 3-months post-index visit

Parental assessment of the care coordination of pediatric care received as measured via the National Survey of Children's Health (2016).

"If yes, during the past 3 months, how often did you get as much help as you wanted with arranging or coordinating your child's health care?"
3-months post-index visit
Parental Assessment of Care Coordination - Satisfaction
Zeitfenster: At the index visit

Parental assessment of the care coordination of pediatric care received as measured via the National Survey of Children's Health (2016).

"Overall, how satisfied are you with the communication among your child's doctors and other health care providers?"

Since this measure is recording the opinions of parents based on a question, the unit would be of participants who responded yes or no to the question above. The number analyzed may differ from the overall number analyzed due to participants not responding to all the prompts on the survey.
At the index visit
Provider and Office Staff Acceptability of WE CARE
Zeitfenster: Post-implementation (within 3 months of completion of the Implementation period)

Assessed post-implementation through qualitative interviews with providers and office staff exploring perceptions of WE CARE's acceptability, including satisfaction with the screening and referral process, perceived appropriateness and usefulness, fit with clinic workflow, burden, and willingness to continue using WE CARE.
Post-implementation (within 3 months of completion of the Implementation period)
Appropriateness of WE CARE-Utilization
Zeitfenster: Baseline

Providers and Office staff appropriateness views on WE CARE measured via survey question on level of satisfaction with training materials for WE Care, as measured by responses on whether they Disagree Strongly, Disagree, Undecided, Agree or Agree Strongly with statements related to utilization, resources, training, and support.
Baseline
Appropriateness of WE CARE-Resources
Zeitfenster: Baseline

Providers and Office staff appropriateness views on WE CARE measured via survey question on level of satisfaction with training materials for WE Care, as measured by responses on whether they Disagree Strongly, Disagree, Undecided, Agree or Agree Strongly with statements related to utilization, resources, training, and support.
Baseline
Appropriateness of WE CARE-Training
Zeitfenster: Baseline

Providers and Office staff appropriateness views on WE CARE measured via survey question on level of satisfaction with training materials for WE Care, as measured by responses on whether they Disagree Strongly, Disagree, Undecided, Agree or Agree Strongly with statements related to utilization, resources, training, and support.
Baseline
Appropriateness of WE CARE-Support
Zeitfenster: Baseline

Providers and Office staff appropriateness views on WE CARE measured via survey question on level of satisfaction with training materials for WE Care, as measured by responses on whether they Disagree Strongly, Disagree, Undecided, Agree or Agree Strongly with statements related to utilization, resources, training, and support.
Baseline
Discussion of Unmet Needs (e.g., Food Insecurity) at Child's Well-child Care Visit
Zeitfenster: At the index visit

Measurement of whether discussion of unmet social needs occurred during pediatric visit.
At the index visit
Parent Recollection of Receipt of Referrals
Zeitfenster: 3 months post-index

Parental recollection of receipt of referrals during pediatric care received.
3 months post-index

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Massachusetts, Worcester

Mitarbeiter

Boston University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pediatric Research in Office Settings
Continuity Research Network

Ermittler

  • Hauptermittler: Arvin Garg, MD, MPH, University of Massachusets Medical School

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

7. Oktober 2019

Primärer Abschluss (Tatsächlich)

26. September 2023

Studienabschluss (Tatsächlich)

1. November 2023

Studienanmeldedaten

Zuerst eingereicht

26. September 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. September 2016

Zuerst gepostet (Geschätzt)

29. September 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H-35482
  • R01HD090191 (US NIH Stipendium/Vertrag)

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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