小児科診療における健康の社会的決定要因に対処するための介入の実施 (PROSWECARE)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Boston Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Usual Care-Control
Participants in the usual care group will receive standard pediatric care. |
Standard pediatric care. |
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実験的：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. |
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. |
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実験的：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Receipt of Community Resources
時間枠：3 months post-index visit
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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
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Provider Referrals for Unmet Material Needs Received at Visit
時間枠：At the index visit
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sustainability of WE CARE--Survey Distribution
時間枠：6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice
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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
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Sustainability of WE CARE--Appropriate Referrals Made by Providers
時間枠：6 months, 12 months, 18 months and 24 months post implementation of WE CARE at practice
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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
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Parental Assessment of Patient Satisfaction
時間枠：At the index visit
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Parental assessment of satisfaction of pediatric care received as measured by the Clinician and Group Survey. |
At the index visit
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Parental Assessment of Family Centeredness
時間枠：At the index visit
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Parental assessment of family centeredness of pediatric care received as measured by the National Survey of Children's Health (2016). |
At the index visit
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Parental Assessment of Care Coordination - Extra Help
時間枠：3-months post-index visit
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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
|
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Parental Assessment of Care Coordination - Amount of Help
時間枠：3-months post-index visit
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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
|
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Parental Assessment of Care Coordination - Satisfaction
時間枠：At the index visit
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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
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Provider and Office Staff Acceptability of WE CARE
時間枠：Post-implementation (within 3 months of completion of the Implementation period)
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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)
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Appropriateness of WE CARE-Utilization
時間枠：Baseline
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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
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Appropriateness of WE CARE-Resources
時間枠：Baseline
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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
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Appropriateness of WE CARE-Training
時間枠：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
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Appropriateness of WE CARE-Support
時間枠：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
|
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Discussion of Unmet Needs (e.g., Food Insecurity) at Child's Well-child Care Visit
時間枠：At the index visit
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Measurement of whether discussion of unmet social needs occurred during pediatric visit. |
At the index visit
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Parent Recollection of Receipt of Referrals
時間枠：3 months post-index
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Parental recollection of receipt of referrals during pediatric care received. |
3 months post-index
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協力者と研究者
協力者
捜査官
- 主任研究者：Arvin Garg, MD, MPH、University of Massachusets Medical School
出版物と役立つリンク
一般刊行物
- Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
- Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social determinants of health at well child care visits: a cluster RCT. Pediatrics. 2015 Feb;135(2):e296-304. doi: 10.1542/peds.2014-2888. Epub 2015 Jan 5.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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