Screening For Social Determinants Of Health In Routine Diabetes Care (SDOH)
Social determinants of health (SDOH) exert a powerful influence on the everyday management of type 1 diabetes (T1D) and short and long term outcomes of T1D. Experts agree that identifying and addressing negative social determinants of health (SDOH) may help accomplish numerous T1D care goals and promote health equity in treatment. However, fundamental research gaps in achieving these goals remain, including optimal screening and management processes for identification of negative social determinants of health (SDOH) , and how to develop robust partnerships with community-based organizations (CBOs) that address social determinants of health (SDOH) with high potential for sustainability and scalability. This project will generate new knowledge regarding how to implement a social work-led social determinants of health (SDOH) screening and referral program designed to aid families of youth with T1D who face several vulnerabilities, including food insecurity. The team will implement a single arm, pragmatic clinical trial with contemporaneous, non- randomized controls; whereby all families with a child enrolled in the California Children's Services (CCS) program (which provides specialized medical care for low-income families of youth with a qualifying chronic medical condition) will receive access to a novel social work-led social determinants of health (SDOH) screening and referral program.
Outcomes will be compared against youth with T1D who are also seen in our Westwood Pediatric Endocrinology clinic but who are not enrolled in the CCS program and will not receive access to the social determinants of health (SDOH) intervention. The study team has established partnerships with several community-based organizations (CBOs) across Los Angeles County that provide social services, including food-related services, to receive referrals for CCS families who screen positive for having a social need. The study team will assess the feasibility and acceptability of this screening and referral protocol among families, CBOs, and providers (Aim 1) by measuring key implementation outcomes (comprehensive documentation of social determinants of health (SDOH) screening, result, and referral in the patients' medical record) and acceptability outcomes (self-reported satisfaction with the program by families and barriers and facilitators by CBOs and providers). The team will additionally estimate the effect of this intervention (Aim 2) by measuring changes (pre/post intervention) in families reported social needs, diabetes-related quality of life, and in the child's glycemic control (measured by HbA1c). Results from this work can provide a roadmap for sustainable and scalable social determinants of health (SDOH) interventions with potential to improve outcomes for youth with T1D in an equity-informed manner.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Lauren Wisk, PhD
- 電話番号:310-267-5308
- メール:lwisk@mednet.ucla.edu
研究場所
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California
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Los Angeles、California、アメリカ、90095
- University of California, Los Angeles
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コンタクト:
- Lauren Wisk, PhD
- 電話番号:310-267-5308
- メール:lwisk@mednet.ucla.edu
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 1) patients who are 0-21 years old, diagnosed with T1D, and receive T1D care from the UCLA Pediatric Diabetes program at the Westwood clinic, and/or 2) parents/legal guardians of a child with T1D and whose child is 21 years old or under and receives T1D care from the UCLA Pediatric Diabetes program at the Westwood clinic.
Exclusion Criteria:
- 1) patients who are over 21 years old and diagnosed with Type 2 Diabetes or prediabetes, and 2) parents/legal guardians of a child with type 2 diabetes or prediabetes and whose child is over 21 years old.
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:防止
- 割り当て:非ランダム化
- 介入モデル:並列代入
- 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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介入なし:通常通りの扱い
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実験的:SDOH Screening and Intervention Program
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This study is proposing a social work-led SDOH screening and intervention program.
Social workers will screen patients/families for SDOH and respond based on the results of the screen.
Patients/families identified as "low risk" (i.e., do not screen positive on the SDOH screener) will receive information about 1degree.org and phone follow-up two weeks after visit to see if there are any questions about the platform or any changes to their social circumstances that they wish to discuss with the social work team.
Patients/families identified as "high risk" (i.e., screen positive on the SDOH screener) will receive the 1degree.org
information sheet as well as receive specific agency referrals to our partner food bank organizations and two week phone follow-up to assess referral success; these patients/families will subsequently receive follow-up calls every two weeks until the referral is complete or the patient/family discloses that their identified food insecurity is resolved.
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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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Documentation of SDOH screening
時間枠:Baseline visit, final follow-up (6 months post-baseline)
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The primary feasibility outcomes include documentation of SDOH screening (performed vs not), result (positive vs negative), and referrals (made vs not, completed vs not) in the medical record.
The study will quantify the prevalence of each of these individually, as well as collectively to identify the extent to which documentation was comprehensive (i.e., screening and result, plus referral when appropriate, all documented).
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Baseline visit, final follow-up (6 months post-baseline)
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Family-reported satisfaction with screening (acceptability)
時間枠:All three survey time points (pre, immediate post, 6-month post)
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A 3-item measure of patient satisfaction with care, rated on a 10-point Likert scale, will be assessed in an immediate post-visit survey, and the in-depth Consumer Assessment of Healthcare Providers and Systems (CAHPS) will be used in the pre/post surveys.
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All three survey time points (pre, immediate post, 6-month post)
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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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Change in Hemoglobin A1c
時間枠:baseline and 6 months follow-up
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For our secondary clinical outcome of change in HbA1c, a continuous variable, we will compare the change in HbA1c, as documented in the clinical record, from baseline to that of 6 months post-intervention.
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baseline and 6 months follow-up
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協力者と研究者
捜査官
- 主任研究者:Lauren Wisk, PhD、Lauren Wisk
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB#25-0333
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。