Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS) (I-ACCESS)
調査の概要
詳細な説明
In Aim 1, we will interview up to 30 clinical leaders and front-line staff across the two healthcare systems and community-based practices to understand workflows and opportunities for I-ACCESS integration. Assessment constructs will focus on understanding structural characteristics (including information technology infrastructure), available resources, culture, compatibility, relational connections, communications, and access to knowledge. These data will inform the creation of tailored process maps to outline processes and procedures to prepare each site for I-ACCESS implementation and elucidate when, how, and by whom I-ACCESS screening should be done.
In Aim 2, we will implement I-ACCESS as part of routine clinical practice for eight months at each site. Using a pre-/post-approach, we will examine whether I-ACCESS screening increases the number of financial counseling and oncology social work referrals (primary outcome). We will also examine counseling dispositions, receipt of services among those referred to financial support, and the predictive accuracy of the screening tool (secondary outcomes).
In Aim 3, we will analyze approximately 225 patient and 25 clinician surveys, informed by the Practical, Robust, Implementation and Sustainability Model, to gather feedback on I-ACCESS delivery, procedures, and barriers/facilitators to implementation. Based upon survey findings, we will then focus on key implementation determinants and outcomes through in-depth, semi-structured interviews with up to 40 stakeholders. Stakeholders will include patients, caregivers, healthcare providers, financial counselors, clinical support staff, and hospital administration at participating clinical sites.
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：Brianna Connelly
- 電話番号：919-964-2343
- メール：brianna_connelly@med.unc.edu
研究場所
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New York
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New York、New York、アメリカ、10016
- Perlmutter Cancer Center
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コンタクト：
- Brianna Connelly
- 電話番号：919-964-2343
- メール：brianna_connelly@med.unc.edu
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コンタクト：
- Bridgette
- 電話番号：646-221-6953
- メール：Bridgette.Thom@unc.edu
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North Carolina
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Burlington、North Carolina、アメリカ、27215
- Cone Health Alamance Regional
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コンタクト：
- Brianna Connelly
- 電話番号：919-964-2343
- メール：brianna_connelly@med.unc.edu
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コンタクト：
- Bridgette Thom
- 電話番号：646-221-6953
- メール：Bridgette.Thom@unc.edu
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Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina at Chapel Hill
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Hendersonville、North Carolina、アメリカ、28791
- UNC Health Pardee
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コンタクト：
- Brianna Connelly
- 電話番号：919-964-2343
- メール：brianna_connelly@med.unc.edu
-
コンタクト：
- Bridgette Thom
- 電話番号：646-221-6953
- メール：Bridgette.Thom@unc.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients: Treatment for cancer at study site, over age 18 years, speak/read English or Spanish; Caregivers: Identified caregiver of a patient with cancer offered financial hardship screening, over age 18 years, speak/read English or Spanish; Staff/Clinicians: Involvement with I-ACCESS pilot implementation; over age 18 years, speak/read English or Spanish
Exclusion Criteria:
- Unable to read of speak English or Spanish
- Under the age of 18 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：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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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他の：Financial Screener
Determine the effectiveness of the I-ACCESS screening tool in facilitating patient referrals for financial hardship counseling across diverse clinical practice settings.
Patients who meet inclusion criteria will be screened for financial toxicity for financial toxicity using a 2-question screener tool developed from the COST ( a financial toxicity screening measure).
Patients who screen positive for financial toxicity will be appropriately referred to available counseling resources.
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Patients who screen positive for financial toxicity on the 2-question screener tool, will be referred to available counseling or navigation resources available at each site.
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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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Screening completion
時間枠：From enrollment to the end of the intervention at 8 months.
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Ratio of the number of completed screens to the number of eligible patients
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From enrollment to the end of the intervention at 8 months.
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Rate of referral assistance
時間枠：From enrollment to the end of the intervention at 8 months.
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Ratio of the number of patients referred to counseling to the number of patients screened positive for financial distress
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From enrollment to the end of the intervention at 8 months.
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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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Type of referral
時間枠：From enrollment to the end of the intervention at 8 months.
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Count/percent of reason for referral (out-of-pocket costs, non-medical expense, benefit counseling, medication cost, other)
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From enrollment to the end of the intervention at 8 months.
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Counseling content
時間枠：From enrollment to the end of the intervention at 8 months.
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Count/percent of counseling disposition (general, insurance, external referral, other)
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From enrollment to the end of the intervention at 8 months.
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Applications for assistance
時間枠：From enrollment to the end of the intervention at 8 months.
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Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)
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From enrollment to the end of the intervention at 8 months.
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Referrals to external resources
時間枠：From enrollment to the end of the intervention at 8 months.
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Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)
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From enrollment to the end of the intervention at 8 months.
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Predictive accuracy of tool
時間枠：From enrollment through the end of data analysis at 12 months
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Sensitivity, specificity, positive predictive value, and negative predictive value of tool vs. documented bill-paying challenges
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From enrollment through the end of data analysis at 12 months
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Acceptability of Intervention Measure
時間枠：4-6 months after implementation of I-ACCESS
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Patient and clinician perception of intervention acceptability
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4-6 months after implementation of I-ACCESS
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Intervention Appropriateness Measure
時間枠：4-6 months after implementation of I-ACCESS
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Patient and clinician perception of intervention appropriateness
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4-6 months after implementation of I-ACCESS
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Feasibility of Intervention Measure
時間枠：4-6 months after intervention completion
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Patient and clinician perception of intervention feasibility
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4-6 months after intervention completion
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協力者と研究者
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
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。