ラーニング・ヘルス・システム・トライアル
実用的な無作為化比較学習医療システム試験
To evaluate the real-world effectiveness and implementation strategies for mPATH-Lung, investigators propose a pragmatic, randomized controlled trial across an academic Learning Health System. The trial will contrast several approaches to participant outreach and will specifically target engaging fully powered cohorts of racial/ethnic minorities and rural residents.
調査の概要
状態
条件
詳細な説明
Primary Objective: Evaluate the real-world effectiveness of mPATH-Lung in increasing lung cancer screening rates across diverse populations.
Secondary Objectives
- Compare the differential effectiveness of three outreach strategies for engaging participants with mPATH-Lung across vulnerable rural or ethnic/racial minority population subgroups.
- Estimate the additional revenue generated by mPATH-Lung through increased screening and downstream care.
- Evaluate the potential for over-screening and the impact of applying HEDIS-based exclusion criteria
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：Study Coordinator
- 電話番号：704-355-2000
- メール：Aliza.randazzo@advocatehealth.org
研究連絡先のバックアップ
- 名前：Brent Heideman, Jr., MD
- メール：brent.heideman@advocatehealth.org
研究場所
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27157
- 募集
- Atrium Health Wake Forest Baptist
-
コンタクト：
- Study Coordinator
-
コンタクト：
- Study Coordinator, MD
- 電話番号：704-355-2000
- メール：Aliza.randazzo@advocatehealth.org
-
主任研究者：
- Brent Heideman, Jr., MD
-
-
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:
Eligible patients will:
- Meet the Medicare criteria for lung cancer screening, as updated in February 2022:
- Age 50 - 77 years
- Smoked at least 20 pack years
- Current smoker or quit smoking within the past 15 years
- Be established with a primary care provider within the Atrium Health Wake Forest Baptist health network (defined as having completed at least 1 primary care appointment in the past 6 months or have completed at least 2 primary care appointments within the past 18 months or being scheduled to see a health network primary care provider within the next 30 days).
- Have a patient portal account or cellphone number listed in the electronic health record
- Have a North Carolina address listed in the electronic health record
Exclusion Criteria:
The following patients will be excluded:
- Patients flagged as needing a language interpreter in the electronic health record for any language other than Spanish (electronic messages and intervention are deliverable in English or Spanish only)
- Those for whom lung cancer screening would be or may be inappropriate:
electronic health record Prior history of lung cancer electronic health record Chest CT within the last 12 months electronic health record Those meeting the HEDIS COL-E measure exclusion criteria based on significant comorbidities and/or frailty.
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：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm A
Patient portal message first followed by up to 3 reminder text messages. |
If the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder if they start the mPATH-Lung program but do not complete it. If the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial portal message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder. |
|
実験的：Arm B
Text message only with up to 3 reminder text messages. |
If the participant has an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, a final reminder text message a day before their scheduled appointment, and potentially an 'in progress' text message reminder. If the participant does not have an upcoming scheduled appointment, they will receive a reminder text message 5 days after initial message, the final reminder message 8 days after the initial message, and potentially an 'in progress' text message reminder. |
|
実験的：Arm C
Portal message only with no reminder messages. |
Participant will only receive portal message with no reminder text messages. |
|
アクティブコンパレータ：Usual Care Arm
Patients receive usual care. |
Standard of care |
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 |
|---|---|---|
|
Number of Participants to Complete Lung Screening CT - Primary Effectiveness
時間枠：90 days
|
Completion of the lung screening CT by participants. |
90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with Eligibility for Lung Screening
時間枠：90 days
|
Reach of the mPATH-Lung platform, defined as the participants who determine their eligibility for lung screening within the mPATH-Lung program within 90 days of the first invitation. Investigators will determine reach overall, within subgroups, and within study arms. |
90 days
|
|
Number of Requests for Lung Screening
時間枠：90 days
|
Requests for lung screening within the mPATH-Lung program |
90 days
|
|
Number of Orders for Lung Screening CT Scans
時間枠：Within 90 days of randomization
|
Orders for lung screening CT scans for participants in study arms |
Within 90 days of randomization
|
|
Amount of Revenue Generated
時間枠：12 months following completion of screenings
|
Revenue (costs) generated from lung cancer screening and follow-up care. |
12 months following completion of screenings
|
|
Number of Participants that Represent Over-screening
時間枠：90 days
|
Among patients with newly diagnosed lung cancer by lung screening, the participants that represent over-screening, defined as a patient being deemed too ill for potentially curative surgery on blinded chart review. |
90 days
|
協力者と研究者
捜査官
- 主任研究者：Brent Heideman, Jr., MD、Wake Forest Baptist Comprehensive Cancer Center
研究記録日
主要日程の研究
研究開始 (実際)
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。