Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits
Effect of Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits on Colorectal Cancer Screening
調査の概要
詳細な説明
Colorectal cancer (CRC) screening can save lives but is under-used, especially among minority and low-income patients in urban safety-net systems. Interventions among safety-net patients have improved screening but require additional refinement. For example, the investigators demonstrated that mailing free home fecal immunochemical tests (FIT) to urban safety-net patients doubled screening uptake (59% vs. 30%, p<.001); however a full 41% who received FIT kits still did not complete screening. Drawing from economics, behavioral science, and healthcare delivery science, the investigators propose a spatially informed randomized intervention to further improve screening uptake. By targeting all patients in a single neighborhood at one time using waves of mailed invitations, the GeoMail intervention is designed to amplify social contagion among neighbors (i.e., positive communications and reinforcement among neighbors to complete screening) thereby increasing screening uptake. GeoMail will be live for 12 months. This intervention will not change the content of FIT kits that are already to be mailed under usual care conditions at Parkland, it will only change the timing of mailing. The aims of this study are to:
Aim 1: Conduct and evaluate outcomes from a GeoMail intervention - a geographically clustered randomized trial comparing geographically clustered mailed screening invitations (treatment) to non-clustered invitations (usual care).
Hypotheses (H): H1.1: Patient-level and H1.2: Neighborhood-level screening will be higher in the treatment neighborhoods, compared to usual-care neighborhoods.
Aim 2: Evaluate whether patient-level or neighborhood-level indicators of patient density, race/ethnicity, and socioeconomic disadvantage moderate GeoMail impact on CRC screening.
H2.1-3: All three types of factors will moderate the GeoMail intervention impact
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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Texas
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Dallas、Texas、アメリカ、75235
- Parkland Health & Hospital System
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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:
- Males and females
- Age 50-64 years
- Seen at least one time at a Parkland primary care clinic within one year prior to randomization
- Participants in Parkland's medical assistance program for the uninsured (Parkland Financial Assistance), Medicaid, or private/other insurance
- All races and ethnicities
Exclusion Criteria:
Up-to-date with CRC screening, defined by:
- Colonoscopy in the last 10 years
- Sigmoidoscopy in the last 5 years
- FIT in the last 11 months
- Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps
- Address or phone number not on file
- Incarcerated
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：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 FIT Screening Strategy
Mailed outreach invitation to complete FIT include: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).
Up to three "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
Centralized processes to promote guideline-based follow-up.
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Patients in usual care neighborhoods will receive FIT kits randomly throughout the year.
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実験的：GeoMail FIT Screening Strategy
The experimental arm differs from the active comparator in one way: patients living in treated ZIP codes will receive the mailed outreach at the same time.
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Patients in treated neighborhoods will receive kits at the same time.
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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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Patient-level Colorectal Cancer (CRC) Screening
時間枠：Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail).
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Defined as screening completed within 6 months of when the FIT kit is mailed for each patient by any recommended screening modality (FIT, colonoscopy, sigmoidoscopy; i.e., the proportion of treated vs. usual care patients who have completed screening).
Screening will be measured using electronic medical record procedure, result, and billing data (Parkland-specific, CPT, ICD9/10 codes) and will be considered complete when satisfactory (e.g., adequate sample collection) FIT or colonoscopy test results are received.
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Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail).
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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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Neighborhood-level Screening
時間枠：Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail).
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Defined for each neighborhood (defined as patient block group of residence) as the number of all screening-eligible patients who are up-to-date with screening guidelines (defined as FIT ≤18 months, sigmoidoscopy ≤5 years, or colonoscopy ≤10 years) divided by the total screening-eligible block group Parkland patient population.
The analysis will determine GeoMail impact on treated block groups while differencing change in the outcome that occurs in usual care block groups using a difference-in-difference model (DID) to measure change in neighborhood level screening for each block group before and after GeoMail intervention at 2 time points: on the day prior to GeoMail going live and at 6 months after mailing the last GeoMail kit (i.e., 18 months after start of GeoMail).
This outcome measures the population level impact of GeoMail across all patients in the block group, including those not mailed a FIT kit because they were already up-to-date and thus ineligible for the mailing.
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Assessed after 12 months of mailings are complete (i.e., 18 months after start of GeoMail).
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FIT Kit Completed
時間枠：Assessed after 6 and 12 months of mailings.
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Defined as FIT completed within 6 months of when the FIT kit is mailed.
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Assessed after 6 and 12 months of mailings.
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FIT Kit Returned Unopened
時間枠：Assessed after 6 and 12 months of mailings.
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Defined as FIT kit returned unopened within 6 months of when the FIT kit is mailed.
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Assessed after 6 and 12 months of mailings.
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Patient-level CRC Screening
時間枠：Assessed 2 and 3 years after completion of mailings.
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Defined as any recommended screening modality.
Screening will be measured using electronic medical record procedure, result, and billing data and will be considered complete when satisfactory FIT or colonoscopy test results are received.
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Assessed 2 and 3 years after completion of mailings.
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Neighborhood-level Screening
時間枠：Assessed 2 and 3 years after completion of mailings.
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Defined for each neighborhood as the number of all screening-eligible patients who are up-to-date with screening guidelines divided by the total screening-eligible block group Parkland patient population.
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Assessed 2 and 3 years after completion of mailings.
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協力者と研究者
捜査官
- 主任研究者：Sandi Pruitt, PhD、Ut Southwestern
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 (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
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