Opt-in vs. Opt-out for Breast Cancer Screening
Opt-in vs. Opt-out Mammography Screening Outreach: a Randomized Controlled Trial
調査の概要
詳細な説明
This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different outreach strategies in improving adherence to breast cancer screening via mammography.
Average risk female Veterans who are due for breast cancer screening (defined as aged 45-75 with no previous history of bilateral mastectomy, not under hospice care, and alive at the time of screening) will be identified through administrative data.
Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 2 and 4) to the following interventions:
Arm 1: Automated phone opt-in message Intervention Type: Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent Arm 2: Opt-out scheduling Intervention Type: Consult automatically sent and Veteran called to schedule screening
Randomization will be stratified within arms by prior screening status (prior screener vs. never screener).
The study's primary outcome of interest is screening completion at 100 days post randomization. The study's secondary outcome of interest is screening scheduling at 100 days post randomization. Subgroup analysis aim 1 will explore whether the differences in breast cancer screening completion between investigational groups varies according to the Veterans' race/ethnicity. Subgroup analysis aim 2 will explore whether the differences in breast cancer screening scheduling between investigational groups varies according to the Veterans' race/ethnicity. Enrollment in the trial will occur between March 1, 2022 and August 31, 2022.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Stefanie Deeds, MD
- 電話番号:206-314-0507
- メール:Stefanie.Deeds@va.gov
研究連絡先のバックアップ
- 名前:Alaina Mori, MS
- 電話番号:206-247-6782
- メール:Alaina.Mori@va.gov
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98108
- VA Puget Sound Health Care System
-
-
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:
- female Veterans aged 45-75
- assigned to a primary care provider at the VA Puget Sound as of January 1, 2022 with at least 1 year of prior data available
- due for breast cancer screening (have not had a mammogram in the last 12 months)
Exclusion Criteria:
- must not be any indication of current receipt of hospice care
- no record of recent death in the administrative data
- not scheduled for either a screening or diagnostic mammogram within the following 12 weeks from assessment.
- not have a personal history of bilateral mastectomy.
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:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Automated phone opt-in message
Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent
|
Automated message via phone call (audiocare)
|
|
実験的:Opt-out scheduling
Consult automatically sent and Veteran called to schedule screening
|
Scheduling via non-automated phone call
|
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 |
|---|---|---|
|
Percentage of mammograms completed at 100 days post randomization
時間枠:100 days post randomization
|
Percent of mammograms completed
|
100 days post randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of mammograms scheduled at 100 days post randomization
時間枠:100 days post randomization
|
Percent of mammograms scheduled
|
100 days post randomization
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of mammograms cancelled at 100 days post randomization
時間枠:100 days post randomization
|
Percent of mammograms cancelled
|
100 days post randomization
|
|
Percentage of mammograms active at 100 days post randomization
時間枠:100 days post randomization
|
Percent of mammograms active
|
100 days post randomization
|
協力者と研究者
捜査官
- 主任研究者:Ashok Reddy, MD、VA Puget Sound Health Care System
- 主任研究者:Stefanie Deeds, MD、VA Puget Sound Health Care System
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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。