Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination
キーワード
概要
説明
The broad, long-term objective is to substantially increase human papillomavirus (HPV) vaccination rates by deploying effective population-health interventions in clinical practices across the United States. As part of this effort, the investigators intend to evaluate two evidence-based interventions with innovative enhancements at six Mayo Clinic primary care practices (PCP) to evaluate their individual and combined impact on rates of HPV vaccination among female and male patients. Aim 1, "Less Pain, Less Fuss, Right Now!", will test the hypothesis that, as compared to no intervention (current practice), a practice-level intervention utilizing reminder-recalls featuring the availability of non-medication and medication anesthetics, the convenience of nurse-only visits, and the use of persuasive language for early, on-time vaccinations will improve HPV vaccine delivery rates. Aim 2, "Make It Count!", will test the hypothesis that, as compared to no intervention, a provider level intervention utilizing a missed-opportunities assessment and feedback intervention applying social pressure (specific peer-performance comparisons) and equipping providers with a strong-recommendation toolkit will improve HPV vaccine delivery rates. Aim 3 will test the hypothesis that simultaneous implementation of interventions targeting individual, interpersonal, and organizational factors will have a synergistic effect on HPV vaccine delivery rates. To accomplish Aims 1-3, the investigators will use a stepped-wedge cluster randomized trial with an integrated process evaluation. The cluster approach prevents cross-contamination between patients or providers as we allocate two separate interventions (Aims 1 and 2) in the six PCPs. The stepped-wedge design, which ensures all practices eventually receive the same set of interventions, permits the single institutional review board overseeing all six PCPs to approve the study without requiring recruitment and consent of individual patients or providers. The stepped-wedge approach also permits the investigators to test the presence of each of the interventions in each PCP, making trial participation more attractive, while also allowing each practice to serve as its own control, reducing the bias due to imbalanced risk factors across practices. The factorial design allows the investigators to use a single trial to test two interventions and assess each individually and in combination. The design also conserves sample size while maintaining power. The investigators will measure the impact separately in females and males, 11-12 years of age for the rates of receipt of HPV vaccine doses due. Rigorously tested, highly effective, population-level interventions are essential if the US is to reach the Healthy People 2020 goal for HPV vaccination. The rigor, design, and high likelihood of success of this study will provide key evidence regarding practice- and provider-level interventions to improve HPV vaccination rates. Mayo Clinic's best practices inform not only its own 70 practices across five states but its Mayo Clinic Care Network, which consists of nearly 40 health-care organizations across 26 states and Puerto Rico.
日付
| 最終確認済み: | 02/29/2020 |
| 最初に提出された: | 01/24/2018 |
| 提出された推定登録数: | 04/09/2018 |
| 最初の投稿: | 04/17/2018 |
| 最終更新が送信されました: | 03/03/2020 |
| 最終更新日: | 03/04/2020 |
| 実際の研究開始日: | 03/31/2018 |
| 一次完了予定日: | 12/30/2023 |
| 研究完了予定日: | 12/30/2023 |
状態または病気
介入/治療
Behavioral: Current care
Behavioral: Reminder-recall
Behavioral: Audit-and-feedback
Behavioral: Combined reminder-recall and audit-and-feedback
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Other: Practice A Practice A will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice A will be assigned to receive the current care intervention. in the second step, Practice A will be assigned to receive the current care intervention. In the third step, Practice A will receive the reminder-recall intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention. | |
| Other: Practice B Practice B will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice B will be assigned to receive the current care intervention. In the second step, Practice B will be assigned to receive the reminder-recall intervention. In the third step, Practice B will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention. | |
| Other: Practice C Practice C will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice C will be assigned to receive the current care intervention. In the second step, Practice C will be assigned to receive the audit-and-feedback intervention. In the third step, Practice C will receive the audit-and-feedback intervention. In the fourth step, Practice C will receive the combined reminder-recall and audit-and-feedback intervention. | |
| Other: Practice D Practice D will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice D will be assigned to receive the current care intervention. In the second step, Practice D will be assigned to receive the current care intervention. In the third step, Practice D will receive the audit-and-feedback intervention. In the fourth step, Practice D will receive the combined reminder-recall and audit-and-feedback intervention. | |
| Other: Practice E Practice E will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice E will be assigned to receive the current care intervention. In the second step, Practice E will be assigned to receive the reminder-recall intervention. In the third step, Practice E will receive the reminder-recall intervention. In the fourth step, Practice E will receive the combined reminder-recall and audit-and-feedback intervention. | |
| Other: Practice F Practice F will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice F will be assigned to receive the current care intervention. In the second step, Practice F will be assigned to receive the audit-and-feedback intervention. In the third step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention. |
適格基準
| 研究の対象となる年齢 | 11 Years に 11 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Empaneled in one of the six participating primary care practices - 11 to 12 years of age at the first day of each of the 12-month-long steps - Due during that 12-month-long step for at least one dose of the HPV vaccine Exclusion Criteria: - Not empaneled in one of the six participating practices - Empaneled in one of the six participating practices but less than 11 years of age or more than 12 years of age on the first day of each 12 month long step - Not due during that 12-month-long step for a dose of HPV vaccine. |
結果
主な結果の測定
1. Rates of HPV-vaccine receipt [12 months, 24 months, 36 months, and 48 months]
二次的な結果の測定
1. Rates of HPV vaccine-initiation [12 months, 24 months, 36 months, and 48 months]
2. Rates of HPV vaccine-completion [12 months, 24 months, 36 months, and 48 months]
その他の成果対策
1. Rates of HPV-vaccine receipt in females [12 months, 24 months, 36 months, and 48 months]
2. Rates of HPV-vaccine receipt in males [12 months, 24 months, 36 months, and 48 months]
3. Rates of HPV-vaccine receipt at 11 years of age [12 months, 24 months, 36 months, and 48 months]
4. Rates of HPV-vaccine receipt at 12 years of age [12 months, 24 months, 36 months, and 48 months]
5. Rates of HPV-vaccine receipt of dose 1 [12 months, 24 months, 36 months, and 48 months]
6. Rates of HPV-vaccine receipt of dose 2 [12 months, 24 months, 36 months, and 48 months]
7. Rates of HPV-vaccine receipt of dose 3 [12 months, 24 months, 36 months, and 48 months]
8. Rates of HPV-vaccine receipt in patients empaneled to family physicians [12 months, 24 months, 36 months, and 48 months]
9. Rates of HPV-vaccine receipt in patients empaneled to pediatricians [12 months, 24 months, 36 months, and 48 months]
10. Rates of HPV-vaccine receipt in patients empaneled to family medicine nurse practitioners [12 months, 24 months, 36 months, and 48 months]
11. Rates of HPV-vaccine receipt in patients empaneled to pediatric nurse practitioners [12 months, 24 months, 36 months, and 48 months]
12. Rates of HPV-vaccine receipt in patients empaneled to family medicine residents [12 months, 24 months, 36 months, and 48 months]
13. Rates of HPV-vaccine receipt in patients empaneled to pediatric residents [12 months, 24 months, 36 months, and 48 months]
14. Rates of missed opportunities for HPV-vaccine receipt [11 months (m), 12 m, 13 m, 14 m, 15 m, 16 m, 17 m, 18 m, 19 m, 20 m, 21 m, 22 m, 23 m, 24 m, 25 m, 26 m, 27 m, 28 m, 29 m, 30 m, 31 m, 32 m, 33 m, 34 m, 35 m, 36 m, 37 m, 38 m, 39 m, 40 m, 41 m, 42 m, 43 m, 44 m, 45 m, 46 m, and 47 m]
