Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve Provider Recommendation and HPV Vaccination Rates Among Latino/a Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 13th birthday.
研究概览
简要总结
The purpose of this study is to determine the provider- and practice-level characteristics that influence the impact of implementation strategies guided by practice facilitation in each clinical practice, to test whether the facilitator-driven provider- and practice-level implementation strategies increase provider recommendations and Human Papilloma Virus (HPV) vaccination rates and to evaluate implementation and future sustainability of the facilitator-driven implementation strategies across nine clinical practice sites
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FQHC's with less than 60% HPV vaccine initiation rate for 11-12 year old adolescents overall at their practice sites
- •FQHC's that have family medicine and/or pediatric practices
- •a total adolescent patient population at least 50% Latino
- •be willing for Health Care Provider (HCP) and staff members to receive education, training, and support; complete standardized measurement, and agree to randomization.
- •Providers, aged 18 and over, employed at each FQHC (4 staff per practice)
- •Staff, aged 18 and over, employed at each FQHC (5 staff per practice)
- •Implementation team members (i.e., administrative designee, health care providers, immunization navigators, and other staff), aged 18 and over, employed at each FQHC (4 members per practice)
- •Parents (aged 18 and over) of patients ages 11-17 seeking care at each FQHC (25 per practice).
排除标准
- •FQHCs that participated in the pilot study were excluded.
研究组 & 干预措施
Step 1 (3 clinics)-15 months control then 30 months intervention
干预措施: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates (Other)
Step 2 (3 clinics)-21 months control then 24 months intervention
干预措施: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates (Other)
Step 3 (3 clinics)-27 months control then 18 months intervention
干预措施: Facilitator-driven provider- and practice-level implementation strategies for influencing provider recommendations and practice-level HPV vaccination rates (Other)
结局指标
主要结局
Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 13th birthday.
时间窗: From baseline to end of study ( about 60 months from baseline)
Percentage of vaccine-eligible males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after their first dose and before their 13th birthday.
时间窗: From baseline to end of study ( about 60 months from baseline)
次要结局
- Percentage of vaccine-eligible males and females at each clinic who received the first valid dose of the HPV vaccine series before their 18th birthday.(From baseline to end of study ( about 60 months from baseline))
- Percentage of vaccine-eligible 13-14 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 6-12 months after first dose and before their 15th birthday(From baseline to end of study ( about 60 months from baseline))
- Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the second valid dose of the HPV vaccine series 2 months after first dose and before their 18th birthday(From baseline to end of study ( about 60 months from baseline))
- Percentage of vaccine-eligible 15-17 y/o males and females at each clinic who received the third valid dose of the HPV vaccine series 4 months after second dose and before their 18th birthday.(From baseline to end of study ( about 60 months from baseline))
- Percentage of non-well visits in which HPV vaccine was not administered, among all visits for active vaccine-eligible patients ages 11-17 by clinic(From baseline to end of study ( about 60 months from baseline))
- Percentage of males and females at each clinic who received Tdap and MenACWY at age 11 as a requirement to attend 7th grade in Texas.(From baseline to end of study ( about 60 months from baseline))
研究者
Daisy Y. Morales Campos
Associate Professor
The University of Texas Health Science Center, Houston