Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities: A Pilot Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 398
- 试验地点
- 4
- 主要终点
- Child influenza vaccination status at influenza season's end (defined as March 31, 2025 for season 1 and March 31, 2026 for season 2 if a 2nd season of recruitment is necessary)
研究概览
简要总结
While the COVID-19 pandemic has highlighted health disparities, Black children have unduly suffered and died from seasonal influenza for decades. Through sustained partnership with Black community stakeholders, novel community-engaged research methods, and an innovative intervention approach, this proposal will explore, develop, and test a Digital Storytelling intervention to reduce influenza vaccination disparities in Black children aged 6 months to 5 years. This project will advance our understanding of engagement methods and interventions that improve health equity and serve as a model for future work to address vaccination disparities, ensuring all individuals have the chance to fulfill their potential free of preventable diseases.
详细描述
Study Aim: To (a) assess acceptability, appropriateness, and feasibility of the digital storytelling (DST) intervention, and (b) estimate a pilot effect size of the intervention, via a Pragmatic Trial in 2 clinics in historically Black neighborhoods.
Overview: A pilot pragmatic trial of a DST intervention in caregivers of children 6 mo. to 5 yrs. (n = 200) receiving care at two clinics in historically Black neighborhoods in Denver, CO during one influenza season (10/1/24-3/30/25), assessing pragmatic outcomes and pilot effectiveness with mixed methods.
Setting & Design: The investigators will pilot the intervention at 2 Denver Health primary care clinics in historically Black neighborhoods. These clinics serve >3,000 empaneled Black children and provided >6,000 influenza vaccines to children in 2020-21. Caregivers will be eligible if their child is empaneled (i.e., had 1 well child visit in last 18 months), will be 6 months to 5 years old during the upcoming influenza season (10/1 to 3/30), and has no medical contraindications to vaccination. The investigators will exclude caregivers whose first language is not English, as digital stories will be narrated in English, or are younger than 18 years. A research assistant will recruit caregiver-child dyads from May 1, 2024 to September 30, 2024 in clinic waiting rooms. Caregivers will complete a survey with demographic and vaccine hesitancy items and provide their cell phone number and e-mail address for intervention purposes.
Intervention Description: While this work is highly emergent in nature and exact implementation details are subject to stakeholder refinement, the investigators anticipate the following structure. On October 1st, dyads will be randomized to intervention or control groups (1:1 ratio). Intervention caregivers will receive a series of 6 monthly texts with embedded digital stories and accompanying health messaging. Control caregivers will receive usual care.
Outcomes: Our primary aim will be child influenza vaccination status, extracted from our electronic health record (EHR) at season's end (March 30, 2025). Caregivers assigned to the intervention group (n = 100) will receive a follow-up survey with validated measures assessing their perceptions of intervention feasibility, acceptability, and appropriateness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregivers of a child who is empaneled at Denver Health (e.g. had 1 well child visit in last 18 months)
- •Child will be aged 6 months to 5 years during the influenza season in which the trial will be conducted (season 1: 10/1/24-3/31/25; season 2 (if needed): 10/1/25-3/31/26)
- •Child has no medical contraindications to vaccination (e.g., severe allergy to one of the vaccine ingredients, history of Guillan-Barre Syndrome)
排除标准
- •- Caregivers whose first language is not English
研究组 & 干预措施
Digital storytelling group
Caregivers will receive a series of digital stories by text message designed to increase influenza vaccine confidence.
干预措施: Digital storytelling (Behavioral)
Control group
Caregivers will receive standard care.
结局指标
主要结局
Child influenza vaccination status at influenza season's end (defined as March 31, 2025 for season 1 and March 31, 2026 for season 2 if a 2nd season of recruitment is necessary)
时间窗: Baseline, up to 1 year
Binary variable: Vaccinated (if a child received 1 or more doses of influenza vaccine), Unvaccinated (if a child received 0 doses)
Child Participant Vaccination During the 2024-2025 Influenza Season
时间窗: 196 Days
Child participant receipt of 1 or more doses of influenza vaccine from the date influenza vaccines were available at study sites (9/16/24) through the last date of the study period (3/31/25).
次要结局
- Intervention Feasibility(through study completion, an average of 1 year)
- Intervention Acceptability(through study completion, an average of 1 year)
- Intervention Appropriateness(through study completion, an average of 1 year)
- Digital Story Reach(181 days)