Formative research implications on design of a randomized controlled trial for oral health promotion in children.
Formative research implications on design of a randomized controlled trial for oral health promotion in children.
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DOI：
10.1186/s40814-018-0344-y
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发表时间：
2018-01-01
影响因子：
1.7
通讯作者：
Sandoval, Anna
中科院分区：
文献类型：
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作者：
Martin, Molly A;Lee, Helen H;Sandoval, Anna
背景：协调口腔健康促进 (CO-OP) 芝加哥试验将测试社区卫生工作者 (CHW) 干预措施对改善早期儿童龋齿高危儿童口腔健康行为的有效性。在实施整群随机对照试验之前，我们进行了形成性评估以确定最终设计。我们使用定性方法来评估拟议的招募、数据收集和干预计划的可行性和可接受性。方法：在 10 个儿科初级保健诊所和 10 个女婴和儿童特殊补充营养计划 (WIC) 中心进行了关键知情人访谈 (N=37) 和现场观察，以从招募和干预地点的提供者和管理人员那里获得见解。与儿童照顾者一起进行了八个焦点小组（N = 68），以了解家长的观点。应用扎根理论的概念编码方法将数据组织成最终主题。结果：家庭、诊所和 WIC 中心都对口腔健康的额外支持非常感兴趣，并对 CHW 充满热情。挑战包括相互竞争的家庭优先事项，这可能会干扰研究注册和干预效果。登记和干预实施的物理空间是一些站点的主要障碍。对于一些家庭来说，进行家访以收集数据和提供干预措施是不可接受的。这些挑战和障碍促使我们对试验设计做出重大改变。我们打开了在多个位置进行数据收集的选项。我们取消了仅限家庭的试验部分。随机分配到非干预组的诊所和 WIC 中心现在将在研究结论中提供 CHW。最后，我们将 CHW 口腔健康主题与家庭的需求结合起来。结论：我们进行了全面的形成性评估，以确定 CO-OP 芝加哥试验的可行性和可接受性。虽然试验的总体接受度很高，但结果凸显了拟议试验实施计划的具体问题，并导致了一些关键的设计变更。此类形成性工作需要大量的前期投资，但我们预计它将通过更好的招聘、保留、干预实施和遵守以及结果传播来转化为节省。
BACKGROUND: The COordinated Oral health Promotion (CO-OP) Chicago trial will test the efficacy of a community health worker (CHW) intervention to improve oral health behaviors for children at high risk for early childhood caries. Before implementing the cluster-randomized controlled trial, we conducted a formative assessment to determine the final design. We used qualitative methods to assess the feasibility and acceptability of the proposed recruitment, data collection, and intervention plan.METHODS: Key informant interviews (N=37) and site observations were conducted at 10 pediatric primary care clinics and 10 Special Supplemental Nutrition Program for Women Infant and Children (WIC) centers to gain insight from providers and administrators at the locations where recruitment and intervention will occur. Eight focus groups (N=68) were conducted with caregivers of children to capture the parent perspective. Conceptual coding methods from grounded theory were applied to organize the data into the final themes.RESULTS: Families, clinics, and WIC centers were all very interested in additional supports for oral health and were enthusiastic about CHWs. Challenges included competing family priorities that might interfere in study enrollment and intervention efficacy. Physical space for enrollment and intervention delivery was a major barrier for some sites. Home visits for data collection and intervention delivery would be unacceptable for some families. These challenges and barriers prompted us to make major changes in our trial design. We opened the option for data collection to occur in multiple locations. We eliminated the home-only arm of the trial. Clinics and WIC centers that are randomized to the non-intervention arm will now have CHWs available at the study conclusion. Finally, we aligned the CHW oral health topics to the needs of families.CONCLUSIONS: We conducted this comprehensive formative assessment to determine the feasibility and acceptability of the CO-OP Chicago trial. While overall acceptance of the trial was high, the results highlighted specific issues with the proposed trial implementation plan and led to several critical design changes. This type of formative work requires a significant upfront investment but we expect it will translate into savings through better recruitment, retention, intervention implementation and adherence, and result dissemination.