McClure Jennifer B, Blasi Paula R, Cook Andrea, Bush Terry, Fishman Paul, Nelson Jennifer, Anderson Melissa L, Catz Sheryl L
Kaiser Permanente Washington Health Research Institute (formerly, Group Health Research Institute), 1730 Minor Ave, Suite 1600, Seattle, WA 98101, USA.
Alere Wellbeing, Optum Center for Wellbeing Research, 999 3rd Ave., Suite 2000, Seattle, WA 98104, USA.
Contemp Clin Trials. 2017 Jun;57:90-97. doi: 10.1016/j.cct.2017.04.003. Epub 2017 Apr 12.
Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve their use of oral health care. This paper details the rationale, design, and methods of a large, semi-pragmatic, randomized clinical trial designed to address this gap. Participants are recruited via the Oregon, Nebraska and Louisiana state-sponsored tobacco quitlines and randomized to receive standard quitline care versus standard care plus a multi-modal oral health promotion program (Oral Health 4 Life) integrated within the quitline services. All participants are followed for 6months to assess the impact of the intervention on smoking abstinence and utilization of professional dental care. In addition, the study will assess the cost of the intervention and provide practical guidance to states on whether the intervention is financially feasible to implement, should the intervention be effective. This study protocol may be useful to others interested in promoting oral health among smokers, those interested in partnering with tobacco quitlines to extend standard services to address other high risk health behaviors among smokers, or those interested in semi-pragmatic trial design.
吸烟者患口腔疾病的风险很高。因此,他们是人群层面公共口腔健康促进工作的重要目标群体。虽然牙科保健专业人员经常与患者讨论吸烟问题,但尚未做出系统努力为吸烟者提供干预措施以改善他们对口腔保健的利用。本文详细介绍了一项大型、半实用性随机临床试验的基本原理、设计和方法,该试验旨在填补这一空白。参与者通过俄勒冈州、内布拉斯加州和路易斯安那州政府资助的戒烟热线招募,并随机分为两组,一组接受标准戒烟热线护理,另一组接受标准护理加一项整合在戒烟热线服务中的多模式口腔健康促进项目(“终身口腔健康”)。所有参与者将被随访6个月,以评估干预措施对戒烟和专业牙科护理利用情况的影响。此外,该研究将评估干预措施的成本,并在干预措施有效的情况下,为各州提供关于该干预措施在经济上是否可行实施的实用指导。本研究方案可能对其他有兴趣在吸烟者中促进口腔健康的人、有兴趣与戒烟热线合作以扩展标准服务来解决吸烟者其他高风险健康行为的人,或对半实用性试验设计感兴趣的人有用。