一项使用联络人员改善重度精神疾病患者看牙情况的双臂随机可行性试验：方案文件。
A two-arm, randomised feasibility trial using link workers to improve dental visiting in people with severe mental illness: a protocol paper.
作者信息
Hilton Claire, Morris Abigail, Burnside Girvan, Harris Rebecca, Aggarwal Vishal R, Procter Sarah, Griffiths Robert, French Paul, Laverty Louise, Lobban Fiona, Berry Katherine, Shiers David, Golby Rebecca, Fazekas Fanni, Valemis Kyriakos, Perry Antonia, Newens Connie, Kerry Eirian, Mupinga Pauline, Gkioni Efstathia, Lodge Christopher, Dawber Alison, Elliott Emma, Lunat Farah, Palmier-Claus Jasper
机构信息
The Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, UK.
Institute of Population Health, University of Liverpool, Liverpool, UK.
出版信息
Pilot Feasibility Stud. 2023 Sep 8;9(1):157. doi: 10.1186/s40814-023-01383-2.
BACKGROUND
People with severe mental illness (e.g. psychosis, bipolar disorder) experience poor oral health compared to the general population as shown by more decayed, missing and filled teeth and a higher prevalence of periodontal disease. Attending dental services allows treatment of oral health problems and support for prevention. However, people with severe mental illness face multiple barriers to attending routine dental appointments and often struggle to access care. Link work interventions use non-clinical support staff to afford vulnerable populations the capacity, opportunity, and motivation to navigate use of services. The authors have co-developed with service users a link work intervention for supporting people with severe mental illness to access routine dental appointments. The Mouth Matters in Mental Health Study aims to explore the feasibility and acceptability of this intervention within the context of a feasibility randomised controlled trial (RCT) measuring outcomes related to the recruitment of participants, completion of assessments, and adherence to the intervention. The trial will closely monitor the safety of the intervention and trial procedures.
METHODS
A feasibility RCT with 1:1 allocation to two arms: treatment as usual (control) or treatment as usual plus a link work intervention (treatment). The intervention consists of six sessions with a link worker over 9 months. Participants will be adults with severe mental illness receiving clinical input from secondary care mental health service and who have not attended a planned dental appointment in the past 3 years. Assessments will take place at baseline and after 9 months. The target recruitment total is 84 participants from across three NHS Trusts. A subset of participants and key stakeholders will complete qualitative interviews to explore the acceptability of the intervention and trial procedures.
DISCUSSION
The link work intervention aims to improve dental access and reduce oral health inequalities in people with severe mental illness. There is a dearth of research relating to interventions that attempt to improve oral health outcomes in people with mental illness and the collected feasibility data will offer insights into this important area.
TRIAL REGISTRATION
The trial was preregistered on ISRCTN (ISRCTN13650779) and ClinicalTrials.gov (NCT05545228).
背景
与普通人群相比，患有严重精神疾病（如精神病、双相情感障碍）的人口腔健康状况较差，表现为龋齿、缺牙和补牙情况更多，牙周病患病率更高。接受牙科服务有助于治疗口腔健康问题并提供预防支持。然而，患有严重精神疾病的人在参加常规牙科预约时面临多重障碍，且往往难以获得护理服务。联络工作干预措施利用非临床支持人员，使弱势群体有能力、有机会且有动力顺利使用各项服务。作者与服务使用者共同开发了一种联络工作干预措施，以支持患有严重精神疾病的人获得常规牙科预约。“心理健康中的口腔问题”研究旨在探讨在一项可行性随机对照试验（RCT）背景下该干预措施的可行性和可接受性，该试验测量与招募参与者、完成评估以及坚持干预相关的结果。试验将密切监测干预措施和试验程序的安全性。
方法
一项可行性随机对照试验，按1:1比例分为两组：常规治疗（对照组）或常规治疗加联络工作干预（治疗组）。干预措施包括在9个月内与一名联络工作人员进行六次会面。参与者将是患有严重精神疾病的成年人，他们正在接受二级护理心理健康服务的临床治疗，且在过去3年中未参加过计划中的牙科预约。评估将在基线时和9个月后进行。目标招募总数为来自三个国民保健服务信托基金的84名参与者。一部分参与者和关键利益相关者将完成定性访谈，以探讨干预措施和试验程序的可接受性。
讨论
联络工作干预措施旨在改善患有严重精神疾病的人的牙科服务可及性，并减少口腔健康不平等现象。关于试图改善患有精神疾病的人的口腔健康结果的干预措施的研究匮乏，所收集的可行性数据将为这一重要领域提供见解。
试验注册
该试验已在国际标准随机对照试验编号注册库（ISRCTN13650779）和美国国立医学图书馆临床试验注册平台（NCT05545228）上进行了预注册。
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