Quemada-González Casta, Morales-Asencio José Miguel, Hurtado María M, Martí-García Celia
Mental Health Unit, Regional University Hospital, Instituto de Investigación Biomédica de Málaga (IBIMA), 29009, Málaga, Spain.
Faculty of Health Sciences, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.
BMC Nurs. 2022 Apr 20;21(1):92. doi: 10.1186/s12912-022-00870-w.
To evaluate the impact of a nurse navigation program on treatment adherence and resolution of hepatitis C infection in patients with severe mental disorder.
An open, randomized, controlled trial with blinded outcome assessment. The intervention group will engage in a nurse navigation program designed by mental health nurses. The program involves active screening for patients with severe mental disorder. The patients and caregivers included in the program will receive information, training, support and guidance throughout the treatment and recovery process, which involves different healthcare professionals and units. The control group will receive the standard of care, which includes follow-up by a family physician, referral to the hepatologist, serological testing, new referral to the hepatologist, onset of treatment, and follow-up. Multidisciplinary care will be provided along a coordinated and seamless clinical pathway led by a nurse navigator. The primary endpoints are total recovery (hepatitis C cure) and treatment adherence. Occurrence of symptoms of schizophrenia and health-related quality of life will be also recorded. Follow-up of patients will be performed three and six months after the administration of antiviral treatment. The study was authorised by the Ethics Committee of Malaga in December 2021. Funding was approved in March 2021.
If this intervention is proven to be effective in improving treatment access and adherence, it will represent a step forward in addressing a chronic health issue that is 16 times more prevalent in the population with severe mental disease. Finally, this intervention may lead to the detection of undertreated HCV infection in this population of patients.
This protocol has been registered in ClinicalTrials.gov with identifier code NCT04891445 on May 18, 2021.
评估护士导航计划对重度精神障碍患者丙型肝炎感染治疗依从性和治愈情况的影响。
一项采用盲法结局评估的开放性随机对照试验。干预组将参与由精神科护士设计的护士导航计划。该计划包括对重度精神障碍患者进行积极筛查。纳入该计划的患者及其护理人员将在整个治疗和康复过程中获得信息、培训、支持和指导，这涉及不同的医疗专业人员和科室。对照组将接受标准治疗，包括家庭医生随访、转诊至肝病专家、血清学检测、再次转诊至肝病专家、开始治疗以及随访。多学科护理将沿着由护士导航员主导的协调且无缝衔接的临床路径提供。主要终点是完全康复（丙型肝炎治愈）和治疗依从性。还将记录精神分裂症症状的出现情况以及与健康相关的生活质量。在给予抗病毒治疗后3个月和6个月对患者进行随访。该研究于2021年12月获得马拉加伦理委员会批准。资金于2021年3月获批。
如果该干预措施被证明能有效改善治疗可及性和依从性，这将代表在解决一个在重度精神疾病患者中患病率高出16倍的慢性健康问题方面向前迈进了一步。最后，该干预措施可能会促使在这类患者群体中发现治疗不足的丙型肝炎感染情况。
本方案已于2021年5月18日在ClinicalTrials.gov上注册，标识符代码为NCT04891445。
