INCLUDE研究：整合并改善社区炎症性风湿病患者的护理；识别共病：一项试点随机对照试验方案
The INCLUDE study: INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community; identifying multimorbidity: Protocol for a pilot randomized controlled trial.
作者信息
Hider Samantha L, Bucknall Milica, Cooke Kelly, Cooke Kendra, Finney Andrew G, Goddin Dave, Healey Emma L, Hennings Susie, Herron Daniel, Jinks Clare, Lewis Martyn, Machin Annabelle, Mallen Christian, Wathall Simon, Chew-Graham Carolyn A
机构信息
Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
Haywood Academic Rheumatology Centre, Haywood Hospital, Stoke-on-Trent, UK.
出版信息
J Comorb. 2018 Aug 2;8(1):2235042X18792373. doi: 10.1177/2235042X18792373. eCollection 2018.
BACKGROUND
Patients with inflammatory rheumatic conditions such as rheumatoid arthritis, polymyalgia rheumatica and ankylosing spondylitis are at increased risk of common comorbidities such as cardiovascular disease, osteoporosis and anxiety and depression which lead to increased morbidity and mortality. These associated morbidities are often un-recognized and under-treated. While patients with other long-term conditions such as diabetes are invited for routine reviews in primary care, which may include identification and management of co-morbidities, at present this does not occur for patients with inflammatory conditions, and thus, opportunities to diagnose and optimally manage these comorbidities are missed.
OBJECTIVE
To evaluate the feasibility and acceptability of a nurse-led integrated care review (the INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community (INCLUDE) review) for people with inflammatory rheumatological conditions in primary care.
DESIGN
A pilot cluster randomized controlled trial will be undertaken to test the feasibility and acceptability of a nurse-led integrated primary care review for identification, assessment and initial management of common comorbidities including cardiovascular disease, osteoporosis and anxiety and depression. A process evaluation will be undertaken using a mixed methods approach including participant self-reported questionnaires, a medical record review, an INCLUDE EMIS template, intervention fidelity checking using audio-recordings of the INCLUDE review consultation and qualitative interviews with patient participants, study nurses and study general practitioners (GPs).
DISCUSSION
Success of the pilot study will be measured against the engagement, recruitment and study retention rates of both general practices and participants. Acceptability of the INCLUDE review to patients and practitioners and treatment fidelity will be explored using a parallel process evaluation.
TRIAL REGISTRATION
ISRCTN12765345.
背景
患有类风湿关节炎、风湿性多肌痛和强直性脊柱炎等炎性风湿性疾病的患者，患心血管疾病、骨质疏松症以及焦虑和抑郁等常见合并症的风险增加，这些合并症会导致发病率和死亡率上升。这些相关的合并症往往未被识别且治疗不足。虽然患有糖尿病等其他长期疾病的患者会被邀请到初级保健机构进行常规复查，其中可能包括合并症的识别和管理，但目前炎性疾病患者并未如此，因此错过了诊断和优化管理这些合并症的机会。
目的
评估由护士主导的综合护理复查（社区炎性风湿性疾病患者综合与改善护理（INCLUDE）复查）在初级保健中对炎性风湿性疾病患者的可行性和可接受性。
设计
将进行一项试点整群随机对照试验，以测试由护士主导的综合初级保健复查对识别、评估和初步管理包括心血管疾病、骨质疏松症以及焦虑和抑郁在内的常见合并症的可行性和可接受性。将采用混合方法进行过程评估，包括参与者自我报告问卷、病历审查、INCLUDE EMIS模板、使用INCLUDE复查咨询录音进行干预保真度检查以及对患者参与者、研究护士和研究全科医生（GP）进行定性访谈。
讨论
试点研究的成功将根据全科医疗实践和参与者的参与度、招募率和研究保留率来衡量。将使用并行过程评估来探索INCLUDE复查对患者和从业者的可接受性以及治疗保真度。
试验注册
ISRCTN12765345。
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