Institute of General Practice and Health Services Research, University of Zurich, Pestalozzistrasse 24, 8091 Zurich, Switzerland.
Trials. 2014 Mar 27;15:96. doi: 10.1186/1745-6215-15-96.
The Swiss health ministry launched a national quality program 'QualiCCare' in 2011 to improve health care for patients with COPD.The aim of this study is to determine whether participation in the COPD quality initiative ('QualiCCare') improves adherence to recommended clinical processes and shows impact on patients' COPD care and on the impact of COPD on a person's life.
CAROL is a cluster-randomized controlled trial with randomization on the general practioner (GP) level. Thirty GPs will be randomly assigned to equally sized intervention group or control group.Each GP will approach consecutively and regardless of the reason for the current consultation, patients aged 45 years or older, with a smoking history of ≥ ten pack-years (PY). Patients with confirmed (by spirometric evaluation) COPD will be included in the study. GPs in the intervention group will receive 'QualiCCare' education, which addresses knowledge, decision-making and behavioural aspects as well as delivery of care according to COPD quality indicators and evidence-based key elements. In the control group, no educational intervention will be applied and COPD patients will be treated as usual. The study period is one year.The primary outcome measure is an aggregated score of relevant clinical processes defining elements in the care of patients with COPD: smoking cessation counseling, influenza vaccination, motivation for physical activity, appropriate pharmacotherapy, patient education and collaborative care. Given a power of 90% and a significance level alpha of 5%, 15 GPs recruiting eight patients each will be necessary in both study arms. With an assumed dropout rate of 20%, 288 patients will need to be included.
It is important to develop and implement interventions that add value to COPD care considering quality and efficiency. Care pathways modifying the knowledge and behavior of physicians have the potential for improving care by transferring knowledge to clinical practice.
ClinicalTrials.gov: NCT01921556.
瑞士卫生部于 2011 年发起了一项名为“QualiCCare”的国家质量计划，以改善 COPD 患者的医疗保健。本研究旨在确定参与 COPD 质量倡议（“QualiCCare”）是否能提高对推荐临床流程的遵从性，并对患者 COPD 护理和 COPD 对个人生活的影响产生影响。
CAROL 是一项集群随机对照试验，在全科医生（GP）层面进行随机分组。30 名全科医生将被随机分为同等大小的干预组或对照组。每位 GP 将连续接触，无论当前咨询的原因是什么，年龄在 45 岁或以上、吸烟史≥10 包年（PY）的患者。将患有经肺量计评估确认（COPD）的患者纳入研究。干预组的 GP 将接受“QualiCCare”教育，该教育涉及知识、决策和行为方面，以及根据 COPD 质量指标和循证关键要素提供护理。对照组不进行教育干预，将按照常规治疗 COPD 患者。研究期为一年。主要结局指标是综合评分相关的临床过程，确定 COPD 患者护理的要素：戒烟咨询、流感疫苗接种、身体活动动机、适当的药物治疗、患者教育和协作护理。考虑到 90%的功效和 5%的显著性水平，在两个研究组中，需要招募 15 名 GP，每名 GP 招募 8 名患者。假设 20%的脱落率，需要纳入 288 名患者。
考虑到质量和效率，开发和实施为 COPD 护理增值的干预措施非常重要。改变医生知识和行为的护理途径有可能通过将知识转移到临床实践中来改善护理。
ClinicalTrials.gov：NCT01921556。
