AmbuFlex/WestChronic, Occupational Medicine, University Research Clinic, Aarhus University, Herning, Denmark.
Department of Nephrology, Aarhus University Hospital, Aarhus, Denmark.
BMC Health Serv Res. 2019 Sep 4;19(1):631. doi: 10.1186/s12913-019-4461-y.
Outpatient care is steadily changing from hospital consultations to other platforms, such as phone consultation and online virtual clinics. It is prudent to maintain quality of care with such initiatives. Currently, patients with chronic kidney disease (CKD) have frequent scheduled visits, but it may be possible to optimise the frequency of hospital consultations using information from patient-reported outcome (PRO) questionnaires filled in at home (PRO-based follow-up). This approach may provide a more individually tailored follow-up based on actual needs for clinical attention. We aimed to evaluate the effectiveness of the quality of care, use of resources and patient outcomes associated with PRO-based follow-up in patients with CKD.
This study is a pragmatic, non-inferiority, randomised controlled trial in outpatients with CKD (Grove BE et al., Qual Life Res 27: S143, 2018). Newly referred patients with an estimated glomerular filtration rate (eGFR) of ≤40 ml/min 1.73m will be randomised to either: 1. PRO-based remote follow-up 2. PRO-based telephone consultation 3. Usual outpatient follow-up (control group) In the two intervention groups, a diagnosis-specific PRO questionnaire completed by the patient at home will substitute for usual outpatient follow-up visits. The PRO questionnaire will in part be used as a screening tool to identify patients in need of outpatient contact and to identify focus areas. Responses from the questionnaire will be processed according to a disease-specific algorithm and assigned green, yellow or red status according to patients' needs. The primary outcome will be loss of renal function evaluated by eGFR. Secondary outcomes are 1. Clinical outcomes, including initiation of acute dialyses, hospitalisation and mortality, 2. Utilisation of healthcare resources and 3. PRO measures, primarily quality of life (Euroqol EQ-5D) and illness perception (Brief Illness Perception Questionnaire (BIPQ).
Benefits and possible drawbacks of the PRO-based follow-up will be evaluated. If PRO-based follow-up proves non-inferior to usual outpatient follow-up, a reorganisation of routine clinical practice in nephrology outpatient clinics may occur. Further, results may impact other patient groups with chronic conditions attending regular follow-up.
ClinicalTrials.gov identifier NCT03847766 (Retrospectively registered on January 23, 2019).
门诊服务正稳步从医院咨询转向其他平台，如电话咨询和在线虚拟诊所。在开展此类服务时，谨慎维持医疗质量至关重要。目前，慢性肾脏病（CKD）患者的就诊频率较高，但通过在家填写患者报告结局（PRO）问卷（基于 PRO 的随访），可能可以优化就诊频率。这种方法可以根据实际临床关注度需求，为患者提供更个性化的随访。我们旨在评估基于 PRO 的随访在 CKD 患者中的医疗质量、资源利用和患者结局的有效性。
这是一项在 CKD 门诊患者中进行的实用、非劣效性、随机对照试验（Grove BE 等人，Qual Life Res 27: S143, 2018）。估算肾小球滤过率（eGFR）≤40 ml/min/1.73m2 的新转诊患者将被随机分配到以下三组之一：1. 基于 PRO 的远程随访；2. 基于 PRO 的电话咨询；3. 常规门诊随访（对照组）。在这两个干预组中，患者在家中填写的特定于疾病的 PRO 问卷将替代常规门诊随访。PRO 问卷将部分用作筛选工具，以识别需要门诊接触的患者，并确定重点领域。问卷的回复将根据特定于疾病的算法进行处理，并根据患者的需求分配绿色、黄色或红色状态。主要结局为 eGFR 评估的肾功能丧失。次要结局包括 1. 临床结局，包括开始急性透析、住院和死亡，2. 医疗资源利用，3. PRO 测量，主要是生活质量（EuroQol EQ-5D）和疾病感知（Brief Illness Perception Questionnaire (BIPQ)）。
将评估基于 PRO 的随访的优点和可能的缺点。如果基于 PRO 的随访被证明不劣于常规门诊随访，肾内科门诊常规临床实践可能会发生改变。此外，结果可能会影响其他接受常规随访的慢性疾病患者群体。
ClinicalTrials.gov 标识符 NCT03847766（2019 年 1 月 23 日回顾性注册）。
