Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID): a randomised controlled trial in systemic cancer treatment

BMC Cancer

Study Protocol

Claire Hulme¹  Jenny Hewison²  Faye Samy³  Julia Brown³  Leon Bamforth⁴  Carolyn Morris⁵  Mark Conner⁶  Kate Absolom⁷  Lorraine Warrington⁷  Galina Velikova⁸  Patricia Holch⁹ 

[1] Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK;Centre for Health Services Research, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK;Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK;Leeds Teaching Hospitals NHS Trust, St James’s Institute of Oncology, Leeds, UK;Patient Representative, eRAPID systemic treatment workgroup, Leeds, UK;School of Psychology, University of Leeds, Leeds, UK;Section of Patient Centred Outcomes Research (PCOR), Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK;Section of Patient Centred Outcomes Research (PCOR), Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK;Leeds Teaching Hospitals NHS Trust, St James’s Institute of Oncology, Leeds, UK;Section of Patient Centred Outcomes Research (PCOR), Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK;Psychology Group, School of Social Sciences, Faculty of Health and Social Sciences, Leeds Beckett University, Leeds, UK;

关键词: Cancer;    Adverse events;    Patient reported outcome measures (PROMs);    Patient reported outcomes (PROs);    Electronic patient records;    Electronic health records;    Internet;    Intervention;    Self-management;    Chemotherapy;   

DOI  :  10.1186/s12885-017-3303-8

 received in 2017-02-10, accepted in 2017-04-25,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundeRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an internet based system for patients to self-report symptoms and side effects (adverse events or AE) of cancer treatments. eRAPID allows AE reporting from home and patient reported data is accessible via Electronic Patient Records (EPR) for use in routine care. The system can generate alerts to clinical teams for severe AE and provides patient advice on managing mild AEs. The overall aims of eRAPID are to improve the safe delivery of cancer treatments, enhance patient care and standardise AE documentation.MethodsThe trial is a prospective randomised two-arm parallel group design study with repeated measures and mixed methods. Participants (adult patients with breast cancer on neo-adjuvant or adjuvant chemotherapy, colorectal and gynaecological cancer receiving chemotherapy) are randomised to receive the eRAPID intervention or usual care over 18 weeks of treatment. Participants in the intervention arm receive training in using the eRAPID system to provide routine weekly adverse event reports from home. Hospital staff can access eRAPID reports via the EPR and use the information during consultations or phone calls with patients.Prior to commencing the full trial an internal pilot phase was conducted (N = 87 participants) to assess recruitment procedures, consent and attrition rates, the integrity of the intervention information technology and establish procedures for collecting outcome data. The overall target sample for the trial is N = 504.The primary outcome of the trial is quality of life (FACT-G) with secondary outcomes including health economics (costs to patients and the NHS), process of care (e.g. contacts with the hospital, number of admissions, clinic appointments and changes to treatment/medications) and patient self-efficacy. Outcome data is collected at baseline, 6, 12, 18 weeks and 12 months. The intervention is also being evaluated via end of study interviews with patient participants and clinical staff.DiscussionThe pilot phase was completed in February 2016 and recruitment and attrition rates met criteria for continuing to the full trial. Recruitment recommenced in May 2016 and is planned to continue until December 2017. Overall findings will determine the value of the eRAPID intervention for supporting the care of patients receiving systemic cancer treatment.Trial registrationCurrent Controlled Trials ISRCTN88520246. Registered 11 September 2014.

【 授权许可】

CC BY   
© The Author(s). 2017