Self-reported MeasUrement of Physical and PsychosOcial Symptoms Response Tool (SUPPORT-dialysis): systematic symptom assessment and management in patients on in-centre haemodialysis - a parallel arm, non-randomised feasibility pilot study protocol

被引：1

作者：

Gill, Jasleen Kaur ^{[1
,2
]}

Pucci, Maria ^{[2
]}

Samudio, Ana ^{[2
]}

Ahmed, Tibyan ^{[2
]}

Siddiqui, Rabail ^{[2
]}

Edwards, Nathaniel ^{[2
]}

Marticorena, Rosa M. ^{[3
]}

Donnelly, Sandra ^{[3
]}

Lok, Charmaine ^{[4
]}

Wentlandt, Kirsten ^{[4
]}

Wolofsky, Kayla ^{[5
]}

Mucsi, Istvan ^{[6
]}

机构：

[1] Univ Toronto, Inst Med Sci, St George Campus, Toronto, ON, Canada

[2] UHN, Multiorgan Transplant, Toronto, ON, Canada

[3] Nephrol Program, Sir William Osler Hlth Syst, Brampton, ON, Canada

[4] UHN, Div Cardiol, Toronto, ON, Canada

[5] Dept Support Care, UHN, Toronto, ON, Canada

[6] Univ Toronto, Multiorgan Transplant Program, Med, Toronto, ON, Canada

来源：

BMJ OPEN | 2024年 / 14卷 / 01期

基金：

加拿大健康研究院;

关键词：

NEPHROLOGY; Dialysis; Patient Reported Outcome Measures; End stage renal failure; QUALITY-OF-LIFE; MINIMALLY IMPORTANT DIFFERENCES; SOCIAL DIFFICULTIES; OUTCOME MEASURE; KIDNEY-DISEASE; VALIDATION; DEPRESSION; FATIGUE; PROMIS; VALIDITY;

D O I：

10.1136/bmjopen-2023-080712

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction Patients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment, using electronic patient reported outcomes measure (ePROMs) linked to systematic symptom management, could improve such outcomes. Clinical implementation of ePROMs have been successful in routine oncology care, but not used for patients on dialysis. In this study, we describe a pilot study of ePROM-based systematic symptom monitoring and management intervention in patients treated with in-centre haemodialysis.Methods and analysis This is a parallel-arm, controlled pilot of adult patients receiving in-centre maintenance haemodialysis. Participants in the intervention arm will complete ePROMs once a month for 6 months. ePROMs will be scored real time and the results will be shared with participants and with the clinical team. Moderate-severe symptoms will be flagged using established cut-off scores. Referral options for those symptoms will be shared with the clinical team, and additional symptom management resources will also be provided for both participants and clinicians. Participants in the control arm will be recruited at a different dialysis unit, to prevent contamination. They will receive usual care, except that they will complete ePROMs without the presentation of results to participants of the clinical team. The primary objectives of the pilot are to assess (1) the feasibility of a larger, randomised clinical effectiveness trial and (2) the acceptability of the intervention. Interviews conducted with participants and staff will be assessed using a content analysis approach.Ethics and dissemination Ethical approval for this study was obtained from the University Health Network (REB#21-5199) and the William Osler Health System (#23-0005). All study procedures will be conducted in accordance with the standards of University Health Network research ethics board and with the 1964 Helsinki declaration and its later amendments. Results of this study will be shared with participants, patients on dialysis and other stakeholders using lay language summaries, oral presentations to patients and nephrology professionals. We will also be publishing the results in a peer-reviewed journal and at scientific meetings.Protocol version 4 (16 November 2022).Trial registration number NCT05515991.

引用

页数：9