Jennifer E. Flythe , Cassandra B. Picataggio , Leah Bernardo , Lorien S. Dalrymple , Robert J. Kossmann , Darren A. DeWalt , Laura C. Hanson , Virginia Wang , Mark L. Unruh , Jesse Y. Hsu , Laura M. Dember
{"title":"SMaRRT-HD研究的设计和基本原理:对接受维持性血液透析的个体进行症状监测的一项实用的随机试验。","authors":"Jennifer E. Flythe , Cassandra B. Picataggio , Leah Bernardo , Lorien S. Dalrymple , Robert J. Kossmann , Darren A. DeWalt , Laura C. Hanson , Virginia Wang , Mark L. Unruh , Jesse Y. Hsu , Laura M. Dember","doi":"10.1016/j.cct.2025.108058","DOIUrl":null,"url":null,"abstract":"<div><div>Individuals with hemodialysis-dependent kidney failure often suffer from numerous symptoms that contribute to poor patient outcomes. The Symptom Monitoring in Renal Replacement Therapy-Hemodialysis (SMaRRT-HD) Study is a pragmatic randomized trial of monitoring and follow-up of symptoms for individuals receiving maintenance hemodialysis. The trial uses an effectiveness-implementation hybrid design with randomization at the clinic level to compare the effectiveness of once monthly symptom monitoring with supported clinician follow-up via an electronic patient-reported outcome measure (ePROM) system called SMaRRT-HD compared to routine symptom monitoring without supported follow-up (Usual Care) to improve patient-reported and biomedical outcomes over a 12-month intervention period. This manuscript describes the design of the trial with a focus on the effectiveness evaluation component. The primary outcome is symptom severity ascertained with the Dialysis Symptom Index at 6 and 12 months. Secondary outcomes are additional patient-reported outcomes (PROs) including health-related quality of life, fatigue, pain, hemodialysis recovery time, depression, anxiety, and healthcare engagement and biomedical outcomes including hospitalizations, missed hemodialysis treatments, and shortened hemodialysis treatments. Exploratory outcomes include death and quality of communication between patients and clinicians. The trial will include up to 36 hemodialysis clinics located across the United States. The enrollment targets are 2400 participants for the Full Cohort from which the biomedical outcomes will be ascertained, and 1200 participants for the PRO Subset from which PROs will be ascertained. 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Dember\",\"doi\":\"10.1016/j.cct.2025.108058\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>Individuals with hemodialysis-dependent kidney failure often suffer from numerous symptoms that contribute to poor patient outcomes. The Symptom Monitoring in Renal Replacement Therapy-Hemodialysis (SMaRRT-HD) Study is a pragmatic randomized trial of monitoring and follow-up of symptoms for individuals receiving maintenance hemodialysis. The trial uses an effectiveness-implementation hybrid design with randomization at the clinic level to compare the effectiveness of once monthly symptom monitoring with supported clinician follow-up via an electronic patient-reported outcome measure (ePROM) system called SMaRRT-HD compared to routine symptom monitoring without supported follow-up (Usual Care) to improve patient-reported and biomedical outcomes over a 12-month intervention period. This manuscript describes the design of the trial with a focus on the effectiveness evaluation component. The primary outcome is symptom severity ascertained with the Dialysis Symptom Index at 6 and 12 months. Secondary outcomes are additional patient-reported outcomes (PROs) including health-related quality of life, fatigue, pain, hemodialysis recovery time, depression, anxiety, and healthcare engagement and biomedical outcomes including hospitalizations, missed hemodialysis treatments, and shortened hemodialysis treatments. Exploratory outcomes include death and quality of communication between patients and clinicians. The trial will include up to 36 hemodialysis clinics located across the United States. The enrollment targets are 2400 participants for the Full Cohort from which the biomedical outcomes will be ascertained, and 1200 participants for the PRO Subset from which PROs will be ascertained. 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Design and rationale of the SMaRRT-HD study: A pragmatic, randomized trial of symptom monitoring for individuals receiving maintenance hemodialysis
Individuals with hemodialysis-dependent kidney failure often suffer from numerous symptoms that contribute to poor patient outcomes. The Symptom Monitoring in Renal Replacement Therapy-Hemodialysis (SMaRRT-HD) Study is a pragmatic randomized trial of monitoring and follow-up of symptoms for individuals receiving maintenance hemodialysis. The trial uses an effectiveness-implementation hybrid design with randomization at the clinic level to compare the effectiveness of once monthly symptom monitoring with supported clinician follow-up via an electronic patient-reported outcome measure (ePROM) system called SMaRRT-HD compared to routine symptom monitoring without supported follow-up (Usual Care) to improve patient-reported and biomedical outcomes over a 12-month intervention period. This manuscript describes the design of the trial with a focus on the effectiveness evaluation component. The primary outcome is symptom severity ascertained with the Dialysis Symptom Index at 6 and 12 months. Secondary outcomes are additional patient-reported outcomes (PROs) including health-related quality of life, fatigue, pain, hemodialysis recovery time, depression, anxiety, and healthcare engagement and biomedical outcomes including hospitalizations, missed hemodialysis treatments, and shortened hemodialysis treatments. Exploratory outcomes include death and quality of communication between patients and clinicians. The trial will include up to 36 hemodialysis clinics located across the United States. The enrollment targets are 2400 participants for the Full Cohort from which the biomedical outcomes will be ascertained, and 1200 participants for the PRO Subset from which PROs will be ascertained. The findings of the trial will inform approaches to symptom monitoring and follow-up for people with hemodialysis-dependent kidney failure.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.