Washington University School of Medicine - Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
NCT Number: NCT02970201
Dialysis treatment non-adherence is a prevalent problem among the end-stage renal population receiving chronic hemodialysis. The complications associated with missed or shortened dialysis sessions are serious and frequently require emergent medical care or hospitalization. Previous studies have shown that electronic messages have significantly improved attendance rates in a primary care setting, but these messages have not been validated in the chronic dialysis population.
An electronic intervention has been developed by Epharmix, a WUSTL IDEA Labs (ideas.wustl.edu) team, which has the capacity to use automated SMS text messages and/or phone calls to notify patients prior to each upcoming appointment, as well as alert a designated patient advocate. Patients receiving the messages are provided with key contact information for a dialysis rescheduling phone line, transportation resources, social work services, etc. They may also receive instructions on what to do if they are experiencing physical symptoms and need educational facts about dialysis. In particular, the intervention is designed to demonstrate to patients that the center cares and is concerned for their health and wellbeing. This intervention may potentially improve patient adherence to their scheduled sessions, increase patient satisfaction with their treatment, and prevent medical complications associated with missed dialysis appointments.
This study aims to determine whether an electronic intervention, which sends SMS text messages or phone calls of key dialysis treatment information, is able to improve dialysis treatment session attendance among dialysis patients with a history of poor attendance. We secondarily aim to identify the factors that may be barriers to dialysis treatment session attendance and the emergency department or hospital utilization associated with missed dialysis treatments.
Patients will be prospectively identified, recruited, and randomized into two groups. Group A will receive the electronic intervention prior to their appointments; Group B will not receive any electronic intervention. After 8 weeks, crossover will occur for both groups and the study will continue for an additional 8 weeks. Participants' clinic records will be reviewed to determine the numbers of missed and attended appointments, as well as records of ED visits and hospital admissions. Subjects will be asked to complete a post-study satisfaction questionnaire.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
St Louis, Missouri, 63110, United States
Dialysis treatment non-adherence is a prevalent problem among the end-stage renal population receiving chronic hemodialysis. The complications associated with missed or shortened dialysis sessions are serious and frequently require emergent medical care or hospitalization. Previous studies have shown that electronic messages have significantly improved attendance rates in a primary care setting, but have not been validated in the chronic dialysis population.
An electronic intervention has been developed by Epharmix, a WUSTL IDEA Labs (ideas.wustl.edu) team, which has the capacity to use SMS text messaging to phone call recordings to notify patients prior to each of their upcoming appointment times, with the option of also alerting a designated patient advocate. Patients receiving the messages are provided with key contact information for a dialysis rescheduling phone line, transportation resources, social work services, etc. This intervention may potentially improve patient adherence with scheduled sessions, increase patient satisfaction with their treatment and prevent medical complications associated with missing dialysis.
This study aims to determine whether an electronic intervention, which sends SMS text messages or phone calls of key dialysis treatment information, is able to improve dialysis session attendance among patients with a history of poor attendance. Our secondary aim is to identify factors that may be barriers to dialysis appointment attendance and are associated with emergency department (ED) or hospital utilization.
Procedures: Dialysis patients of the Chromalloy American Kidney Center (CAKC) at Barnes Jewish Hospital (BJH) and the Washington University Dialysis Center (WUDC) will be included in this study. Two cohorts will be prospectively identified, one group consisting of individuals with a history of occasional non-attendance to treatment sessions, defined as 2-3 missed sessions out of 24 consecutive sessions in the past 8 weeks; the other group consisting of individuals who are frequently non-adherent (4-6 missed sessions in the past 24 consecutive sessions). Patients from each cohort will be recruited and then randomized to either the experimental or the control group. Group A will receive the electronic intervention featuring automated SMS text message and/or phone call prior to their appointments; Group B will not receive any electronic intervention. After 8 weeks, crossover will occur for both groups and the study will continue for an additional 8 weeks.
At time of enrollment, all subjects will be asked to complete a questionnaire to determine the demographic characteristics of the study population of interest and identify possible socio-economic factors contributing to non-adherence to the prescribed 3 times weekly dialysis schedule. The participants' clinic records will be reviewed to determine the numbers of missed and attended appointments, as well as records of ED visits and hospital admissions through BJH. Subjects will be asked to complete a post-questionnaire to rate their satisfaction with their current schedule of dialysis and their satisfaction with the electronic intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The EpxDialysis intervention consists of automated SMS text or voice messages delivered to the patient's preferred phone number three times per week. These messages provide details about the subject's upcoming hemodialysis session, anticipatory guidance regarding clinically-concerning symptoms, as well as the option for direct call routing to the dialysis center for rescheduling sessions.
Time frame: 16 weeks
The primary objective of this prospective randomized control study is to assess the effects of an electronic intervention, which sends automated SMS text messages or pre-recorded phone messages, on attendance rate to dialysis sessions among non-adherent dialysis patients.
Time frame: 16 weeks
Compare the number of emergency department visits and hospitalizations between groups during intervention and control phases
Washington University School of Medicine
Other
Improving Adherence in Renal Dialysis Patients; a Randomized Crossover Trial for an Electronic Intervention
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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