Clinical trial NCT02970201: Improving Adherence in Renal Dialysis Patients Through Electronic Interventions
Official title: Improving Adherence in Renal Dialysis Patients; a Randomized Crossover Trial for an Electronic Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endstage Renal Disease
Keywords: eHealth
mHealth
Hemodialysis
Adherence
Electronic intervention
ESRD
Nephrology
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All potential subjects are between 18 and 75 years of age, and have been receiving hemodialysis treatments, scheduled for 3 sessions/week, for at least 8 weeks at the Chromalloy American Kidney Center or Washington University Dialysis Center.
* The individuals will be prospectively identified as whether they have a history of occasional non-attendance to dialysis treatments, defined as 2-3 missed appointments in the preceding 8 week period or 24 scheduled sessions. These subjects will be enrolled as part of one cohort. Individuals who have frequent non-attendance, defined as 4-6 missed appointments in the preceding 8 week period or 24 scheduled sessions, will be enrolled as a second cohort.
* Subjects must be able to provide a phone number at which they can either receive SMS text messages and/or phone calls. The cost of messages will be paid for by the sender. Subjects must be able and willing to provide consent and authorize access of their medical record and dialysis clinic record for study use.

Exclusion Criteria:

* Persons not receiving ongoing hemodialysis treatments or new patients with less than 8 weeks of treatments at the dialysis center.
* Persons not intended to receive 3 dialysis treatments/week for the next 8 weeks.
* Pregnant individuals.
* Persons unable to be contacted by phone call or SMS text message, or unwilling to provide their contact number.
* Persons unwilling to consent and follow the assigned regimen and complete the required follow up.
* Persons with severe neurological or cognitive disorders, limiting their ability to provide consent.

Primary outcomes:
measure: Dialysis appointment attendance
timeFrame: 16 weeks
Secondary outcomes:
measure: Hospitalization
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Will R Ross, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: U.S. Renal Data System Annual Data Report. Chapter 1: Incidence, prevalence, patient characteristics and modality. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD https://www.usrds.org/2015/view/v2_01.aspx (2015)
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citation: Lamping, D. L. & Campbell, K. A. Hemodialysis Compliance: Assessment, Prediction, and Intervention: Part II. Seminars in dialysis 3, (1990).
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