Clinical trial NCT03605875: A Web Application for Improving Communication on Hemodialysis Rounds
Official title: Voicing Individual Concerns for Engagement in Hemodialysis (VOICE-HD): a Web Application for Rounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemodialysis
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 allocation
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate a web application tool that hemodialysis patients can use outside of dialysis time to log and prioritize their concerns for the nephrologists. Specifically, the investigators will compare the usability of a web application tool to a structured paper form. The investigators will also use data from semi-structured interviews to better understand the experience and acceptability of the web app among patient participants randomized to the web application and among participating nephrologists.

Primary outcome

-Usability (effectiveness, efficiency, satisfaction)

Secondary outcomes

-Quality of the patient-physician interaction (Communication Assessment Tool (CAT-14))

Detailed description: Usability is defined as Effectiveness (\>70%)

* Number of people submitting a concern/ number of people with opportunity to submit a concern
* Number of concerns entered/number of times concern was satisfactorily addressed

Efficiency

* Proportion of non-completed tasks (\<70%)
* The amount of time to complete one concern

Satisfaction

* Semistructured interviews
* Usability survey

Eligibility criteria: Inclusion Criteria:

* Chronic in-center hemodialysis patients in Edmonton, Alberta and Winnipeg, Manitoba
* Able to provide consent, understand and read English or have a family member that can do this for them

Exclusion Criteria:

* Planning to change modality within the next year

Primary outcomes:
measure: Effectiveness - Number of patients submitting a concern divided by the number of patients
timeFrame: 8 weeks
measure: Effectiveness - Number of concerns entered divided by the number of concerns that were satisfactorily addressed
timeFrame: 8 weeks
measure: Efficiency - The amount of time to complete one concern
timeFrame: 8 weeks
measure: Satisfaction - Usability survey
timeFrame: 8 weeks
Secondary outcomes:
measure: Communication Assessment Tool
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Edmonton General Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: Seven Oaks General Hospital
state: Manitoba
Study officials:
affiliation: University of Alberta
name: Stephanie Thompson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson S, Schick-Makaroff K, Bello A, Tonelli M, Wiebe N, Buzinski R, Courtney M, Szigety S, Shah N, Bohm C. Voicing Individual Concerns for Engagement in Hemodialysis (VOICE-HD): A Mixed Method, Randomized Pilot Trial of Digital Health in Dialysis Care Delivery. Can J Kidney Health Dis. 2021 Jul 27;8:20543581211032857. doi: 10.1177/20543581211032857. eCollection 2021.