A Web Application for Improving Communication on Hemodialysis Rounds

Voicing Individual Concerns for Engagement in Hemodialysis (VOICE-HD): a Web Application for Rounds

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))

Study Overview

• Status: Completed
• Conditions: Hemodialysis
• Intervention / Treatment: Behavioral: Web-App; Behavioral: Paper

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

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Royal Alexandra Hospital
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital
    • Edmonton, Alberta, Canada
      • Edmonton General Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Seven Oaks General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Web-App; A customized web-app tool to be used by patients to communicate concerns to their nephrologist	Behavioral: Web-App; Cambian IT Health solutions from Surrey BC developed the infrastructure
Active Comparator: Paper; A customized paper tool to be used by patients to communicate concerns to their nephrologist	Behavioral: Paper; Contains similar questions to the Web-App tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness - Number of patients submitting a concern divided by the number of patients	Number of patients submitting a concern divided by the number of patients with an opportunity to submit a concern	8 weeks
Effectiveness - Number of concerns entered divided by the number of concerns that were satisfactorily addressed	Number of concerns entered divided by the number of concerns that were satisfactorily addressed	8 weeks
Efficiency - The amount of time to complete one concern	The amount of time to log a concern in the web app	8 weeks
Satisfaction - Usability survey	Usability survey Defined as greater than 70% of users who agree or strongly agree with the statement on the usability survey. Ranked on a 5 -point Likert scale	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Communication Assessment Tool	Items rated from 1 (poor) to 5 (excellent). Published at Makoul et al. Patient Educ Couns 2007	8 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Stephanie Thompson, MD PhD, University of Alberta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Pro00076483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No