A Web Application for Improving Communication on Hemodialysis Rounds

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605875
• Other study ID #: Pro00076483
• Status: Completed
• Phase: Phase 3
• Start date: November 28, 2018
• Est. completion date: December 13, 2019

Study information

• Verified date: March 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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))

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 13, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Behavioral:
• Web-App
Cambian IT Health solutions from Surrey BC developed the infrastructure
• Paper
Contains similar questions to the Web-App tool

Locations

Country	Name	City	State
Canada	Edmonton General Hospital	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Seven Oaks General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Efficiency - The amount of time to complete one concern	The amount of time to log a concern in the web app	8 weeks
Primary	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	Communication Assessment Tool	Items rated from 1 (poor) to 5 (excellent). Published at Makoul et al. Patient Educ Couns 2007	8 weeks