Effectiveness of an Online Portal for Delivery of Care to Home Dialysis Patients

Peritoneal Dialysis Clinical Trial

Official title:

Effectiveness of an Online Portal for Delivery of Care to Home Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128347
• Other study ID #: eportal 2014-316
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: July 25, 2016
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Home dialysis has many potential benefits compared to in-center hemodialysis including improved quality of life, reduced hospital admission and reduced cost. However, some patients perceive that home modalities are associated with increased isolation from the healthcare system, substandard care or higher risk of catastrophic events. Providing better support for home dialysis patients may enhance their ability to maintain at home, improve their health outcomes, increase quality of life and improve satisfaction with care. In other chronic disease populations a secure, online communication portal between physicians and patients has proven useful in enhancing care for patients. Thus far, the utility of an online portal communication system has not been tested in a cohort of home dialysis patients. The investigators hypothesize that this novel form of communication will improve care and outcomes for home dialysis patients. Therefore, in a cohort of home dialysis patients, the purposes of this study are as follows: 1) Does an online patient-portal improve patient satisfaction with home dialysis care? 2) Does an online patient-portal improve quality of life? 3) Does an online patient-portal reduce hospitalization and health service utilization?

Description:

Home dialysis (including peritoneal dialysis and home hemodialysis) has a number of potential benefits over in-center hemodialysis (including lower healthcare costs and improved quality of life for patients). However, overall quality of life remains low compared to the general population. Furthermore, home dialysis patients (primarily those on peritoneal dialysis) continue to experience a high rate of hospitalization. Finally, there can be improvement in patient satisfaction with home dialysis, particularly in the areas of shared decision making and handling of patient requests.

Regarding satisfaction with care, peritoneal dialysis patients have identified that "attentiveness to concerns", and clarity of recommendations is important. Improved satisfaction in turn, may be associated with improvements in quality of life. Therefore, identifying novel communication systems for home dialysis patients is crucial. The use of eHealth online portals that support online communication between patients and healthcare workers is increasing. An interface that allows patients to discuss treatment plans and address clinical problems while obviating the need for telephone communication has been shown to be beneficial in some studies. Such a system may improve patient satisfaction, reduce health service utilization, and potentially improve health outcomes.

Thus far, the feasibility and potential benefit of an eHealth online portal to facilitate communication has not been evaluated in home dialysis. Therefore, in a cohort of home dialysis patients, the purpose of this study is to identify the following: 1) Does an online portal improve patient satisfaction with home dialysis care? 2) Does an online portal improve quality of life? 3) Does an online portal reduce hospitalization and health service utilization? Overall, we hope that this study will inform the need to pursue a larger, multicenter trial to more rigorously evaluate the utility of this novel form of communication for home dialysis patients.

We will conduct a prospective pilot study of prevalent (receiving home dialysis for at least three months) home dialysis patients (including both peritoneal dialysis and home hemodialysis) at Capital Health. Consecutive patients that are evaluated in the home dialysis clinic over a 4-month period will be enrolled in the study if they provide consent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prevalent (>=3 months) home dialysis patients (peritoneal dialysis or home hemodialysis)

Exclusion Criteria:

• Does not provide consent

• On home dialysis for less than 3 months

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hemodialysis, Home
• Peritoneal Dialysis

Intervention

Other:
• Electronic Patient Portal
RelayHealth is a web-based application that allows patients and clinicians to communicate through a secure, password protected online electronic portal with data transfer capabilities. The system allows physicians and nurses to view patient questions, patient data and transmit messages to patients in response to questions or after clinic visits in an electronic message. In addition, patients can be made aware of upcoming investigations or clinic visits. Patients can also use the interface to identify any proposed changes (which would minimize recall mistakes after clinic visits) and submit queries pertaining to dialysis. Both patients and clinicians are made aware of new messages through email prompt, which moderates the asynchronous nature of electronic communication. Telephone communication can be maintained, but reserved for more urgent issues that require immediate assistance.

Locations

Country	Name	City	State
Canada	Capital Health	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Karthik Tennankore

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of Portal	A modified version of the Acceptability E scale (Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8) will be administered at 6 and 12 months in patients utilizing the portal, to assess their perception of the tool itself.	12 months	No
Other	Patient Satisfaction with the Portal	A secondary patient satisfaction questionnaire (Schachter ME, Bargman JM, Copland M, Hladunewich M, Tennankore KK, Levin A, Oliver M, Pauly RP, Perl J, Zimmerman D, Chan CT. Rationale for a home dialysis virtual ward: design and implementation. BMC Nephrol. 2014 Feb 14;15:33) will be used to assess patient satisfaction with the portal.	12 months	No
Primary	Change in Patient Satisfaction	Patient satisfaction will be examined in all patients at 0, 6 and 12 months using the Consumer Quality index (CQI) instrument (van der Veer SN, Jager KJ, Visserman E, Beekman RJ, Boeschoten EW, de Keizer NF, Heuveling L, Stronks K, Arah OA. Development and validation of the Consumer Quality index instrument to measure the experience and priority of chronic dialysis patients. Nephrol Dial Transplant. 2012 Aug;27(8):3284-91. This Dutch-language tool will be translated to English using a validated translation procedure.	12 months	No
Secondary	Change in Quality of Life	Patient quality of life will be measured in all patients at 0, 6 and 12 months after initiating the study. Specifically, change from baseline in the EuroQol-5D will be evaluated at 6 and 12 months after initiation of the patient portal.	12 Months	No
Secondary	Hospitalization and Health-Care Utilization Rates	Healthcare service utilization will consist of number and duration of hospitalizations, number of emergency room visits (for both dialysis and non-dialysis related complaints), number of non-advised drop-in visits to the home dialysis unit and number/duration and type of telephone contacts with the home dialysis unit. All utilization measures will be retrospectively assessed over the preceding three to twelve months (depending on available data) to get a baseline rate.	12 Months	No