Does Access to an EHR Patient Portal Influence Chronic Disease Outcomes?

Diabetes Clinical Trial

Official title:

Does Access to an EHR Patient Portal Influence Chronic Disease Outcomes? A Randomised Trial Assessing Clinical and Behavioural Change Outcomes in Patients With CHF, Diabetes, or Secondary CVD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147706
• Other study ID #: 051761
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: July 25, 2011
• Start date: September 2004
• Est. completion date: August 2006

Study information

• Verified date: July 2011
• Source: Robert Wood Johnson Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if patients with congestive heart failure, diabetes or secondary cardiovascular diseases, who access HealthMedia's online tailored behavior change programs on the electronic health record patient portal have better clinical and behavioral change outcomes.

Description:

The specific aims of the study are to determine if e-portal interventions influence:

• Measures of patient activation, patient self-management, treatment adherence, patient satisfaction with care, and disease specific knowledge.

• Process measures relevant to appropriate care for CVD, CHF, and DM.

• Clinical markers of cardiovascular or diabetes morbidity and risk.

These aims will be evaluated in one-year prospective study. Patients who use the portal will be randomized to control (i.e., access to routine portal-related information) and intervention groups (i.e., targeted and periodic messages designed to capture data relevant to self-management; to improve knowledge of their specific disease, tests, and risks; to devise time-dependent goals; and to motivate self-efficacy). Outcomes including activation, satisfaction, and adherence will be measured by telephone interview prior to and one year after intervention, and by lab and clinical measures and data available from the EHR. We will also evaluate potential selection issues among those who sign on to the e-portal by administering the same baseline interview to a matched (by disease and by age) random sample of patients who do not sign on to the e-portal.

Patients with chronic diseases are likely to experience particular benefit from online e-health resources as they have greater information needs and participate in self-management.(Camer, 2000) Unlike traditional office visits, online interactions eliminate the need to travel, are always available and give the patient access to a broad range of information, helping them actively participate in their own care.(Brown, 1999) There is growing evidence that patient education and engagement using e-health applications results in improved patient outcomes in the care of chronic illnesses, improved patient-physician communication, and reduction of anxiety for caregivers.(Brennan et al., 2001; Bronson et al., 1986; Bronson & O'Meara, 1986; Ross et al., 2003a, 2003b) We anticipate demonstrating clinically meaningful improvements in chronic disease health status, using evidence-based science delivered in behaviorally-validated ways.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult age 18 years or older

• Have medical records in the Geisinger Electronic Health Record

• Have congestive heart failure and/or Diabetes and/or cardiovascular disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Disease
• Congestive Heart Failure
• Diabetes
• Heart Failure

Intervention

Procedure:
• Tailored Healthmedia programs on EHR Patient Portal

Locations

Country	Name	City	State
United States	Center for Health Research & Rural Advocacy. Geisinger Clinic	Danville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Robert Wood Johnson Foundation	New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge, behavior change, relevant clinical measures