Clinical trial NCT00147706: Does Access to an EHR Patient Portal Influence Chronic Disease Outcomes?
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Diabetes
Cardiovascular Disease
Keywords: Electronic Health Record
Patient Portal
Chronic Diseases
Lead sponsor: Robert Wood Johnson Foundation
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
First posted: 2005-09-07
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: knowledge, behavior change, relevant clinical measures
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Center for Health Research & Rural Advocacy. Geisinger Clinic
state: Pennsylvania
Study officials:
affiliation: Geisinger Health Systems
name: Walter F Stewart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Nirav R Shah, MD. MPH
role: STUDY_CHAIR
References: