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

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ClinicalTrials.gov Identifier: NCT00147706
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : July 26, 2011
Sponsor:
Collaborator:
New York University School of Medicine
Information provided by:
Robert Wood Johnson Foundation

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Diabetes Cardiovascular Disease Procedure: Tailored Healthmedia programs on EHR Patient Portal Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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 Start Date : September 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. knowledge, behavior change, relevant clinical measures


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147706


Locations
United States, Pennsylvania
Center for Health Research & Rural Advocacy. Geisinger Clinic
Danville, Pennsylvania, United States, 17822-2602
Sponsors and Collaborators
Robert Wood Johnson Foundation
New York University School of Medicine
Investigators
Principal Investigator: Walter F Stewart, PhD Geisinger Health Systems
Study Chair: Nirav R Shah, MD. MPH New York University School of Medicine

Responsible Party: Nirav Shah, MD, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00147706     History of Changes
Other Study ID Numbers: 051761
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Robert Wood Johnson Foundation:
Electronic Health Record
Patient Portal
Chronic Diseases

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Chronic Disease
Heart Diseases
Disease Attributes
Pathologic Processes