Shared Online Health Records for Patient Safety and Care

November 9, 2005 updated by: Agency for Healthcare Research and Quality (AHRQ)

The study uses a randomized, prospective cohort design to assess the impact of shared online health records on 1) patient safety, 2) health goal adherence and outcomes, 3) documentation of family history, and 4) barriers to the adoption of patient-physician communication technology.

Hypothesis: the respective interventions will result in 1) improved patient safety 2) greater adherence to health care maintenance and chronic disease guidelines 3) more accurate documentation of family history 4) the identification of technology adoption enablers and barriers.

Study Overview

Status

Unknown

Conditions

Diabetes

Intervention / Treatment

Device: online health information journal

Detailed Description

During the first phase of the study, primary care practice patients continue to receive "usual care" while their physician's offices are using Patient Gateway, an Internet portal offering secure messaging, common requests, chart information, and health information that has already been developed. Also in this first phase, all patients using Patient Gateway will receive an electronic letter explaining the research study and a link to an electronic consent form. In addition to recruitment of subjects, phase 1 allows for baseline data to be collected.

In the second phase, study clinics will be randomized into one of two intervention "arms". Study subjects whose clinics are randomized into Arm 1 will be invited to review and comment on their medication, allergy, and diabetes information through Patient Gateway; they can then submit this information to their primary care physician for review. Those randomized into Arm 2 will report on their health maintenance status and family history and submit this information to their primary care physician through Patient Gateway prior to a scheduled visit. Chart reviews performed at the end of Phase 1 and Phase 2 will be conducted to identify differences in process measures and outcome measures between intervention and control groups.

In addition, a medication phone survey sub-study will be conducted to evaluate the effect of the new Patient Gateway features on medication management.

Study Type

Interventional

Enrollment

5400

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Not yet recruiting
    - Beacon Hill/Downtown Primary Care
    - Contact:
      
      Richard Winickoff, MD
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Bulfinch Medical Group
    - Contact:
      
      Charles Weiss, MD
  - Boston, Massachusetts, United States, 02114
    - Not yet recruiting
    - Massachusetts General Hospital Women's Health Associates
    - Contact:
      
      Karen Carlson, MD
  - Charlestown, Massachusetts, United States, 02129
    - Recruiting
    - Charlestown Health Center
    - Contact:
      
      Michael Garrity, MD
  - Chestnut Hill, Massachusetts, United States, 02467
    - Recruiting
    - Brigham & Women's Hospital Women's Health Center
    - Contact:
      
      Lori Farnan, MD
  - Chestnut Hill, Massachusetts, United States, 02467
    - Not yet recruiting
    - Brigham & Women's Physicians Group
    - Contact:
      
      Jonathan Appelbaum, MD
  - Jamaica Plain, Massachusetts, United States, 02130
    - Not yet recruiting
    - Brigham Primary Physicians at Faulkner
    - Contact:
      
      Michael Healey, MD
  - Jamaica Plain, Massachusetts, United States, 02130
    - Not yet recruiting
    - Southern Jamaica Plain Health Center
    - Contact:
      
      Michael Lambert, MD
  - Norwood, Massachusetts, United States, 02062
    - Recruiting
    - Brigham & Women's Hospital at Norwood
    - Contact:
      
      Louise Schneider, MD
  - Revere, Massachusetts, United States, 02151
    - Not yet recruiting
    - Revere Health Center
    - Contact:
      
      Eric Weil, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

All patients, who are enrolled in Patient Gateway, of physicians and practices participating in the study.

Exclusion Criteria:

Any patients who are not enrolled in Patient Gateway or do not belong to a participating practice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
1. ADEs
2. duration of ameliorable medication side effects
3. health goal adherence rates
4. diabetes outcomes
5. familial risk factor documentation rates
6. user satisfaction surveys
7. user metrics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator: Blackford Middleton, MD, MPH, MSc, Brigham & Women's Hospital, Partners HealthCare System, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

September 1, 2007

Study Registration Dates

First Submitted

November 9, 2005

First Submitted That Met QC Criteria

November 9, 2005

First Posted (Estimate)

November 11, 2005

Study Record Updates

Last Update Posted (Estimate)

November 11, 2005

Last Update Submitted That Met QC Criteria

November 9, 2005

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Other Study ID Numbers

R01HS013326 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.