- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00589173
An Interactive Preventive Health Record (IPHR) to Promote Patient-Centered Preventive Care
July 22, 2012 updated by: Virginia Commonwealth University
Americans only receive 50% of indicated preventive services.
We hypothesize that an interactive preventive health record (IPHR) will increase the delivery of recommended screening tests, immunizations, and counseling.
The IPHR will function as a highly sophisticated personal health record for prevention, linking patients directly to their health information in the electronic record of their primary care physician.
The functions of the IPHR will extend beyond those of personal health records by providing tailored recommendations, links to educational resources and decision aids, and patient and clinician reminders.
Year one will focus on updating and refining an existing IPHR prototype.
The second and third year, through a randomized controlled trial, will examine the effectiveness of the IPHR.
Outcomes will include (1) whether the IPHR increases the delivery of recommended preventive services, (2) whether participants use the IPHR, and (3) whether the IPHR increases shared decision-making and improves clinician-patient communication.
The study will take place in seven primary care practices in the Virginia Ambulatory Care Outcomes Network (ACORN) that utilize a common electronic medical record (EMR).
A randomly selected sample of 5,500 of the practices' 228,000 patients, stratified by age and gender, will be assigned in a one-to-one ratio to receive a request from their clinician to use the IPHR (intervention group) or receive "usual" preventive care (control group).
A Preventive Services Survey, which uses standardized questions to evaluate the delivery of preventive care, will be mailed to 4,500 patients and the CAHPS Clinician & Group Survey will be mailed to 1,000 patients.
Surveys will be mailed pre-intervention, 6 month post-intervention, and 18 months post-intervention.
Delivery of preventive care will be measured by the Preventive Services Survey and EMR data, while shared decision-making and clinician-patient communication will be measured by the CAHPS survey.
The change from baseline to 6 and 18 months post-intervention for the control and intervention groups will be compared.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5500
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
-
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Virginia
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Fairfax, Virginia, United States, 22033
- Fairfax Family Practice Centers
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-
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All adult patients seen in the study practices within the previous year
Exclusion Criteria:
- Age <18 years
- Age >75 years
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Patients referred to the IPHR
|
Preventive health record designed to a) show patients the status of their preventive care recorded in their electronic record and b) make recommendations on what USPSTF endorsed preventive services that the user needs to receive.
|
|
Active Comparator: Control
Patients receiving "standard" preventive care
|
Existing mechanisim for receiving preventive care in primary care (i.e.
patients not referred to the IPHR).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The proportion of control and intervention subjects who are current on EACH individual indicated preventive service
Time Frame: Annual for three years
|
Annual for three years
|
|
The proportion of control and intervention subjects who are current on ALL indicated preventive services
Time Frame: Annual for three years
|
Annual for three years
|
|
The mean score for intervention and control subjects for quality of clinician communication (CAPHS-CGS questions 14-20); and frequency with which patients report sharing medical decisions (CAHPS questions SD 1-3)
Time Frame: Annual for three years
|
Annual for three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The proportion of intervention subjects who visit the IPHR and establish an account
Time Frame: During enrollment period
|
During enrollment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alex H Krist, MD MPH, Virginia Commonwealth University
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
- Krist AH, Peele E, Woolf SH, Rothemich SF, Loomis JF, Longo DR, Kuzel AJ. Designing a patient-centered personal health record to promote preventive care. BMC Med Inform Decis Mak. 2011 Nov 24;11:73. doi: 10.1186/1472-6947-11-73.
- Krist AH, Woolf SH. A vision for patient-centered health information systems. JAMA. 2011 Jan 19;305(3):300-1. doi: 10.1001/jama.2010.2011. No abstract available.
- Krist AH, Woolf SH, Rothemich SF, Johnson RE, Peele JE, Cunningham TD, Longo DR, Bello GA, Matzke GR. Interactive preventive health record to enhance delivery of recommended care: a randomized trial. Ann Fam Med. 2012 Jul-Aug;10(4):312-9. doi: 10.1370/afm.1383.
- Kerns JW, Krist AH, Longo DR, Kuzel AJ, Woolf SH. How patients want to engage with their personal health record: a qualitative study. BMJ Open. 2013 Jul 30;3(7):e002931. doi: 10.1136/bmjopen-2013-002931.
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
September 1, 2007
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
December 25, 2007
First Submitted That Met QC Criteria
January 8, 2008
First Posted (Estimate)
January 9, 2008
Study Record Updates
Last Update Posted (Estimate)
July 24, 2012
Last Update Submitted That Met QC Criteria
July 22, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- PD300045
- RFA-07-007
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.