An Interactive Preventive Health Record (IPHR) to Promote Patient-Centered Preventive Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00589173
First received: December 25, 2007
Last updated: July 22, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Prevention
Behavioral: Interactive Preventive Health Record (IPHR)
Behavioral: "Standard" preventive care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Interactive Preventive Health Record (IPHR) to Promote Patient-Centered Preventive Care

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • The proportion of control and intervention subjects who are current on EACH individual indicated preventive service [ Time Frame: Annual for three years ] [ Designated as safety issue: No ]
  • The proportion of control and intervention subjects who are current on ALL indicated preventive services [ Time Frame: Annual for three years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of intervention subjects who visit the IPHR and establish an account [ Time Frame: During enrollment period ] [ Designated as safety issue: No ]

Enrollment: 5500
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Patients referred to the IPHR
Behavioral: Interactive Preventive Health Record (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
Behavioral: "Standard" preventive care
Existing mechanisim for receiving preventive care in primary care (i.e. patients not referred to the IPHR).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients seen in the study practices within the previous year

Exclusion Criteria:

  • Age <18 years
  • Age >75 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589173

Locations
United States, Virginia
Fairfax Family Practice Centers
Fairfax, Virginia, United States, 22033
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Alex H Krist, MD MPH Virginia Commonwealth University