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

Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589173
• Other study ID #: PD300045
• Secondary ID: RFA-07-007
• Status: Completed
• Phase: N/A
• First received: December 25, 2007
• Last updated: July 22, 2012
• Start date: September 2007
• Est. completion date: June 2011

Study information

• Verified date: July 2012
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5500
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age <18 years

• Age >75 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prevention

Intervention

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.
• "Standard" preventive care
Existing mechanisim for receiving preventive care in primary care (i.e. patients not referred to the IPHR).

Locations

Country	Name	City	State
United States	Fairfax Family Practice Centers	Fairfax	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of control and intervention subjects who are current on EACH individual indicated preventive service		Annual for three years	No
Primary	The proportion of control and intervention subjects who are current on ALL indicated preventive services		Annual for three years	No
Primary	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)		Annual for three years	No
Secondary	The proportion of intervention subjects who visit the IPHR and establish an account		During enrollment period	No

External Links

•   A How-To Guide for Using Patient-Centered Personal Health Records to Promote Prevention
•   The Interactive Preventive Health Record (IPHR) tested in this trial