NCT00589173

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

3.8 years

First QC Date

December 25, 2007

Last Update Submit

July 22, 2012

Conditions

Keywords

Preventive CareHealth information technologyPersonal health record

Outcome Measures

Primary Outcomes (3)

  • The proportion of control and intervention subjects who are current on EACH individual indicated preventive service

    Annual for three years

  • The proportion of control and intervention subjects who are current on ALL indicated preventive services

    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)

    Annual for three years

Secondary Outcomes (1)

  • The proportion of intervention subjects who visit the IPHR and establish an account

    During enrollment period

Study Arms (2)

Intervention

EXPERIMENTAL

Patients referred to the IPHR

Behavioral: Interactive Preventive Health Record (IPHR)

Control

ACTIVE COMPARATOR

Patients receiving "standard" preventive care

Behavioral: "Standard" preventive care

Interventions

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.

Intervention

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

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \<18 years
  • Age \>75 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fairfax Family Practice Centers

Fairfax, Virginia, 22033, United States

Location

Related Publications (4)

  • 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.

    PMID: 22115059BACKGROUND
  • 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.

    PMID: 21245186BACKGROUND
  • 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.

Related Links

Study Officials

  • Alex H Krist, MD MPH

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2007

First Posted

January 9, 2008

Study Start

September 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations