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

• ClinicalTrials.gov Identifier: NCT00589173
• Recruitment Status: Completed
• First Posted: January 9, 2008
• Last Update Posted: July 24, 2012
• Sponsor: Virginia Commonwealth University
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Virginia Commonwealth University

Tracking Information

• First Submitted Date: December 25, 2007
• First Posted Date: January 9, 2008
• Last Update Posted Date: July 24, 2012
• Study Start Date: September 2007
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 8, 2008)

• The proportion of control and intervention subjects who are current on EACH individual indicated preventive service [ Time Frame: 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 ]
• 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 ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 8, 2008): The proportion of intervention subjects who visit the IPHR and establish an account [ Time Frame: During enrollment period ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Interactive Preventive Health Record (IPHR) to Promote Patient-Centered Preventive Care
• Official Title: An Interactive Preventive Health Record (IPHR) to Promote Patient-Centered Preventive Care
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: 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.
• Behavioral: "Standard" preventive care
  Existing mechanisim for receiving preventive care in primary care (i.e. patients not referred to the IPHR).

Study Arms

• Experimental: Intervention
  Patients referred to the IPHR
  Intervention: Behavioral: Interactive Preventive Health Record (IPHR)
• Active Comparator: Control
  Patients receiving "standard" preventive care
  Intervention: Behavioral: "Standard" preventive care

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 8, 2008): 5500
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Age <18 years
• Age >75 years

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00589173
• Other Study ID Numbers: PD300045; RFA-07-007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Virginia Commonwealth University
• Original Responsible Party: Alex Krist Md MPH, Virginia Commonwealth University
• Current Study Sponsor: Virginia Commonwealth University
• Original Study Sponsor: Same as current
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Alex H Krist, MD MPH; Virginia Commonwealth University

• PRS Account: Virginia Commonwealth University
• Verification Date: July 2012