Personal Health Records and Elder Medication Use Quality

August 26, 2019 updated by: Elizabeth A Chrischilles, University of Iowa

Purpose: To examine the impact of a personal health record (PHR) on medication use safety among older adults.

Background: Online PHRs have potential as tools to manage health information. We know little about how to make PHRs accessible for older adults and what effects this will have.

Methods: A PHR was designed and pretested with older adults and tested in a six-month randomized controlled trial. After completing mailed baseline questionnaires, eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or serve as a standard care control group (n=273). Follow-up questionnaires measured change from baseline medication use, medication reconciliation behaviors, and medication management problems.

Study Overview

Study Type

Interventional

Enrollment (Actual)

1163

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

    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

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

65 years to 95 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Computer use within the past month.
  • Age 65+

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personal Health Record (PHR)
Subjects were sent an invitation to use an online Personal Health Record (PHR)

Iowa PHR is a Web-based application that features a tabbed interface design. Users can enter, view, and print their current and past medicines, allergies, health conditions, and health event tracking over time. An embedded tutorial video provides assistance with the system. The PHR was developed and refined using participatory design and focus group sessions as well as evaluation in a usability laboratory. The resulting design emphasizes the reduction of physical and cognitive demands on users, focusing on simplicity, readability, and quick navigation.

Iowa PHR displayed a message when a user entered a medication with an associated Assessing Care of Vulnerable Elders project (ACOVE-3) safety concern. This included 16 safety issues for 12 drugs or drug classes with safety concerns. We also adapted four general medication use patient safety indicators from the ACOVE project and displayed them to all users on a rotating basis upon login.

No Intervention: Usual care
Subjects received usual care (no invitation or access to the study PHR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean (SD) number of prescription drugs
Time Frame: Baseline and 6 months
Baseline and 6 months
Mean (SD) number of over-the-counter drugs
Time Frame: Baseline and 6 months
Baseline and 6 months
Any change in medication use in past 3 months
Time Frame: Baseline and 6 months
Baseline and 6 months
Started prescription drug
Time Frame: Baseline and 6 months
Baseline and 6 months
Stopped prescription drug
Time Frame: Baseline and 6 months
Baseline and 6 months
Changed strength/dose of prescription drug
Time Frame: Baseline and 6 months
Baseline and 6 months
Keep list of current medications
Time Frame: Baseline and 6 months
Baseline and 6 months
Reason for medications on list
Time Frame: Baseline and 6 months
Baseline and 6 months
Usually shows medication list to doctor
Time Frame: Baseline and 6 months
Baseline and 6 months
Put over-the-counter drugs on list
Time Frame: Baseline and 6 months
Baseline and 6 months
Updated list in past 3 months
Time Frame: Baseline and 6 months
Baseline and 6 months
At last doctor visit, asked whether keep a medication list
Time Frame: Baseline and 6 months
Baseline and 6 months
At last doctor visit, had medication list
Time Frame: Baseline and 6 months
Baseline and 6 months
At last doctor visit showed medication list
Time Frame: Baseline and 6 months
Baseline and 6 months
Someone asked about medication strength at last doctor visit (for all medications)
Time Frame: Baseline and 6 months
Baseline and 6 months
Someone asked about medication strength at last doctor visit (for some medications)
Time Frame: Baseline and 6 months
Baseline and 6 months
At last doctor visit, doctor compared records with what patient said they were taking
Time Frame: Baseline and 6 months
Baseline and 6 months
At last doctor visit, differences found between doctor and patient medication records
Time Frame: Baseline and 6 months
Baseline and 6 months
Use of potentially inappropriate medications (ACOVE)
Time Frame: Baseline and 6 months

List of potentially inappropriate medications derived from the Assessing Care of Vulnerable Elders project (ACOVE-3)

Shrank WH, Polinski JM, Avorn J. Quality Indicators for Medication Use in Vulnerable Elders. J Am Geriatr Soc 2007;55:S373-S382.

Baseline and 6 months
Taking 2 or more NSAIDS (including aspirin)
Time Frame: Baseline and 6 months
Baseline and 6 months
Mean (SD) number of medication management problems
Time Frame: Baseline and 6 months
Baseline and 6 months
Knows how to recognize side effects
Time Frame: 6 months
6 months
Medication side effects in past 3 months
Time Frame: Baseline and 6 months
Baseline and 6 months
Mean (SD) modified Morisky adherence score
Time Frame: Baseline and 6 months
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elizabeth A Chrischilles, PhD, University of Iowa

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

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

July 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 200708714
  • R18HS017034 (U.S. AHRQ Grant/Contract)

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.

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