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Completed

NCT Number: NCT02012712

Personal Health Records and Elder Medication Use Quality

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.

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Key information

Conditions

Adverse Reaction to Drug Behavior Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Physician-Patient Relations Treatment Adherence and Compliance

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Personal Health Record (PHR)

Behavioral

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.

Primary outcomes

  1. Mean (SD) number of prescription drugs

    Time frame: Baseline and 6 months

  2. Mean (SD) number of over-the-counter drugs

    Time frame: Baseline and 6 months

  3. Any change in medication use in past 3 months

    Time frame: Baseline and 6 months

  4. Started prescription drug

    Time frame: Baseline and 6 months

  5. Stopped prescription drug

    Time frame: Baseline and 6 months

  6. Changed strength/dose of prescription drug

    Time frame: Baseline and 6 months

  7. Keep list of current medications

    Time frame: Baseline and 6 months

  8. Reason for medications on list

    Time frame: Baseline and 6 months

  9. Usually shows medication list to doctor

    Time frame: Baseline and 6 months

  10. Put over-the-counter drugs on list

    Time frame: Baseline and 6 months

  11. Updated list in past 3 months

    Time frame: Baseline and 6 months

  12. At last doctor visit, asked whether keep a medication list

    Time frame: Baseline and 6 months

  13. At last doctor visit, had medication list

    Time frame: Baseline and 6 months

  14. At last doctor visit showed medication list

    Time frame: Baseline and 6 months

  15. Someone asked about medication strength at last doctor visit (for all medications)

    Time frame: Baseline and 6 months

  16. Someone asked about medication strength at last doctor visit (for some medications)

    Time frame: Baseline and 6 months

  17. At last doctor visit, doctor compared records with what patient said they were taking

    Time frame: Baseline and 6 months

  18. At last doctor visit, differences found between doctor and patient medication records

    Time frame: Baseline and 6 months

  19. 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.

  20. Taking 2 or more NSAIDS (including aspirin)

    Time frame: Baseline and 6 months

  21. Mean (SD) number of medication management problems

    Time frame: Baseline and 6 months

  22. Knows how to recognize side effects

    Time frame: 6 months

  23. Medication side effects in past 3 months

    Time frame: Baseline and 6 months

  24. Mean (SD) modified Morisky adherence score

    Time frame: Baseline and 6 months

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2013
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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