- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Computer use within the past month.
- Age 65+
Study Plan
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 |
|---|---|
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Experimental: Personal Health Record (PHR)
Subjects were sent an invitation to use an online Personal Health Record (PHR)
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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. |
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No Intervention: Usual care
Subjects received usual care (no invitation or access to the study PHR)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean (SD) number of prescription drugs
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Mean (SD) number of over-the-counter drugs
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Any change in medication use in past 3 months
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Started prescription drug
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Stopped prescription drug
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Changed strength/dose of prescription drug
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Keep list of current medications
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Reason for medications on list
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Usually shows medication list to doctor
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Put over-the-counter drugs on list
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Updated list in past 3 months
Time Frame: Baseline and 6 months
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Baseline and 6 months
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At last doctor visit, asked whether keep a medication list
Time Frame: Baseline and 6 months
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Baseline and 6 months
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At last doctor visit, had medication list
Time Frame: Baseline and 6 months
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Baseline and 6 months
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At last doctor visit showed medication list
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Someone asked about medication strength at last doctor visit (for all medications)
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Someone asked about medication strength at last doctor visit (for some medications)
Time Frame: Baseline and 6 months
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Baseline and 6 months
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At last doctor visit, doctor compared records with what patient said they were taking
Time Frame: Baseline and 6 months
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Baseline and 6 months
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At last doctor visit, differences found between doctor and patient medication records
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Use of potentially inappropriate medications (ACOVE)
Time Frame: Baseline and 6 months
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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
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Taking 2 or more NSAIDS (including aspirin)
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Mean (SD) number of medication management problems
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Knows how to recognize side effects
Time Frame: 6 months
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6 months
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Medication side effects in past 3 months
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Mean (SD) modified Morisky adherence score
Time Frame: Baseline and 6 months
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Baseline and 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth A Chrischilles, PhD, University of Iowa
Publications and helpful links
General Publications
- Hourcade, J.P., Chrischilles, E.A., Gryzlak, B.M., Hanson, B.M., Dunbar, D.E., Eichmann, D.A. and Lorentzen, R.R. (2011). Design Lessons for Older Adult Personal Health Records Software from Older Adults. Proceedings of 6th International Conference on Universal Access in Human-Computer Interaction, held as part of HCI International. Lecture Notes in Computer Science, 6766, 176-85.
- Witry MJ, Doucette WR, Daly JM, Levy BT, Chrischilles EA. Family physician perceptions of personal health records. Perspect Health Inf Manag. 2010 Jan 1;7(Winter):1d.
- Chrischilles EA, Hourcade JP, Doucette W, Eichmann D, Gryzlak B, Lorentzen R, Wright K, Letuchy E, Mueller M, Farris K, Levy B. Personal health records: a randomized trial of effects on elder medication safety. J Am Med Inform Assoc. 2014 Jul-Aug;21(4):679-86. doi: 10.1136/amiajnl-2013-002284. Epub 2013 Dec 10.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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