Personal Health Records and Elder Medication Use Quality

Study Overview
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Brief Summary
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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.

Official Title
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Personal Health Records and Elder Medication Use Quality

Conditions
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Adverse Reaction to Drug, Health Behavior, Medication Adherence, Physician-Patient Relations

Intervention / Treatment
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* Behavioral: Personal Health Record (PHR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Computer use within the past month. Age 65+

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personal Health Record (PHR)<br>Subjects were sent an invitation to use an online Personal Health Record (PHR) | Behavioral: Personal Health Record (PHR)<br>* 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.<br>|
| No Intervention: Usual care<br>Subjects received usual care (no invitation or access to the study PHR) | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personal health record, medication management, patient safety