Clinical trial NCT02012712: Personal Health Records and Elder Medication Use Quality
Official title: Personal Health Records and Elder Medication Use Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Reaction to Drug
Health Behavior
Medication Adherence
Physician-Patient Relations
Keywords: Personal health record
medication management
patient safety
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 1163
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Mean (SD) number of prescription drugs
timeFrame: Baseline and 6 months
measure: Mean (SD) number of over-the-counter drugs
timeFrame: Baseline and 6 months
measure: Any change in medication use in past 3 months
timeFrame: Baseline and 6 months
measure: Started prescription drug
timeFrame: Baseline and 6 months
measure: Stopped prescription drug
timeFrame: Baseline and 6 months
measure: Changed strength/dose of prescription drug
timeFrame: Baseline and 6 months
measure: Keep list of current medications
timeFrame: Baseline and 6 months
measure: Reason for medications on list
timeFrame: Baseline and 6 months
measure: Usually shows medication list to doctor
timeFrame: Baseline and 6 months
measure: Put over-the-counter drugs on list
timeFrame: Baseline and 6 months
measure: Updated list in past 3 months
timeFrame: Baseline and 6 months
measure: At last doctor visit, asked whether keep a medication list
timeFrame: Baseline and 6 months
measure: At last doctor visit, had medication list
timeFrame: Baseline and 6 months
measure: At last doctor visit showed medication list
timeFrame: Baseline and 6 months
measure: Someone asked about medication strength at last doctor visit (for all medications)
timeFrame: Baseline and 6 months
measure: Someone asked about medication strength at last doctor visit (for some medications)
timeFrame: Baseline and 6 months
measure: At last doctor visit, doctor compared records with what patient said they were taking
timeFrame: Baseline and 6 months
measure: At last doctor visit, differences found between doctor and patient medication records
timeFrame: Baseline and 6 months
measure: Use of potentially inappropriate medications (ACOVE)
timeFrame: Baseline and 6 months
measure: Taking 2 or more NSAIDS (including aspirin)
timeFrame: Baseline and 6 months
measure: Mean (SD) number of medication management problems
timeFrame: Baseline and 6 months
measure: Knows how to recognize side effects
timeFrame: 6 months
measure: Medication side effects in past 3 months
timeFrame: Baseline and 6 months
measure: Mean (SD) modified Morisky adherence score
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Elizabeth A Chrischilles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.