Personal Health Records and Elder Medication Use Quality

Health Behavior Clinical Trial

Official title:

Personal Health Records and Elder Medication Use Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012712
• Other study ID #: 200708714
• Secondary ID: R18HS017034
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1163
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

• Computer use within the past month.

• Age 65+

Related Conditions & MeSH terms

• Adverse Reaction to Drug
• Drug-Related Side Effects and Adverse Reactions
• Health Behavior
• Medication Adherence
• Physician-Patient Relations

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (3)

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):67 — View 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.

Witry MJ, Doucette WR, Daly JM, Levy BT, Chrischilles EA. Family physician perceptions of personal health records. Perspect Health Inf Manag. 2010 Jan 1;7:1d. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean (SD) number of prescription drugs		Baseline and 6 months
Primary	Mean (SD) number of over-the-counter drugs		Baseline and 6 months
Primary	Any change in medication use in past 3 months		Baseline and 6 months
Primary	Started prescription drug		Baseline and 6 months
Primary	Stopped prescription drug		Baseline and 6 months
Primary	Changed strength/dose of prescription drug		Baseline and 6 months
Primary	Keep list of current medications		Baseline and 6 months
Primary	Reason for medications on list		Baseline and 6 months
Primary	Usually shows medication list to doctor		Baseline and 6 months
Primary	Put over-the-counter drugs on list		Baseline and 6 months
Primary	Updated list in past 3 months		Baseline and 6 months
Primary	At last doctor visit, asked whether keep a medication list		Baseline and 6 months
Primary	At last doctor visit, had medication list		Baseline and 6 months
Primary	At last doctor visit showed medication list		Baseline and 6 months
Primary	Someone asked about medication strength at last doctor visit (for all medications)		Baseline and 6 months
Primary	Someone asked about medication strength at last doctor visit (for some medications)		Baseline and 6 months
Primary	At last doctor visit, doctor compared records with what patient said they were taking		Baseline and 6 months
Primary	At last doctor visit, differences found between doctor and patient medication records		Baseline and 6 months
Primary	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
Primary	Taking 2 or more NSAIDS (including aspirin)		Baseline and 6 months
Primary	Mean (SD) number of medication management problems		Baseline and 6 months
Primary	Knows how to recognize side effects		6 months
Primary	Medication side effects in past 3 months		Baseline and 6 months
Primary	Mean (SD) modified Morisky adherence score		Baseline and 6 months

External Links

•   [Manuscript] Design Lessons for Older Adult Personal Health Records Software from Older Adults
•   Project final report