NCT02012712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
Last Updated

August 28, 2019

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

November 6, 2013

Last Update Submit

August 26, 2019

Conditions

Adverse Reaction to DrugHealth BehaviorMedication AdherencePhysician-Patient Relations

Keywords

Personal health recordmedication managementpatient safety

Outcome Measures

Primary Outcomes (24)

  • 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

Study Arms (2)

Personal Health Record (PHR)

EXPERIMENTAL

Subjects were sent an invitation to use an online Personal Health Record (PHR)

Behavioral: Personal Health Record (PHR)

Usual care

NO INTERVENTION

Subjects received usual care (no invitation or access to the study PHR)

Interventions

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.

Personal Health Record (PHR)

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

  • 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.

    BACKGROUND

  • 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.

    PMID: 20697465BACKGROUND

  • 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.

    PMID: 24326536RESULT

Related Links

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsHealth BehaviorMedication Adherence

Interventions

Health Records, Personal

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Medical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Officials

  • Elizabeth A Chrischilles, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2013

First Posted

December 16, 2013

Study Start

July 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 28, 2019

Record last verified: 2017-03

Locations

US(1)