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Personal Health Records and Elder Medication Use Quality

Primary Purpose

Adverse Reaction to Drug, Health Behavior, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personal Health Record (PHR)
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adverse Reaction to Drug focused on measuring Personal health record, medication management, patient safety

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Personal Health Record (PHR)

Usual care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 6, 2013
Last Updated
August 26, 2019
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT02012712
Brief Title
Personal Health Records and Elder Medication Use Quality
Official Title
Personal Health Records and Elder Medication Use Quality
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Reaction to Drug, Health Behavior, Medication Adherence, Physician-Patient Relations
Keywords
Personal health record, medication management, patient safety

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personal Health Record (PHR)
Arm Type
Experimental
Arm Description
Subjects were sent an invitation to use an online Personal Health Record (PHR)
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Subjects received usual care (no invitation or access to the study PHR)
Intervention Type
Behavioral
Intervention Name(s)
Personal Health Record (PHR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean (SD) number of prescription drugs
Time Frame
Baseline and 6 months
Title
Mean (SD) number of over-the-counter drugs
Time Frame
Baseline and 6 months
Title
Any change in medication use in past 3 months
Time Frame
Baseline and 6 months
Title
Started prescription drug
Time Frame
Baseline and 6 months
Title
Stopped prescription drug
Time Frame
Baseline and 6 months
Title
Changed strength/dose of prescription drug
Time Frame
Baseline and 6 months
Title
Keep list of current medications
Time Frame
Baseline and 6 months
Title
Reason for medications on list
Time Frame
Baseline and 6 months
Title
Usually shows medication list to doctor
Time Frame
Baseline and 6 months
Title
Put over-the-counter drugs on list
Time Frame
Baseline and 6 months
Title
Updated list in past 3 months
Time Frame
Baseline and 6 months
Title
At last doctor visit, asked whether keep a medication list
Time Frame
Baseline and 6 months
Title
At last doctor visit, had medication list
Time Frame
Baseline and 6 months
Title
At last doctor visit showed medication list
Time Frame
Baseline and 6 months
Title
Someone asked about medication strength at last doctor visit (for all medications)
Time Frame
Baseline and 6 months
Title
Someone asked about medication strength at last doctor visit (for some medications)
Time Frame
Baseline and 6 months
Title
At last doctor visit, doctor compared records with what patient said they were taking
Time Frame
Baseline and 6 months
Title
At last doctor visit, differences found between doctor and patient medication records
Time Frame
Baseline and 6 months
Title
Use of potentially inappropriate medications (ACOVE)
Description
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.
Time Frame
Baseline and 6 months
Title
Taking 2 or more NSAIDS (including aspirin)
Time Frame
Baseline and 6 months
Title
Mean (SD) number of medication management problems
Time Frame
Baseline and 6 months
Title
Knows how to recognize side effects
Time Frame
6 months
Title
Medication side effects in past 3 months
Time Frame
Baseline and 6 months
Title
Mean (SD) modified Morisky adherence score
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Computer use within the past month. Age 65+
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Chrischilles, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
background
PubMed Identifier
20697465
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.
Results Reference
background
PubMed Identifier
24326536
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.
Results Reference
result
Links:
URL
http://link.springer.com/chapter/10.1007%2F978-3-642-21663-3_19
Description
[Manuscript] Design Lessons for Older Adult Personal Health Records Software from Older Adults
URL
http://healthit.ahrq.gov/ahrq-funded-projects/personal-health-records-and-elder-medication-use-quality
Description
Project final report

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Personal Health Records and Elder Medication Use Quality

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