Adverse Reaction to DrugNCT02012712
Personal Health Records and Elder Medication Use Quality
A study testing Personal Health Record (PHR) in people with Adverse Reaction to Drug and Health Behavior, run by University of Iowa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Adverse Reaction to Drug, Health Behavior, Medication Adherence
- What is being tested?
- Personal Health Record (PHR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,163 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Computer use within the past month.
- Age 65+
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Adverse Reaction to Drug, Health Behavior, Medication Adherence, Physician-Patient Relations
- Being tested
- Personal Health Record (PHR)
- Keywords
- Personal health record, medication management, patient safety
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Health Behavior, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Health Record (PHR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personal Health Record (PHR) | Experimental | Subjects were sent an invitation to use an online Personal Health Record (PHR) Receives: Behavioral: Personal Health Record (PHR) |
| Usual care | No intervention | Subjects received usual care (no invitation or access to the study PHR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean (SD) number of prescription drugs
Measured: Baseline and 6 months
Mean (SD) number of over-the-counter drugs
Measured: Baseline and 6 months
Any change in medication use in past 3 months
Measured: Baseline and 6 months
Started prescription drug
Measured: Baseline and 6 months
Stopped prescription drug
Measured: Baseline and 6 months
Changed strength/dose of prescription drug
Measured: Baseline and 6 months
Keep list of current medications
Measured: Baseline and 6 months
Reason for medications on list
Measured: Baseline and 6 months
Usually shows medication list to doctor
Measured: Baseline and 6 months
Put over-the-counter drugs on list
Measured: Baseline and 6 months
Updated list in past 3 months
Measured: Baseline and 6 months
At last doctor visit, asked whether keep a medication list
Measured: Baseline and 6 months
At last doctor visit, had medication list
Measured: Baseline and 6 months
At last doctor visit showed medication list
Measured: Baseline and 6 months
Someone asked about medication strength at last doctor visit (for all medications)
Measured: Baseline and 6 months
Someone asked about medication strength at last doctor visit (for some medications)
Measured: Baseline and 6 months
At last doctor visit, doctor compared records with what patient said they were taking
Measured: Baseline and 6 months
At last doctor visit, differences found between doctor and patient medication records
Measured: 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.
Measured: Baseline and 6 months
Taking 2 or more NSAIDS (including aspirin)
Measured: Baseline and 6 months
Mean (SD) number of medication management problems
Measured: Baseline and 6 months
Knows how to recognize side effects
Measured: 6 months
Medication side effects in past 3 months
Measured: Baseline and 6 months
Mean (SD) modified Morisky adherence score
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adverse Reaction to DrugStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth A Chrischilles, University of Iowa
- Investigators
- Elizabeth A Chrischilles, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012712
- Sponsor's protocol ID
- 200708714
- Other IDs
- R18HS017034
- Status last verified
- Mar 2017
- First submitted
- 6 Nov 2013
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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(Winter):1d.
PubMed 20697465Chrischilles 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.
PubMed 24326536
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Health Records and Elder Medication Use Quality
- ClinicalTrials.gov ID
- NCT02012712
- Acronym / sponsor ID
- 200708714
- Conditions
- Adverse Reaction to Drug, Health Behavior, Medication Adherence, Physician-Patient Relations
- Keywords
- Personal health record, medication management, patient safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,163 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personal Health Record (PHR) | Experimental | Behavioral: Personal Health Record (PHR)Subjects were sent an invitation to use an online Personal Health Record (PHR) |
| Usual care | No intervention | –Subjects received usual care (no invitation or access to the study PHR) |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Computer use within the past month.
- Age 65+
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Personal Health Record (PHR) |
Primary outcome
Mean (SD) number of prescription drugs
Time frame: Baseline and 6 months
Mean (SD) number of over-the-counter drugs
Time frame: Baseline and 6 months
Any change in medication use in past 3 months
Time frame: Baseline and 6 months
Started prescription drug
Time frame: Baseline and 6 months
Stopped prescription drug
Time frame: Baseline and 6 months
Changed strength/dose of prescription drug
Time frame: Baseline and 6 months
Keep list of current medications
Time frame: Baseline and 6 months
Reason for medications on list
Time frame: Baseline and 6 months
Usually shows medication list to doctor
Time frame: Baseline and 6 months
Put over-the-counter drugs on list
Time frame: Baseline and 6 months
Updated list in past 3 months
Time frame: Baseline and 6 months
At last doctor visit, asked whether keep a medication list
Time frame: Baseline and 6 months
At last doctor visit, had medication list
Time frame: Baseline and 6 months
At last doctor visit showed medication list
Time frame: Baseline and 6 months
Someone asked about medication strength at last doctor visit (for all medications)
Time frame: Baseline and 6 months
Someone asked about medication strength at last doctor visit (for some medications)
Time frame: Baseline and 6 months
At last doctor visit, doctor compared records with what patient said they were taking
Time frame: Baseline and 6 months
At last doctor visit, differences found between doctor and patient medication records
Time frame: Baseline and 6 months
Use of potentially inappropriate medications (ACOVE)
Time frame: Baseline and 6 months
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)
Time frame: Baseline and 6 months
Mean (SD) number of medication management problems
Time frame: Baseline and 6 months
Knows how to recognize side effects
Time frame: 6 months
Medication side effects in past 3 months
Time frame: Baseline and 6 months
Mean (SD) modified Morisky adherence score
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- BackgroundHourcade, 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: PubMed 20697465Witry 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 publication: PubMed 24326536Chrischilles 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.
- \[Manuscript\] Design Lessons for Older Adult Personal Health Records Software from Older AdultsLink provided by the sponsor.
- Project final reportLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Chrischilles, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Health Record (PHR) in people with Adverse Reaction to Drug and Health Behavior, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean (SD) number of prescription drugs (time frame: Baseline and 6 months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02012712, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.