Medication Histories in Outpatient Clinic PatientsNCT01208987
Improving Laboratory Follow-up by Delivering an Enhanced Medication List to Outpatient Physician Practices
A study testing Medication History was printed in people with Medication Histories in Outpatient Clinic Patients, run by Indiana University at 1 site in United States.
Trial summary
The investigators plan to develop a process to create an Enhanced Medication List. The INPC (Indiana Network for Patient Care) already obtains histories of medications dispensed by pharmacies from several sources: pharmacy benefit managers, RxHub, insurance companies, Medicaid, SureScripts, Wishard Health Services. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Medication Histories in Outpatient Clinic Patients
- What is being tested?
- Medication History was printed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,256 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2007to 1 Oct 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatient clinic patient visits
Who cannot join
- Age 18 and under
Trial locations and contacts
1 site in 1 country.
About this study
The investigators plan to develop a process to create an Enhanced Medication List. The INPC (Indiana Network for Patient Care) already obtains histories of medications dispensed by pharmacies from several sources: pharmacy benefit managers, RxHub, insurance companies, Medicaid, SureScripts, Wishard Health Services. The investigators will collect all the medication data available through the INPC for an individual patient. The investigators will enhance this medication list by including medication categories, improving the structure and appearance, displaying results of relevant laboratory tests, and adding decision support reminders. The investigators will test the value of such an "Enhanced Medication List" by providing it to outpatient physician practices (through the DOCS4DOCS clinical messaging service, or as a fax), preferably on the day that the patient has an office visit with the physician. The investigators will determine whether this intervention improves patient care: whether there are higher rates of recommended laboratory follow-up monitoring as a result; whether there are lower rates of harmful drug-drug interactions. The investigators will also seek the opinions of physicians regarding the benefit of this intervention.
- Being tested
- Medication History was printed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication History was printedOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention (with Medication History) | Experimental | these patient visits generated a medication history Receives: Other: Medication History was printed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of medications (on a patient's medication list) for which recent (within 12 months) laboratory test monitoring is missing.
The hypothesis is that the intervention (a medication history printed for the patient) would help the physician identify incomplete monitoring of laboratory test results for a subset of medications. (For example, Potassium test levels should be obtained every 12 months for patients using diuretics, according to NCQA HEDIS guidelines.) With time, the intervention group should have less medications for which laboratory test results are incomplete. Therefore, the intervention group should have less medications with decision support reminders warning of incomplete laboratory test monitoring.
Measured: Laboratory tests during the previous 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study start28 Sep 2007
- Primary completion1 Oct 2011
- Study completion1 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Histories in Outpatient Clinic PatientsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208987
- Sponsor's protocol ID
- 0710-59
- Status last verified
- Mar 2023
- First submitted
- 23 Sep 2010
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Laboratory Follow-up by Delivering an Enhanced Medication List to Outpatient Physician Practices
- ClinicalTrials.gov ID
- NCT01208987
- Acronym / sponsor ID
- 0710-59
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,256 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 28 Sep 2007 (actual)
- Primary completion
- 1 Oct 2011 (actual)
- Study completion
- 1 Oct 2011 (actual)
- First posted
- 24 Sep 2010 (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.
The investigators plan to develop a process to create an Enhanced Medication List. The INPC (Indiana Network for Patient Care) already obtains histories of medications dispensed by pharmacies from several sources: pharmacy benefit managers, RxHub, insurance companies, Medicaid, SureScripts, Wishard Health Services. The investigators will collect all the medication data available through the INPC for an individual patient. The investigators will enhance this medication list by including medication categories, improving the structure and appearance, displaying results of relevant laboratory tests, and adding decision support reminders. The investigators will test the value of such an "Enhanced Medication List" by providing it to outpatient physician practices (through the DOCS4DOCS clinical messaging service, or as a fax), preferably on the day that the patient has an office visit with the physician. The investigators will determine whether this intervention improves patient care: whether there are higher rates of recommended laboratory follow-up monitoring as a result; whether there are lower rates of harmful drug-drug interactions. The investigators will also seek the opinions of physicians regarding the benefit of this intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention (with Medication History) | Experimental | Other: Medication History was printedthese patient visits generated a medication history |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatient clinic patient visits
Key exclusion criteria (1 listed)
- Age 18 and under
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 |
|---|---|---|
| Medication History was printed | Other | Intervention (with Medication History) |
Primary outcome
Count of medications (on a patient's medication list) for which recent (within 12 months) laboratory test monitoring is missing.
Time frame: Laboratory tests during the previous 12 months
The hypothesis is that the intervention (a medication history printed for the patient) would help the physician identify incomplete monitoring of laboratory test results for a subset of medications. (For example, Potassium test levels should be obtained every 12 months for patients using diuretics, according to NCQA HEDIS guidelines.) With time, the intervention group should have less medications for which laboratory test results are incomplete. Therefore, the intervention group should have less medications with decision support reminders warning of incomplete laboratory test monitoring.
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 10 Mar 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication History was printed in people with Medication Histories in Outpatient Clinic Patients, run by Indiana University 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 1 inclusion and 1 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 10 Mar 2023. 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?
Count of medications (on a patient's medication list) for which recent (within 12 months) laboratory test monitoring is missing. (time frame: Laboratory tests during the previous 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2023.