Diabetes Mellitus Type INCT01669473
A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
A study testing EHR Based Strategy to promote Safe and Appropriate Drug Use in people with Diabetes Mellitus Type I and Diabetes Mellitus Type II, run by Northwestern University at 2 sites in United States.
Trial summary
This study seeks to evaluate a low-literacy strategy in a primary health care setting for promoting safe and effective prescription medication use among English and Spanish-speaking patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus Type I, Diabetes Mellitus Type II
- What is being tested?
- EHR Based Strategy to promote Safe and Appropriate Drug Use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Sep 2016
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-years old or older;
- have a diagnosis of diabetes mellitus either by ICD-billing codes or indicative medications;
- are prescribed at least (3) chronic condition medications according to the EHR medication list;
- are English or Spanish-speaking;
- have no imminent intention to move or change clinics within the next year;
- score 4 or higher on the six-question screener based on the Mini-Mental Status Exam;
- are primarily responsible for administering their own medications;
- prescribed a new chronic condition medication (including refills, and change in titrations) during their clinic visit and day.
Who cannot join
- under age of 18 years-old;
- does not speak English or Spanish;
- dependent on assistance for medication administration;
- scored less than 4 on the six-question screener;
- not prescribed a new medication or changed medication at clinical appointment;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60654
About this study
This study seeks to evaluate a low-literacy strategy in a primary health care setting for promoting safe and effective prescription medication use among English and Spanish-speaking patients with diabetes.
The investigators hypothesize that in comparison with patients receiving standard care, the patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies in their medication lists; 3) take their medication regimen more efficiently; 4) have greater adherence to their medication regimen.
Read the detailed description
The strategy takes advantage of health information technology to assist patients with Medication Therapy Management (MTM) tasks, intervening with a set of low-literacy MTM printed tools triggered by the Electronic Health Record (EHR) in a primary health care clinic. Patients at the University of Illinois at Chicago (UIC) Medicine Clinic who are randomized to the intervention arm will be given three printed tools, one when they check in to the clinic and the other two when they check out. The Electronic Health Record (EHR) triggers the printing of these tools, and the receptionist hands them to the patient. Patients receive either English or Spanish language materials depending on the preference determined in the screening process and stored in their EHR.
Specific Aims
- Refine and Field Test an EHR strategy for generating and distributing low literacy prescription information for English and Spanish-speaking patients
- Assess the process of the EHR intervention and its fidelity for providing prescription information for patients at the point of prescribing and dispensing medications.
- Evaluate the effectiveness of the EHR strategy to improve medication understanding, reconciliation, regimen consolidation, and adherence compared to standard care.
In addition, we will be powered to also investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure, HbA1c, and LDL cholesterol.
- Being tested
- EHR Based Strategy to promote Safe and Appropriate Drug Use
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR Based Strategy to promote Safe and Appropriate Drug UseOther
The printed tools presented in the intervention include:
- Medication Review: a consolidated list of the medications a patient is currently taking.
- Medication Sheet: a medication information sheet, including simplified prescription instructions, for each medication that a patient is newly prescribed.
- Medication List: a table that lists all medications taken by the patient and provides an orientation on how to best organize and simplify their medication regimen
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | EHR Based Strategy to promote Safe and Appropriate Drug Use
Patients randomized to the intervention arm will be given (3) print tools to assist in safe and appropriate medication use. These include a Medreview, Medsheet,and Medlist. Receives: Other: EHR Based Strategy to promote Safe and Appropriate Drug Use |
| Standard Care Arm | No intervention | The control group will receive regular standard care at the Clinic. They will not receive any print tools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
We will determine to what extent presenting low-literacy information about prescription medicines to patients with diabetes affects their adherence to a medication regimen compared to patients under standard care.
Adherence for each prescription medication will be measured through multiple methodologies.
Measured: One month after patients receive intervention materials
Secondary outcomes (1)
Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol.
We will investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure for patients with hypertension, HbA1 for patients with diabetes, and LDL cholesterol for patients with hyperlipidemia, through chart extraction at pre and post-intervention.
Measured: Baseline interview and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJun 2013
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type IStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago
- Responsible party
- Principal investigator, Bruce Lambert, Northwestern University
- Investigators
- Bruce Lambert, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669473
- Sponsor's protocol ID
- 1U19HS021093-01
- Status last verified
- Sep 2016
- First submitted
- 3 Aug 2012
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Przytula K, Bailey SC, Galanter WL, Lambert BL, Shrestha N, Dickens C, Falck S, Wolf MS. A primary care, electronic health record-based strategy to promote safe drug use: study protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:17. doi: 10.1186/s13063-014-0524-x.
PubMed 25622970
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
- ClinicalTrials.gov ID
- NCT01669473
- Acronym / sponsor ID
- 1U19HS021093-01
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Illinois Chicago
- Study start
- Jun 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Aug 2012 (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.
This study seeks to evaluate a low-literacy strategy in a primary health care setting for promoting safe and effective prescription medication use among English and Spanish-speaking patients with diabetes.
The investigators hypothesize that in comparison with patients receiving standard care, the patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies in their medication lists; 3) take their medication regimen more efficiently; 4) have greater adherence to their medication regimen.
Detailed description
The strategy takes advantage of health information technology to assist patients with Medication Therapy Management (MTM) tasks, intervening with a set of low-literacy MTM printed tools triggered by the Electronic Health Record (EHR) in a primary health care clinic. Patients at the University of Illinois at Chicago (UIC) Medicine Clinic who are randomized to the intervention arm will be given three printed tools, one when they check in to the clinic and the other two when they check out. The Electronic Health Record (EHR) triggers the printing of these tools, and the receptionist hands them to the patient. Patients receive either English or Spanish language materials depending on the preference determined in the screening process and stored in their EHR.
Specific Aims
- Refine and Field Test an EHR strategy for generating and distributing low literacy prescription information for English and Spanish-speaking patients
- Assess the process of the EHR intervention and its fidelity for providing prescription information for patients at the point of prescribing and dispensing medications.
- Evaluate the effectiveness of the EHR strategy to improve medication understanding, reconciliation, regimen consolidation, and adherence compared to standard care.
In addition, we will be powered to also investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure, HbA1c, and LDL cholesterol.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: EHR Based Strategy to promote Safe and Appropriate Drug UseEHR Based Strategy to promote Safe and Appropriate Drug Use Patients randomized to the intervention arm will be given (3) print tools to assist in safe and appropriate medication use. These include a Medreview, Medsheet,and Medlist. |
| Standard Care Arm | No intervention | –The control group will receive regular standard care at the Clinic. They will not receive any print tools. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-years old or older;
- have a diagnosis of diabetes mellitus either by ICD-billing codes or indicative medications;
- are prescribed at least (3) chronic condition medications according to the EHR medication list;
- are English or Spanish-speaking;
- have no imminent intention to move or change clinics within the next year;
Key exclusion criteria (5 listed)
- under age of 18 years-old;
- does not speak English or Spanish;
- dependent on assistance for medication administration;
- scored less than 4 on the six-question screener;
- not prescribed a new medication or changed medication at clinical appointment;
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 |
|---|---|---|
| EHR Based Strategy to promote Safe and Appropriate Drug UseThe printed tools presented in the intervention include: 1. Medication Review: a consolidated list of the medications a patient is currently taking. 2. Medication Sheet: a medication information sheet, including simplified prescription instructions, for each medication that a patient is newly prescribed. 3. Medication List: a table that lists all medications taken by the patient and provides an orientation on how to best organize and simplify their medication regimen | Other | Intervention Arm |
Primary outcome
Medication adherence
Time frame: One month after patients receive intervention materials
We will determine to what extent presenting low-literacy information about prescription medicines to patients with diabetes affects their adherence to a medication regimen compared to patients under standard care. Adherence for each prescription medication will be measured through multiple methodologies.
1 secondary outcome
Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol.
Time frame: Baseline interview and after 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 22 Sep 2016.
- Derived from this study: PubMed 25622970Przytula K, Bailey SC, Galanter WL, Lambert BL, Shrestha N, Dickens C, Falck S, Wolf MS. A primary care, electronic health record-based strategy to promote safe drug use: study protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:17. doi: 10.1186/s13063-014-0524-x.
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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.
Bruce Lambert, PhD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR Based Strategy to promote Safe and Appropriate Drug Use in people with Diabetes Mellitus Type I and Diabetes Mellitus Type II, run by Northwestern University at 2 sites 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 8 inclusion and 5 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Medication adherence (time frame: One month after patients receive intervention materials). 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 NCT01669473, which also lists 1 linked publication.
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 22 Sep 2016.