HypertensionNCT00979225
Clinical Decision Support for Medication Management and Adherence
A study testing Medication Management report and Care manager email notices in people with Hypertension and Diabetes Mellitus, run by Duke University at 1 site in United States.
Trial summary
This three-year, grant funded project will be conducted by the Division of Clinical Informatics in the Department of Community and Family Medicine at Duke University Medical Center. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Stroke
- What is being tested?
- Medication Management report and Care manager email notices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Carolina Access Medicaid patients continuously enrolled for 10 of 12 months prior to August 2009
- Patients assigned to one of 14 participating primary care clinics within the Northern Piedmont Community Care Network
- At least one of six IOM priority conditions: hypertension, diabetes mellitus, stroke, ischemic heart disease, heart failure, or persistent asthma
Who cannot join
- Patient opted-out
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Improving Quality Through Decision Support for Evidence-Based Pharmacotherapy
This three-year, grant funded project will be conducted by the Division of Clinical Informatics in the Department of Community and Family Medicine at Duke University Medical Center. The project seeks to improve care quality and safety in an ambulatory care setting through clinical decision support for evidence-based (EB) pharmacotherapy delivered as point-of-care reports to clinic-based practitioners and as population health-based alerts to care managers.
This project will build upon a regional Health Information Exchange (HIE) network created to connect providers serving 37,000 Medicaid beneficiaries from both rural and urban settings in a 5 county region in the Northern Piedmont of North Carolina. This network includes 16 private practices, 3 federally qualified health centers, 5 rural health centers, 3 urgent care facilities, 10 government agencies, 5 hospitals, and 2 cross-disciplinary care management teams.
The proposed information system will be based on an emerging standard for decision support and will utilize routinely available claims and scheduling data in order to serve as a replicable model for broader use of decision support for medication management. Increased availability and use of decision support tools for medication management can be expected to reduce medication errors, improve health care quality at an acceptable cost, and augment disease management for patients and populations.
Read the detailed description
The study will be conducted in accordance with the following four specific aims:
Aim 1: Expand the functionality of an existing decision support system in use within a regional HIE network to incorporate EB pharmacotherapy guidelines and to promote medication adherence. Primary care clinicians will receive EB pharmacotherapy suggestions and a patient-specific summary of prescription claims data delivered to the point-of-care via fax. Care managers will receive alerts delivered via email to encourage patients to arrange follow-up clinic appointments because of possible medication non-adherence.
Aim 2: Implement and evaluate the impact of the two interventions on adherence to EB pharmacotherapy recommendations among Medicaid patients with high priority conditions as designated by the Institute of Medicine (IOM) in ambulatory care settings through a three-arm randomized controlled trial.
Aim 3: Compare resource utilization and assess the economic attractiveness (cost-savings or cost-effectiveness) of the interventions to promote medication adherence and EB pharmacotherapy.
Aim 4: Disseminate information regarding the development and impact of the interventions through Web teleconferences, professional meetings, educational lectures, and peer review journals.
- Conditions
- Hypertension, Diabetes Mellitus, Stroke, Myocardial Ischemia, Heart Failure, Asthma
- Being tested
- Medication Management report, Care manager email notices
- Keywords
- health information technology, clinical decision support, medication management, medication adherence
- Medical subject headings
- Hypertension, Diabetes Mellitus, Stroke, Myocardial Ischemia, Heart Failure, Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Management reportOther
Also called Medication management reports
Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.
Care manager email noticesOther
Also called Care manager notices
Community-based care managers receive email notices if the patient has not seen his/her primary care provider in the past 6 months, has low adherence to medications, and has no scheduled appointment.
| Study group | Role | What they receive |
|---|---|---|
| Medication report | Experimental | Medication reports delivered to providers at the point of care Receives: Other: Medication Management report |
| Med. report plus care manager notices | Experimental | Medication reports delivered to providers at the point of care and notices sent electronically to care managers Receives: Other: Medication Management report; Other: Care manager email notices |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period.
Measured: Baseline, 12 months
Secondary outcomes (12)
Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class
Measured: Baseline, 12 months
Rates of adherence to pharmacotherapy rules for a specific IOM priority condition.
Measured: Baseline, 12 months
Rates of adherence to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.
Measured: Baseline, 6 months
Rates of adherence by drug class to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.
Measured: Baseline, 6 months
Rates of adherence by IOM condition to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.
Measured: Baseline, 6 months
The proportion of email notices that were followed up by a documented care management encounter within 30 days.
Measured: 12 months
The proportion of email notices that were followed up by a completed clinic encounter within 60 days.
Measured: 12 months
Resource use and medical costs associated with the interventions and their delivery, as well as direct healthcare costs (inpatient and outpatient).
Measured: 12 months
Provider satisfaction measured using standard usability survey instruments.
Measured: 12 months
Outpatient encounter rates.
Measured: Baseline, 12 months
Emergency department encounter rates.
Measured: Baseline, 12 months
Inpatient hospitalization rates.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Duke 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
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Northern Piedmont Carolina Community Care Partners, North Carolina Division of Medical Assistance, North Carolina Office of Rural Health and Community Care
- Responsible party
- Sponsor
- Investigators
- David F Lobach, MD, PhD, MS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979225
- Sponsor's protocol ID
- Pro00002524
- Other IDs
- R18HS017072
- Status last verified
- Dec 2012
- First submitted
- 15 Sep 2009
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality Through Decision Support for Evidence-Based Pharmacotherapy
- ClinicalTrials.gov ID
- NCT00979225
- Acronym / sponsor ID
- Pro00002524
- Conditions
- Hypertension, Diabetes Mellitus, Stroke, Myocardial Ischemia, Heart Failure, Asthma
- Keywords
- health information technology, clinical decision support, medication management, medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Northern Piedmont Carolina Community Care Partners, North Carolina Division of Medical Assistance, North Carolina Office of Rural Health and Community Care
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Sep 2009 (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 three-year, grant funded project will be conducted by the Division of Clinical Informatics in the Department of Community and Family Medicine at Duke University Medical Center. The project seeks to improve care quality and safety in an ambulatory care setting through clinical decision support for evidence-based (EB) pharmacotherapy delivered as point-of-care reports to clinic-based practitioners and as population health-based alerts to care managers.
This project will build upon a regional Health Information Exchange (HIE) network created to connect providers serving 37,000 Medicaid beneficiaries from both rural and urban settings in a 5 county region in the Northern Piedmont of North Carolina. This network includes 16 private practices, 3 federally qualified health centers, 5 rural health centers, 3 urgent care facilities, 10 government agencies, 5 hospitals, and 2 cross-disciplinary care management teams.
The proposed information system will be based on an emerging standard for decision support and will utilize routinely available claims and scheduling data in order to serve as a replicable model for broader use of decision support for medication management. Increased availability and use of decision support tools for medication management can be expected to reduce medication errors, improve health care quality at an acceptable cost, and augment disease management for patients and populations.
Detailed description
The study will be conducted in accordance with the following four specific aims:
Aim 1: Expand the functionality of an existing decision support system in use within a regional HIE network to incorporate EB pharmacotherapy guidelines and to promote medication adherence. Primary care clinicians will receive EB pharmacotherapy suggestions and a patient-specific summary of prescription claims data delivered to the point-of-care via fax. Care managers will receive alerts delivered via email to encourage patients to arrange follow-up clinic appointments because of possible medication non-adherence.
Aim 2: Implement and evaluate the impact of the two interventions on adherence to EB pharmacotherapy recommendations among Medicaid patients with high priority conditions as designated by the Institute of Medicine (IOM) in ambulatory care settings through a three-arm randomized controlled trial.
Aim 3: Compare resource utilization and assess the economic attractiveness (cost-savings or cost-effectiveness) of the interventions to promote medication adherence and EB pharmacotherapy.
Aim 4: Disseminate information regarding the development and impact of the interventions through Web teleconferences, professional meetings, educational lectures, and peer review journals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medication report | Experimental | Other: Medication Management reportMedication reports delivered to providers at the point of care |
| Med. report plus care manager notices | Experimental | Other: Medication Management report, Other: Care manager email noticesMedication reports delivered to providers at the point of care and notices sent electronically to care managers |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Carolina Access Medicaid patients continuously enrolled for 10 of 12 months prior to August 2009
- Patients assigned to one of 14 participating primary care clinics within the Northern Piedmont Community Care Network
- At least one of six IOM priority conditions: hypertension, diabetes mellitus, stroke, ischemic heart disease, heart failure, or persistent asthma
Key exclusion criteria (1 listed)
- Patient opted-out
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 Management reportAlso: Medication management reportsPatients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care. | Other | Med. report plus care manager notices, Medication report |
| Care manager email noticesAlso: Care manager noticesCommunity-based care managers receive email notices if the patient has not seen his/her primary care provider in the past 6 months, has low adherence to medications, and has no scheduled appointment. | Other | Med. report plus care manager notices |
Primary outcome
Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period.
Time frame: Baseline, 12 months
12 secondary outcomes
Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class
Time frame: Baseline, 12 months
Rates of adherence to pharmacotherapy rules for a specific IOM priority condition.
Time frame: Baseline, 12 months
Rates of adherence to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.
Time frame: Baseline, 6 months
Rates of adherence by drug class to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.
Time frame: Baseline, 6 months
Rates of adherence by IOM condition to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.
Time frame: Baseline, 6 months
The proportion of email notices that were followed up by a documented care management encounter within 30 days.
Time frame: 12 months
The proportion of email notices that were followed up by a completed clinic encounter within 60 days.
Time frame: 12 months
Resource use and medical costs associated with the interventions and their delivery, as well as direct healthcare costs (inpatient and outpatient).
Time frame: 12 months
Provider satisfaction measured using standard usability survey instruments.
Time frame: 12 months
Outpatient encounter rates.
Time frame: Baseline, 12 months
Emergency department encounter rates.
Time frame: Baseline, 12 months
Inpatient hospitalization rates.
Time frame: Baseline, 12 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 11 Dec 2012.
Related trials for Hypertension
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
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.
David F Lobach, MD, PhD, MS principal investigator
Duke University
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 Management report and Care manager email notices in people with Hypertension and Diabetes Mellitus, run by Duke 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 3 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 11 Dec 2012. 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?
Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period. (time frame: Baseline, 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 11 Dec 2012.