DiabetesMEDFOCUSNCT02215408
MEDication Focused Outpatient Care for Underutilization of Secondary Prevention
A study testing CVRS Intervention in people with Diabetes and Hyperlipidemia, run by Korey Kennelty at 18 sites in United States.
Trial summary
The study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the University of Iowa can increase use of national standards of care in clinics Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Diabetes, Hyperlipidemia, Hypertension
- What is being tested?
- CVRS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 18 sitesUnited States
- Study dates
- 20 Jan 2015to 30 Sep 2018
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speakers age 55 or greater
- Must have a medical history of at least one of the following:
- Coronary artery disease
- Myocardial infarction
- Stroke
- Transient Ischemic Attack
Show all 11Show fewer
- Atrial Fibrillation
- Systolic heart failure
- Peripheral vascular disease/claudication
- Carotid artery disease
- Diabetes with either: Low density lipoprotein (LDL) 100 or greater AND/OR systolic blood pressure 140 or higher or diastolic blood pressure 90 or higher
Who cannot join
- Signs of acute angina, stroke, heart failure or renal failure
- Systolic blood pressure 200 or greater or diastolic blood pressure 115 or greater
- Significant hepatic disease, including: Cirrhosis, Hepatitis B or C infection, Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) 3 times control or higher, or total bilirubin 2.0 mg/dl or higher
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Texas Tech University Health Science Center
Amarillo, Texas, 79106
SUNY-University of Buffalo
Buffalo, New York, 14260
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27559
Genesis Health System
Davenport, Iowa, 52803
Midwestern University
Downers Grove, Illinois, 60515
University of Florida
Gainesville, Florida, 32601
Memorial Hermann Hospital System
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Wisconsin
Madison, Wisconsin, 53715
Wheaton Franciscan Medical Group
Milwaukee, Wisconsin, 53210
Milwaukee Health Services,Inc.
Milwaukee, Wisconsin, 53212
Temple University
Philadelphia, Pennsylvania, 19140
Idaho State University
Pocatello, Idaho, 83209
University of Utah
Salt Lake City, Utah, 84112-5820
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Siouxland Medical Education Foundation
Sioux City, Iowa, 51104
University of South Florida
Tampa, Florida, 33612
Northeast Iowa Medical Education Foundation
Waterloo, Iowa, 50702
About this study
The study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the University of Iowa can increase use of national standards of care in clinics
Read the detailed description
This project conducted a multicenter, cluster-randomized study utilizing a centralized CVRS for medical offices with large geographic, racial and ethnic diversity to determine the extent to which the CVRS model will be implemented. Twenty primary care offices were randomized to either the CVRS arm or a usual care arm, and 18 continued in the study. Each clinic enrolled 20-30 patients per office for a total of 402 subjects, of which 186 represented racial minorities.
Subjects in the intervention arm clinic had regular contact by phone, email or text with a CVRS clinical pharmacist housed at the University of Iowa. The pharmacist communicated with the subject, with the site clinical pharmacist and, as needed, with the site provider to optimize both the subject's pharmaceutical regimen and lifestyle behaviors. The CVRS intervention lasted for 12 months.
A complex algorithm was used to calculate the degree to which the subject's care and medical regimen follows national guidelines for reducing the risk of developing cardiovascular risk.
Post-intervention telephone interviews are being conducted with 20 intervention subjects in order to assess their experience with the intervention and barriers and facilitators to the intervention.
- Conditions
- Diabetes, Hyperlipidemia, Hypertension, Cardiovascular Disease
- Being tested
- CVRS Intervention
- Keywords
- Diabetes, Hyperlipidemia, Hypertension, Cardiovascular Disease
- Medical subject headings
- Diabetes Mellitus, Hyperlipidemias, Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVRS InterventionBehavioural
A clinical pharmacist working in the University of Iowa CVRS followed each patient for 12 months, working on lifestyle modification and recommending medication changes to the patient's clinical pharmacist in the local clinic.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patient received usual care from the provider in the local clinic. |
| CVRS Intervention | Experimental | CVRS pharmacist followed the patient for 12 months in order to decrease the patient's risk of developing cardiovascular disease. Receives: Behavioral: CVRS Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean percent of applicable Guideline Advantage standards of care that are met at 12 months
Of the 53 specific standards of care listed in the Guideline Advantage criteria, the mean percent of those standards applicable to each subject that are met at the 12 month time point
Measured: 12 months
Secondary outcomes (2)
The average cost per subject, measured in dollars and cents, of implementing the intervention
The cost per subject will include costs for visits to the primary care physician, the cost of prescribed drugs, and the cost for the time spent by study pharmacists communicating with the patient, creating a care plan, and communicating with the patient's primary care provider.
Measured: 12 months
The percent of intervention group patients who rate the intervention as helpful (versus not helpful)
Of the subset of 20 intervention group patients who are interviewed about the study intervention, the percent who state that the intervention was helpful (versus not helpful).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study start20 Jan 2015
- Primary completion30 Jun 2017
- Study completion30 Sep 2018
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 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korey Kennelty
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Korey Kennelty, University of Iowa
- Investigators
- Barry L. Carter, PharmD, Principal investigator, University of IowaChristopher Coffey, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215408
- Sponsor's protocol ID
- 201309828
- Acronym
- MEDFOCUS
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2014
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) datasets will be created without direct or indirect identifiers and reviewed to make sure that elements cannot be used to potentially identify individual subjects. We will create datasets in transport format and package them along with a copy of the protocol, data dictionaries, and a manual that shows the user how to import the data into their own system. Datasets will include baseline data, interim visit data, ancillary data, procedural based data and outcome data, along with laboratory measurements.
Publications
Carter BL, Coffey CS, Chrischilles EA, Ardery G, Ecklund D, Gryzlak B, Vander Weg MW, James PA, Christensen AJ, Parker CP, Gums T, Finkelstein RJ, Uribe L, Polgreen LA; MEDication Focused Outpatient Care for Underutilization of Secondary Prevention Trial Investigators. A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence. Pharmacotherapy. 2015 Jul;35(7):653-62. doi: 10.1002/phar.1603. Epub 2015 Jun 25.
PubMed 26111939Carter BL, Ardery G. Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones. J Am Heart Assoc. 2016 Dec 19;5(12):e004432. doi: 10.1161/JAHA.116.004432. No abstract available.
PubMed 27993832Kennelty K, Coffey CS, Ardery G, Uribe L, Yankey J, Ecklund D, James PA, Vander Weg MW, Chrischilles EA, Christensen AJ, Polgreen LA, Gryzlak B, Carter BL. A cluster randomized trial to evaluate a centralized remote clinical pharmacy service in large, health system primary care clinics. J Am Coll Clin Pharm. 2021 Oct;4(10):1287-1299. doi: 10.1002/jac5.1497. Epub 2021 Jul 2.
PubMed 37265855
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEDication Focused Outpatient Care for Underutilization of Secondary Prevention
- ClinicalTrials.gov ID
- NCT02215408
- Acronym / sponsor ID
- MEDFOCUS / 201309828
- Conditions
- Diabetes, Hyperlipidemia, Hypertension, Cardiovascular Disease
- Keywords
- Diabetes, Hyperlipidemia, Hypertension, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Korey KenneltyUniversity, hospital or other
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 13 Aug 2014 (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 study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the University of Iowa can increase use of national standards of care in clinics
Detailed description
This project conducted a multicenter, cluster-randomized study utilizing a centralized CVRS for medical offices with large geographic, racial and ethnic diversity to determine the extent to which the CVRS model will be implemented. Twenty primary care offices were randomized to either the CVRS arm or a usual care arm, and 18 continued in the study. Each clinic enrolled 20-30 patients per office for a total of 402 subjects, of which 186 represented racial minorities.
Subjects in the intervention arm clinic had regular contact by phone, email or text with a CVRS clinical pharmacist housed at the University of Iowa. The pharmacist communicated with the subject, with the site clinical pharmacist and, as needed, with the site provider to optimize both the subject's pharmaceutical regimen and lifestyle behaviors. The CVRS intervention lasted for 12 months.
A complex algorithm was used to calculate the degree to which the subject's care and medical regimen follows national guidelines for reducing the risk of developing cardiovascular risk.
Post-intervention telephone interviews are being conducted with 20 intervention subjects in order to assess their experience with the intervention and barriers and facilitators to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patient received usual care from the provider in the local clinic. |
| CVRS Intervention | Experimental | Behavioral: CVRS InterventionCVRS pharmacist followed the patient for 12 months in order to decrease the patient's risk of developing cardiovascular disease. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- English speakers age 55 or greater
- Must have a medical history of at least one of the following:
- Coronary artery disease
- Myocardial infarction
- Stroke
Key exclusion criteria (3 listed)
- Signs of acute angina, stroke, heart failure or renal failure
- Systolic blood pressure 200 or greater or diastolic blood pressure 115 or greater
- Significant hepatic disease, including: Cirrhosis, Hepatitis B or C infection, Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) 3 times control or higher, or total bilirubin 2.0 mg/dl or higher
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 |
|---|---|---|
| CVRS InterventionA clinical pharmacist working in the University of Iowa CVRS followed each patient for 12 months, working on lifestyle modification and recommending medication changes to the patient's clinical pharmacist in the local clinic. | Behavioural | CVRS Intervention |
Primary outcome
The mean percent of applicable Guideline Advantage standards of care that are met at 12 months
Time frame: 12 months
Of the 53 specific standards of care listed in the Guideline Advantage criteria, the mean percent of those standards applicable to each subject that are met at the 12 month time point
2 secondary outcomes
The average cost per subject, measured in dollars and cents, of implementing the intervention
Time frame: 12 months
The percent of intervention group patients who rate the intervention as helpful (versus not helpful)
Time frame: 24 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 23 Jul 2021.
- Background: PubMed 26111939Carter BL, Coffey CS, Chrischilles EA, Ardery G, Ecklund D, Gryzlak B, Vander Weg MW, James PA, Christensen AJ, Parker CP, Gums T, Finkelstein RJ, Uribe L, Polgreen LA; MEDication Focused Outpatient Care for Underutilization of Secondary Prevention Trial Investigators. A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence. Pharmacotherapy. 2015 Jul;35(7):653-62. doi: 10.1002/phar.1603. Epub 2015 Jun 25.
- Background: PubMed 27993832Carter BL, Ardery G. Avoiding Pitfalls With Implementation of Randomized Controlled Multicenter Trials: Strategies to Achieve Milestones. J Am Heart Assoc. 2016 Dec 19;5(12):e004432. doi: 10.1161/JAHA.116.004432. No abstract available.
- Derived from this study: PubMed 37265855Kennelty K, Coffey CS, Ardery G, Uribe L, Yankey J, Ecklund D, James PA, Vander Weg MW, Chrischilles EA, Christensen AJ, Polgreen LA, Gryzlak B, Carter BL. A cluster randomized trial to evaluate a centralized remote clinical pharmacy service in large, health system primary care clinics. J Am Coll Clin Pharm. 2021 Oct;4(10):1287-1299. doi: 10.1002/jac5.1497. Epub 2021 Jul 2.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) datasets will be created without direct or indirect identifiers and reviewed to make sure that elements cannot be used to potentially identify individual subjects. We will create datasets in transport format and package them along with a copy of the protocol, data dictionaries, and a manual that shows the user how to import the data into their own system. Datasets will include baseline data, interim visit data, ancillary data, procedural based data and outcome data, along with laboratory measurements.
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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.
Barry L. Carter, PharmD principal investigator
University of Iowa
Christopher Coffey, PhD principal investigator
University of Iowa
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVRS Intervention in people with Diabetes and Hyperlipidemia, run by Korey Kennelty at 18 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 11 inclusion and 3 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 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
The mean percent of applicable Guideline Advantage standards of care that are met at 12 months (time frame: 12 months). 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 NCT02215408, 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 23 Jul 2021.