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Diabetes MellitusICARENCT01983813

Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care

A study testing PHCVRS Intervention and Personal Health Record in people with Diabetes Mellitus and Hypertension, run by Korey Kennelty at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The trial will examine whether a centralized Prevention Health \& Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
PHCVRS Intervention and Personal Health Record
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
12 sitesUnited States
Study dates
19 Mar 2014to Apr 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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Section A: Demographic Criteria
  • Patient was seen in your clinic or practice at least once in the past 24 months
  • English-speaking male or female
  • Age is 50 or older at medical record screening
  • Section B: Risk Factors - Must have at least one of the following conditions
  • Uncontrolled diabetes (Hemoglobin A1c > or + 7.5)
Show all 20Show fewer
  • Elevated LDL cholesterol > 110 for patients with PAD, CAD, stroke or diabetes or > 140 otherwise
  • Elevated blood pressure with:
  • Systolic BP >= 140 or Diastolic BP >=90 in persons with diabetes or chronic kidney disease OR
  • Systolic BP >= 150 in persons with uncomplicated hypertension
  • Section C: Cardiovascular Conditions - total number of risk factors in Section B (above) plus number of conditions Section C (below) must be THREE OR MORE
  • History of coronary artery disease
  • Previous Heart Attack
  • History of Stroke
  • History of Transient Ischemic Attack
  • History of Atrial fibrillation
  • History of Peripheral Vascular Disease / claudication
  • History of carotid artery disease
  • Current smoker
  • Obesity with BMI > 30

Who cannot join

  • Section D: Exclusion Criteria - has NONE of the following:
  • Inability to give informed consent
  • Pregnant
  • Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
  • Cancer diagnosis with a life expectancy estimated less than 2 years
  • Residence in a nursing home or diagnosis of dementia
Show all 10Show fewer
  • No telephone or a hearing impairment not allowing them to use a phone
  • Refusal to consider attempting to use the internet at home, community center, library, medical office or other source to access the PHRM
  • Patient has plans to move from the area or transfer care to a different clinic in the next 12 months
  • Omron blood pressure cuff cannot be used on patient's arm for any reason

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Akron Mercy Medical Clinic

    Akron, Iowa, 51001-0200

  • Iowa Specialty Hospitals - Belmond Clinic

    Belmond, Iowa, 50421

  • Employee Health Clinic, Mercy Cedar Rapids

    Cedar Rapids, Iowa, 52403

  • Iowa Speciality Hospitals - Clarion Clinic

    Clarion, Iowa, 50525

  • Great River Medical Group

    Davenport, Iowa, 52897

  • Des Moines University Family Medicine Clinic

    Des Moines, Iowa, 50312

  • Grinnell Regional Family Practice

    Grinnell, Iowa, 50112-1833

  • Knoxville Hospital Clinic

    Knoxville, Iowa, 50138

  • Newton Clinic, P.C.

    Newton, Iowa, 50208-3137

  • UI Health Care-River Crossing

    Riverside, Iowa, 52327

  • Siouxland Community Health Center

    Sioux City, Iowa, 511105

  • Burlington Area Family Practice Center

    West Burlington, Iowa, 52655-1645

Other trials in United States

About this study

The trial will examine whether a centralized Prevention Health \& Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease.

Read the detailed description

The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities.

This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects.

Being tested
PHCVRS Intervention, Personal Health Record
Keywords
Diabetes, High Blood Pressure, High Cholesterol, Heart Irregularity, Stroke
Medical subject headings
Diabetes Mellitus, Hypertension, Coronary Artery Disease, Atrial Fibrillation, Stroke, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHCVRS InterventionOther

    A clinical pharmacist at the PHCVRS will follow each participant in the PHCVRS arm for 12 months, including:

    1. Contact via email, phone or text every 2-4 weeks
    2. Assessment and counseling for medication adherence, side effects, and lifestyle modifications to decrease risk of cardiovascular disease.
    3. Collaborative communication with the participant's physician to address gaps in screening or therapy, update medication list, and recommend medication changes.

    Each participant in this arm will also have access to an online Personal Health Record that can be used to track medications, diagnosed conditions and laboratory values related to cardiovascular disease risk.

  • Personal Health RecordOther

    Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions

Study groups in NCT01983813
Study groupRoleWhat they receive
PHCVRS interventionExperimentalEach participant will receive communication with a clinical pharmacist for 12 months to decrease risk of developing cardiovascular disease.
Receives: Other: PHCVRS Intervention; Other: Personal Health Record
Usual care/Personal Health RecordOtherWill receive usual medical care plus access to an online Personal Health Record, where the participant can document medications and diagnosed conditions.
Receives: Other: Personal Health Record

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply.

    The primary outcome measure was adherence to the GA criteria as a surrogate for quality of care because each subject had varying gaps in guideline-concordant care, depending on their specific cardiovascular conditions and preventative care needs.

    Measured: 12 months for each participant

Secondary outcomes (1)

  1. Control of blood pressure, low density lipoprotein cholesterol and hemoglobin A1c.

    Secondary aims included control of BP, diabetes mellitus, and lipids for subjects whose conditions were not controlled at baseline.

    Measured: 12 months for each participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2013 (estimated)
  2. Study start19 Mar 2014
  3. Primary completionNov 2016
  4. Study completionApr 2018

Resources

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
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01983813
Sponsor's protocol ID
201308707
Acronym
ICARE
Status last verified
Aug 2019
First submitted
28 Oct 2013
Last updated
13 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual, de-identified data will be shared with the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BIOLINCC). Data and supporting materials will include: * The analytic data set used in the main outcomes paper * Source data sets used to create the analytic data set (for baseline and 12 month follow up data collection points) * Informed consent document * Study protocol and manuals * Subject brochure and subject handout * Case report forms (baseline and 12 month follow up) * Summary of data redactions * Summary of protocol changes over time All dates will be converted to days or months from a reference event; no text will be included (e.g., comments).

Publications

  • Carter BL, Levy BT, Gryzlak B, Chrischilles EA, Vander Weg MW, Christensen AJ, James PA, Moss CA, Parker CP, Gums T, Finkelstein RJ, Xu Y, Dawson JD, Polgreen LA. A centralized cardiovascular risk service to improve guideline adherence in private primary care offices. Contemp Clin Trials. 2015 Jul;43:25-32. doi: 10.1016/j.cct.2015.04.014. Epub 2015 May 4.

    PubMed 25952471

  • Yang R, Carter BL, Gums TH, Gryzlak BM, Xu Y, Levy BT. Selection bias and subject refusal in a cluster-randomized controlled trial. BMC Med Res Methodol. 2017 Jul 10;17(1):94. doi: 10.1186/s12874-017-0368-7.

    PubMed 28693427

  • Kennelty KA, Polgreen LA, Carter BL. Team-Based Care with Pharmacists to Improve Blood Pressure: a Review of Recent Literature. Curr Hypertens Rep. 2018 Jan 18;20(1):1. doi: 10.1007/s11906-018-0803-0.

    PubMed 29349522

  • Carter BL. Will Team-Based Care Really be Implemented? J Clin Hypertens (Greenwich). 2015 Sep;17(9):692-3. doi: 10.1111/jch.12578. Epub 2015 Jun 1. No abstract available.

    PubMed 26032927

  • Carter 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 27993832

  • Patel E, Pevnick JM, Kennelty KA. Pharmacists and medication reconciliation: a review of recent literature. Integr Pharm Res Pract. 2019 Apr 30;8:39-45. doi: 10.2147/IPRP.S169727. eCollection 2019.

    PubMed 31119096

  • Carter BL. Collaborative care model for hypertension. J Clin Hypertens (Greenwich). 2018 Jan;20(1):96-97. doi: 10.1111/jch.13142. Epub 2017 Dec 13. No abstract available.

    PubMed 29237101

  • Carter BL, Levy B, Gryzlak B, Xu Y, Chrischilles E, Dawson J, Vander Weg M, Christensen A, James P, Polgreen L. Cluster-Randomized Trial to Evaluate a Centralized Clinical Pharmacy Service in Private Family Medicine Offices. Circ Cardiovasc Qual Outcomes. 2018 Jun;11(6):e004188. doi: 10.1161/CIRCOUTCOMES.117.004188.

    PubMed 29884657

Questions about this trial

What is this clinical trial studying?

A study testing PHCVRS Intervention and Personal Health Record in people with Diabetes Mellitus and Hypertension, run by Korey Kennelty at 12 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 20 inclusion and 10 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 13 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 12 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?

Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. (time frame: 12 months for each participant). 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 NCT01983813, which also lists 8 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 13 Aug 2019.

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