Health Promoters and Pharmacists in Diabetes Team Management

NCT ID: NCT01498159

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2018-01-31

Brief Summary

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This research evaluates a diabetes management intervention designed to improve medication adherence and intensify therapy to reach goals in blood sugar, blood pressure, and cholesterol levels. This study will determine the benefit and cost of adding community health promoters to pharmacist disease management services. If there is benefit, then this approach may help reduce the burden of diabetes and its related complications among minorities with diabetes.

Detailed Description

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Many African-Americans and Latinos with diabetes do not achieve the recommended goals for normal blood sugar, blood pressure, or cholesterol level, placing them at high risk for complications. This study will evaluate the impact of a novel intervention designed to improve lifestyle behaviors and medication adherence, and intensify therapy to reach goals. The first component of the intervention includes a clinic-based pharmacist disease management program. The program includes detailed patient assessments, physician-approved treatment plans, patient education and support services to enhance medication adherence. In addition, this program includes intensification of medication therapy to improve blood sugar, blood pressure, and cholesterol levels to reach recommended goals. The second component of the intervention includes health promoters (HPs), or community-based lay health workers. Health promoters are commonly found in minority communities and provide assistance for individuals overcoming language, cultural, and other barriers to conventional health care services. They may provide autonomy support and solve problems related to medication adherence barriers. Furthermore, health promoters may complement pharmacist activities by improving access to medications, assisting in continuity of care with providers, monitoring response to therapy, and reinforcing educational messages. The proposed study will determine whether the addition of health promoters to clinic based pharmacist service delivery improves care. The study will involve the recruitment of 300 African-American and Latino adults with uncontrolled diabetes through the University of Illinois Medical Center in Chicago and randomization to one of two groups: (1) pharmacist management (Pharm) for 12 months; or (2) pharmacist management with HP support (Pharm+HP) for 12 months. Cross-over will occur at 12 months such that the Pharm group will be intensified by the addition of HP support and HP support will be phased out from the Pharm+HP group to assess maintenance. The specific aims include: (1) To evaluate the effectiveness of Pharm+HP compared with Pharm alone on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels; (2) To evaluate the maintenance of improved diabetes behaviors as well as clinical outcomes by phasing out HP support from the Pharm+HP group after year 1; (3) To evaluate the intensification offered by adding an HP after one year of Pharm alone; and (4) To evaluate the cost and cost-effectiveness of Pharm+HP and Pharm alone.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pharmacist + Health Promoter

Participants in this group will receive support from both a pharmacist and health promoter. Number of sessions will be determined by the study team member and patient.

Group Type EXPERIMENTAL

Pharmacist disease/medication management

Intervention Type BEHAVIORAL

Pharmacist-patient encounters

Intervention Type BEHAVIORAL

Pharmacist medication intensification and adherence support

Intervention Type BEHAVIORAL

Pharmacist communication with primary care physicians

Intervention Type BEHAVIORAL

Pharmacist documentation in electronic medical record

Intervention Type BEHAVIORAL

Health promoter-patient encounters in-person or by phone

Intervention Type BEHAVIORAL

Health promoter medication and lifestyle support

Intervention Type BEHAVIORAL

Health promoter communication with pharmacists

Intervention Type BEHAVIORAL

Pharmacist

Participants will receive support from pharmacist.

Group Type ACTIVE_COMPARATOR

Pharmacist disease/medication management

Intervention Type BEHAVIORAL

Pharmacist-patient encounters

Intervention Type BEHAVIORAL

Pharmacist medication intensification and adherence support

Intervention Type BEHAVIORAL

Pharmacist communication with primary care physicians

Intervention Type BEHAVIORAL

Pharmacist documentation in electronic medical record

Intervention Type BEHAVIORAL

Interventions

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Pharmacist disease/medication management

Intervention Type BEHAVIORAL

Pharmacist-patient encounters

Intervention Type BEHAVIORAL

Pharmacist medication intensification and adherence support

Intervention Type BEHAVIORAL

Pharmacist communication with primary care physicians

Intervention Type BEHAVIORAL

Pharmacist documentation in electronic medical record

Intervention Type BEHAVIORAL

Health promoter-patient encounters in-person or by phone

Intervention Type BEHAVIORAL

Health promoter medication and lifestyle support

Intervention Type BEHAVIORAL

Health promoter communication with pharmacists

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-identified as Latino/Hispanic or African-American
* Verbal fluency in English or Spanish
* Age 21 or above
* History of type 2 diabetes (\> 1 year)
* Hemoglobin A1c ≥ 8.0% (within 1 year)
* Receives primary care at UIMC (\> 1 year)
* Taking at least one oral medication for diabetes or hypertension

Exclusion Criteria

* Unable to verbalize comprehension of study or impaired decision making (e.g., dementia)
* Lives outside Chicago communities of recruitment (3+ months/year)
* Household member already participating in same study
* Plans to move from the Chicago area within the next year
* Pregnant or trying to get pregnancy
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Ben Gerber

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ben S Gerber, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Lisa K Sharp, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Gerber BS, Cano AI, Caceres ML, Smith DE, Wilken LA, Michaud JB, Ruggiero LA, Sharp LK. A pharmacist and health promoter team to improve medication adherence among Latinos with diabetes. Ann Pharmacother. 2010 Jan;44(1):70-9. doi: 10.1345/aph.1M389. Epub 2009 Dec 22.

Reference Type BACKGROUND
PMID: 20028957 (View on PubMed)

Gerber BS, Rapacki L, Castillo A, Tilton J, Touchette DR, Mihailescu D, Berbaum ML, Sharp LK. Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes. BMC Public Health. 2012 Oct 23;12:891. doi: 10.1186/1471-2458-12-891.

Reference Type BACKGROUND
PMID: 23088168 (View on PubMed)

Sharp LK, Tilton JJ, Touchette DR, Xia Y, Mihailescu D, Berbaum ML, Gerber BS. Community Health Workers Supporting Clinical Pharmacists in Diabetes Management: A Randomized Controlled Trial. Pharmacotherapy. 2018 Jan;38(1):58-68. doi: 10.1002/phar.2058. Epub 2017 Nov 30.

Reference Type RESULT
PMID: 29121408 (View on PubMed)

Nabulsi NA, Yan CH, Tilton JJ, Gerber BS, Sharp LK. Clinical pharmacists in diabetes management: What do minority patients with uncontrolled diabetes have to say? J Am Pharm Assoc (2003). 2020 Sep-Oct;60(5):708-715. doi: 10.1016/j.japh.2020.01.024. Epub 2020 Feb 27.

Reference Type DERIVED
PMID: 32115392 (View on PubMed)

Locatelli SM, Sharp LK, Syed ST, Bhansari S, Gerber BS. Measuring Health-related Transportation Barriers in Urban Settings. J Appl Meas. 2017;18(2):178-193.

Reference Type DERIVED
PMID: 28961153 (View on PubMed)

Related Links

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Other Identifiers

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R01DK091347

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-0099

Identifier Type: -

Identifier Source: org_study_id

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