Health Promoters and Pharmacists in Diabetes Team Management

Diabetes Mellitus Clinical Trial

Official title:

Health Promoters and Pharmacists in Diabetes Team Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498159
• Other study ID #: 2011-0099
• Secondary ID: R01DK091347
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: January 2018

Study information

• Verified date: April 2018
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: January 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Pharmacist disease/medication management

• Pharmacist-patient encounters

• Pharmacist medication intensification and adherence support

• Pharmacist communication with primary care physicians

• Pharmacist documentation in electronic medical record

• Health promoter-patient encounters in-person or by phone

• Health promoter medication and lifestyle support

• Health promoter communication with pharmacists

Locations

Country	Name	City	State
United States	University of Illinois Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Hemoglobin A1c	24 months
Secondary	Diabetes Knowledge	Diabetes Knowledge	24 months
Secondary	Autonomous Self-Regulation	Autonomous Self-Regulation	24 months
Secondary	Perceived Competence	Perceived Competence	24 months
Secondary	Medication Adherence	Medication Adherence	24 months
Secondary	Body mass index	Body mass index	24 months
Secondary	Diabetes Self-Care Behaviors	Diabetes Self-Care Behaviors	24 months
Secondary	Quality of Life	Quality of Life	24 months
Secondary	Healthcare Utilization	Healthcare Utilization	24 months
Secondary	Systolic Blood Pressure	Systolic Blood Pressure	24 months
Secondary	Diastolic Blood Pressure	Diastolic Blood Pressure	24 months
Secondary	LDL Cholesterol	LDL Cholesterol	24 months

External Links

•   IHRP Study Description