Clinical trial NCT01498159: Health Promoters and Pharmacists in Diabetes Team Management
Official title: Health Promoters and Pharmacists in Diabetes Team Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Pharmacists
Community Health Aides
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-12-23
Enrollment: 244
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 24 months
Secondary outcomes:
measure: Diabetes Knowledge
timeFrame: 24 months
measure: Autonomous Self-Regulation
timeFrame: 24 months
measure: Perceived Competence
timeFrame: 24 months
measure: Medication Adherence
timeFrame: 24 months
measure: Body mass index
timeFrame: 24 months
measure: Diabetes Self-Care Behaviors
timeFrame: 24 months
measure: Quality of Life
timeFrame: 24 months
measure: Healthcare Utilization
timeFrame: 24 months
measure: Systolic Blood Pressure
timeFrame: 24 months
measure: Diastolic Blood Pressure
timeFrame: 24 months
measure: LDL Cholesterol
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Medical Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Ben S Gerber, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Lisa K Sharp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. Epub 2017 Nov 30.
citation: 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.
citation: 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.