Adherence and Intensification of Medications (AIM) Implementation Study

Hypertension Clinical Trial

Official title:

Adherence and Intensification of Medications: A Population-Based Clinical Pharmacists Implementation Study Among Hypertensive Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00495794
• Other study ID #: SDP 06-128
• Secondary ID: R18DK076622-01
• Status: Completed
• Phase: N/A
• First received: June 29, 2007
• Last updated: April 6, 2015
• Start date: August 2008
• Est. completion date: July 2012

Study information

• Verified date: July 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control.

Objectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.

Description:

Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control.

Objectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.

Methods: In this cluster randomized implementation trial, we will proactively identify, using clinical automated data, all diabetes patients within 3 VA sites who have poor blood pressure control and either poor refill adherence or insufficient medication intensification. (NIDDK R18 funds 2 non-VA sites.) Adherence and treatment intensification patterns will also be evaluated for glycemia and lipids if either of these risk factors is poorly controlled. Clinical pharmacists, trained in motivational interviewing techniques and guided by computerized adherence modules, will identify barriers to medication adherence and provide adherence counseling. They will also be authorized to change and titrate medications following site-specific algorithms. Patients in the non-intervention (control) teams will receive usual care. Blood pressure control and refill adherence will be assessed 6-months after the end of the intervention period. We will also conduct a formative evaluation during the course of the study and assess implementation attainment and potential for dissemination.

Status: Data analysis complete. (Enrollment numbers are for VA and non-VA sites [control and intervention].)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4622
• Est. completion date: July 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

VA inclusion criteria

1. Must be a veteran at a study site;

2. Have a diagnosis of diabetes;

3. Meet blood pressure, medication adherence and intensification requirements (as determined by the study team)

Exclusion Criteria:

VA Exclusion

1. Dementia

2. Traumatic brain injury

3. Pregnancy

4. Age <18 or >100

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

Behavioral:
• Clinical pharmacist-based intervention
Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Kaiser Permanente, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Heisler M, Hofer TP, Klamerus ML, Schmittdiel J, Selby J, Hogan MM, Bosworth HB, Tremblay A, Kerr EA. Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study. Trials. 2010 Oct 12;11 — View Citation

Heisler M, Hofer TP, Schmittdiel JA, Selby JV, Klamerus ML, Bosworth HB, Bermann M, Kerr EA. Improving blood pressure control through a clinical pharmacist outreach program in patients with diabetes mellitus in 2 high-performing health systems: the adhere — View Citation

Klamerus ML, Kerr EA, Bosworth HB, Schmittdiel JA, Heisler M. Characteristics of diabetic patients associated with achieving and maintaining blood pressure targets in the Adherence and Intensification of Medications program. Chronic Illn. 2014 Mar;10(1):6 — View Citation

Meddings J, Kerr EA, Heisler M, Hofer TP. Physician assessments of medication adherence and decisions to intensify medications for patients with uncontrolled blood pressure: still no better than a coin toss. BMC Health Serv Res. 2012 Aug 21;12:270. doi: 1 — View Citation

Selby JV, Schmittdiel JA, Fireman B, Jaffe M, Ransom LJ, Dyer W, Uratsu CS, Reed ME, Kerr EA, Hsu J. Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial. BMC Health Serv Res. 2012 Jul 2;12:183. doi: 10.118 — View Citation

Sussman JB, Zulman DM, Hayward R, Hofer TP, Kerr EA. Cardiac risk is not associated with hypertension treatment intensification. Am J Manag Care. 2012 Aug;18(8):414-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic Blood Pressure		6 months prior to 6 months after the intervention period	No
Secondary	A1c Control		12 months after intervention period	No
Secondary	LDL Control		12 months after invention period	No