Adherence and Intensification of Medications (AIM) Implementation Study

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00495794
First received: June 29, 2007
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Diabetes
Hypertension
Behavioral: Clinical pharmacist-based intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adherence and Intensification of Medications: A Population-Based Clinical Pharmacists Implementation Study Among Hypertensive Diabetes Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in BP (systolic) control [ Time Frame: 6 months preceding and following the intervention period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A1c control (change in % of eligible patients w/an average A1c>8%); LDL-c control (change in % of eligible patients w/an LDL-c>100mg/dl); Medication adherence; Medication intensification (increase in dosage and/or addition of another medication class) [ Time Frame: 6 months preceding and following the 12 month intervention period ] [ Designated as safety issue: No ]

Enrollment: 4622
Study Start Date: August 2008
Study Completion Date: July 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Patients with diabetes identified as having poor BP control AND (adherence or intensification problems)
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

Detailed 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: Not recruiting, analyzing data. (Enrollment numbers are for VA and non-VA sites [control and intervention].)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495794

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: M. E. Michele Heisler, MD MPA VA Ann Arbor Healthcare System
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00495794     History of Changes
Other Study ID Numbers: SDP 06-128, R18DK076622-01
Study First Received: June 29, 2007
Last Updated: April 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
diabetes
hypertension
adherence
implementation
medications
organization of care

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014