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: September 10, 2014
Last verified: September 2014

June 29, 2007
September 10, 2014
August 2008
March 2010   (final data collection date for primary outcome measure)
Change in Systolic Blood Pressure [ Time Frame: 6 months prior to 6 months after the intervention period ] [ Designated as safety issue: No ]
Change in BP (systolic) control
Complete list of historical versions of study NCT00495794 on ClinicalTrials.gov Archive Site
  • A1c Control [ Time Frame: 12 months after intervention period ] [ Designated as safety issue: No ]
  • LDL Control [ Time Frame: 12 months after invention period ] [ Designated as safety issue: No ]
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)
Not Provided
Not Provided
 
Adherence and Intensification of Medications (AIM) Implementation Study
Adherence and Intensification of Medications: A Population-Based Clinical Pharmacists Implementation Study Among Hypertensive Diabetes Patients

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.

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].)

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Hypertension
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
  • Experimental: Pharmacist management
    Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)
    Intervention: Behavioral: Clinical pharmacist-based intervention
  • No Intervention: Usual care
    Eligible patients receive usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4622
July 2012
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00495794
SDP 06-128, R18DK076622-01
Yes
Department of Veterans Affairs
Department of Veterans Affairs
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Kaiser Permanente
Principal Investigator: M. E. Michele Heisler, MD MPA VA Ann Arbor Healthcare System
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP