NCT00495794

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,622

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 11, 2014

Completed
Last Updated

April 28, 2015

Status Verified

July 1, 2014

Enrollment Period

1.6 years

First QC Date

June 29, 2007

Results QC Date

September 3, 2014

Last Update Submit

April 6, 2015

Conditions

DiabetesHypertension

Keywords

diabeteshypertensionadherenceimplementationmedicationsorganization of care

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic Blood Pressure

    6 months prior to 6 months after the intervention period

Secondary Outcomes (2)

  • A1c Control

    12 months after intervention period

  • LDL Control

    12 months after invention period

Study Arms (2)

Pharmacist management

EXPERIMENTAL

Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)

Behavioral: Clinical pharmacist-based intervention

Usual care

NO INTERVENTION

Eligible patients receive usual care

Interventions

Clinical pharmacist-based interventionBEHAVIORAL

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

Pharmacist management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be a veteran at a study site;
  • Have a diagnosis of diabetes;
  • Meet blood pressure, medication adherence and intensification requirements (as determined by the study team)

You may not qualify if:

  • Dementia
  • Traumatic brain injury
  • Pregnancy
  • Age \<18 or \>100

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related 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;11:95. doi: 10.1186/1745-6215-11-95.

    PMID: 20939913RESULT

  • 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):60-73. doi: 10.1177/1742395313496590. Epub 2013 Jul 26.

    PMID: 23892775RESULT

  • 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 adherence and intensification of medications cluster randomized, controlled pragmatic trial. Circulation. 2012 Jun 12;125(23):2863-72. doi: 10.1161/CIRCULATIONAHA.111.089169. Epub 2012 May 8.

    PMID: 22570370RESULT

  • 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: 10.1186/1472-6963-12-270.

    PMID: 22909303RESULT

  • 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.

    PMID: 22928756RESULT

  • 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: 10.1186/1472-6963-12-183.

    PMID: 22747998RESULT

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

In the intervention arm, only 53% of subjects had a pharmacist encounter. Higher rates of participation might have led to a more substantial initial improvement and a detectable longer term effect.

Results Point of Contact

Title
Dr. Michele Heisler
Organization
VA Center for Clinical Management Research; University of Michigan
mheisler@umich.edu
734-845-3504

Study Officials

  • M. E. Michele Heisler, MD MPA

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2007

First Posted

July 3, 2007

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Study Completion

July 1, 2012

Last Updated

April 28, 2015

Results First Posted

September 11, 2014

Record last verified: 2014-07

Locations

US(1)