Clinical Trial: Proactive Diabetes Case Management

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

Purpose

The consequences of current deficiencies in type 2 diabetes mellitus (T2DM) care are staggering, and conventional approaches to improve care have failed. Treatment guidelines and case management have been advocated as solutions to this problem. However, traditional approaches to guideline implementation have been discouraging and the cost-effectiveness of case management has not been rigorously evaluated. This study addresses two VA HSR&D priority areas: (1) guideline dissemination; and (2) evaluating managed care techniques for use in VA. The study has the following specific aims: (1) to evaluate the impact of a targeted, proactive T2DM case management intervention on: (a) glycemic control, (b) adherence to minimum standards, (c) short-term resource utilization, (d) veteran satisfaction, and (e) short-term patient physiologic and functional outcomes; and (2) using Monte Carlo simulations, estimate the expected impact of changes in key processes of care and intermediate outcomes on end-stage outcomes and long-term costs. The study is a randomized controlled trial. Veterans (n = 246) at two VAMCs who met specific eligibility criteria were recruited to participate in the study and randomly assigned to the intervention or control groups. Study participants are being followed for approximately 18 months. The intervention consists of two nurse practitioners who are actively monitoring and coordinating patient care, guided by approved treatment algorithms. Primary data sources include: (1) a baseline and exit examination; (2) a baseline and exit survey; and (3) the VA medical information system. The primary outcome measure is glycemic control as measured by hemoglobin A1c (HbA1c). Secondary outcomes include serum LDL, veteran satisfaction, functional status, eye and kidney screening, foot integrity, blood pressure, resource utilization and costs. The data will be analyzed using the change in the primary and secondary outcome measures over the study period as dependent variables. A subgroup analysis also will be conducted to examine those with poorer glycemic control at baseline (HbA1c > 9.5%) vs. those with better baseline control. A Monte Carlo simulation model will be used to estimate the expected long-term benefits of the intervention. Cost estimates also will be incorporated to evaluate the long term cost-effectiveness of the intervention.

Condition Treatment or Intervention
Diabetes Mellitus
 Behavior: Case Management

MedlinePlus related topics:  Diabetes

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment

Further Study Details: 

Expected Total Enrollment:  260

Study start: September 1998;  Study completion: February 2002

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Patients were eligible to participate in the study if their most current hemoglobin A1c (HbA1c) was >=8.5 (reported within the last year); they had at least 1 prescription for an oral hypoglycemic agent, insulin, or monitoring supplies filled in the last year; and, they had an outpatient visit scheduled with a general internist, nurse practitioner, or physician assistant between May, 1999 and January, 2000.

Patients were not eligible for the study if the patient (or another member of the household when applicable) indicated that they: (1) were under 18 years of age; (2) had never been diagnosed with diabetes; (3) had been diagnosed with Type 1 diabetes or had been diagnosed before age 30; (4) did not have a telephone; (5) did not speak English; (6) were not competent for interview; (7) did not receive their primary diabetes care within the VA system; (8) were currently receiving treatment for cancer (other than non-melanoma); (9) had been diagnosed with kidney failure, congestive heart failure (and were short of breath at rest), liver disease, or blindness; (10) changed residences during certain months of the year; (11) planned to move in the near future; or their HbA1c obtained at baseline was < 7.5%.


Location Information


Michigan
      VA Ann Arbor Healthcare System, Ann Arbor,  Michigan,  48113-0170,  United States

      VA Ann Arbor Healthcare System, Ann Arbor,  Michigan,  48113-0170,  United States

      VA Ann Arbor Healthcare System, Ann Arbor,  Michigan,  48113-0170,  United States

      VA Ann Arbor Healthcare System, Ann Arbor,  Michigan,  48113-0170,  United States

More Information

Study ID Numbers:  IIR 97-077
Record last reviewed:  November 2000
Last Updated:  October 13, 2004
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00013208
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005