Internet Intervention to Improve Rural Diabetes Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00403091
First received: November 21, 2006
Last updated: August 10, 2010
Last verified: August 2010
  Purpose

Rural Diabetes Online Care (RDOC) will develop an Internet-based intervention for rural primary care physicians, focusing on improving care for adult patients with diabetes. The intervention, drawing upon the principles of quality improvement and providing tools for system-based changes in practice, is designed for the rural practice, where resources are constrained.


Condition Intervention
Diabetes Mellitus Type 2
Behavioral: Internet Intervention
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Internet Intervention to Improve Rural Diabetes Care

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • A1c [ Time Frame: January 2005-present ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: January 2005-present ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: January 2005-present ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Eye screening [ Time Frame: January 2005-present ] [ Designated as safety issue: No ]
  • Foot exam [ Time Frame: January 2005-present ] [ Designated as safety issue: No ]
  • Kidney disease monitored [ Time Frame: January 2005-present ] [ Designated as safety issue: No ]
  • Dietary or exercise advice [ Time Frame: January 2005-present ] [ Designated as safety issue: No ]
  • Smoking cessation advice [ Time Frame: January 2005-present ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: April 2005
Study Completion Date: April 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Behavioral: Internet Intervention
Internet-based intervention aims to improve guideline adherence by rural physicians caring for adult patients with type 2 diabetes.
Active Comparator: Control Behavioral: Control
The comparison group will receive a text-based, non-interactive Internet posting of publicly available resources.

Detailed Description:

This 4-year randomized trial of an Internet-based intervention aims to improve guideline adherence by rural physicians caring for adult patients with type 2 diabetes.

Objectives. (1) Assess barriers to implementation of diabetes guidelines and identify solutions through focus groups and case-based vignette surveys; (2) Develop and implement an interactive Internet intervention including individualized physician performance feedback; (3) Evaluate the intervention in a randomized controlled trial; and (4) Examine the sustainability of improved guideline adherence once feedback ceases.

Methods. In partnership with the University of Alabama rural medicine program, we will randomize 200 rural physician offices to an intervention or comparison arm. Our 18-month intervention, customized to the individual physician in real-time, consists of Internet learning modules with case-based education, performance feedback, and benchmarks. The comparison group will receive a text-based, non-interactive Internet posting of publicly available resources. Nurse practitioners and physician assistants from the offices of study physicians may also participate in the Internet modules. Outcomes will be based on previously developed and validated quality measures for diabetes. The intervention will cover screening, diagnosis, treatment, and prevention. Performance feedback will include 10-15 charts per intervention physician. The main analysis, conducted at the physician level, will compare differential improvement in guideline adherence between the study arms. Ancillary analyses will examine the effects of physician characteristics, other providers in the office, and patient characteristics (e.g., comorbidities, ethnicity, gender, age, and socioeconomic status). Multivariable techniques will adjust for repeated measures, clustering of patients within physicians, and multiple providers within a single office.

Study Population. RDOC will enroll 200 physicians from rural Alabama, Mississippi, Georgia, Tennessee, Florida, Arkansas, Kentucky, North Carolina, South Carolina, Missouri, and West Virginia. Participating physicians will be randomized to receive the intervention or to a comparison group, which will receive traditional, text-based continuing medical education (CME). Each participating physician will allow two rounds of medical record abstraction to be conducted in his/her office. Results from the medical record review: (1) be used in the intervention to provide physicians with personal performance feedback and (2) used to examine change in performance for the intervention and comparison physicians as an evaluation of the entire study.

Significance. This study offers a technologically advanced, theory-grounded intervention for improving care of a high-risk, underserved population. With expertise in translating research into practice, rural medicine, behavioral medicine, health informatics, and clinical diabetes, our multidisciplinary team has a proven record of collaboration. This project will produce an evidence-based and replicable intervention that can be sustained in the "real world," and easily modified for other diseases. This project is substantially improved after making important changes recommended in the second review.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Rural Primary Care Physicians

Exclusion Criteria:

  • Non-rural non-primary care physicians
  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: NCT00403091

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
University of Alabama
Tuscaloosa, Alabama, United States, 35487
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Jeroan J Allison, MD, MS Epi University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Carlos Estrada, UAB
ClinicalTrials.gov Identifier: NCT00403091     History of Changes
Other Study ID Numbers: X050111012, R18 DK065001
Study First Received: November 21, 2006
Last Updated: August 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Diabetes mellitus
Internet
Education, Professional
Quality Indicators, Health Care
Quality of Health Care
Hypertension
Hyperlipidemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014