Internet Intervention to Improve Rural Diabetes Care

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Behavioral: Internet Intervention; Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Tuscaloosa, Alabama, United States, 35487
      • University of Alabama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Rural Primary Care Physicians

Exclusion Criteria:

• Non-rural non-primary care physicians

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A1c	January 2005-present
Blood Pressure	January 2005-present
Lipids	January 2005-present

Secondary Outcome Measures

Outcome Measure	Time Frame
Eye screening	January 2005-present
Foot exam	January 2005-present
Kidney disease monitored	January 2005-present
Dietary or exercise advice	January 2005-present
Smoking cessation advice	January 2005-present

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jeroan J Allison, MD, MS Epi, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Safford MM, Allison JJ, Kiefe CI. Patient complexity: more than comorbidity. the vector model of complexity. J Gen Intern Med. 2007 Dec;22 Suppl 3(Suppl 3):382-90. doi: 10.1007/s11606-007-0307-0.
• Safford MM, Shewchuk R, Qu H, Williams JH, Estrada CA, Ovalle F, Allison JJ. Reasons for not intensifying medications: differentiating "clinical inertia" from appropriate care. J Gen Intern Med. 2007 Dec;22(12):1648-55. doi: 10.1007/s11606-007-0433-8. Epub 2007 Oct 24.
• Foster PP, Williams JH, Estrada CA, Higginbotham JC, Voltz ML, Safford MM, Allison J. Recruitment of rural physicians in a diabetes internet intervention study: overcoming challenges and barriers. J Natl Med Assoc. 2010 Feb;102(2):101-7. doi: 10.1016/s0027-9684(15)30497-1.
• Billue KL, Safford MM, Salanitro AH, Houston TK, Curry W, Kim Y, Allison JJ, Estrada CA. Medication intensification in diabetes in rural primary care: a cluster-randomised effectiveness trial. BMJ Open. 2012 Sep 17;2(5):e000959. doi: 10.1136/bmjopen-2012-000959. Print 2012.

Helpful Links

• Rural Diabetes Online Care Project Website

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: November 21, 2006
• First Submitted That Met QC Criteria: November 22, 2006
• First Posted (Estimate): November 23, 2006

Study Record Updates

• Last Update Posted (Estimate): August 11, 2010
• Last Update Submitted That Met QC Criteria: August 10, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Hypertension; Quality of Health Care; Hyperlipidemia; Diabetes mellitus; Internet; Education, Professional; Quality Indicators, Health Care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: X050111012; R18DK065001 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No