Internet Intervention to Improve Rural Diabetes Care

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Internet Intervention to Improve Rural Diabetes Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403091
• Other study ID #: X050111012
• Secondary ID: R18DK065001
• Status: Completed
• Phase: N/A
• First received: November 21, 2006
• Last updated: August 10, 2010
• Start date: April 2005
• Est. completion date: April 2010

Study information

• Verified date: August 2010
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: April 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Rural Primary Care Physicians

Exclusion Criteria:

• Non-rural non-primary care physicians

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Internet Intervention
Internet-based intervention aims to improve guideline adherence by rural physicians caring for adult patients with type 2 diabetes.
• Control
The comparison group will receive a text-based, non-interactive Internet posting of publicly available resources.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Alabama	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Safford MM, Allison JJ, Kiefe CI. Patient complexity: more than comorbidity. the vector model of complexity. J Gen Intern Med. 2007 Dec;22 Suppl 3:382-90. — View Citation

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. Epub 2007 Oct 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c		January 2005-present	No
Primary	Blood Pressure		January 2005-present	No
Primary	Lipids		January 2005-present	No
Secondary	Eye screening		January 2005-present	No
Secondary	Foot exam		January 2005-present	No
Secondary	Kidney disease monitored		January 2005-present	No
Secondary	Dietary or exercise advice		January 2005-present	No
Secondary	Smoking cessation advice		January 2005-present	No

External Links

•   Rural Diabetes Online Care Project Website