Clinical trial NCT00403091: Internet Intervention to Improve Rural Diabetes Care
Official title: Internet Intervention to Improve Rural Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes mellitus
Internet
Education, Professional
Quality Indicators, Health Care
Quality of Health Care
Hypertension
Hyperlipidemia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-11-23
Enrollment: 205
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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 criteria: Inclusion Criteria:

* Rural Primary Care Physicians

Exclusion Criteria:

* Non-rural non-primary care physicians

Primary outcomes:
measure: A1c
timeFrame: January 2005-present
measure: Blood Pressure
timeFrame: January 2005-present
measure: Lipids
timeFrame: January 2005-present
Secondary outcomes:
measure: Eye screening
timeFrame: January 2005-present
measure: Foot exam
timeFrame: January 2005-present
measure: Kidney disease monitored
timeFrame: January 2005-present
measure: Dietary or exercise advice
timeFrame: January 2005-present
measure: Smoking cessation advice
timeFrame: January 2005-present
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jeroan J Allison, MD, MS Epi
role: PRINCIPAL_INVESTIGATOR
References:
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(Suppl 3):382-90. doi: 10.1007/s11606-007-0307-0.
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. doi: 10.1007/s11606-007-0433-8. Epub 2007 Oct 24.
citation: 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.
citation: 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.