Improving Risk Factors for Diabetes Complications in Primary Care

NCT00482768 | Completed DMC

• 1 other identifier: R18DK075692
• Study Type: interventional
• Target: 2,493
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test an intervention in primary care clinics to improve three risk factors for diabetes complications: glucose control, blood pressure and cholesterol. Subjects in the study will be clinic staff and clinicians, not patients. The intervention is Practice Facilitation. Practice facilitation occurs when a trained facilitator meets with a team of staff and clinicians in each practice over a period of several months. Facilitation meetings create time for learning and reflection by members of the team and improves their communication so that they can adopt and implement a strategy to improve patient care

Conditions

Type 2 Diabetes

Keywords

Diabetes, type II; Primary Health Care; Outpatient Care

Outcome Measures

Primary Outcomes (1)

• glycosylated hemoglobin

  36 months

Secondary Outcomes (3)

• systolic blood pressure

  36 months

• LDL-cholesterol

  36 months

• Change in risk of coronary heart disease

  36 months

Study Arms (2)

1

EXPERIMENTAL

Intervention clinics will receive practice facilitation visits at regular intervals over a 12-month period.

Behavioral: Practice Facilitation

2

NO INTERVENTION

Control clinics will deliver usual care for patients with diabetes.

Interventions

Practice Facilitation BEHAVIORAL

Clinics in the experimental arm will meet with a trained facilitator to work on change strategies that will improve risk factors for diabetes complications.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care practice with 5 or fewer physicians
• The practice must have seen at least 50 patients with type 2 diabetes in the past 90 days

You may not qualify if:

• Practice owned by a large vertically integrated health care system

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Texas Health Sciences Center

San Antonio, Texas, 78229-4404, United States

Location

Related Publications (8)

• Parchman ML, Pugh JA, Culler SD, Noel PH, Arar NH, Romero RL, Palmer RF. A group randomized trial of a complexity-based organizational intervention to improve risk factors for diabetes complications in primary care settings: study protocol. Implement Sci. 2008 Mar 5;3:15. doi: 10.1186/1748-5908-3-15.

  PMID: 18321386 BACKGROUND

• Noel PH, Lanham HJ, Palmer RF, Leykum LK, Parchman ML. The importance of relational coordination and reciprocal learning for chronic illness care within primary care teams. Health Care Manage Rev. 2013 Jan-Mar;38(1):20-8. doi: 10.1097/HMR.0b013e3182497262.

  PMID: 22310483 BACKGROUND

• Bowers KW, Robertson M, Parchman ML. How inclusive leadership can help your practice adapt to change. Fam Pract Manag. 2012 Jan-Feb;19(1):8-11. No abstract available.

  PMID: 22335375 BACKGROUND

• Culler SD, Parchman ML, Lozano-Romero R, Noel PH, Lanham HJ, Leykum LK, Zeber JE. Cost estimates for operating a primary care practice facilitation program. Ann Fam Med. 2013 May-Jun;11(3):207-11. doi: 10.1370/afm.1496.

  PMID: 23690319 BACKGROUND

• Mackey K, Parchman ML, Leykum LK, Lanham HJ, Noel PH, Zeber JE. Impact of the Chronic Care Model on medication adherence when patients perceive cost as a barrier. Prim Care Diabetes. 2012 Jul;6(2):137-42. doi: 10.1016/j.pcd.2011.12.004. Epub 2012 Jan 20.

  PMID: 22264426 BACKGROUND

• Arar NH, Noel PH, Leykum L, Zeber JE, Romero R, Parchman ML. Implementing quality improvement in small, autonomous primary care practices: implications for the patient-centred medical home. Qual Prim Care. 2011;19(5):289-300.

  PMID: 22186171 BACKGROUND

• Parchman ML, Noel PH, Culler SD, Lanham HJ, Leykum LK, Romero RL, Palmer RF. A randomized trial of practice facilitation to improve the delivery of chronic illness care in primary care: initial and sustained effects. Implement Sci. 2013 Aug 22;8:93. doi: 10.1186/1748-5908-8-93.

  PMID: 23965255 RESULT

• Noel PH, Parchman ML, Palmer RF, Romero RL, Leykum LK, Lanham HJ, Zeber JE, Bowers KW. Alignment of patient and primary care practice member perspectives of chronic illness care: a cross-sectional analysis. BMC Fam Pract. 2014 Mar 29;15:57. doi: 10.1186/1471-2296-15-57.

  PMID: 24678983 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Polly H Noel, PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2013
• Last Updated: March 19, 2018

Record last verified: 2011-03

Locations

US (1)