The Impact of the Trial Coordinator in the Diabetes Control and Complications Trial (DCCT)

Ahern, Joann; Grove, N.; Strand, Trudy; Wesche, J.; Seibert, C; Brenneman, Anne T.; Tamborlane, William V.

doi:10.1177/014572179301900606

Cited by 44 publications

(18 citation statements)

References 7 publications

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“…As new and creative methods to deliver education are explored, the coordinator plays a pivotal role in ensuring accountability and continuity of the educational process (23,60–62). The individual serving as the coordinator will be most effective if there is familiarity with the lifelong process of managing a chronic disease (e.g., diabetes) and with program management.…”

Section: Standardsmentioning

confidence: 99%

National Standards for Diabetes Self-Management Education

Funnell

Brown

Childs³

et al. 2009

Diabetes Care

558

124

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Diabetes self-management education (DSME) is a critical element of care for all people with diabetes and is necessary in order to improve patient outcomes. The National Standards for DSME are designed to define quality diabetes self-management education and to assist diabetes educators in a variety of settings to provide evidence-based education. Because of the dynamic nature of health care and diabetes-related research, these Standards are reviewed and revised approximately every 5 years by key organizations and federal agencies within the diabetes education community.A Task Force was jointly convened by the American Association of Diabetes Educators and the American Diabetes Association in the summer of 2006. Additional organizations that were represented included the American Dietetic Association, the Veteran's Health Administration, the Centers for Disease Control and Prevention, the Indian Health Service, and the American Pharmaceutical Association. Members of the Task Force included a person with diabetes; several health services researchers/ behaviorists, registered nurses, and registered dietitians; and a pharmacist.The Task Force was charged with reviewing the current DSME standards for their appropriateness, relevance, and scientific basis. The Standards were then reviewed and revised based on the available evidence and expert consensus. DEFINITION ANDOBJECTIVES -Diabetes self-management education (DSME) is the ongoing process of facilitating the knowledge, skill, and ability necessary for diabetes self-care. This process incorporates the needs, goals, and life experiences of the person with diabetes and is guided by evidence-based standards. The overall objectives of DSME are to support informed decision-making, self-care behaviors, problem-solving and active collaboration with the health care team and to improve clinical outcomes, health status, and quality of life.GUIDING PRINCIPLES -Before the review of the individual Standards, the Task Force identified overriding principles based on existing evidence that would be used to guide the review and revision of the DSME Standards. These are:1. Diabetes education is effective for improving clinical outcomes and quality of life, at least in the short-term (1-7). 2. DSME has evolved from primarily didactic presentations to more theoretically based empowerment models (3,8). 3. There is no one "best" education program or approach; however, programs incorporating behavioral and psychosocial strategies demonstrate improved outcomes (9 -11). Additional studies show that culturally and ageappropriate programs improve outcomes (12-16) and that group education is effective (4,6,7,17,18). 4. Ongoing support is critical to sustain progress made by participants during the DSME program (3,13,19,20). 5. Behavioral goal-setting is an effective strategy to support self-management behaviors (21). STANDARDSStructure Standard 1. The DSME entity will have documentation of its organizational structure, mission statement, and goals and will recognize and support quality DSME ...

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Section: Standardsmentioning

confidence: 99%

National Standards for Diabetes Self-Management Education

Funnell

Brown

Childs³

et al. 2009

Diabetes Care

558

124

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“…team of nurse educators, nutritionists, diabetologists, and psychosocial support staff [3]. It is the opinion of this author that the nurse educators and dieticians working together with a common philosophy of empowerment helped teach, support, and focus the efforts of our patients during the DCCT [4].…”

Section: The Diabetes Control and Complications Trial And Other Studiesmentioning

confidence: 97%

Complications of pediatric and adolescent type 1 diabetes mellitus

Brink¹

2001

Curr Diab Rep

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Type 1 diabetes mellitus is potentially associated with serious microvascular and macrovascular complications, although these are usually subclinical during the pediatric and adolescent years. There is no "grace" period for the beginnings of such complications. Duration of diabetes, glycemic control, age, and pubertal stage are critical factors contributing toward development of such problems. Other risk factors include family history (genetic predisposition), hyperlipidemia, hypertension, and smoking. The Diabetes Control and Complications Trial (DCCT) proved the importance of glycemic control and emphasized the ability of improved glucose control to prevent or decrease retinopathy, nephropathy, and neuropathy using a multidisciplinary same-philosophy-of-care approach plus targeted glucose and hemoglobin A(1c) values. Other natural history and intervention studies support the findings of the DCCT. Although our current tools are not perfect, they allow us to decrease microangiopathic complications very significantly if we educate our patients and their family members. Metabolic control counts.

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“…Historically, the field of research nursing and/or study coordination has lacked clear and consistent definition, standardization and an established professional development trajectory (1, 2) . Reports describing the SC role in the 1980's emphasized the importance of selecting candidates with the appropriate skills and experience necessary to successfully implement clinical trials (3, 4) . Roles for nurses in cancer clinical trials became common and resulted in an attempt to standardize a job description by the Oncology Nursing Society (5, 6) .…”

Section: Introductionmentioning

confidence: 99%

“…Several of the SCs were among the first to earn the Certified Diabetes Educator (CDE) credential (1986) and many assumed active roles in professional organizations on both a local and national level. Two papers were authored by SCs regarding their role and work within the DCCT (3, 4) , and SCs were listed along with PIs as contributing authors of the primary outcome publication (15) . As the DCCT ended, its SCs were well positioned to assume additional responsibilities within the EDIC study.…”

Section: Introductionmentioning

confidence: 99%

Evolution of the study coordinator role: The 28-year experience in Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC)

et al. 2012

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Background The role of the study coordinator (SC) in multi-center studies of long duration has received limited attention. Purpose To describe the evolution of the SC's role during the 28-year Diabetes Control and Complications Trial (DCCT) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC) study. Methods The evolution in the SC position from the traditional role of protocol implementation to that of research collaborator and co-investigator, based on personal experience and observation, is described in detail. Findings from a survey regarding professional demographics and job satisfaction, completed by all 28 SC's in 2010, provided additional information. We used dimensions of the SC role specific to DCCT/EDIC to construct a classification schema of functions and responsibilities that describe the SC role. Results Among the 28 SCs, 24 were nurses, 12 held bachelor's degrees, 11 had a master's degree, 19 were Certified Diabetes Educators (CDEs), 12 had worked with DCCT/EDIC for more than 20 years and 5 had been with the study since its inception (> 26 years). Responses confirmed a high degree of functional consistency across sites with data acquisition, performing study procedures, recruitment and consent for additional ancillary studies, regulatory management, scheduling, clinical consultation and ongoing contact with study participants frequently reported. Study-wide leadership activities, a category not generally included in the usual SC role, were reported by approximately 30% of SCs. The level of professional satisfaction was high with two thirds being very satisfied, one third moderately to quite satisfied, and none dissatisfied. Limitations The limitations include a relatively small sample size, self-reported data, and a single long-term multicenter trial and observational follow up study on which we based our findings and conclusions. Conclusions By optimizing their organizational and scientific contributions to the overall research endeavor, SCs in DCCT/EDIC have made major contributions to the unprecedented success of the study and report high job satisfaction. The efforts of the SCs have been integral to the remarkably high participant retention and data completion rates. The DCCT/EDIC experience may serve as a model for the role of the SC in future diabetes and other multi-center clinical trials.

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The Impact of the Trial Coordinator in the Diabetes Control and Complications Trial (DCCT)

Cited by 44 publications

References 7 publications

National Standards for Diabetes Self-Management Education

National Standards for Diabetes Self-Management Education

Complications of pediatric and adolescent type 1 diabetes mellitus

Evolution of the study coordinator role: The 28-year experience in Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC)

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