Program Reinforcement Impacts Self Management (PRISM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Linda Siminerio, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01343056
First received: April 19, 2011
Last updated: June 13, 2012
Last verified: June 2012

April 19, 2011
June 13, 2012
April 2011
October 2012   (final data collection date for primary outcome measure)
Which group (of four total groups) has the highest number of patients reach their self-initiated behavioral goals [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Diabetes Self Management Education (DSME) is an important part of the treatment for diabetes. Unfortunately, the positive effects of education sometimes wane over time. We are evaluating four distinct methods of follow up for behavior goals set by the participant. We will evaluate success by measuring how many patients in each of the four total groups reach their self-initiated behavioral goals.
Same as current
Complete list of historical versions of study NCT01343056 on ClinicalTrials.gov Archive Site
  • Improvement of clinical indicator - HbA1C blood test [ Time Frame: 6 weeks, 3 months and 6 months. ] [ Designated as safety issue: No ]
    We will assess this clinical indicator to evaluate improvement in each of the four arms of the study.
  • Improvement of clinical indicator - lipid panel [ Time Frame: 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
    We will assess this clinical indicator to evaluate improvement in each of the four arms of the study.
Same as current
Not Provided
Not Provided
 
Program Reinforcement Impacts Self Management (PRISM)
Program Reinforcement Impacts Self Management

Patients who receive DSME (Diabetes Self Management Education) will be enrolled in a 4 arm, randomized study with each group receiving a different method of follow up. The 4 arms will be evaluated based on clinical indicators, goal achievement and patient satisfaction.

As the diabetes burden worsens, the need for people to become more involved in self-management will increase. Research has demonstrated that diabetes self-management education (DSME) can improve HbA1C levels by 0.76%. While the rates of diabetes are increasing, the numbers of educators available are shrinking. This is a particular hardship in underserved and military communities where the supply of health care providers is already scarce. Our investigative team has led efforts in supporting DSME in the PA state-wide deployment of the Chronic Care Model (CCM) and reported findings nationally on innovative ways to increase the pool of education services by integrating educators into primary care, establishing nurse clinics in underserved communities and demonstrating that an educator position could be sustained by reimbursement. A 0.76% reduction associated to DSME can be considered an enormous benefit and is equivalent to the impact of most pharmacologic treatments for diabetes. Unfortunately, however the benefits of DSME decrease over time. This suggests that sustained improvements require contact and follow-up. SMS is defined as the process of ongoing support of patient self-care, to sustain the gains following DSME. There is often confusion among the terms self-management education (DSME) and self-management support (SMS). DSME is associated with the provision of knowledge and skills training delivered by a health care professional, e.g. nurses, dietitians, etc. SMS is defined as the process of making and refining changes in health care systems (and the community) to support patient self-care and maintain the gains made following DSME. We know that SMS is currently provided by diabetes educators, but only one 3-6 month follow up is usual care. It has been suggested that SMS can be provided by community workers, peers with diabetes, and office staff within community sites, like PCP offices, and wellness centers, etc. The National Standards for DSME and American Diabetes Association (ADA) Education Recognition Program (ERP) require that SMS approaches be delivered and documented, yet no evidence has been provided to define who should deliver it and how often. This uncertainty has led to many programs delivering SMS in an unstructured, non-standardized and at times haphazard fashion. Practical approaches designed for providing SMS have the potential to sustain improvements. The objective of this study is to compare Self-Management Support (SMS) interventions following Diabetes Self-Management Education (DSME) and determine which will be more likely to maintain improvements in behavioral and clinical outcomes following DSME while achieving patient satisfaction.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Diabetes Mellitus
Behavioral: Four different methods of follow up of goal attainment post diabetes education shall be evaluated.
The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids.
Other Name: Diabetes education support
  • Office Staff follow up of diabetes education
    A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.
    Intervention: Behavioral: Four different methods of follow up of goal attainment post diabetes education shall be evaluated.
  • Peer follow up of diabetes education
    A person with diabetes trained as a "peer" shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.
    Intervention: Behavioral: Four different methods of follow up of goal attainment post diabetes education shall be evaluated.
  • Usual Care
    ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.
    Intervention: Behavioral: Four different methods of follow up of goal attainment post diabetes education shall be evaluated.
  • Educator support follow up
    A diabetes educator will provide follow up support.
    Intervention: Behavioral: Four different methods of follow up of goal attainment post diabetes education shall be evaluated.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A person with diabetes referred for diabetes education

Exclusion Criteria:

  • Gestational diabetes and pregnancy
  • If a person has recently had diabetes education, they will not be enrolled in the study
Both
Not Provided
No
Contact: Linda Siminerio, PhD, CDE 412-864-0157 simineriol@upmc.edu
Contact: Janis McWilliams, MSN, CDE, BC-ADM 412-864-0159 mcwilliamsjr@upmc.edu
United States
 
NCT01343056
PRO10090392
No
Linda Siminerio, University of Pittsburgh
University of Pittsburgh
Penn State University
Principal Investigator: Linda Siminerio, RN, PhD, CDE University of Pittsburgh
Principal Investigator: Robert Gabbay, MD, PhD Penn State University
University of Pittsburgh
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP