Program Reinforcement Impacts Self Management (PRISM)

This study is currently recruiting participants.
Verified June 2012 by University of Pittsburgh
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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Behavioral: Four different methods of follow up of goal attainment post diabetes education shall be evaluated.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Program Reinforcement Impacts Self Management

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
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.
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
Educator support follow up
A diabetes educator will provide follow up support.
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343056

Contacts
Contact: Linda Siminerio, PhD, CDE 412-864-0157 simineriol@upmc.edu
Contact: Janis McWilliams, MSN, CDE, BC-ADM 412-864-0159 mcwilliamsjr@upmc.edu

Locations
United States, Pennsylvania
Pennsylvania State University Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Robert Gabbay, MD, PhD    717-531-3592    rgabbay@psu.edu   
Contact: Lisa Ambrocio    717-531-1383    lambrocio@hmc.psu.edu   
Principal Investigator: Robert Gabay, MD         
Sub-Investigator: Lisa Ambrocio         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Linda Siminerio, RN, PhD, CDE         
Sub-Investigator: Janis McWilliams, MSN, CDE, BC-ADM         
Sponsors and Collaborators
University of Pittsburgh
Penn State University
Investigators
Principal Investigator: Linda Siminerio, RN, PhD, CDE University of Pittsburgh
Principal Investigator: Robert Gabbay, MD, PhD Penn State University
  More Information

No publications provided

Responsible Party: Linda Siminerio, Linda Siminerio, RN, PhD, CDE, Executive Director, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01343056     History of Changes
Other Study ID Numbers: PRO10090392
Study First Received: April 19, 2011
Last Updated: June 13, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Diabetes Self Management Education (DSME)
Diabetes
Self Management Support (SMS)

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014