Clinical trial NCT01343056: Program Reinforcement Impacts Self Management (PRISM)
Official title: Program Reinforcement Impacts Self Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Self Management Education (DSME)
Diabetes
Self Management Support (SMS)
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2011-04-27
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Hemoglobin A1C (HbA1C, %)
timeFrame: 6 months
Secondary outcomes:
measure: Total Cholesterol (mg/dL)
timeFrame: 6 months
measure: High Density Lipoprotein (HDL, mg/dL)
timeFrame: 6 months
measure: Low Density Lipoprotein (LDL, mg/dL)
timeFrame: 6 months
measure: Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores
timeFrame: 6 months
measure: Body Mass Index
timeFrame: 6 months
measure: Diastolic Blood Pressure
timeFrame: 6 months
measure: Systolic Blood Pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Linda Siminerio, RN, PhD, CDE
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Robert Gabbay, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siminerio L, Ruppert KM, Gabbay RA. Who can provide diabetes self-management support in primary care? Findings from a randomized controlled trial. Diabetes Educ. 2013 Sep-Oct;39(5):705-13. doi: 10.1177/0145721713492570. Epub 2013 Jun 19.