Program Reinforcement Impacts Self Management (PRISM) (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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Office Staff Support; Behavioral: Peer Support; Behavioral: Usual Care Support; Behavioral: Educator 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.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Pennsylvania State University
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Office Staff follow up education; A designee in the office staff shall be assigned to follow up with the patient for for behavioral goal setting attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up. The intervention is the follow up goal attainment and office staff have been trained on elements of goal attainment.	Behavioral: Office Staff Support; The intervention includes the Office staff of primary care practices trained to provide diabetes support for behavioral goal setting were tasked to follow up with patients via phone following completion of diabetes self-management education.
Active Comparator: Peer follow up 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 behavioral goal attainment.The intervention is the follow up goal attainment and peers have been trained on elements of goal attainment.	Behavioral: Peer Support; Community peers trained to provide diabetes support for behavioral goal setting were tasked to follow up with patients via phone following completion of diabetes self-management education.
Active Comparator: 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. The intervention is the diabetes educator making a phone call to the patient to ask how they are doing.	Behavioral: Usual Care Support; Diabetes educators provided patient follow up for behavioral goal setting support according to traditional clinical guidelines following completion of diabetes self-management.
Active Comparator: Educator support follow up; A diabetes educator will provide follow up support and make monthly call to the patient to ascertain behavioral goal setting attainment. The diabetes educator uses behavioral goal setting as an education intervention. The educator calls patient to determine goal attainment. That is the intervention.	Behavioral: Educator Support; Diabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin A1C (HbA1C, %)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cholesterol (mg/dL)		6 months
High Density Lipoprotein (HDL, mg/dL)		6 months
Low Density Lipoprotein (LDL, mg/dL)		6 months
Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores	The DES-SF is a validated, 8 item scale that measures the self-efficacy of patients with diabetes. Responses are selected from a 5-point Likert scale (Strongly Disagree (1), Somewhat Disagree (2), Neutral (3), Somewhat Agree (4), Strongly Agree (5)). The scale is scored by averaging the scores of all completed items (sum of scores divided by 8). A positive number represents an improvement in overall patient self-efficacy (empowerment) from the baseline score and 6 month follow up time point.	6 months
Body Mass Index	Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight.	6 months
Diastolic Blood Pressure	Diastolic blood pressure is the pressure when the heart is at rest between beats.	6 months
Systolic Blood Pressure	Systolic blood pressure is the pressure when the heart beats while pumping blood.	6 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Penn State University
• Investigators: Principal Investigator: Linda Siminerio, RN, PhD, CDE, University of Pittsburgh; Principal Investigator: Robert Gabbay, MD, PhD, Penn State University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 19, 2011
• First Submitted That Met QC Criteria: April 26, 2011
• First Posted (Estimate): April 27, 2011

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; Diabetes Self Management Education (DSME); Self Management Support (SMS)
• Other Study ID Numbers: PRO10090392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No