Program Reinforcement Impacts Self Management (PRISM) (PRISM)

• ClinicalTrials.gov Identifier: NCT01343056
• Recruitment Status: Completed
• First Posted: April 27, 2011
• Results First Posted: April 18, 2017
• Last Update Posted: June 2, 2017
• Sponsor: University of Pittsburgh
• Collaborator: Penn State University
• Information provided by (Responsible Party): Linda Siminerio, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus	Behavioral: Office Staff Support; Behavioral: Peer Support; Behavioral: Usual Care Support; Behavioral: Educator Support	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 141 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Program Reinforcement Impacts Self Management
• Study Start Date: April 2011
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: October 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Hemoglobin A1C (HbA1C, %) [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Total Cholesterol (mg/dL) [ Time Frame: 6 months ]
2. High Density Lipoprotein (HDL, mg/dL) [ Time Frame: 6 months ]
3. Low Density Lipoprotein (LDL, mg/dL) [ Time Frame: 6 months ]
4. Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores [ Time Frame: 6 months ]

   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.

5. Body Mass Index [ Time Frame: 6 months ]
   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. Diastolic Blood Pressure [ Time Frame: 6 months ]
   Diastolic blood pressure is the pressure when the heart is at rest between beats.
7. Systolic Blood Pressure [ Time Frame: 6 months ]
   Systolic blood pressure is the pressure when the heart beats while pumping blood.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Pennsylvania

Pennsylvania State University

Hershey, Pennsylvania, United States, 17033

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

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

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.

• Responsible Party: Linda Siminerio, Linda Siminerio, RN, PhD, CDE, Executive Director, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01343056
• Other Study ID Numbers: PRO10090392
• First Posted: April 27, 2011
• Results First Posted: April 18, 2017
• Last Update Posted: June 2, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Linda Siminerio, University of Pittsburgh:

Diabetes Self Management Education (DSME); Diabetes; Self Management Support (SMS)