Program Reinforcement Impacts Self Management (PRISM)

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Office Staff Support; Behavioral: Peer Support; Behavioral: Educator Support; Behavioral: Usual Care Support

• Registration Number: NCT01343056
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Primary Completion: 2012-12
• Study Completion: 2013-10
• Results First Submitted: 2015-12-07
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-06
• Results First Posted: 2017-04-18
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• A person with diabetes referred for diabetes education

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Exclusion Criteria

• Gestational diabetes and pregnancy
• If a person has recently had diabetes education, they will not be enrolled in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Office Staff follow up education	Office Staff Support	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.
Peer follow up education	Peer Support	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.
Educator support follow up	Educator Support	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.
Usual Care	Usual Care Support	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.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C (HbA1C, %)	6 months

Secondary Outcome Measures

Name	Time	Method
Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores	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.
Diastolic Blood Pressure	6 months	Diastolic blood pressure is the pressure when the heart is at rest between beats.
High Density Lipoprotein (HDL, mg/dL)	6 months
Body Mass Index	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.
Systolic Blood Pressure	6 months	Systolic blood pressure is the pressure when the heart beats while pumping blood.
Low Density Lipoprotein (LDL, mg/dL)	6 months
Total Cholesterol (mg/dL)	6 months

Trial Locations

Locations (2)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Pennsylvania State University; 🇺🇸 Hershey, Pennsylvania, United States