Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

Study Overview
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Brief Summary
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The purpose of this research is to determine if meeting in a group with other subjects with diabetes can reduce barriers to starting insulin.

Detailed Description
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Diabetes is a common, morbid and expensive disease among veterans. Achieving and maintaining adequate glycemic control can reduce the devastating complications of diabetes. Unfortunately a large percentage of veterans with type 2 diabetes continue to have poorly controlled blood sugars. Insulin is the most potent medication for reducing glycemia, but is not used often enough due to barriers that are both patient and provider driven. We propose to conduct a pilot study to evaluate the feasibility of establishing an insulin education group that would serve to educate patients about insulin, to initiate insulin in a group setting, and to provide appropriate follow-up of those who start insulin. If the intervention is successful, we plan to develop a multicenter study to test rigorously the effect of this approach. Specific Aims: To determine if psychological barriers to insulin initiation in patients with uncontrolled type 2 diabetes are favorably affected by a group insulin education and insulin initiation visit, as measured by the Barriers to Insulin Treatment (BIT) Questionaire before and after the intervention. To evaluate the feasibility of the intervention as measured by the percent of patients who are referred to the class, but either cancel without rescheduling or fail to report and the percent of patients who begin insulin. To evaluate the safety of the intervention as measured by the proportion of patients experiencing hypoglycemic symptoms; proportion of patients requiring sugar intake to manage hypoglycemia; and the proportion of patients requiring assistance to manage hypoglycemia.

Official Title
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Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Insulin Education Class


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary care patient at McGuire Veterans Affairs Medical Center in Richmond, Virginia Age > 18 years Inadequately controlled diabetes (HbA1c > 8.0%) and not on insulin (using most recent HbA1c, within 1 month of the first visit) Primary Care Provider referral to insulin initiation/education group Patient brings home glucose readings to first visit Exclusion Criteria: Patient is reluctant to participate in a group visit for any reason Patient unwilling to sign consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Education Class Participants<br>Participation in an insulin educational class at week 0 and again at week 2 | Other: Insulin Education Class<br>* Participation in an Insulin Education Class at week 0 and week 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes | The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. Reported here is the change in BIT score from baseline. This was assessed by paired t-test. | 2 weeks | 
| Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0) | The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10 point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score can be calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 1 is reported here. | Visit 1 (week 0) | 
| Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2) | The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 2 is reported here. | Visit 2 (week 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Who Begin Insulin |  | 2 weeks | 
| Number of Subjects Experiencing Hypoglycemic Symptoms | Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits | 2 weeks | 
| Number of Patients Experiencing a Severe Hypoglycemic Event | Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin, teaching