Comparative Effectiveness of Two Approaches to Diabetes Management in the Uninsured
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 25 - 75 |
| Updated: | 5/5/2014 |
| Start Date: | August 2011 |
| End Date: | July 2014 |
| Contact: | Susan E Hazelett, MS |
| Email: | hazelets@summahealth.org |
| Phone: | 330-375-3051 |
Comparative Effectiveness of Two Community Based Diabetes Management Approaches
The results of the pre-pilot and pilot studies will be used to determine the feasibility of
a fully powered trial that will test the effectiveness of two different approaches to
diabetes management in an uninsured diabetic population who receives their care from a
community based free clinic, namely nurse-directed interdisciplinary care management
compared to peer-led self management. Effective programs for the uninsured diabetic will
benefit both the individual and society by preventing serious illness, decreasing mortality
and disability, decreasing medical debt, stimulating economic growth, improving business
productivity, reducing job lock, decreasing health disparities, improving quality of life,
and reducing cost shifting by decreasing uncompensated care. Findings will be generalizable
to uninsured and insured patients across a wide spectrum of chronic conditions.
a fully powered trial that will test the effectiveness of two different approaches to
diabetes management in an uninsured diabetic population who receives their care from a
community based free clinic, namely nurse-directed interdisciplinary care management
compared to peer-led self management. Effective programs for the uninsured diabetic will
benefit both the individual and society by preventing serious illness, decreasing mortality
and disability, decreasing medical debt, stimulating economic growth, improving business
productivity, reducing job lock, decreasing health disparities, improving quality of life,
and reducing cost shifting by decreasing uncompensated care. Findings will be generalizable
to uninsured and insured patients across a wide spectrum of chronic conditions.
The randomized [pre-pilot] and pilot studies will inform the design of a fully powered trial
that will test the effectiveness of a nurse-led interdisciplinary care management
intervention (CM) for improving [hemoglobin A1c] in uninsured diabetic patients who receive
their primary medical care from a community-based free clinic compared to similar patients
who undergo peer-led self management (SM). The comparative effectiveness of these approaches
has not been tested in a randomized trial.
To ensure the success of the pilot study the investigators will perform a 6 month pre-pilot
study using 10 patients per group. This pre-pilot will be used to establish protocols
covering enrollment, HIPAA, consent, interventions and outcome measurement. The subsequent 1
year pilot will be used to demonstrate feasibility, estimate recruitment, attendance and
follow up, refine inclusion criteria, provide power analysis, optimize the interventions and
determine appropriate secondary outcomes for a fully powered trial. For the pilot, thirty
patients will be randomized to the CM intervention for the first 6 months. Major components
of the nurse-led CM model include: 1) assessment and goal setting for self-management; 2)
education for self efficacy and productive clinical encounters; 3) access to specialist care
via an interdisciplinary team; 4) evidence-based treatment recommendations responsive to
patients' goals; and 5) care coordination by a nurse care manager. From 6-12 months patients
will return to usual clinic care.
The 30 patients randomized to the SM group will be invited to attend weekly peer-led SM
training broadly based on the Stanford University Diabetes Self-management Program's Train
the Trainer Model. The training will occur over 6 weeks and will cover topics common to
most chronic disease SM programs including: goal setting, self-management of chronic
conditions, making action plans, feedback and problem solving, handling emotions, symptom
management techniques, communication with health care providers, medications and making
treatment decisions. The peer advisors and a nurse will then lead 1 hour monthly group
sessions for the remainder of the first 6 months for review/revision of action plans, review
of self management techniques and ongoing social persuasion and modeling. From 6-12 months
patients will return to usual clinic care.
For the pilot, outcome measures will be obtained at 6 and 12 months. For this pilot, the
investigators will not test any hypotheses. Instead, effect sizes and confidence intervals
will be calculated for each outcome. These results will be used for power analysis. The
results will also allow us to see which interventions are most effective on which outcomes
and allow us to optimize the interventions to have the greatest impact on the primary
outcome, hemoglobin A1c. Cost effectiveness will be determined in a fully powered trial.
that will test the effectiveness of a nurse-led interdisciplinary care management
intervention (CM) for improving [hemoglobin A1c] in uninsured diabetic patients who receive
their primary medical care from a community-based free clinic compared to similar patients
who undergo peer-led self management (SM). The comparative effectiveness of these approaches
has not been tested in a randomized trial.
To ensure the success of the pilot study the investigators will perform a 6 month pre-pilot
study using 10 patients per group. This pre-pilot will be used to establish protocols
covering enrollment, HIPAA, consent, interventions and outcome measurement. The subsequent 1
year pilot will be used to demonstrate feasibility, estimate recruitment, attendance and
follow up, refine inclusion criteria, provide power analysis, optimize the interventions and
determine appropriate secondary outcomes for a fully powered trial. For the pilot, thirty
patients will be randomized to the CM intervention for the first 6 months. Major components
of the nurse-led CM model include: 1) assessment and goal setting for self-management; 2)
education for self efficacy and productive clinical encounters; 3) access to specialist care
via an interdisciplinary team; 4) evidence-based treatment recommendations responsive to
patients' goals; and 5) care coordination by a nurse care manager. From 6-12 months patients
will return to usual clinic care.
The 30 patients randomized to the SM group will be invited to attend weekly peer-led SM
training broadly based on the Stanford University Diabetes Self-management Program's Train
the Trainer Model. The training will occur over 6 weeks and will cover topics common to
most chronic disease SM programs including: goal setting, self-management of chronic
conditions, making action plans, feedback and problem solving, handling emotions, symptom
management techniques, communication with health care providers, medications and making
treatment decisions. The peer advisors and a nurse will then lead 1 hour monthly group
sessions for the remainder of the first 6 months for review/revision of action plans, review
of self management techniques and ongoing social persuasion and modeling. From 6-12 months
patients will return to usual clinic care.
For the pilot, outcome measures will be obtained at 6 and 12 months. For this pilot, the
investigators will not test any hypotheses. Instead, effect sizes and confidence intervals
will be calculated for each outcome. These results will be used for power analysis. The
results will also allow us to see which interventions are most effective on which outcomes
and allow us to optimize the interventions to have the greatest impact on the primary
outcome, hemoglobin A1c. Cost effectiveness will be determined in a fully powered trial.
Inclusion Criteria:
- patients will be eligible if they are between the ages of 25 and 75,
- have a diagnosis of diabetes (type II) with a hemoglobin A1c >[7.0] There will be no
exclusions based on gender, race or ethnicity.
Exclusion Criteria:
- have no other illness that would dominate their care (e.g., terminal cancer, numerous
exacerbations of CHF), and
- are not pregnant.
- patients must have no cognitive impairment.
We found this trial at
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