The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Outcomes

Study Overview
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Brief Summary
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This study investigates whether an intensive lifestyle intervention for type 2 diabetes had long-term effects on Medicare enrollment, health care use, and health care spending.

Detailed Description
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The Look AHEAD study tested whether participants with type 2 diabetes assigned to an intensive lifestyle intervention (ILI) for weight loss exhibited reductions in cardiovascular morbidity and mortality, relative to a control group receiving usual care and diabetes support and education. During the 12-year intervention period, the ILI led to persistent reductions in weight, waist circumference, and hemoglobin A1c and improvements in physical fitness. In addition, the ILI led to reductions in hospitalizations, hospital days, and prescription drug spending during the intervention period (through 2012). However, the longer-term effects (2012 and later) on health care use and spending remain unknown. In an ongoing ancillary study, the researchers are investigating the effects of the ILI on economic outcomes, during and after the study. As a part of this study, the study team is linking consenting Look AHEAD participants to Medicare databases. The researchers will investigate the long-term effects of ILI on health care use and health care spending. By 2012 nearly all Look AHEAD participants were eligible for Medicare due to age (over 65). To the extent that Look AHEAD participants developed severe disabilities, the participants may have gained Medicare eligibility earlier through enrollment in Social Security Disability Insurance (SSDI). Thus, the researchers will also test for differences in the Medicare enrollment channel between ILI and control group participants, specifically whether the groups enrolled through SSDI at different rates.

Official Title
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The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Eligibility, Health Care Use, and Health Care Spending

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Intensive lifestyle intervention
* Behavioral: Diabetes support and education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Look AHEAD participation: met age requirements and other criteria at time of study enrollment (as noted in Look AHEAD Research Group (2013)) Consented to administrative data linkages Provided individual identifiers that could be linked with Medicare databases Were successfully linked to Medicare data Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ILI/ Treatment group<br>This group includes Look AHEAD participants who were initially assigned to the intensive lifestyle intervention, consented to administrative data linkages, and were successfully linked to Medicare databases. | Behavioral: Intensive lifestyle intervention<br>* Lifestyle intervention focused on weight loss through diet and physical activity<br>|
| Control group<br>This group includes Look AHEAD participants who were initially assigned to the diabetes support and education control arm, consented to administrative data linkages, and were successfully linked to Medicare databases. | Behavioral: Diabetes support and education<br>* Behavioral intervention focused on diabetes support and education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total inpatient (general hospital/acute care) discharges | This is based on patient-level HEDIS specifications. | 12-years | 
| Total inpatient (general hospital/acute care) days | This is based on patient-level HEDIS specifications. | 12-years | 
| Total number of emergency department visits | This is based on patient-level HEDIS specifications. | 12-years | 
| Medicare Part D Prescription Drug Fill Count | Derived measure indicating number of 30-day supply equivalents in each year. | 12-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Medicare spending | Sums Medicare payments across service use categories | 12-years | 
| Medicare inpatient payments | Patient-level inpatient payments | 12-years | 
| Medicare Part D drug payments | Part D plan payments for covered drugs in a given year | 12-years | 
| Medicare Part D drug costs | Gross drug costs for all Part D drugs for a given year | 12-years | 
| Medicare outpatient visits | Based on patient-level HEDIS specifications | 12-years | 
| Medicare hospital outpatient payments | Based on Medicare records | 12-years | 
| Medicare Part B physician payments | Based on Medicare records | 12-years | 
| Medicare Skilled Nursing Facility payments | Based on Medicare records | 12-years |