The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Outcomes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ILI/ Treatment group 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
Lifestyle intervention focused on weight loss through diet and physical activity
|
| Control group 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
Behavioral intervention focused on diabetes support and education
|
Outcome Measures
Primary Outcome Measures
- Total inpatient (general hospital/acute care) discharges [12-years]
This is based on patient-level HEDIS specifications.
- Total inpatient (general hospital/acute care) days [12-years]
This is based on patient-level HEDIS specifications.
- Total number of emergency department visits [12-years]
This is based on patient-level HEDIS specifications.
- Medicare Part D Prescription Drug Fill Count [12-years]
Derived measure indicating number of 30-day supply equivalents in each year.
Secondary Outcome Measures
- Total Medicare spending [12-years]
Sums Medicare payments across service use categories
- Medicare inpatient payments [12-years]
Patient-level inpatient payments
- Medicare Part D drug payments [12-years]
Part D plan payments for covered drugs in a given year
- Medicare Part D drug costs [12-years]
Gross drug costs for all Part D drugs for a given year
- Medicare outpatient visits [12-years]
Based on patient-level HEDIS specifications
- Medicare hospital outpatient payments [12-years]
Based on Medicare records
- Medicare Part B physician payments [12-years]
Based on Medicare records
- Medicare Skilled Nursing Facility payments [12-years]
Based on Medicare records
Other Outcome Measures
- Originally eligible for Medicare through Old Age and Survivor's Insurance [12-years]
This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File
- Originally eligible for Medicare through Disability Insurance Benefits [12-years]
This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File
- Originally eligible for Medicare due to End Stage Renal Disease (ESRD) [12-years]
This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File
- Hospital readmissions [12-years]
Based on HEDIS specifications
- Inpatient medicine discharges [12-years]
Based on patient-level HEDIS specifications
- Inpatient surgical discharges [12-years]
Based on patient-level HEDIS specifications
- Inpatient medicine days [12-years]
Based on patient-level HEDIS specifications
- Inpatient surgical days [12-years]
Based on patient-level HEDIS specifications
- Medicare Dialysis Payments [12-years]
Based on Medicare records
- Medicare Durable Medical Equipment payments [12-years]
Based on Medicare records
- Medicare Imaging + Test payments [12-years]
Based on Medicare records
Eligibility Criteria
Criteria
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:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Minnesota
- University of Southern California
- Wake Forest University
Investigators
- Principal Investigator: Peter J Huckfeldt, PhD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
- UP-16-00706