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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Intensive lifestyle intervention; Behavioral: Diabetes support and education

• Registration Number: NCT03952728
• Lead Sponsor: University of Minnesota

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-12-19
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2796

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ILI/ Treatment group	Intensive lifestyle intervention	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.
Control group	Diabetes support and education	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.

Primary Outcome Measures

Name	Time	Method
Total inpatient (general hospital/acute care) discharges	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.
Total inpatient (general hospital/acute care) days	12-years	This is based on patient-level HEDIS specifications.

Secondary Outcome Measures

Name	Time	Method
Medicare hospital outpatient payments	12-years	Based on Medicare records
Total Medicare spending	12-years	Sums Medicare payments across service use categories
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 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 B physician payments	12-years	Based on Medicare records
Medicare Skilled Nursing Facility payments	12-years	Based on Medicare records