Clinical trial NCT03952728: The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Outcomes
Official title: The Long-term Effects of an Intensive Lifestyle Intervention for Type 2 Diabetes on Medicare Eligibility, Health Care Use, and Health Care Spending
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Wake Forest University
First posted: 2019-05-16
Enrollment: 2796
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes Look AHEAD participants that consented to administrative data linkages, provided individual identifiers that could be linked with Medicare data, and were successfully linked to Medicare data.

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.

Eligibility 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:

-

Primary outcomes:
measure: Total inpatient (general hospital/acute care) discharges
timeFrame: 12-years
measure: Total inpatient (general hospital/acute care) days
timeFrame: 12-years
measure: Total number of emergency department visits
timeFrame: 12-years
measure: Medicare Part D Prescription Drug Fill Count
timeFrame: 12-years
Secondary outcomes:
measure: Total Medicare spending
timeFrame: 12-years
measure: Medicare inpatient payments
timeFrame: 12-years
measure: Medicare Part D drug payments
timeFrame: 12-years
measure: Medicare Part D drug costs
timeFrame: 12-years
measure: Medicare outpatient visits
timeFrame: 12-years
measure: Medicare hospital outpatient payments
timeFrame: 12-years
measure: Medicare Part B physician payments
timeFrame: 12-years
measure: Medicare Skilled Nursing Facility payments
timeFrame: 12-years
Other outcomes:
measure: Originally eligible for Medicare through Old Age and Survivor's Insurance
timeFrame: 12-years
measure: Originally eligible for Medicare through Disability Insurance Benefits
timeFrame: 12-years
measure: Originally eligible for Medicare due to End Stage Renal Disease (ESRD)
timeFrame: 12-years
measure: Hospital readmissions
timeFrame: 12-years
measure: Inpatient medicine discharges
timeFrame: 12-years
measure: Inpatient surgical discharges
timeFrame: 12-years
measure: Inpatient medicine days
timeFrame: 12-years
measure: Inpatient surgical days
timeFrame: 12-years
measure: Medicare Dialysis Payments
timeFrame: 12-years
measure: Medicare Durable Medical Equipment payments
timeFrame: 12-years
measure: Medicare Imaging + Test payments
timeFrame: 12-years
Locations:
Study officials:
affiliation: University of Minnesota
name: Peter J Huckfeldt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.
citation: Huckfeldt PJ, Frenier C, Pajewski NM, Espeland M, Peters A, Casanova R, Pi-Sunyer X, Cheskin L, Goldman DP. Associations of Intensive Lifestyle Intervention in Type 2 Diabetes With Health Care Use, Spending, and Disability: An Ancillary Study of the Look AHEAD Study. JAMA Netw Open. 2020 Nov 2;3(11):e2025488. doi: 10.1001/jamanetworkopen.2020.25488.