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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03952728
• Other study ID #: UP-16-00706
• Status: Completed
• Start date: December 19, 2016
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2796
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Intensive lifestyle intervention
Lifestyle intervention focused on weight loss through diet and physical activity
• Diabetes support and education
Behavioral intervention focused on diabetes support and education

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	University of Southern California, Wake Forest University

References & Publications (2)

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 — View 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. Erratum in: N Engl J Med. 2014 May 8;370(19):1866. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Originally eligible for Medicare through Old Age and Survivor's Insurance	This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File	12-years
Other	Originally eligible for Medicare through Disability Insurance Benefits	This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File	12-years
Other	Originally eligible for Medicare due to End Stage Renal Disease (ESRD)	This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File	12-years
Other	Hospital readmissions	Based on HEDIS specifications	12-years
Other	Inpatient medicine discharges	Based on patient-level HEDIS specifications	12-years
Other	Inpatient surgical discharges	Based on patient-level HEDIS specifications	12-years
Other	Inpatient medicine days	Based on patient-level HEDIS specifications	12-years
Other	Inpatient surgical days	Based on patient-level HEDIS specifications	12-years
Other	Medicare Dialysis Payments	Based on Medicare records	12-years
Other	Medicare Durable Medical Equipment payments	Based on Medicare records	12-years
Other	Medicare Imaging + Test payments	Based on Medicare records	12-years
Primary	Total inpatient (general hospital/acute care) discharges	This is based on patient-level HEDIS specifications.	12-years
Primary	Total inpatient (general hospital/acute care) days	This is based on patient-level HEDIS specifications.	12-years
Primary	Total number of emergency department visits	This is based on patient-level HEDIS specifications.	12-years
Primary	Medicare Part D Prescription Drug Fill Count	Derived measure indicating number of 30-day supply equivalents in each year.	12-years
Secondary	Total Medicare spending	Sums Medicare payments across service use categories	12-years
Secondary	Medicare inpatient payments	Patient-level inpatient payments	12-years
Secondary	Medicare Part D drug payments	Part D plan payments for covered drugs in a given year	12-years
Secondary	Medicare Part D drug costs	Gross drug costs for all Part D drugs for a given year	12-years
Secondary	Medicare outpatient visits	Based on patient-level HEDIS specifications	12-years
Secondary	Medicare hospital outpatient payments	Based on Medicare records	12-years
Secondary	Medicare Part B physician payments	Based on Medicare records	12-years
Secondary	Medicare Skilled Nursing Facility payments	Based on Medicare records	12-years