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

• ClinicalTrials.gov Identifier: NCT03952728
• Recruitment Status: Active, not recruiting
• First Posted: May 16, 2019
• Last Update Posted: August 31, 2021
• Sponsor: University of Minnesota
• Collaborators: University of Southern California; Wake Forest University
• Information provided by (Responsible Party): University of Minnesota

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

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

• Study Type: Observational
• Actual Enrollment: 3574 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: December 19, 2016
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: June 30, 2022

Groups and Cohorts

Group/Cohort	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 :

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

Secondary Outcome Measures :

1. Total Medicare spending [ Time Frame: 12-years ]
   Sums Medicare payments across service use categories
2. Medicare inpatient payments [ Time Frame: 12-years ]
   Patient-level inpatient payments
3. Medicare Part D drug payments [ Time Frame: 12-years ]
   Part D plan payments for covered drugs in a given year
4. Medicare Part D drug costs [ Time Frame: 12-years ]
   Gross drug costs for all Part D drugs for a given year
5. Medicare outpatient visits [ Time Frame: 12-years ]
   Based on patient-level HEDIS specifications
6. Medicare hospital outpatient payments [ Time Frame: 12-years ]
   Based on Medicare records
7. Medicare Part B physician payments [ Time Frame: 12-years ]
   Based on Medicare records
8. Medicare Skilled Nursing Facility payments [ Time Frame: 12-years ]
   Based on Medicare records

Other Outcome Measures:

1. Originally eligible for Medicare through Old Age and Survivor's Insurance [ Time Frame: 12-years ]
   This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File
2. Originally eligible for Medicare through Disability Insurance Benefits [ Time Frame: 12-years ]
   This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File
3. Originally eligible for Medicare due to End Stage Renal Disease (ESRD) [ Time Frame: 12-years ]
   This is based on "Original Reason for Entitlement" field in Medicare Beneficiary Summary File
4. Hospital readmissions [ Time Frame: 12-years ]
   Based on HEDIS specifications
5. Inpatient medicine discharges [ Time Frame: 12-years ]
   Based on patient-level HEDIS specifications
6. Inpatient surgical discharges [ Time Frame: 12-years ]
   Based on patient-level HEDIS specifications
7. Inpatient medicine days [ Time Frame: 12-years ]
   Based on patient-level HEDIS specifications
8. Inpatient surgical days [ Time Frame: 12-years ]
   Based on patient-level HEDIS specifications
9. Medicare Dialysis Payments [ Time Frame: 12-years ]
   Based on Medicare records
10. Medicare Durable Medical Equipment payments [ Time Frame: 12-years ]
    Based on Medicare records
11. Medicare Imaging + Test payments [ Time Frame: 12-years ]
    Based on Medicare records

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Sponsors and Collaborators

University of Minnesota

University of Southern California

Wake Forest University

Investigators

• Principal Investigator: Peter J Huckfeldt, PhD; University of Minnesota

More Information

Publications of Results:

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.

Other Publications:

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03952728
• Other Study ID Numbers: UP-16-00706
• First Posted: May 16, 2019
• Last Update Posted: August 31, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Use of Medicare data is restricted under a data use agreement between the Centers of Medicare and Medicaid Services and University of Southern California, Wake Forest, and the University of Minnesota.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases