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

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ClinicalTrials.gov Identifier: NCT03952728
Recruitment Status : Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
University of Southern California
Wake Forest University
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.


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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 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicare

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




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 ]
  7. Medicare Part B physician payments [ Time Frame: 12-years ]
  8. Medicare SNF payments [ Time Frame: 12-years ]

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 ]
  10. Medicare DME payments [ Time Frame: 12-years ]
  11. Medicare Imaging + Test payments [ Time Frame: 12-years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952728


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
University of Southern California
Wake Forest University
Investigators
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Principal Investigator: Peter J Huckfeldt, PhD University of Minnesota - Clinical and Translational Science Institute

Publications:
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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03952728     History of Changes
Other Study ID Numbers: LookAHEAD_Medicare
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
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 USC, Wake Forest, and the University of Minnesota.

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

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases