Estimating the Impact of Obesity Medications on Clinical and Economic Outcomes
The goal of this observational study is to identify the impact of incretin-based obesity medications (e.g., GLP-1 and GLP-1/GIP) on health and economic outcomes among adults who get their health insurance through their employers. The main questions it aims to answer are:
- Is obesity medication usage is associated with reduced body mass index (BMI) and weight?
- Is obesity medication usage is associated with reduced utilization of emergency department and inpatient care or obesity-related conditions over time?
- Is obesity medication usage is associated with increased utilization of outpatient care over time?
- Is obesity medication usage is associated with slower growth in direct medical costs over time?
- Is obesity medication usage is associated with improvements in health measures?
- Is obesity medication usage associated with reduced workplace costs?
Researchers will compare individuals who have prescriptions for obesity medications to those without to see if differences in health and costs of care exist.
The study uses existing medical and pharmacy claims data.
調査の概要
詳細な説明
Incretin-based therapies that work by mimicking the action of the natural hormone GLP-1 and GLP-1/GIP have garnered the most excitement and demonstrated promising results in the management of obesity. This project seeks to estimate the impact of incretin-based obesity medications on clinical and economic outcomes in real-world settings. It proposes to fill gaps in the current literature by focusing on patients from self-insured organizations, measuring direct and indirect costs, establishing a long-term cohort, and by merging claims with electronic health record (EHR) data for more comprehensive measures.
The impact of incretin-based obesity medications on clinical and economic outcomes will be assessed in a dynamic cohort design. The cohort will be drawn from the employees and their working age dependents of large, self-insured (or "self-funded") organizations in the state of Indiana (i.e., "employers"). Employer organizations agreeing to participate will provide medical and pharmacy claims as well as data on workplace performance (if available) from 2018-2029. The primary exposure of interest is documented receipt of any GLP-1 obesity medication (regardless of manufacturer or brand name). A series of fixed-effects regression models will estimate the association between exposure to incretin-based obesity medications and clinical, utilization, and cost outcomes. This dynamic cohort approach, 1) individuals and participating employer organizations may enter and exit the cohort over time and 2) individuals may switch between on or off exposure over time.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Indiana
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Indianapolis、Indiana、アメリカ、46203
- Indiana University
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
The study cohort is limited to employees and adult dependents aged 18-64 who receive their health insurance coverage from self-insured Indiana employers that agree to participate in the study.
To be included in the study, the individuals must:
- Be an Indiana resident;
- Have health insurance benefits provided by participating employers (includes employees and dependents);
- Be between the ages of 18 and 64;
Meet the eligibility criteria for an obesity medication prescription:
- BMI of ≥ 30 (obesity) or
- BMI of ≥ 25 (overweight) and at least one body weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease). If the prescribing eligibility criteria are updated in the future, we will update accordingly.
- Individuals must have at least 6 months of enrollment prior to study inclusion (i.e., prior to the index date), though we may use additional pre-treatment data if available.
An individual who meets any of the following criteria will be excluded from participation in the cohort:
- Has a condition associated with weight loss: a diagnosis of cancer (except for non-melanoma skin cancer), pancreatitis, eating disorders (e.g., anorexia nervosa and avoidant restrictive food intake disorder), HIV, unintentional weight loss, or cirrhosis at baseline;
- Has a condition for which obesity medications are contraindicated (for example, medullary thyroid carcinoma, multiple endocrine neoplasia, etc.).
- Receipt of diabetes-indicated incretin-based medications. If an individual has a claim for a related incretin-based therapy diabetes medication (e.g., Mounjaro, Ozempic, Rybelsus, Victoza) without an obesity-medication claim during the study period, the individual will be excluded from analysis.
- Prior bariatric surgery.
- Evidence of prior use of incretin-based obesity medications for weight loss.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Persistent use of incretin-based obesity medication
Persistent use is defined as continuous treatment with no gaps greater than 60 days between prescription fills.
Discontinuation is defined as a gap exceeding 60 days following the expected end date of a prescription fill (based on days' supply).
Exposure will be measured longitudinally from the index date until discontinuation or censoring.
Days of supply will be calculated from pharmacy claims, and we will account for stockpiling by allowing early refills to extend coverage forward in time.
If days' supply is missing, it will be imputed using prescribing guidelines or external data sources.
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Documented receipt of any GLP-1 and GLP-1/GIP obesity medication during an observation period.
他の名前：
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No documented receipt of incretin-based obesity medication during observation period
Working-age adults (age 18 to 64) insured by participating Indiana-based employers that do not use any incretin-based obesity medication for weight loss.
Identified by no claim for obesity medications (accounting for days supply and available refills).
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in subject body weight.
時間枠：6 months periods from 2018 to 2029
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Measured in pounds.
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6 months periods from 2018 to 2029
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Change in subject body mass index (BMI).
時間枠：6 months periods from 2018 to 2029
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Defined as Weight (kg) / height (m)2.
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6 months periods from 2018 to 2029
|
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Change in obesity and overweight classification.
時間枠：6 months periods from 2018 to 2029
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Body mass index categorized according to Centers for Disease Control & Prevention groupings (i.e., normal, overweight, class 1 obesity, class 2 obesity, class 3 obesity)
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6 months periods from 2018 to 2029
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in emergency department visits.
時間枠：6 months periods from 2018 to 2029
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Total visits
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6 months periods from 2018 to 2029
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Change in obesity-related emergency department visits.
時間枠：6 months periods from 2018 to 2029
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Visit with obesity-related diagnosis code (E66.1-E66.3,
Z68.30-768.45),
metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease & steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).
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6 months periods from 2018 to 2029
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Change in non-obesity related emergency department visits.
時間枠：6 months periods from 2018 to 2029
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Visit without any of the following: obesity-related diagnosis code (E66.1-E66.3,
Z68.30-768.45),
metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease & steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).
|
6 months periods from 2018 to 2029
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Change in preventable emergency department visits.
時間枠：6 months periods from 2018 to 2029
|
Preventable visits include those that are:
|
6 months periods from 2018 to 2029
|
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Change in non-preventable emergency department visits.
時間枠：6 months periods from 2018 to 2029
|
Non-preventable visits are defined as emergency department care was required and ambulatory care treatment could not have prevented the condition.
|
6 months periods from 2018 to 2029
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Change in inpatient admissions.
時間枠：6 months periods from 2018 to 2029
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Total number of distinct hospitalizations (i.e.
admissions).
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6 months periods from 2018 to 2029
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Change in obesity-related inpatient admissions.
時間枠：6 months periods from 2018 to 2029
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Total hospitalizations with obesity-related diagnosis code (E66.1-E66.3,
Z68.30-768.45),
metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease & steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).
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6 months periods from 2018 to 2029
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Change in non-obesity-related inpatient admissions.
時間枠：6 months periods from 2018 to 2029
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Total hospitalizations without obesity-related diagnosis code (E66.1-E66.3,
Z68.30-768.45),
metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease & steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD).
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6 months periods from 2018 to 2029
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Change in inpatient admissions that began in the emergency department.
時間枠：6 months periods from 2018 to 2029
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Total hospitalizations where the subject was admitted from the emergency department.
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6 months periods from 2018 to 2029
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Change in direct admit inpatient admissions
時間枠：6 months periods from 2018 to 2029
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Total hospitalizations that were admitted directly from the community, i.e. not transferred from the emergency department.
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6 months periods from 2018 to 2029
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Change in 30 day inpatient readmissions.
時間枠：6 months periods from 2018 to 2029
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Count of hospital admissions (to any facility) occurring within 30 days of a hospital stay.
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6 months periods from 2018 to 2029
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Change in outpatient visits.
時間枠：6 months periods from 2018 to 2029
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Any in-person office visits with primary care, family medicine, internal medicine, or any specialty (including behavioral health); excludes phone visits.
Total visits, as well as separated by obesity-related vs non-obesity related.
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6 months periods from 2018 to 2029
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Change in obesity-related outpatient visits.
時間枠：6 months periods from 2018 to 2029
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Total in-person office visits with primary care, family medicine, internal medicine, or any specialty (including behavioral health) with any of the following: obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease & steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD). Excludes: phone visits. |
6 months periods from 2018 to 2029
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Change in non-obesity-related outpatient visits
時間枠：6 months periods from 2018 to 2029
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Total in-person office visits with primary care, family medicine, internal medicine, or any specialty (including behavioral health) without any of the following: obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease & steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD). Excludes: phone visits. |
6 months periods from 2018 to 2029
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Change in total medical spending.
時間枠：6 months periods from 2018 to 2029
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All medical costs paid (inpatient, outpatient, emergency department, and rehabilitation costs).
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6 months periods from 2018 to 2029
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Change in total pharmacy spending.
時間枠：6 months periods from 2018 to 2029
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All pharmacy costs paid.
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6 months periods from 2018 to 2029
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Change in total pharmacy spending excluding incretin-based medications.
時間枠：6 months periods from 2018 to 2029
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All pharmacy costs excluding the cost of incretin obesity medications
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6 months periods from 2018 to 2029
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Change in total spending on obesity-related complications
時間枠：6 months periods from 2018 to 2029
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All medical costs paid where the claim is associated with any of the following: obesity-related diagnosis code (E66.1-E66.3, Z68.30-768.45), metabolic syndrome, type 2 diabetes, chronic kidney disease, cardiovascular disease, osteoarthritis of the knee, depression, anxiety, metabolic dysfunction-associated steatohepatitis, nonalcoholic fatty liver disease & steatohepatitis, obstructive sleep apnea, hyperlipidemia, hypertension, cerebrovascular disease, asthma, gastroesophageal reflux disease (GERD), or chronic obstructive pulmonary disease (COPD). Excludes: telehealth / phone visits. |
6 months periods from 2018 to 2029
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in absenteeism.
時間枠：6 months periods from 2018 to 2029
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Total number of sick leave days (costs estimated from published estimates or salary information if available).
|
6 months periods from 2018 to 2029
|
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Change in retention / turnover.
時間枠：6 months periods from 2018 to 2029
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Percent of employees that end employment for any reason.
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6 months periods from 2018 to 2029
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Change in disability claims.
時間枠：6 months periods from 2018 to 2029
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Total worker's compensation claims regardless of disability period.
|
6 months periods from 2018 to 2029
|
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Change in clinical A1C laboratory values.
時間枠：6 months periods from 2018 to 2029
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hemoglobin A1C or HbA1c values
|
6 months periods from 2018 to 2029
|
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Change in blood pressure laboratory values.
時間枠：6 months periods from 2018 to 2029
|
Systolic and diastolic
|
6 months periods from 2018 to 2029
|
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Change in cholesterol laboratory values.
時間枠：6 months periods from 2018 to 2029
|
cholesterol blood test (a lipid panel or lipid profile
|
6 months periods from 2018 to 2029
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Joshua R Vest, PhD, MPH、Indiana University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 00855196
- 26469 (その他の識別子：Indiana University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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