Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine
2026年7月1日 更新者：Jenna Wiens、University of Michigan
The researchers are investigating if using a risk-based prediction score or benefit-based prediction score to allocate transition of care (TOC) interventions is more effective in reducing the rate of unplanned hospital readmissions or death within 30 days of hospital discharge.
調査の概要
詳細な説明
The intervention affects only how the TOC bundle is assigned and does not alter how the telephone calls are delivered. For example, both care navigators and pharmacists receive the same patient information and follow the same call procedures before and after the intervention.
Individuals with predicted benefits greater than the 40% quantile are assigned the phone call bundle while others were not assigned the bundle. During the trial the 40% quantile will be dynamically determined using discharge data from the previous week.
研究の種類
介入
入学 (推定)
5000
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Stephanie Shepard, PhD
- 電話番号：734-647-1098
- メール：sdokeefe@umich.edu
研究場所
-
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- The University of Michigan
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コンタクト：
- Stephanie Shepard, PhD
- 電話番号：734-647-1098
- メール：sdokeefe@umich.edu
-
主任研究者：
- Jenna Wiens, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Patient meets the primary care established rule at Michigan Medicine (MM), AND
- Patient's primary care physician (PCP) Department is one of our General Medicine or Family Medicine or Medical-Pediatrics departments, AND
- Inpatient class is Inpatient or Observation or Obs Greater than 48 hours or Outpatient in a Bed or Extended Recovery or Hospital Care at Home Inpatient or Hospital Care at Home Observation, AND
- Discharged from General Medicine or Family Medicine or Medicine Observation services, AND
- Disposition of home or home with home care
Exclusion Criteria:
- Physician Organization of Michigan Accountable Care Organization (POM ACO)
- Sepsis patients (had a diagnosis of sepsis during admission, active or resolved on the hospital problem list)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Control Arm/Standard of care
The Control Arm, in which patients with a LACE Index score of 9 or greater on the day of hospital discharge will receive TOC interventions.
This is the currently implemented allocation policy at Michigan Medicine.
In this setting, approximately 60% of patients receive the TOC intervention.
Thus, we will use a threshold of the 40th percentile for assigning the TOC telephone call bundle.
Note that to maintain the 60% intervention rate throughout the study, the score threshold (LACE 9 or greater) will be monitored and dynamically adjusted.
The LACE Index has four components: Length of Stay (L), Acuity of the Admission (A), Comorbidities (C), and Emergency Department Visits (E), and estimates the risk of a patient having an unplanned hospital readmission after being discharged from their current encounter.
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The LACE Index has four components: Length of Stay (L), Acuity of the Admission (A), Comorbidities (C), and Emergency Department Visits (E), and estimates the risk of a patient having an unplanned hospital readmission after being discharged from their current encounter.
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実験的：Experimental Arm
The Experimental Arm, in which Causal-Hospital reAdmission Risk Prediction Model (C-HARP) scores will be used to allocate TOC interventions.
C-HARP is a machine learning model that leverages routinely collected and stored patient data in the electronic health record (EHR) to estimate how much a patient will benefit from receiving MM's TOC telephone call bundle.
The assignment threshold will be defined as the 40th percentile of C-HARP scores within the most recent 100 days of the target cohort, so that approximately 60% of patients are assigned the telephone call bundle.
Based on current retrospective data, this threshold corresponds to a C-HARP score of 18.
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The Experimental Arm will allocate TOC interventions based on scores generated by the Causal-Hospital reAdmission Risk Prediction Model (C-HARP), C-HARP is a linear model that leverages routinely collected and stored patient data in the electronic health record (EHR) to estimate how much a patient will benefit from receiving Michigan Medicine's (MM's) TOC telephone call bundle.
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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 |
|---|---|---|
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The number of 30-day all-cause unplanned readmission or death
時間枠：30 calendar days following the index discharge
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An unplanned readmission is defined as any not canceled inpatient, outpatient, or observation hospital admission with an admission type not recorded as "scheduled."
Deaths are determined using the Michigan Death Index and matched to patient records using Social Security numbers.
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30 calendar days following the index discharge
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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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The number of 90-day all-cause unplanned readmission or death
時間枠：90 calendar days following the index discharge
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An unplanned readmission is defined as any not canceled inpatient, outpatient, or observation hospital admission with an admission type not recorded as "scheduled."
Deaths are determined using the Michigan Death Index and matched to patient records using Social Security numbers.
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90 calendar days following the index discharge
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Time to first 90-day all-cause unplanned readmission or death
時間枠：90 calendar days following the index discharge
|
An unplanned readmission is defined as any not canceled inpatient, outpatient, or observation hospital admission with an admission type not recorded as "scheduled."
Deaths are determined using the Michigan Death Index and matched to patient records using Social Security numbers.
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90 calendar days following the index discharge
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TOC telephone call bundle completion (care navigator call)
時間枠：5 calendar days after discharge.
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A care navigator call is considered complete if a completed call record is observed within 5 calendar days after discharge. Calls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission. |
5 calendar days after discharge.
|
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TOC telephone call bundle completion (clinical pharmacist call)
時間枠：14 calendar days after discharge
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A clinical pharmacist call is considered complete if a completed call record is observed within 14 calendar days after discharge. Calls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission. |
14 calendar days after discharge
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TOC telephone call bundle completion (both calls)
時間枠：14 calendar days after discharge
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Completed the care navigator call and completed the clinical pharmacist call. Calls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission. |
14 calendar days after discharge
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Jenna Wiens, PhD、University of Michigan
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年8月1日
研究の完了 (推定)
2027年9月1日
試験登録日
最初に提出
2026年7月1日
QC基準を満たした最初の提出物
2026年7月1日
最初の投稿 (実際)
2026年7月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月8日
QC基準を満たした最後の更新が送信されました
2026年7月1日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。