Hybrid III Trial of Automated Referral to Comprehensive Geriatric Assessment for Frail Older Surgical Patients
Leveraging the Learning Health System to Enhance Age-Friendly Surgical Care: A Hybrid Type III Randomized Trial to Optimize Preoperative Readiness
The goal of this observational study is to learn about automated referrals to Perioperative Optimization of Senior Health (POSH). The main question it aims to answer is:
- Do automated referrals to POSH increase the number of people who attend the clinic?
調査の概要
詳細な説明
Preoperative comprehensive geriatric assessment (pCGA) is an existing clinical intervention (herein referred to by the clinic that delivers the intervention, as Perioperative Optimization for Senior Health, POSH) to address frailty among older adults before elective surgery; however, this highly effective intervention is resource-intensive and variably delivered to a limited number of eligible patients. The researchers will conduct a 12-month trial embedded in the electronic health record that will test the effect of automated referrals to the POSH clinic on implementation outcomes (reach and adoption) of POSH and secondarily on the delivery of age-friendly process measures for surgical care (effectiveness). The primary hypothesis is that randomizing frail older adults (age 80 years and older) who are planning major surgery to an automated referral will increase the reach of POSH, and the adoption among surgeons while simultaneously improving processes associated with age-friendly care (decreasing potentially inappropriate medication use as measured by anticholinergic burden (ACB) score, increasing documentation of baseline cognitive status, increasing use of physical therapy (PT) referrals, and improving the percentage of patients with advanced care planning paperwork on file before surgery).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Randi Cartmill
- 電話番号：608-263-9316
- メール：cartmill@wisc.edu
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53792
- University of Wisconsin
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 80 or older
- Scheduled for an elective surgery with a planned overnight stay
- Scores indicate frailty
Exclusion Criteria:
- Scheduled for transplant or cardiothoracic surgery
- Undergoing emergency or urgent surgery
- POSH clinic evaluation within the past 6 months
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
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Automated referrals
Participants will receive an automated referral to POSH when screened by the electronic frailty index (a clinical decision support device built into the EHR) |
Participants who screen for frailty (using the frailty score calculator device embedded in the EHR) will receive an automated referral to POSH clinic through their electronic health record. |
|
アクティブコンパレータ：Usual care
Participants will receive usual care in which surgeons can choose to directly refer patients to POSH. |
Surgeons will be notified of frailty score (as calculated using the frailty score calculator device embedded in the EHR). Surgeons can choose to refer patients directly to POSH. |
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 |
|---|---|---|
|
Number of participants who attend POSH
時間枠：90 days
|
The number of eligible participants who attend POSH will be compared across arms. |
90 days
|
|
Number of surgeons who refer to POSH
時間枠：90 days
|
The number of surgeons who refer patients to POSH will be compared to those in the same clinical departments for both arms. |
90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anticholinergic Burden Score
時間枠：90 days
|
Anticholinergic Burden (ACB) score measures the degree to which the patient's prescribed medications block the neurotransmitter acetylcholine. Median scores will be compared for the intervention and control groups. Higher scores in older adults correlate with increased risks of confusion, functional impairment, falls, and mortality. |
90 days
|
|
Documentation of preoperative cognitive status
時間枠：90 days
|
Number of eligible participants will be compared with number who have documented cognitive status according to a validated cognitive screening instrument. |
90 days
|
|
Physical therapy (PT) referrals
時間枠：90 days
|
The number of eligible participants compared to participants who receive a PT referral. |
90 days
|
|
Advanced care planning (ACP) on file
時間枠：90 days
|
Number of participants with ACP on file before surgery will be compared to number of eligible participants. |
90 days
|
協力者と研究者
捜査官
- 主任研究者：Julia Berian、University of Wisconsin, Madison
研究記録日
主要日程の研究
研究開始 (推定)
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
その他の研究ID番号
- 2026-0832
- UWMSN | SMPH | Surgery - Colon (その他の識別子：UW Madison)
- Protocol Version 5/29/26 (その他の識別子：UW Madison)
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
The researchers will share a deidentified participant-level dataset containing the information collected in this study and outcome measures, except for protected health information (PHI).
IPD 共有時間枠
Scientific data will be available once the primary results are published. Data will be available indefinitely.
IPD 共有アクセス基準
Data are available on request from the principal investigator with a DUA. Supporting materials will be available on a public website that will be created for this purpose.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
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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