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Cognitive Training for the Prevention of Postoperative Delirium

2021年3月23日 更新者:Phillip Vlisides、University of Michigan

Cognitive Training for the Prevention of Postoperative Delirium: a Pilot Study

Postoperative delirium is a significant public health concern, affecting up to 70% of elderly patients presenting for surgery. Furthermore, postoperative delirium is associated with increased mortality, persistent cognitive decline, increased hospital length of stay, and elevated healthcare costs. Unfortunately, there is a lack of evidence-based strategies that consistently and effectively reduce the risk of delirium. In fact, although the American Geriatrics Society has released guidelines for the prevention of postoperative delirium, the evidence supporting many of the proposed preventive measures has been deemed low quality.

Cognitive training exercises have been shown to improve cognitive function and functional status in community-dwelling elderly adults, and benefits may last for several months to years. Specifically, training exercises have led to improved performance in attention, short-term memory, and visuospatial processing; all of which are implicated as clinical features of delirium. Cognitive training has also strengthened connectivity in brain networks implicated in postoperative delirium. Thus, given these specific neurological benefits afforded, preoperative cognitive training may provide protection against the development of postoperative delirium. As such, the aim of this pilot study is to assess the feasibility of implementing a preoperative cognitive training program for surgical patients at high-risk for delirium and other associated complications.

調査の概要

詳細な説明

This will be a single-center study conducted at the University of Michigan Health System. Participants will be prospectively enrolled and randomized to the interventional group (cognitive training) or control group (no training). Recruitment will take place at the University of Michigan Domino's Farms preoperative clinic at least seven days prior to scheduled, elective surgery. The recruitment goal will be 30 patients per group (total N=60) in this feasibility study. A computer-generated, stratified randomization schedule will be utilized.

This study will use an adaptive cognitive training battery that specifically targets attention, working memory, and visuospatial processing (BrainHQ, Posit Science Corporation, San Francisco, CA). These tests have been successfully used across diverse patient populations, demonstrating improvements in cognition and functional outcomes to varying degrees. The level of difficulty of each test is automatically adjusted depending on the participant's performance, with test difficulty increasing as user performance improves. Participants will access the training software platform via home internet connection, and our study team will be able to monitor training progress.

Delirium assessments will be performed using the Confusion Assessment Method, 3-minute diagnostic assessment (3D-CAM) or CAM-ICU as appropriate, and they will take place at baseline, in the postanesthesia recovery unit (PACU), and twice daily from postoperative day (POD) 1-3. The assessor performing the CAM interviews will be blinded to the intervention. Our team has completed formal training in CAM methodology through the NIH-funded (K07AG041835) Center of Excellence for Delirium in Aging: Research, Training, and Educational Enhancement (CEDARTREE) at Beth Israel Deaconess Hospital, Boston, MA.

Cognitive function will be briefly assessed throughout the study period using three tests from the NIH Toolbox Cognition Battery - Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, and the Pattern Comparison Processing Speed Test. Collectively, these tests assess executive function, attention, working memory, and processing speed, which are cognitive domains affected by delirium as described above. These tests have been validated in adults up to the age of 85, and they will be administered, via calibrated iPad, to participants at baseline, the morning of surgery, and at the conclusion of the POD3 visit. The purpose of this testing will be to assess for sustained, transferred, cognitive gains afforded by training in the intervention group.

Delirium is a grave public health concern, particularly for surgical patients. Cognitive training has shown promise with improving clinical and neurophysiological traits associated with delirium, though this potential efficacy has not been tested in a preventive manner in vulnerable surgical patients. Cognitive prehabilitation, via targeted cognitive training exercises, may serve as feasible strategy for reducing the risk of delirium its and associated morbidity and mortality.

研究の種類

介入

入学 (実際)

61

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。

研究場所

    • Michigan
      • Ann Arbor、Michigan、アメリカ、48109
        • University of Michigan Medical School

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

60年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Patients 60 years of age and older
  • Major noncardiac, non-major vascular, non-intracranial surgery
  • Daily access to computer and internet use prior to surgery

Exclusion Criteria:

  • Pre-existing cognitive impairment (preoperative delirium and/or not having capacity to provide informed consent)
  • Severe auditory or visual impairment
  • Emergency surgery
  • No daily computer and internet access
  • Already participating in cognitive training exercises

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:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Cognitive Training
Patients will engage in a daily preoperative cognitive training battery (BrainHQ, Posit Science) that aims to improve attention, memory, and visuospatial processing.
Patients will engage in a daily preoperative cognitive training battery (BrainHQ, Posit Science) that aims to improve attention, memory, and visuospatial processing.
介入なし:No Training
Patients will not undergo preoperative cognitive training. Patients will receive standard preoperative care.

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
Percentage of Delirious Patients per Group
時間枠:By afternoon of postoperative day (POD) 3
Each participant who has experienced at least one episode of delirium by the postoperative day 3 time point, as determined by daily Confusion Assessment Method (CAM) screening, will then be calculated in each group to provide delirium incidence (%).
By afternoon of postoperative day (POD) 3

二次結果の測定

結果測定
メジャーの説明
時間枠
Cognitive Function - Attention, Focus
時間枠:Baseline, immediate preoperative setting, and POD 3
The Flanker Inhibitory Control and Attention Test from the NIH Toolbox Cognition Battery will be used to assess attention and focus in each study group. Uncorrected standard score (n, 0-10, 0 = no correct answers, 10 = all items answered correctly and with median reaction time 500 milliseconds or faster on each trial) will be reported within individuals to assess for cognitive function change throughout the study period.
Baseline, immediate preoperative setting, and POD 3
Cognitive Function - Memory
時間枠:Baseline, immediate preoperative setting, and POD 3
The List Sorting Working Memory Test from the NIH Toolbox Cognition Battery will be used to assess working memory in each study group. Uncorrected standard score (n, 0-26, 0=no items correctly recalled and sequenced, 26=all items correctly recalled and sequenced) will be reported within individuals to assess for cognitive function change throughout the study period.
Baseline, immediate preoperative setting, and POD 3
Cognitive Function - Brain Processing Speed
時間枠:Baseline, immediate preoperative setting, and POD 3
The Pattern Comparison Processing Speed Test from NIH Toolbox Cognition Battery will be used to assess brain processing speed in each group. Uncorrected standard score (n, 0-130, 0=no items answered correctly , 130=all items answered correctly) will be reported within individuals to assess for cognitive function change throughout the study period. Age-adjusted and fully adjusted scaled scores (n) will also be reported
Baseline, immediate preoperative setting, and POD 3
Hospital Length of Stay
時間枠:Length of hospital stay (n = number of days through study completion, up to 30 days) will be assessed in each group
Length of hospital stay (n = number of days through study completion, up to 30 days) will be assessed in each group
Length of ICU Stay
時間枠:Length of ICU stay (n = number of days through study completion, up to 30 days) will be assessed in each group
Length of ICU stay (n = number of days through study completion, up to 30 days) will be assessed in each group
Physical Therapy (PT) Sessions
時間枠:Within the first 7 days after surgery
Percentage (%) of prescribed PT sessions participants are able to successfully complete during the first week after surgery
Within the first 7 days after surgery

その他の成果指標

結果測定
メジャーの説明
時間枠
Pain Severity (1)
時間枠:PACU through POD3
Visual Analogue Scale (mm, 0-100, 0 = no pain, 100 = worst pain imaginable)
PACU through POD3
Pain Severity (2)
時間枠:PACU through POD3
Behavioral Pain Scale (n, 3-12, 3 = no pain, 12 = maximum pain)
PACU through POD3
Postoperative Opioid Administration
時間枠:PACU through POD3
Opioid consumption, converted to morphine equivalents (mg) per day
PACU through POD3

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

  • 主任研究者:Phillip E Vlisides, MD、Department of Anesthesiology - University of Michigan Medical School

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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 (実際)

2017年4月6日

一次修了 (実際)

2018年5月18日

研究の完了 (実際)

2018年5月18日

試験登録日

最初に提出

2016年11月1日

QC基準を満たした最初の提出物

2016年11月10日

最初の投稿 (見積もり)

2016年11月15日

学習記録の更新

投稿された最後の更新 (実際)

2021年3月24日

QC基準を満たした最後の更新が送信されました

2021年3月23日

最終確認日

2021年3月1日

詳しくは

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