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Preoperative Cognitive Screening in Older Spinal Surgical Patients

2021년 6월 30일 업데이트: Deborah Culley, MD, Brigham and Women's Hospital

Preoperative Cognitive Screening in Older Spinal Surgical Patients: Feasibility and Utility for Predicting Morbidity

The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium.

연구 개요

상태

완전한

개입 / 치료

상세 설명

This project is designed as a prospective, single-center observational study. The cohort will consist of 229 consenting subjects ≥ 70 years of age who present to the Brigham and Women's Hospital Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery. These ages are chosen as significant clinical data demonstrate increased cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥ 70 years of age with an American Society of Anesthesiologists (ASA) physical status classification of I-III presenting for elective spine surgery. Exclusion criteria will include planned Intensive Care Unit (ICU) admission postoperatively, history of stroke or brain tumor, uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions); limited use of the dominant hand (limited ability to draw); and or inability to speak, read, or understand English.

Patients will be introduced to the study through a flyer provided to them in their surgeon's office. A study team member will speak with those favorably predisposed to participate to determine if they satisfy eligibility criteria. After obtaining consent, study staff will gain information about the patient's age and years of education. Study staff will administer Health and functional status activities of daily living (ADLs) and instrumental activities of daily living (IADLs), respectively, and the World Health Organization Disability Assessment Scale [WHODAS]) will be administered to all surgical patients. The World Health Organization Disability Assessment Schedule 2.0 is an alternative to the 36-Item Rand Health Survey Short-Form (SF36) to measure physical health and disability. In addition, all patients will be asked if they've had a fall within the last 6 months, whether they've been evaluated for a change in memory or thinking, who accompanied them to their appointment, their employment status and their living situation (alone, institutionalized, living with family members) in a patient survey. The study staff will administer the MiniCog, a simple cognitive screening tool that takes just 2-4 min to complete and has little or no education, language, or race bias. In addition, the Animal Fluency test will be administered, which is a short cognitive screen that takes one minute to complete. Frailty will be measured using the Frail Scale. Other measures of cognitive impairment will be obtained by study staff through: documentation on the patient's standard preoperative form, patient or informant report of diagnosis or evaluation for cognitive impairment or memory concerns, and systematic medical record review. Each enrolled patient will receive a business card listing the investigators' contact information and be advised to expect a follow up telephone up to 6 and 12 months after surgery to verify data elements and reassess functional outcome.

Delirium will be assessed prospectively once per day on postoperative days 1, 2, and 3 if the patient remains hospitalized, by a trained study team member using the Confusion Assessment Method [CAM]. For patients that are in the Intensive Care Unit (ICU) postoperatively, the Confusion Assessment Method for the ICU (CAM-ICU) will be administered prospectively twice per day on postoperative days 1, 2, and 3 if the patient remains hospitalized by a trained study team member (Attachment-CAM-ICU). Delirium is most common on postoperative days 1-3 and the CAM is a well-validated measure of delirium in surgical patients. For functional status, the WHODAS will be administered 6-12 months postoperatively either by personnel in the surgeon's office as part of routine follow up or by study staff or by telephone. We will also collect information on secondary outcomes including discharge to place other than home (rehabilitation, skilled nursing facility), hospital length of stay (LOS), 30-day reoperation or readmission rate, and 30-day mortality. These outcomes are recorded in the medical record, the BWH Balanced Scorecard, an electronic database of all hospitalized patients that tabulates 31 elements of the hospital event, or the Brigham and Women's Hospital BWH Research Patient Database Enhanced Query. Data will also be confirmed by a follow up telephone interview.

연구 유형

관찰

등록 (실제)

229

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • Weiner Center for Preoperative Evaluation

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

70년 이상 (고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

229 consenting subjects ≥ 70 years of age who present to the BWH Weiner Center for Preoperative Evaluation (CPE) prior to elective spine surgery.

설명

Inclusion Criteria:

  • patients 70 years of age and older presenting to the BWH Weiner Center for Preoperative Evaluation
  • undergoing elective spine surgery

Exclusion Criteria:

  • include planned ICU admission postoperatively
  • history of stroke or brain tumor
  • uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions)
  • limited use of the dominant hand (limited ability to draw)
  • inability to speak, read, or understand English.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
older surgical patients
Older surgical patients presenting for elective spine surgery
short cognitive screen, short Frailty screen
다른 이름들:
  • Frailty
  • Animal Fluency

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Delirium by Age
기간: up to 3 days post-op
The median ages of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The Confusion Assessment Method (CAM) is a short diagnostic interview for CAM-defined delirium. Delirium is defined as the sudden change in someone's thinking ability that can have devastating consequences and can be very easily missed due to its frequent subtlety. The 4 CAM features assessed by the CAM include: acute onset or fluctuation, inattention, disorganized thinking, or altered level of consciousness.
up to 3 days post-op
Number of Participants With or Without Delirium by Sex
기간: up to 3 days post-op
Sex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
up to 3 days post-op
Delirium by Body Mass Index
기간: up to 3 days post-op
Median body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
up to 3 days post-op
Number of Participants With or Without Delirium by College Degree
기간: up to 3 days post-op
Counts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
up to 3 days post-op
Participants With an ASA Physical Status Score and the Development of Postoperative Delirium
기간: up to 3 days post-op
The ASA Physical Status Classification System assesses and communicates a patient's pre-anesthesia medical co-morbidities and is on a scale of I-VI. This study recruited patients with an ASA physical status of I-III. ASA I is defined as a normal healthy patient, ASA II is defined as a patient with a mild systemic disease, ASA III is defined as a patient with severe systemic disease. ASA physical status of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
up to 3 days post-op
Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4
기간: up to 3 days post-op
Patients with a metabolic equivalent of task (METS) score < 4 who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The METS score is a ratio of the working metabolic rate relative to the resting metabolic rate and is one way to describe the intensity of an exercise or activity. This was assessed by the preoperative or surgical study staff. A score of < 3 is for light intesity activities, 3-6 for moderate intensity activities, and ≥ 6 for vigorous intensity activities.
up to 3 days post-op
Delirium by Total Number of Medications Taken at Baseline
기간: up to 3 days post-op
Median total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
up to 3 days post-op
Number of Participants With or Without Delirium by Opioid Use
기간: up to 3 days post-op
Patients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
up to 3 days post-op
Number of Participants With or Without Delirium by Alcohol Consumption
기간: up to 3 days post-op
Patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption.
up to 3 days post-op
Number of Participants With or Without Delirium by Presence of Depression
기간: up to 3 days post-op
Patients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.
up to 3 days post-op
Number of Participants With or Without Delirium by Psychiatric History
기간: up to 3 days post-op
Patients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method.
up to 3 days post-op
Delirium by Mini-cog Score
기간: up to 3 days post-op
Median mini-cog score of patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The Mini-Cog is a brief cognitive screening test for visuospatial representation, recall, and executive function. The test involves that includes recalling three words (banana, sunrise, and chair) and a clock drawing. The Mini-Cog has a scale from 0 to 5, a with higher scores suggesting better cognitive performance. One point is designated for each of 3 words recalled and up to two points for the clock drawing component.
up to 3 days post-op
Number of Participants With or Without Delirium by FRAIL Score
기간: up to 3 days post-op
Robust, pre-frail, and frail patients who did or did not develop post-operative delirium as assessed by the confusion assessment method.
up to 3 days post-op
Number of Participants With or Without Delirium by Surgical Invasivness
기간: up to 3 days post-op
Surgical invasiveness for patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The levels of invasiveness were categorized clinically as the following: Tier 1 for microdiscectomy, Tier 2 for lumbar laminectomy, anterior cervical, minimally invasive, foraminotomy, facetectomy, Tier 3 for lumbar fusion, trauma, and post-cervical, and Tier 4 for tumor, infection, deformity, and anterior and posterior cervical. Higher tiers indicate greater levels of invasiveness. Since there were very few patients with an invasiveness of 1 or 4 they were placed into two groups, with invasiveness levels I and 2 or 3 and 4.
up to 3 days post-op

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With In-hospital Complications Were Observed During Their Length of Stay in the Hospital With Death Postoperative Death Monitored up to Day 30.
기간: duration of hospital stay, up to 30 days
In hospital complications after the surgical procedure including: Myocardial Infarction, congestive heart failure (CHF), Cardiac Arrest, Arrythmia, Pneumonia, pulmonary embolism (PE), Reintubation, Stroke, Delirium, Coma>24h, deep wound infection,Superficial wound infection, Sepsis, Renal Failure, urinary tract infection (UTI), Reoperation, deep vein thrombosis (DVT), intensive care unit (ICU) admission,
duration of hospital stay, up to 30 days
Participants' Discharge Location (Home vs. Other Than Home)
기간: up to 30 days after the surgical procedure
Location where patients were discharged (Home vs other than home) on the day of patients discharge from the hospital.
up to 30 days after the surgical procedure

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Deborah Culley, M.D., Brigham and Women's Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 4월 17일

기본 완료 (실제)

2018년 10월 9일

연구 완료 (실제)

2019년 6월 9일

연구 등록 날짜

최초 제출

2016년 3월 14일

QC 기준을 충족하는 최초 제출

2016년 10월 3일

처음 게시됨 (추정)

2016년 10월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 7월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 6월 30일

마지막으로 확인됨

2021년 6월 1일

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Mini Cog에 대한 임상 시험

3
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