This study will be a pilot randomized controlled trial that will determine the effect of an indicator of delirium risk, which will be delivered either via a paper form or via the electronic medical record, on (1)postoperative delirium incidence; and (2)the development of long term cognitive decline and dementia.
Patients will be recruited from a large general, minimally invasive, colorectal, and oncologic, university-based surgical practice. English speaking individuals over the age of 65 with planned major abdominal surgery (encompassing abdominal wall, gastrointestinal and hepatobiliary procedures for benign and malignant diseases) will be screened for eligibility following an initial visit with their surgeon. Inclusion criteria will include a required inpatient stay for ≥ 24 hours following surgery and a scheduled preadmission testing and medical risk stratification visit with an internal medicine provider. Patients will be excluded if they have severe mental illness, hearing and visual impairment, alcohol intoxication or related delirium, central nervous disorder (e.g., stroke, traumatic brain injury), and pregnant or nursing status. Once enrolled, subjects will be randomized using a computer-generated scheme (permuted blocks of four and six) to the PDM or usual care, stratified according to type of surgery (hepatobiliary, gastrointestinal, abdominal wall).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
passive digital marker (PDM) for postoperative delirium risk
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Delirium incidence as measured by the 3D-CAM
The number of subjects diagnosed with delirium via the 3D-CAM questionnaire will be measured. The 3D-CAM is a brief verbal assessment tool that can be used to test patients and study participants for delirium via the Confusion Assessment Method (CAM). The 3D-CAM assessment is scored as either delirium present or delirium not present. Participants will be evaluated daily during the acute post-operative phase of the study (Post-Operative Days 0-7).
Time frame: Daily during post-operative inpatient hospitalization through post-operative day 7
Delirium incidence as measured by the CAM ICU
The number of subjects diagnosed with delirium as assessed by the Confusion Assessment Method ICU will be measured. The CAM ICU is a tool used to assess delirium in adult ICU patients. CAM ICU scoring ranges from 0-7 with scores between 0-2 indicating no delirium, between 3-5 indicating mild to moderate delirium, and between 6-7 indicating severe delirium. Participants will be evaluated daily during the acute post-operative phase of the study (Post-Operative Days 0-7).
Time frame: Daily during post-operative inpatient hospitalization through post-operative day 7
Delirium severity as measured by the CAM ICU
Delirium severity will be assessed via the Confusion Assessment Method ICU, a tool used to assess delirium in adult ICU patients. The CAM ICU is a tool used to assess delirium in adult ICU patients. CAM ICU scoring ranges from 0-7 with scores between 0-2 indicating no delirium, between 3-5 indicating mild to moderate delirium, and between 6-7 indicating severe delirium. Participants will be evaluated daily during the acute post-operative phase of the study (Post-Operative Days 0-7).
Time frame: Daily during post-operative inpatient hospitalization through post-operative day 7
Inpatient falls
The number of inpatient falls will be compared between groups. This data will be extracted from the participants' Electronic Medical Record.
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Time frame: During post-operative inpatient hospitalization through post-operative day 7
Restraint Use
Use of restraints will be compared between groups. This data will be extracted from the participants' Electronic Medical Record.
Time frame: During post-operative inpatient hospitalization through post-operative day 7
Sedative Use
Sedative use will be compared between groups. This data will be extracted from the participants' Electronic Medical Record.
Time frame: During post-operative inpatient hospitalization through post-operative day 7
Use of personal safety attendants
Personal safety attendant use will be compared between groups. This data will be extracted from the participants' Electronic Medical Record.
Time frame: During post-operative inpatient hospitalization through post-operative day 7
Provider Satisfaction
Provider satisfaction will be measured determined by a Simplified System Usability Scale (SSUS). The SSUS will be administered to providers within two weeks of the participant's discharge from the hospital, and providers will be asked to respond within 4 weeks of survey receipt. The SSUS yields a single number representing a composite measure of the overall usability of the system. Scores can range from 0 to 100, with higher scores indicating better usability.
Time frame: Within 2-6 weeks following participant discharge