Delirium in Old AgeNCT06216483
Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium
A study testing PDM Alert in people with Delirium in Old Age, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- PDM Alert
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 21 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old Planned inpatient major surgery requiring inpatient stay ≥ 1 day
Who cannot join
- Baseline cognitive impairment or a diagnosis of Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
- Alcohol or drug withdrawal
- Prisoner status
- Unable to communicate with research staff due to sensory impairments
- Not fluent in English
- Currently has a personal safety attendant
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
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).
- Conditions
- Delirium in Old Age
- Being tested
- PDM Alert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDM AlertOther
passive digital marker (PDM) for postoperative delirium risk
| Study group | Role | What they receive |
|---|---|---|
| No PDM Alert | Placebo comparator | No PDM alert will be placed on subject's record Receives: Other: PDM Alert |
| PDM Alert | Experimental | PDM alert will be placed on subject's record Receives: Other: PDM Alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Daily during post-operative inpatient hospitalization through post-operative day 7
Secondary outcomes (5)
Inpatient falls
The number of inpatient falls will be compared between groups. This data will be extracted from the participants' Electronic Medical Record.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 2-6 weeks following participant discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start23 Jul 2024
- Primary completion20 Mar 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sanjay Mohanty, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216483
- Sponsor's protocol ID
- 15767
- Other IDs
- K23AG071945
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium
- ClinicalTrials.gov ID
- NCT06216483
- Acronym / sponsor ID
- 15767
- Conditions
- Delirium in Old Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No PDM Alert | Placebo comparator | Other: PDM AlertNo PDM alert will be placed on subject's record |
| PDM Alert | Experimental | Other: PDM AlertPDM alert will be placed on subject's record |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years old Planned inpatient major surgery requiring inpatient stay ≥ 1 day
Key exclusion criteria (6 listed)
- Baseline cognitive impairment or a diagnosis of Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
- Alcohol or drug withdrawal
- Prisoner status
- Unable to communicate with research staff due to sensory impairments
- Not fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDM Alertpassive digital marker (PDM) for postoperative delirium risk | Other | No PDM Alert, PDM Alert |
Primary outcome
Delirium incidence as measured by the 3D-CAM
Time frame: Daily during post-operative inpatient hospitalization through post-operative day 7
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).
Delirium incidence as measured by the CAM ICU
Time frame: Daily during post-operative inpatient hospitalization through post-operative day 7
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).
Delirium severity as measured by the CAM ICU
Time frame: Daily during post-operative inpatient hospitalization through post-operative day 7
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).
5 secondary outcomes
Inpatient falls
Time frame: During post-operative inpatient hospitalization through post-operative day 7
Restraint Use
Time frame: During post-operative inpatient hospitalization through post-operative day 7
Sedative Use
Time frame: During post-operative inpatient hospitalization through post-operative day 7
Use of personal safety attendants
Time frame: During post-operative inpatient hospitalization through post-operative day 7
Provider Satisfaction
Time frame: Within 2-6 weeks following participant discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDM Alert in people with Delirium in Old Age, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium incidence as measured by the 3D-CAM (time frame: Daily during post-operative inpatient hospitalization through post-operative day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.