Redesigning the Surgical Pathway (PROMoTE)

Cognitive Impairment Clinical Trial

— PROMoTE  

Official title:

Redesigning the Surgical Pathway: Optimizing PReOperative assessMent in Anesthesia Clinic for adulT Surgical Patients (PROMoTE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114876
• Other study ID #: 5086
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: Stephen Choi, MD, MSc
• Phone: 416-480-4864
• Email: stephen.choi[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cognitive complications, that is problems with thinking and memory, are incredibly common after surgery, occurring in 10-50% of all older surgical patients. These complications can take different forms, but one of the most common is postoperative delirium (POD), a short-term state of confusion. In addition to being stressful for patients and their families, POD is linked to longer hospital stays, increased costs, higher mortality rates and other problems after surgery. Despite this, POD is often not recognized by doctors and there are currently no effective medications to treat POD. However, simple strategies such as helping patients to sleep properly and remain hydrated, have been shown to help.

This study is testing if a delirium-reduction program will reduce postoperative delirium (POD) in older surgical patients. The investigators will first test memory and thought processes before surgery to find people who are most likely to develop POD. Once these people have been identified, they will be enrolled in a program which includes recommendations for their care team (e.g. surgeon, anesthesiologist, nurses) as well as educational materials for them and their family related to things that can be done to prevent delirium. By identifying at-risk patients and making sure that their doctors and caregivers are aware of how to prevent delirium, the investigators expect that this study will make surgery safer for older surgical patients.

Description:

Postoperative delirium (POD), an acute, reversible disturbance in brain function characterized by fluctuating levels of consciousness, attention and cognition is a common postoperative complication in older surgical patients. POD is associated with increased morbidity, mortality, and risk of dementia; in addition to longer hospital stays and increased healthcare costs. Despite this, POD frequently goes unrecognized by healthcare providers and is often poorly proactively managed. There are currently no effective pharmacological treatments for POD, although non-pharmacological prevention strategies (e.g. promoting sleep hygiene, hydration, and early mobilization) have proven effective.

This will be a two-phase, prospective, observational comparative study in patients (age ≥60) presenting for major, elective surgical procedures with an expected postoperative stay ≥1 day(s). In both phases, baseline cognitive screening will be used to identify individuals with evidence of pre-existing cognitive impairment (pre-CI), a key risk factor for POD, and only individuals with pre-CI will be eligible to continue in the study.

Phase I will establish the prevalence of POD and pre-CI in our patient population at Sunnybrook Health Sciences Centre, a tertiary care academic health sciences centre, and act as a control group for Phase II. Phase II will evaluate the effects of a comprehensive delirium-risk prevention bundle, which includes direct-to-patient education and healthcare provider awareness strategies. Participants in both Phase I and Phase II will provide written/verbal informed consent.

In each phase the study team will complete delirium assessments for 130 patients at baseline and on postoperative days 1-3. Demographic and clinical data will be abstracted from participants medical records. PHQ-9 (depression) and AD-8 (dementia screening interview) questionnaires will be completed at baseline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• = 60 years old

• Undergoing major elective surgery (e.g., intra-abdominal, retroperitoneal, major orthopedic) with an expected postoperative stay of at least 1 night

• Evidence of cognitive impairment on baseline screening tests (i.e. any score < 90 on CBB or >10 on S-OMCT)

Exclusion Criteria:

• Patients undergoing cardiac surgery

• Patients undergoing intracranial neurosurgery

• Patients with known substance use disorder (verbally declared by patients)

• Unlikely to comply with study assessment (e.g., no fixed address, without access to internet/computer/phone).

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Delirium
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Other:
• Multicomponent delirium-risk prevention bundle
This multidisciplinary intervention will introduce new practices including: Direct-to-Patient Education Program Directly informing anesthesia and surgery teams about high-risk patients by flagging their chart, and providing suggestions for POD mitigation Flag charts as high risk for POD so that nursing staff in both the PACU and the wards are aware, facilitating implementation of CHASM interventions (i.e. evidence-based delirium prevention protocols). Reinforce CHASM best practices with regular educational sessions for nurses.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of POD before and after implementation of an institutional prospective diagnostic program.	POD evaluated by 3D-CAM and retrospectively using the CHART-DEL method	twice daily on postoperative days 1-3, morning/late afternoon
Secondary	Delirium Severity	Assessed using CAM-S	twice daily on postoperative days 1-3, morning/late afternoon
Secondary	Hospital length of stay	Duration of hospital admission in days	Until discharge, average of 1 week
Secondary	Unit adherence rate to CHASM principles	Unit adherence rate to CHASM principles	Until discharge, average of 1 week