Trial Outcomes & Findings for Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study (NCT NCT05110690)

NCT ID: NCT05110690

Last Updated: 2023-12-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: Through completion of the study (13 months and 5 days)
• Results posted on: 2023-12-18

Participant Flow

Due to the primary outcome measure, the number of participants eligible for consent and enrollment (n=29 participants) needs to be indicated in the participant flow.

Participant milestones

Measure	Patient Participants * Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. * Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
Eligible for Consent and Enrollment STARTED	29
Eligible for Consent and Enrollment COMPLETED	24
Eligible for Consent and Enrollment NOT COMPLETED	5
Enrolled STARTED	24
Enrolled COMPLETED	24
Enrolled NOT COMPLETED	0
Started Intervention STARTED	24
Started Intervention COMPLETED	23
Started Intervention NOT COMPLETED	1
Completion of Intervention STARTED	23
Completion of Intervention COMPLETED	19
Completion of Intervention NOT COMPLETED	4

Reasons for withdrawal

Measure	Patient Participants * Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. * Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
Eligible for Consent and Enrollment Did not consent	5
Started Intervention Ineligible due to canceled surgery	1
Completion of Intervention Lost to Follow-up	1
Completion of Intervention Death	1
Completion of Intervention Withdrawal by Subject	2

Baseline Characteristics

Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study

Baseline characteristics by cohort

Measure	Patient Participants n=23 Participants * Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. * Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
Age, Continuous	68.0 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Through completion of the study (13 months and 5 days)

Population: One participant who signed consent, was considered eligible, and was enrolled to the study ended up having their surgery canceled and became ineligible for the study after enrollment.

Outcome measures

Measure

Patient Participants n=28 Participants * Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. * Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.

Reach of the Study as Measured by the Number of Participants Who Agree to Participate in the Study Out of the Total Eligible Participants

23 Participants

PRIMARY outcome

Timeframe: Through completion of the study (13 months and 5 days)

Population: One participant who signed consent, was considered eligible, and was enrolled to the study ended up having their surgery canceled and became ineligible for the study after enrollment.

Outcome measures

Measure

Patient Participants n=23 Participants * Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. * Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.

Reach of the Intervention Bundle as Measured by the Number of Participants Who Completed the Intervention Out of the Participants Who Agreed to Participate in the Study

19 Participants

SECONDARY outcome

Timeframe: Baseline, 1 month, and 3 months

Outcome measures

Measure	Patient Participants n=23 Participants * Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. * Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
Completeness of Planned Primary Outcome Data Collection at Specified Timepoints as Measured by the Number of Participants Who Completed 100% of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) Baseline	23 Participants
Completeness of Planned Primary Outcome Data Collection at Specified Timepoints as Measured by the Number of Participants Who Completed 100% of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) 1 month	15 Participants
Completeness of Planned Primary Outcome Data Collection at Specified Timepoints as Measured by the Number of Participants Who Completed 100% of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) 3 months	20 Participants

Adverse Events

Patient Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Avidan, MBBCh, FCASA

Washington University School of Medicine

Phone: 314-273-4136

Email: avidanm@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place