Trial Outcomes & Findings for Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR) (NCT NCT04007523)

NCT ID: NCT04007523

Last Updated: 2024-02-21

Results Overview

Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: morning postoperative day one through afternoon of postoperative day three
• Results posted on: 2024-02-21

Participant Flow

Withdrawn (n=3); surgery cancelled (n=2), staff availability (n=1)

Participant milestones

Measure	Usual Care Group Usual care per surgical ward standards	HELP Support System This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Overall Study STARTED	15	12	14	16
Overall Study COMPLETED	15	10	11	13
Overall Study NOT COMPLETED	0	2	3	3

Reasons for withdrawal

Measure	Usual Care Group Usual care per surgical ward standards	HELP Support System This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Overall Study Withdrawal by Subject	0	1	1	0
Overall Study ICU Transfer	0	1	0	0
Overall Study COVID hospital closure	0	0	1	2
Overall Study Surgery cancelled	0	0	1	1

Baseline Characteristics

Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR)

Baseline characteristics by cohort

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Total n=49 Participants Total of all reporting groups
Age, Continuous	76 years STANDARD_DEVIATION 4 • n=5 Participants	76 years STANDARD_DEVIATION 5 • n=7 Participants	78 years STANDARD_DEVIATION 4 • n=5 Participants	77 years STANDARD_DEVIATION 7 • n=4 Participants	77 years STANDARD_DEVIATION 6 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	26 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	48 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	47 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: morning postoperative day one through afternoon of postoperative day three

Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19)

Outcome measures

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Delirium	3 Participants	3 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: morning postoperative day one through afternoon of postoperative day three

Population: Delirium severity data are derived from all available, completed delirium assessments within each group.

For any patient with a completed delirium assessment, the associated severity score will be recorded using the Confusion Assessment Method Long Form Severity Score (n, 0-19, with higher number indicating more severe delirium)

Outcome measures

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Delirium Severity	2 score on a scale Interval 0.0 to 3.0	1 score on a scale Interval 0.0 to 3.0	3 score on a scale Interval 1.0 to 5.0	2 score on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: baseline through postoperative day 2

Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-D) (n, 0-21, 0 = normal, 21 = presence of severe depression symptoms)

Outcome measures

Measure	Usual Care Group n=12 Participants Usual care per surgical ward standards	HELP Support System n=8 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=7 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=11 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D)	1 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: baseline through postoperative day 3

Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-A) (n, 0-21, 0 = normal, 21 = presence of severe anxiety symptoms)

Outcome measures

Measure	Usual Care Group n=13 Participants Usual care per surgical ward standards	HELP Support System n=8 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=7 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=11 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A)	2 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: morning postoperative day one through afternoon of postoperative day three

Proportion of patients in each group (%) experiencing at least one fall

Outcome measures

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Falls	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: morning of surgery until day of hospital discharge, up to 30 days

Total number of days (n) spent in the hospital, up to 30 days

Outcome measures

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Length of Hospital Stay	4 Days Interval 2.0 to 5.0	5 Days Interval 3.0 to 6.0	4 Days Interval 3.0 to 7.0	4 Days Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: day of hospital discharge, up to 30 days

Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility), up to 30 days

Outcome measures

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Discharge Disposition	2 Participants	1 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: day of hospital discharge, up to 30 days

Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment

Outcome measures

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Delayed Discharge - Cognitive Impairment	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: morning of surgery until day of hospital discharge, up to 30 days

Incidence (%) of any new non-surgical site infection while hospitalized

Outcome measures

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
New Non-surgical Site Infection	0 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: morning postoperative day one through 30 days after surgery

Incidence (%) of any new multidrug resistant organism colonization

Outcome measures

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Multidrug Resistant Organism Colonization	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: within 30 days after surgery

Incidence (%)

Outcome measures

Measure	Usual Care Group n=15 Participants Usual care per surgical ward standards	HELP Support System n=10 Participants This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=11 Participants This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=13 Participants Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Mortality	1 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day one through postoperative day three

Cumulative length of time spent with HELP team members

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day one through postoperative day three

Proportion of patients successfully visited by the program

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day one through postoperative day three

Time until initial HELP evaluation

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day one through postoperative day three

Cumulative duration of time spent with family members/caretakers at the bedside

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day one through postoperative day three

The proportion of family-based daily tasks successfully completed will be reported

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day one through postoperative day three

Cumulative length of time spent on prescribed stimulating activities

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day one through postoperative day three

Agreement will be assessed, via Cohen's kappa, between FAM-CAM and research-based CAM assessments.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: day after discharge through 30 days postoperatively

Incidence (%) of positive FAM-CAM assessments post-discharge

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days after hospital discharge

Comprehensive survey that reports on overall health, functional status, physical/mental well-being, and pains (score range, for both overall scale and domain subscales: n, 0-100, 0 = worst score and 100 = best score in relation to the general state of health and quality of life)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days postoperatively

Subjective reporting of cognitive function

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: within 30 days after discharge

Incidence (%) of hospital readmission

Outcome measures

Outcome data not reported

Adverse Events

Usual Care Group

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

HELP Support System

Serious events: 6 serious events

Other events: 2 other events

Deaths: 0 deaths

Family Support System

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Combined Support Systems

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care Group n=15 participants at risk Usual care per surgical ward standards	HELP Support System n=12 participants at risk This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=14 participants at risk This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=16 participants at risk Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	8.3% 1/12 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Cardiac disorders Atrial fibrillation	6.7% 1/15 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	16.7% 2/12 • Number of events 2 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Surgical and medical procedures Bowel Injury	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	7.1% 1/14 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Infections and infestations C. Difficile	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	6.2% 1/16 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.
General disorders Dehydration	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	7.1% 1/14 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
General disorders Difficulty Swallowing	6.7% 1/15 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Cardiac disorders Hypotension	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	8.3% 1/12 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	8.3% 1/12 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Gastrointestinal disorders Ileus	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	8.3% 1/12 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
General disorders Unresponsive	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	8.3% 1/12 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Surgical and medical procedures Wound dehiscence	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	8.3% 1/12 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Gastrointestinal disorders Small bowel obstruction	6.7% 1/15 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.

Other adverse events

Measure	Usual Care Group n=15 participants at risk Usual care per surgical ward standards	HELP Support System n=12 participants at risk This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.	Family Support System n=14 participants at risk This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.	Combined Support Systems n=16 participants at risk Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
General disorders Cough, Shortness of Breath, Penile Pain	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	7.1% 1/14 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Psychiatric disorders Mental Status Change	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	7.1% 1/14 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Cardiac disorders Hypertension	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	7.1% 1/14 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	8.3% 1/12 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Gastrointestinal disorders Abdominal Pain	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	8.3% 1/12 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
Blood and lymphatic system disorders Anemia	13.3% 2/15 • Number of events 2 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	12.5% 2/16 • Number of events 2 • Adverse events were monitored for up to 30 days after surgery.
Respiratory, thoracic and mediastinal disorders Concern for healthcare associated pneumonia	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	6.2% 1/16 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.
General disorders Left-sided facial droop	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	6.2% 1/16 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.
Skin and subcutaneous tissue disorders Cellulitis of left lower leg	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	6.2% 1/16 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.
Cardiac disorders Sinus tachycardia	6.7% 1/15 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/16 • Adverse events were monitored for up to 30 days after surgery.
General disorders Back discomfort	0.00% 0/15 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/12 • Adverse events were monitored for up to 30 days after surgery.	0.00% 0/14 • Adverse events were monitored for up to 30 days after surgery.	6.2% 1/16 • Number of events 1 • Adverse events were monitored for up to 30 days after surgery.

Additional Information

Dr. Phillip Vlisides

Michigan Medicine

Phone: 734-936-4280

Email: pvliside@med.umich.edu

Results disclosure agreements

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