Delirium
Conditions
Keywords
Caregivers, Clinical Decision Support Systems, Cognitive Dysfunction, Confusion, Delirium, Feasibility Studies, Geriatric Assessment, Neurocognitive Disorders
Brief summary
This is a pilot randomized controlled trial that will test whether a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Decision support systems will be tested that provide targeted alerts and recommendations to the Hospital Elder Life Program and family members for delirium prevention.
Detailed description
Delirium is a distressing and common surgical complication, affecting approximately 20-50% of older surgical patients. Postoperative delirium is associated with increased mortality, cognitive and functional decline, and healthcare resource utilization. Prevention programs have been tested with variable success, but the Hospital Elder Life Program (HELP) has consistently been demonstrated to reduce the incidence and impact of delirium. However, substantial resources are needed for program operations, and complementary support systems may help with patient triage and assessment. Family members and caretakers may be able to provide supplementary support with delirium screening and prevention via targeted, therapeutic activities. Thus, an automated postoperative paging system, which elicits additional, focused support from HELP and family members, may augment delirium prevention activities and reduce associated risk. The primary objectives of this study are to determine whether pager-based clinical decision support systems bolster HELP- and family-based therapeutic activities. A secondary objective will be to identify facilitators and barriers to delivering therapeutic interventions for both HELP and family members. Overall, this pilot trial will test the hypothesis that a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Patients (n=60) will be randomized to one of four groups in a factorial design: usual care (n=15), HELP-based paging system (n=15), family-based paging system (n=15), or both HELP- and family-based paging system (n=15). The support systems will consist of automated pager alerts to the HELP program and/or family members and caretakers, depending on group allocation, for providing additional delirium evaluation and therapeutic prevention activities. Outcomes will include various clinical, neurocognitive, and functional measures, and performance metrics will be collected regarding HELP- and family-based interventions.
Interventions
BEHAVIORALFamily 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.
BEHAVIORALHELP 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.
Sponsors
The Claude D. Pepper Older Americans Independence Centers
National Institute on Aging (NIA)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 70 years of age * Major non-cardiac, non-intracranial neurologic, and non-major vascular surgery * Anticipated length of stay at least 72 hours * At least one family member, or caretaker, available on each of the first three postoperative days for trial operations
Exclusion criteria
* Emergency surgery * Severe cognitive impairment (precluding ability to perform delirium assessments) * Planned postoperative ICU admission * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delirium Severity | morning postoperative day one through afternoon of postoperative day three | 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) |
| Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D) | 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) |
| Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A) | 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) |
| Falls | morning postoperative day one through afternoon of postoperative day three | Proportion of patients in each group (%) experiencing at least one fall |
| Length of Hospital Stay | 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 |
| Discharge Disposition | 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 |
| Delayed Discharge - Cognitive Impairment | day of hospital discharge, up to 30 days | Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment |
| New Non-surgical Site Infection | morning of surgery until day of hospital discharge, up to 30 days | Incidence (%) of any new non-surgical site infection while hospitalized |
| Multidrug Resistant Organism Colonization | morning postoperative day one through 30 days after surgery | Incidence (%) of any new multidrug resistant organism colonization |
| Mortality | within 30 days after surgery | Incidence (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| HELP - Duration of Time | postoperative day one through postoperative day three | Cumulative length of time spent with HELP team members |
| HELP - Visitation | postoperative day one through postoperative day three | Proportion of patients successfully visited by the program |
| HELP - Time to Evaluation | postoperative day one through postoperative day three | Time until initial HELP evaluation |
| Family Intervention - Duration of Time | postoperative day one through postoperative day three | Cumulative duration of time spent with family members/caretakers at the bedside |
| Family Intervention - Proportion of Daily Tasks Completed | postoperative day one through postoperative day three | The proportion of family-based daily tasks successfully completed will be reported |
| Family Intervention - Length of Time, Stimulating Activity | postoperative day one through postoperative day three | Cumulative length of time spent on prescribed stimulating activities |
| Agreement - FAM-CAM and Research-based CAM Assessments | postoperative day one through postoperative day three | Agreement will be assessed, via Cohen's kappa, between FAM-CAM and research-based CAM assessments. |
| 30-Day FAM-CAM Assessments | day after discharge through 30 days postoperatively | Incidence (%) of positive FAM-CAM assessments post-discharge |
| 36-Item Short Form Survey | 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) |
| PROMIS Cognitive Abilities (Short Form 4a) | 30 days postoperatively | Subjective reporting of cognitive function |
| Hospital Readmission | within 30 days after discharge | Incidence (%) of hospital readmission |
Countries
United States
Participant flow
Pre-assignment details
Withdrawn (n=3); surgery cancelled (n=2), staff availability (n=1)
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Group Usual care per surgical ward standards | 15 |
| 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. | 10 |
| 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. | 11 |
| 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. | 13 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | COVID hospital closure | 0 | 0 | 1 | 2 |
| Overall Study | ICU Transfer | 0 | 1 | 0 | 0 |
| Overall Study | Surgery cancelled | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Care Group | HELP Support System | Family Support System | Combined Support Systems | Total |
|---|---|---|---|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 4 | 76 years STANDARD_DEVIATION 5 | 78 years STANDARD_DEVIATION 4 | 77 years STANDARD_DEVIATION 7 | 77 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 10 Participants | 10 Participants | 13 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 9 Participants | 10 Participants | 13 Participants | 47 Participants |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 6 Participants | 7 Participants | 26 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 15 | 0 / 12 | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 3 / 15 | 2 / 12 | 3 / 14 | 3 / 16 |
| serious Total, serious adverse events | 3 / 15 | 6 / 12 | 2 / 14 | 1 / 16 |
Outcome results
Primary
Delirium
Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19)
Time frame: morning postoperative day one through afternoon of postoperative day three
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Delirium | 3 Participants |
| HELP Support System | Delirium | 3 Participants |
| Family Support System | Delirium | 1 Participants |
| Combined Support Systems | Delirium | 2 Participants |
p-value: 0.653Fisher Exact
p-value: 0.614Fisher Exact
p-value: 0.999Fisher Exact
Secondary
Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A)
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)
Time frame: baseline through postoperative day 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A) | 2 Participants |
| HELP Support System | Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A) | 1 Participants |
| Family Support System | Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A) | 0 Participants |
| Combined Support Systems | Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A) | 0 Participants |
Secondary
Delayed Discharge - Cognitive Impairment
Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment
Time frame: day of hospital discharge, up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Delayed Discharge - Cognitive Impairment | 0 Participants |
| HELP Support System | Delayed Discharge - Cognitive Impairment | 0 Participants |
| Family Support System | Delayed Discharge - Cognitive Impairment | 0 Participants |
| Combined Support Systems | Delayed Discharge - Cognitive Impairment | 0 Participants |
Secondary
Delirium Severity
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)
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care Group | Delirium Severity | 2 score on a scale |
| HELP Support System | Delirium Severity | 1 score on a scale |
| Family Support System | Delirium Severity | 3 score on a scale |
| Combined Support Systems | Delirium Severity | 2 score on a scale |
Secondary
Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D)
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)
Time frame: baseline through postoperative day 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D) | 1 Participants |
| HELP Support System | Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D) | 1 Participants |
| Family Support System | Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D) | 1 Participants |
| Combined Support Systems | Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D) | 1 Participants |
Secondary
Discharge Disposition
Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility), up to 30 days
Time frame: day of hospital discharge, up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Discharge Disposition | 2 Participants |
| HELP Support System | Discharge Disposition | 1 Participants |
| Family Support System | Discharge Disposition | 3 Participants |
| Combined Support Systems | Discharge Disposition | 1 Participants |
Secondary
Falls
Proportion of patients in each group (%) experiencing at least one fall
Time frame: morning postoperative day one through afternoon of postoperative day three
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Falls | 0 Participants |
| HELP Support System | Falls | 1 Participants |
| Family Support System | Falls | 0 Participants |
| Combined Support Systems | Falls | 0 Participants |
Secondary
Length of Hospital Stay
Total number of days (n) spent in the hospital, up to 30 days
Time frame: morning of surgery until day of hospital discharge, up to 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care Group | Length of Hospital Stay | 4 Days |
| HELP Support System | Length of Hospital Stay | 5 Days |
| Family Support System | Length of Hospital Stay | 4 Days |
| Combined Support Systems | Length of Hospital Stay | 4 Days |
Secondary
Mortality
Incidence (%)
Time frame: within 30 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Mortality | 1 Participants |
| HELP Support System | Mortality | 0 Participants |
| Family Support System | Mortality | 0 Participants |
| Combined Support Systems | Mortality | 0 Participants |
Secondary
Multidrug Resistant Organism Colonization
Incidence (%) of any new multidrug resistant organism colonization
Time frame: morning postoperative day one through 30 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Multidrug Resistant Organism Colonization | 0 Participants |
| HELP Support System | Multidrug Resistant Organism Colonization | 0 Participants |
| Family Support System | Multidrug Resistant Organism Colonization | 0 Participants |
| Combined Support Systems | Multidrug Resistant Organism Colonization | 0 Participants |
Secondary
New Non-surgical Site Infection
Incidence (%) of any new non-surgical site infection while hospitalized
Time frame: morning of surgery until day of hospital discharge, up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | New Non-surgical Site Infection | 0 Participants |
| HELP Support System | New Non-surgical Site Infection | 1 Participants |
| Family Support System | New Non-surgical Site Infection | 1 Participants |
| Combined Support Systems | New Non-surgical Site Infection | 2 Participants |
Other Pre-specified
30-Day FAM-CAM Assessments
Incidence (%) of positive FAM-CAM assessments post-discharge
Time frame: day after discharge through 30 days postoperatively
Other Pre-specified
36-Item Short Form Survey
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)
Time frame: 30 days after hospital discharge
Other Pre-specified
Agreement - FAM-CAM and Research-based CAM Assessments
Agreement will be assessed, via Cohen's kappa, between FAM-CAM and research-based CAM assessments.
Time frame: postoperative day one through postoperative day three
Other Pre-specified
Family Intervention - Duration of Time
Cumulative duration of time spent with family members/caretakers at the bedside
Time frame: postoperative day one through postoperative day three
Other Pre-specified
Family Intervention - Length of Time, Stimulating Activity
Cumulative length of time spent on prescribed stimulating activities
Time frame: postoperative day one through postoperative day three
Other Pre-specified
Family Intervention - Proportion of Daily Tasks Completed
The proportion of family-based daily tasks successfully completed will be reported
Time frame: postoperative day one through postoperative day three
Other Pre-specified
HELP - Duration of Time
Cumulative length of time spent with HELP team members
Time frame: postoperative day one through postoperative day three
Other Pre-specified
HELP - Time to Evaluation
Time until initial HELP evaluation
Time frame: postoperative day one through postoperative day three
Other Pre-specified
HELP - Visitation
Proportion of patients successfully visited by the program
Time frame: postoperative day one through postoperative day three
Other Pre-specified
Hospital Readmission
Incidence (%) of hospital readmission
Time frame: within 30 days after discharge
Other Pre-specified
PROMIS Cognitive Abilities (Short Form 4a)
Subjective reporting of cognitive function
Time frame: 30 days postoperatively