Trial Outcomes & Findings for Preparation for End-of-Life Decision Making in Mild Dementia (NCT NCT03311711)

Last Updated: 2023-04-11

Results Overview

Dyad congruence was assessed using the Goals-of-Care Tool which has been modified to include two scenarios relevant to the context of dementia. There are three response options: "The goals of care should focus on delaying my death no matter what, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment", and "I am not sure". Persons with dementia and surrogates complete this tool independently and their responses are then compared to determine dyad congruence (either congruent in both scenarios or incongruent). If both members of the dyad endorse "I am not sure", they are considered incongruent.

Recruitment status

COMPLETED

Study phase

Target enrollment

242 participants

Primary outcome timeframe

Baseline, follow up phone call at 2-3 days post-intervention

Results posted on

2023-04-11

Participant Flow

Participants were recruited from healthcare clinics in Georgia and Illinois, USA. Participant enrollment began May 4, 2018. Follow-up for the 2-3 day post-intervention assessment was completed by February 3, 2022 and follow up for the 12 months post-intervention time point was completed by December 7, 2022.

In July 2020 the protocol was modified, eliminating the SPIRIT-in person intervention due to the coronavirus disease 2019 (COVID-19) pandemic which prohibited in person research visits. The study design changed to SPIRIT-remote versus usual care and a new randomization method was initiated for the two arm design. Due to the change in randomization method mid-study, participants enrolled before and after the randomization change are analyzed separately (as original or modified randomization).

Participant milestones

Participant milestones
Measure	SPIRIT-in Person - Persons With Dementia, Original Randomization Persons with dementia participating in the SPIRIT intervention in person, during the original randomization design. SPIRIT-in person: The SPIRIT-in person intervention adapted for dementia includes one session and is conducted in a private room at the clinic. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	SPIRIT-in Person - Surrogates, Original Randomization Surrogates participating in the SPIRIT intervention in person, during the original randomization design. SPIRIT-in person: The SPIRIT-in person intervention adapted for dementia includes one session and is conducted in a private room at the clinic. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	SPIRIT-remote - Persons With Dementia, Original Randomization Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	SPIRIT-remote - Surrogates, Original Randomization Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	Usual Care - Persons With Dementia, Original Randomization Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues.	Usual Care - Surrogates, Original Randomization Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues.	SPIRIT-remote - Persons With Dementia, Modified Randomization Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	SPIRIT-remote - Surrogates, Modified Randomization Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	Usual Care - Persons With Dementia, Modified Randomization Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues.	Usual Care - Surrogates, Modified Randomization Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues.
Overall Study STARTED	15	15	12	12	15	15	40	40	39	39
Overall Study COMPLETED	11	11	12	12	15	15	35	35	38	38
Overall Study NOT COMPLETED	4	4	0	0	0	0	5	5	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	SPIRIT-in Person - Persons With Dementia, Original Randomization Persons with dementia participating in the SPIRIT intervention in person, during the original randomization design. SPIRIT-in person: The SPIRIT-in person intervention adapted for dementia includes one session and is conducted in a private room at the clinic. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	SPIRIT-in Person - Surrogates, Original Randomization Surrogates participating in the SPIRIT intervention in person, during the original randomization design. SPIRIT-in person: The SPIRIT-in person intervention adapted for dementia includes one session and is conducted in a private room at the clinic. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	SPIRIT-remote - Persons With Dementia, Modified Randomization Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	SPIRIT-remote - Surrogates, Modified Randomization Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design. SPIRIT-remote: The SPIRIT-remote intervention adapted for dementia includes one session and is conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention lasts 45-60 minutes.	Usual Care - Persons With Dementia, Modified Randomization Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues.	Usual Care - Surrogates, Modified Randomization Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design. Usual care: Participants receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues.
Overall Study Death	1	0	1	0	1	0
Overall Study Death of dyad partner	0	1	0	1	0	1
Overall Study Lost to Follow-up	2	2	1	1	0	0
Overall Study Withdrawal by Subject	1	1	3	3	0	0

Baseline Characteristics

Preparation for End-of-Life Decision Making in Mild Dementia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SPIRIT-in Person - Persons With Dementia, Original Randomization n=15 Participants Persons with dementia participating in the SPIRIT intervention in person, during the original randomization design.	SPIRIT-in Person - Surrogates, Original Randomization n=15 Participants Surrogates participating in the SPIRIT intervention in person, during the original randomization design.	SPIRIT-remote - Persons With Dementia, Original Randomization n=12 Participants Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design.	SPIRIT-remote - Surrogates, Original Randomization n=12 Participants Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the original randomization design.	Usual Care - Persons With Dementia, Original Randomization n=15 Participants Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design.	Usual Care - Surrogates, Original Randomization n=15 Participants Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the original randomization design.	SPIRIT-remote - Persons With Dementia, Modified Randomization n=40 Participants Persons with dementia participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design.	SPIRIT-remote - Surrogates, Modified Randomization n=40 Participants Surrogates participating in the SPIRIT intervention remotely, via teleconference, during the modified randomization design.	Usual Care - Persons With Dementia, Modified Randomization n=39 Participants Persons with dementia receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design.	Usual Care - Surrogates, Modified Randomization n=39 Participants Surrogates receiving the standard information about advance directives that is provided at the time of diagnosis, during the modified randomization design.	Total n=242 Participants Total of all reporting groups
Age, Continuous	75.53 years STANDARD_DEVIATION 10.66 • n=93 Participants	65.20 years STANDARD_DEVIATION 15.36 • n=4 Participants	78.83 years STANDARD_DEVIATION 8.25 • n=27 Participants	67.58 years STANDARD_DEVIATION 7.83 • n=483 Participants	74.00 years STANDARD_DEVIATION 9.00 • n=36 Participants	62.20 years STANDARD_DEVIATION 12.04 • n=10 Participants	74.07 years STANDARD_DEVIATION 8.50 • n=115 Participants	65.60 years STANDARD_DEVIATION 12.89 • n=40 Participants	72.82 years STANDARD_DEVIATION 8.09 • n=8 Participants	68.85 years STANDARD_DEVIATION 9.62 • n=62 Participants	70.34 years STANDARD_DEVIATION 11.07 • n=95 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	9 Participants n=4 Participants	5 Participants n=27 Participants	11 Participants n=483 Participants	8 Participants n=36 Participants	9 Participants n=10 Participants	26 Participants n=115 Participants	27 Participants n=40 Participants	18 Participants n=8 Participants	24 Participants n=62 Participants	146 Participants n=95 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	6 Participants n=4 Participants	7 Participants n=27 Participants	1 Participants n=483 Participants	7 Participants n=36 Participants	6 Participants n=10 Participants	14 Participants n=115 Participants	13 Participants n=40 Participants	21 Participants n=8 Participants	15 Participants n=62 Participants	96 Participants n=95 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=40 Participants	2 Participants n=8 Participants	2 Participants n=62 Participants	6 Participants n=95 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants	15 Participants n=4 Participants	12 Participants n=27 Participants	12 Participants n=483 Participants	15 Participants n=36 Participants	15 Participants n=10 Participants	39 Participants n=115 Participants	39 Participants n=40 Participants	37 Participants n=8 Participants	37 Participants n=62 Participants	236 Participants n=95 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants	5 Participants n=483 Participants	3 Participants n=36 Participants	3 Participants n=10 Participants	8 Participants n=115 Participants	7 Participants n=40 Participants	5 Participants n=8 Participants	6 Participants n=62 Participants	52 Participants n=95 Participants
Race/Ethnicity, Customized White	10 Participants n=93 Participants	10 Participants n=4 Participants	7 Participants n=27 Participants	7 Participants n=483 Participants	11 Participants n=36 Participants	12 Participants n=10 Participants	32 Participants n=115 Participants	32 Participants n=40 Participants	32 Participants n=8 Participants	32 Participants n=62 Participants	185 Participants n=95 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=40 Participants	2 Participants n=8 Participants	1 Participants n=62 Participants	4 Participants n=95 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	1 Participants n=95 Participants
Region of Enrollment United States	15 participants n=93 Participants	15 participants n=4 Participants	12 participants n=27 Participants	12 participants n=483 Participants	15 participants n=36 Participants	15 participants n=10 Participants	40 participants n=115 Participants	40 participants n=40 Participants	39 participants n=8 Participants	39 participants n=62 Participants	242 participants n=95 Participants

PRIMARY outcome

Timeframe: Baseline, follow up phone call at 2-3 days post-intervention

Population: The number of participants analyzed reflects the number of person with dementia and surrogate dyads (two persons per dyad). This analysis includes dyads who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit.

Outcome measures

Outcome measures
Measure	Usual Care, Original Randomization n=15 Participants Person with dementia and surrogate dyads receiving usual care, during the original randomization design.	SPIRIT-in Person, Original Randomization n=15 Participants Person with dementia and surrogate dyads participating in the SPIRIT intervention in person, during the original randomization design.	SPIRIT-remote, Original Randomization n=12 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the original randomization design.	SPIRIT-remote, Modified Randomization n=40 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the modified randomization design.	Usual Care, Modified Randomization n=39 Participants Person with dementia and surrogate dyads receiving usual care, during the modified randomization design.
Dyad Congruence With Goals-of-Care Tool Number of Congruent Dyads at Baseline	11 Participants	9 Participants	4 Participants	24 Participants	30 Participants
Dyad Congruence With Goals-of-Care Tool Number of Incongruent Dyads at Baseline	4 Participants	6 Participants	8 Participants	16 Participants	9 Participants
Dyad Congruence With Goals-of-Care Tool Number of Congruent Dyads at 2-3 Days Post-intervention	11 Participants	11 Participants	9 Participants	34 Participants	32 Participants
Dyad Congruence With Goals-of-Care Tool Number of Incongruent Dyads at 2-3 Days Post-intervention	4 Participants	1 Participants	3 Participants	3 Participants	7 Participants

PRIMARY outcome

Timeframe: Baseline, follow up phone call at 2-3 days post-intervention

Population: This analysis includes participants who completed the indicated study visit. Three dyads from the SPIRIT-in person original randomization, and 3 dyads from the SPIRIT-remote modified randomization did not complete the 2-3 day post-intervention follow up visit.

Surrogate decision-making confidence is measured using the 5-item Decision Making Confidence (DMC) scale. DMC assesses a surrogate's confidence in knowing the patient's wishes, ability to make treatment decisions even in a highly stressful situation, ability to seek information about risks and benefits of medical choices, ability to handle unwanted pressure from others, and ability to communicate with providers about the patient's wishes. Surrogates indicate how confident they are about making medical decisions, if the patient becomes unable to make their own decisions, by their level of agreement with statements along a scale of (0) "not confident at all" to (4) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence.

Outcome measures

Outcome measures
Measure	Usual Care, Original Randomization n=15 Participants Person with dementia and surrogate dyads receiving usual care, during the original randomization design.	SPIRIT-in Person, Original Randomization n=15 Participants Person with dementia and surrogate dyads participating in the SPIRIT intervention in person, during the original randomization design.	SPIRIT-remote, Original Randomization n=12 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the original randomization design.	SPIRIT-remote, Modified Randomization n=40 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the modified randomization design.	Usual Care, Modified Randomization n=39 Participants Person with dementia and surrogate dyads receiving usual care, during the modified randomization design.
Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants Baseline	18.20 score on a scale Standard Deviation 1.78	18.40 score on a scale Standard Deviation 1.24	18.08 score on a scale Standard Deviation 1.73	18.33 score on a scale Standard Deviation 2.21	18.10 score on a scale Standard Deviation 2.10
Surrogate's Decision Making Confidence (DMC) Scale Score Among Phase II Participants 2-3 Days Post-intervention	19.07 score on a scale Standard Deviation 1.39	19.08 score on a scale Standard Deviation 1.24	18.42 score on a scale Standard Deviation 1.83	19.35 score on a scale Standard Deviation 1.14	19.05 score on a scale Standard Deviation 1.23

PRIMARY outcome

Timeframe: Baseline, follow up phone call at 2-3 days post-intervention

The Overall Preparedness Scale for end-of-life decision making for surrogates is a 23-item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 23 to 92, with higher scores indicating higher levels of preparedness.

Outcome measures

Outcome measures
Measure	Usual Care, Original Randomization n=15 Participants Person with dementia and surrogate dyads receiving usual care, during the original randomization design.	SPIRIT-in Person, Original Randomization n=15 Participants Person with dementia and surrogate dyads participating in the SPIRIT intervention in person, during the original randomization design.	SPIRIT-remote, Original Randomization n=12 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the original randomization design.	SPIRIT-remote, Modified Randomization n=40 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the modified randomization design.	Usual Care, Modified Randomization n=39 Participants Person with dementia and surrogate dyads receiving usual care, during the modified randomization design.
Surrogate's Overall Preparedness Scale Baseline	75.53 score on a scale Standard Deviation 9.15	75.27 score on a scale Standard Deviation 6.91	75.75 score on a scale Standard Deviation 9.76	72.15 score on a scale Standard Deviation 8.82	74.69 score on a scale Standard Deviation 7.42
Surrogate's Overall Preparedness Scale 2-3 Days Post-intervention	78.73 score on a scale Standard Deviation 8.42	83.75 score on a scale Standard Deviation 4.05	76.92 score on a scale Standard Deviation 8.18	81.50 score on a scale Standard Deviation 6.97	77.80 score on a scale Standard Deviation 8.32

SECONDARY outcome

Timeframe: Baseline, up to 12 months post-intervention

At the Baseline visit, participants were asked if they had already completed an advance directive. Medical records were reviewed to determine if the patient completed an advance directive (a medical power of attorney or living will) by 12 months post-intervention. If there was no documentation in the medical record, the surrogate was contacted to get confirmation on the status of the Advance Directive.

Outcome measures

Outcome measures
Measure	Usual Care, Original Randomization n=15 Participants Person with dementia and surrogate dyads receiving usual care, during the original randomization design.	SPIRIT-in Person, Original Randomization n=15 Participants Person with dementia and surrogate dyads participating in the SPIRIT intervention in person, during the original randomization design.	SPIRIT-remote, Original Randomization n=12 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the original randomization design.	SPIRIT-remote, Modified Randomization n=40 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the modified randomization design.	Usual Care, Modified Randomization n=39 Participants Person with dementia and surrogate dyads receiving usual care, during the modified randomization design.
Completion of Advance Directives Among Phase II Participants Baseline - Complete	14 Participants	10 Participants	9 Participants	33 Participants	30 Participants
Completion of Advance Directives Among Phase II Participants Baseline - Incomplete	1 Participants	5 Participants	3 Participants	7 Participants	9 Participants
Completion of Advance Directives Among Phase II Participants 12-month cumulative - Complete	15 Participants	12 Participants	12 Participants	38 Participants	38 Participants
Completion of Advance Directives Among Phase II Participants 12-month cumulative - Incomplete	0 Participants	3 Participants	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, follow up phone call at 2-3 days post-intervention

The Overall Preparedness Scale for end-of-life decision making for patients is a 22 item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 22 to 88, with higher scores indicating higher levels of preparedness.

Outcome measures

Outcome measures
Measure	Usual Care, Original Randomization n=15 Participants Person with dementia and surrogate dyads receiving usual care, during the original randomization design.	SPIRIT-in Person, Original Randomization n=15 Participants Person with dementia and surrogate dyads participating in the SPIRIT intervention in person, during the original randomization design.	SPIRIT-remote, Original Randomization n=12 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the original randomization design.	SPIRIT-remote, Modified Randomization n=40 Participants Person with dementia and surrogate dyads participating in the SPIRIT remotely, during the modified randomization design.	Usual Care, Modified Randomization n=39 Participants Person with dementia and surrogate dyads receiving usual care, during the modified randomization design.
Patient's Overall Preparedness Scale Baseline	54.07 score on a scale Standard Deviation 7.54	55.40 score on a scale Standard Deviation 6.97	54.67 score on a scale Standard Deviation 5.14	54.90 score on a scale Standard Deviation 5.71	53.50 score on a scale Standard Deviation 5.96
Patient's Overall Preparedness Scale 2-3 Days Post-intervention	54.93 score on a scale Standard Deviation 9.03	57.83 score on a scale Standard Deviation 6.60	58.57 score on a scale Standard Deviation 5.31	58.78 score on a scale Standard Deviation 5.20	54.69 score on a scale Standard Deviation 5.50

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mi-Kyung Song, PhD

Emory University

Phone: 404-727-3134

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place