Trial Outcomes & Findings for Testing the Implementation of EIT-4-BPSD (NCT NCT03014570)
NCT ID: NCT03014570
Last Updated: 2023-03-07
Results Overview
The Barthel index has a score range of 0-100 with higher scores indicating higher physical function
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
553 participants
Primary outcome timeframe
Baseline, 4 months and 12 months
Results posted on
2023-03-07
Participant Flow
There were 553 residents enrolled into the study from 55 care communities from Maryland and Pennsylvania .
there were no significant events prior to the implementation of the study. No one was excluded.
Participant milestones
| Measure |
Education-Only Control
This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention).
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.
There were 27 sites randomized to control which included 248 participants.
|
EIT-4-BPSD
This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
There were 28 sites randomized to treatment which included 305 participants.
|
|---|---|---|
|
Overall Study
STARTED
|
248
|
305
|
|
Overall Study
COMPLETED
|
123
|
174
|
|
Overall Study
NOT COMPLETED
|
125
|
131
|
Reasons for withdrawal
| Measure |
Education-Only Control
This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention).
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.
There were 27 sites randomized to control which included 248 participants.
|
EIT-4-BPSD
This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
There were 28 sites randomized to treatment which included 305 participants.
|
|---|---|---|
|
Overall Study
COVID-19 Restrictions
|
38
|
24
|
|
Overall Study
Death
|
70
|
79
|
|
Overall Study
Transfer from facility
|
11
|
14
|
|
Overall Study
Hospitalized
|
5
|
3
|
|
Overall Study
Transfer within facility
|
1
|
0
|
|
Overall Study
Site refusal
|
0
|
11
|
Baseline Characteristics
Testing the Implementation of EIT-4-BPSD
Baseline characteristics by cohort
| Measure |
Education-Only Control
n=248 Participants
This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.
|
EIT-4-BPSD
n=305 Participants
This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
|
Total
n=553 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
248 Participants
n=5 Participants
|
305 Participants
n=7 Participants
|
553 Participants
n=5 Participants
|
|
Age, Continuous
|
84 years of age
STANDARD_DEVIATION 10 • n=5 Participants
|
82 years of age
STANDARD_DEVIATION 7 • n=7 Participants
|
83 years of age
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
197 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
419 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
248 participants
n=5 Participants
|
305 participants
n=7 Participants
|
553 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 months and 12 monthsPopulation: Older adults in nursing analysis was a repeated measures
The Barthel index has a score range of 0-100 with higher scores indicating higher physical function
Outcome measures
| Measure |
Education-Only Control
n=123 Participants
This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.
|
EIT-4-BPSD
n=174 Participants
This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
|
|---|---|---|
|
Physical Function as Determined by Barthel Index
Baseline
|
36.52 score on a scale
Standard Deviation 30.72
|
36.56 score on a scale
Standard Deviation 29.82
|
|
Physical Function as Determined by Barthel Index
12 months
|
35.82 score on a scale
Standard Deviation 27.75
|
31.36 score on a scale
Standard Deviation 26.88
|
|
Physical Function as Determined by Barthel Index
4 months
|
33.63 score on a scale
Standard Deviation 30.33
|
33.93 score on a scale
Standard Deviation 28.06
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 12 monthsThe Cornell scale ranges from 0-19 with higher scores representing more depressive symptoms
Outcome measures
| Measure |
Education-Only Control
n=123 Participants
This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.
|
EIT-4-BPSD
n=174 Participants
This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
|
|---|---|---|
|
Depression as Determined by the Cornell Scale for Depression in Dementia
12 months
|
1.72 score on a scale
Standard Deviation 2.5
|
1.86 score on a scale
Standard Deviation 3.12
|
|
Depression as Determined by the Cornell Scale for Depression in Dementia
4 months
|
3.91 score on a scale
Standard Deviation 4.58
|
3.81 score on a scale
Standard Deviation 4.15
|
|
Depression as Determined by the Cornell Scale for Depression in Dementia
Baseline
|
4.11 score on a scale
Standard Deviation 4.57
|
4.39 score on a scale
Standard Deviation 3.81
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 12 monthsThe CMAI score ranges from 0-70 with higher scores indicating more agitation
Outcome measures
| Measure |
Education-Only Control
n=123 Participants
This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.
Education-only Control: This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.
|
EIT-4-BPSD
n=174 Participants
This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
|
|---|---|---|
|
Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)
12 months
|
20.42 score on a scale
Standard Deviation 7.73
|
19.68 score on a scale
Standard Deviation 6.92
|
|
Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)
4 months
|
20.54 score on a scale
Standard Deviation 7.74
|
20.24 score on a scale
Standard Deviation 7.46
|
|
Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)
Baseline
|
20.66 score on a scale
Standard Deviation 8.34
|
21.32 score on a scale
Standard Deviation 8.38
|
Adverse Events
Education-Only Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 70 deaths
EIT-4-BPSD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 79 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Barbara Resnick PhD, CRNP Professor and PI among MPIs of the trial
University of Maryland School of Nursing
Phone: 410 706 5178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place