Trial Outcomes & Findings for Implementation of Function Focused Care in Acute Care (NCT NCT04235374)
NCT ID: NCT04235374
Last Updated: 2025-08-05
Results Overview
A measure of 10 activities of daily living with scores ranging from 0 to 100 and higher scores indicating better physical function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
455 participants
Primary outcome timeframe
Scores at hospital admission, hospital discharge, 1,6, and 12 months post discharge
Results posted on
2025-08-05
Participant Flow
Unit of analysis: hospitals
Participant milestones
| Measure |
FFC-AC-EIT
The stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months to implement Steps 1 to 4 of Function Focused Care for Acute Care Using the Evidence Integration Triangle (FFC-AC-EIT) \[(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families\]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with Alzheimer's Disease and Related Dementia (ADRD) in physical activity while hospitalized.
FFC-AC-EIT: The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
|
Education Only
Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice.
FFC-AC-EIT: The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
|
|---|---|---|
|
Overall Study
STARTED
|
220 6
|
235 6
|
|
Overall Study
COMPLETED
|
105 6
|
129 6
|
|
Overall Study
NOT COMPLETED
|
115 0
|
106 0
|
Reasons for withdrawal
| Measure |
FFC-AC-EIT
The stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months to implement Steps 1 to 4 of Function Focused Care for Acute Care Using the Evidence Integration Triangle (FFC-AC-EIT) \[(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families\]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with Alzheimer's Disease and Related Dementia (ADRD) in physical activity while hospitalized.
FFC-AC-EIT: The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
|
Education Only
Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice.
FFC-AC-EIT: The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
|
|---|---|---|
|
Overall Study
Death
|
91
|
91
|
|
Overall Study
Refused
|
2
|
2
|
|
Overall Study
Unavailable
|
12
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Withdrawal by Legally Authorized Representative
|
10
|
9
|
Baseline Characteristics
Implementation of Function Focused Care in Acute Care
Baseline characteristics by cohort
| Measure |
FFC-AC-EIT
n=220 Participants
treatment with the intervention FFC-AC-EIT
|
Education Only
n=235 Participants
Treatment with control for attention with education only
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
83.6 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
81.4 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
82.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
170 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
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 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
|
49 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
162 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
297 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
|
|
Barthel index
|
49.2 units on a scale
STANDARD_DEVIATION 27.3 • n=5 Participants
|
54.9 units on a scale
STANDARD_DEVIATION 27.1 • n=7 Participants
|
51.5 units on a scale
STANDARD_DEVIATION 27.0 • n=5 Participants
|
|
The Physical Activity Survey
|
8.2 units on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
|
9.6 units on a scale
STANDARD_DEVIATION 6.0 • n=7 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Neuropsychiatric inventory
|
1.4 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 3.2 • n=7 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Delirium
|
1.5 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Pain
|
.02 units on a scale
STANDARD_DEVIATION .2 • n=5 Participants
|
.2 units on a scale
STANDARD_DEVIATION .6 • n=7 Participants
|
.11 units on a scale
STANDARD_DEVIATION .4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Scores at hospital admission, hospital discharge, 1,6, and 12 months post dischargeA measure of 10 activities of daily living with scores ranging from 0 to 100 and higher scores indicating better physical function.
Outcome measures
| Measure |
FFC-AC-EIT
n=220 Participants
treatment with the intervention FFC-AC-EIT
|
Education Only
n=235 Participants
Treatment with control for attention with education only
|
|---|---|---|
|
The Barthel Index
12 month
|
32.0 score on a scale
Standard Deviation 12.1
|
30.1 score on a scale
Standard Deviation 10.8
|
|
The Barthel Index
Baseline
|
49.2 score on a scale
Standard Deviation 27.3
|
54.9 score on a scale
Standard Deviation 27.3
|
|
The Barthel Index
discharge
|
52.0 score on a scale
Standard Deviation 28.5
|
58.7 score on a scale
Standard Deviation 27.6
|
|
The Barthel Index
one month
|
58.2 score on a scale
Standard Deviation 31.7
|
58.0 score on a scale
Standard Deviation 30.6
|
|
The Barthel Index
six month
|
61.1 score on a scale
Standard Deviation 32.0
|
61.4 score on a scale
Standard Deviation 27.3
|
PRIMARY outcome
Timeframe: Baseline (hospital admission), hospital discharge (approximately 3 days),1, 6, and 12 months post dischargePopulation: participants who had data collected at these time points.
The Physical Activity Survey is a subjective measure of time spent in physical activities over 24 hours based on input from an informant. A total of 37 activities iin the following areas are included: locomotion (e.g., walking, wheelchair mobility), personal care (e.g., bathing), structured exercise (e.g., physical and occupational therapy), recreational activity (music), and repetitive behavior (moving objects repeatedly). scores range from 0 to 37 with each activity considered as done at least once during the day. Higher scores are indicative of more physical activities done.
Outcome measures
| Measure |
FFC-AC-EIT
n=220 Participants
treatment with the intervention FFC-AC-EIT
|
Education Only
n=235 Participants
Treatment with control for attention with education only
|
|---|---|---|
|
The Physical Activity Survey
Baseline
|
8.2 score on scale
Standard Deviation 5.0
|
9.6 score on scale
Standard Deviation 6.0
|
|
The Physical Activity Survey
Discharge
|
9.2 score on scale
Standard Deviation 5.7
|
10.1 score on scale
Standard Deviation 6.4
|
|
The Physical Activity Survey
one month
|
13.6 score on scale
Standard Deviation 6.7
|
11.9 score on scale
Standard Deviation 5.7
|
|
The Physical Activity Survey
six month
|
13.9 score on scale
Standard Deviation 6.6
|
12.9 score on scale
Standard Deviation 4.6
|
|
The Physical Activity Survey
twelve month
|
13.4 score on scale
Standard Deviation 6.2
|
11.7 score on scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: baseline (hospital admission) ,hospital discharge (approximately 3 days), 1,6, and 12 months post dischargePopulation: participants who had data collected at these time points.
An assessment for evidence of delirium based on items reflective of behaviors associated with delirium. There are four areas considered: Acute onset and fluctuating course is scored as no (0) or yes (1). Inattention and disorganized thinking are each scored as "absent" (0 points), present in mild form (1 point), or present in severe form (2 points). Altered level of consciousness, is scored as alert or normal (0 points), vigilant or lethargic (1 point), and stupor or coma (2 points). Scores range from 0-7, with a higher score indicating greater severity of delirium.
Outcome measures
| Measure |
FFC-AC-EIT
n=220 Participants
treatment with the intervention FFC-AC-EIT
|
Education Only
n=235 Participants
Treatment with control for attention with education only
|
|---|---|---|
|
The Short Confusion Assessment Method
Baseline
|
1.5 score on a scale
Standard Deviation 1.7
|
2.1 score on a scale
Standard Deviation 1.8
|
|
The Short Confusion Assessment Method
Discharge
|
1.2 score on a scale
Standard Deviation 1.7
|
1.7 score on a scale
Standard Deviation 1.6
|
|
The Short Confusion Assessment Method
One Month
|
2.2 score on a scale
Standard Deviation 1.9
|
2.2 score on a scale
Standard Deviation 1.8
|
|
The Short Confusion Assessment Method
Six month
|
2.1 score on a scale
Standard Deviation 1.7
|
2.5 score on a scale
Standard Deviation 1.9
|
|
The Short Confusion Assessment Method
twelve month
|
2.1 score on a scale
Standard Deviation 1.6
|
2.7 score on a scale
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: baseline (hospital admission) , discharge (approximately 3 days),1,6, and 12 months post discharge nbPopulation: Participants who had data collected at these time points
Assessment of behavioral symptoms including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating is done. The presence of each behavior is scored as present (1) or not present (0). The behaviors are then scored and range from 0 to 12. Higher scores are indicative of more behavioral and psychological symptoms associated with dementia.
Outcome measures
| Measure |
FFC-AC-EIT
n=220 Participants
treatment with the intervention FFC-AC-EIT
|
Education Only
n=235 Participants
Treatment with control for attention with education only
|
|---|---|---|
|
the Brief Neuropsychiatric Inventory
Baseline
|
1.4 units on a scale
Standard Deviation 2.7
|
2.4 units on a scale
Standard Deviation 3.2
|
|
the Brief Neuropsychiatric Inventory
Discharge
|
1.7 units on a scale
Standard Deviation 3.1
|
2.3 units on a scale
Standard Deviation 3.1
|
|
the Brief Neuropsychiatric Inventory
One month
|
6.6 units on a scale
Standard Deviation 5.8
|
6.0 units on a scale
Standard Deviation 5.7
|
|
the Brief Neuropsychiatric Inventory
Six month
|
5.7 units on a scale
Standard Deviation 5.2
|
6.8 units on a scale
Standard Deviation 6.1
|
|
the Brief Neuropsychiatric Inventory
twelve month
|
3.0 units on a scale
Standard Deviation 2.4
|
3.5 units on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post dischargePopulation: participants who had data collected at these time points.
An objective measure of 5 behaviors commonly associated with pain. Each pain behavior is scored from 0 (no evidence) to 2 (persistant behavior). Scores are then summed for a total score that ranges from 0 to 10 with higher scores indicative of more pain.
Outcome measures
| Measure |
FFC-AC-EIT
n=220 Participants
treatment with the intervention FFC-AC-EIT
|
Education Only
n=235 Participants
Treatment with control for attention with education only
|
|---|---|---|
|
Pain in Advanced Dementia Scale (PAINAD)
Baseline
|
.02 units on a scale
Standard Deviation .2
|
.2 units on a scale
Standard Deviation .6
|
|
Pain in Advanced Dementia Scale (PAINAD)
Discharge
|
.4 units on a scale
Standard Deviation 1.1
|
1.2 units on a scale
Standard Deviation 1.8
|
|
Pain in Advanced Dementia Scale (PAINAD)
One month
|
1.6 units on a scale
Standard Deviation 1.7
|
1.2 units on a scale
Standard Deviation 2.0
|
|
Pain in Advanced Dementia Scale (PAINAD)
Six month
|
1.5 units on a scale
Standard Deviation 1.6
|
1.3 units on a scale
Standard Deviation 1.8
|
|
Pain in Advanced Dementia Scale (PAINAD)
twelve month
|
6.4 units on a scale
Standard Deviation 1.7
|
6.4 units on a scale
Standard Deviation 1.8
|
Adverse Events
FFC-AC-EIT
Serious events: 0 serious events
Other events: 136 other events
Deaths: 91 deaths
Education Only
Serious events: 0 serious events
Other events: 140 other events
Deaths: 91 deaths
Serious adverse events
| Measure |
FFC-AC-EIT
n=220 participants at risk
The stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months to implement Steps 1 to 4 of FFC-AC-EIT \[(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families\]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with ADRD in physical activity while hospitalized.
FFC-AC-EIT: The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
|
Education Only
n=235 participants at risk
Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice.
FFC-AC-EIT: The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
|
|---|---|---|
|
General disorders
Events associated with study intervention
|
0.00%
0/220 • Over the 12 month study period
Our adverse events are common occurrences in older adults and none of these were associated with the study intervention or participation in the study.
|
0.00%
0/235 • Over the 12 month study period
Our adverse events are common occurrences in older adults and none of these were associated with the study intervention or participation in the study.
|
Other adverse events
| Measure |
FFC-AC-EIT
n=220 participants at risk
The stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months to implement Steps 1 to 4 of FFC-AC-EIT \[(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families\]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with ADRD in physical activity while hospitalized.
FFC-AC-EIT: The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
|
Education Only
n=235 participants at risk
Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice.
FFC-AC-EIT: The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
|
|---|---|---|
|
General disorders
falls
|
35.5%
78/220 • Over the 12 month study period
Our adverse events are common occurrences in older adults and none of these were associated with the study intervention or participation in the study.
|
40.9%
96/235 • Over the 12 month study period
Our adverse events are common occurrences in older adults and none of these were associated with the study intervention or participation in the study.
|
|
General disorders
Emergency room visits
|
53.6%
118/220 • Over the 12 month study period
Our adverse events are common occurrences in older adults and none of these were associated with the study intervention or participation in the study.
|
48.9%
115/235 • Over the 12 month study period
Our adverse events are common occurrences in older adults and none of these were associated with the study intervention or participation in the study.
|
|
General disorders
Hospitalizations
|
45.0%
99/220 • Over the 12 month study period
Our adverse events are common occurrences in older adults and none of these were associated with the study intervention or participation in the study.
|
34.0%
80/235 • Over the 12 month study period
Our adverse events are common occurrences in older adults and none of these were associated with the study intervention or participation in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place