Acute Medical Event, Dementia, Hospitalization
Conditions
Brief summary
Older adults with Alzheimer's Disease and Related Dementias (ADRD) comprise approximately 25% of hospitalized older adults. These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay. Physical activity during hospitalization (e.g., mobility,bathing, dressing) has a positive impact on older adults including prevention of functional decline, less pain, less delirium, less BPSD, fewer falls, shorter length of stay and decreased unplanned hospital readmissions. Despite known benefits, physical activity is not routinely encouraged and older hospitalized patients spend over 80% of their acute care stay in bed. Challenges to increasing physical activity among older patients with ADRD include environment and policy issues (e.g., lack of access to areas to walk); lack of knowledge among nurses on how to evaluate, prevent and manage delirium and BPSD; inappropriate use of tethers; beliefs among patients, families, and nurses that bed rests helps recovery and prevents falls; and lack of motivation/willingness of patients to get out of bed. To increase physical activity and prevent functional decline while hospitalized we developed Function Focused Care for Acute Care (FFC-AC-EIT) for patients with ADRD. Implementation of FFC-AC-EIT changes how care is provided by having nurses teach, cue, and help patients with ADRD engage in physical activity during all care interactions. FFC-AC-EIT was developed using a social ecological model, social cognitive theory and the Evidence Integration Triangle. It involves a four-step approach that includes: (1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families. The purpose of this study is to test the efficacy of FFC-AC-EIT within 12 hospitals in Maryland and Pennsylvania randomized to FFC-AC-EIT or Function Focused Care Education Only (EO) with 50 patients recruited per hospital (total sample 600 patients). Aim 1 will focus on efficacy at the patient level based primarily on physical activity, function, and participation in function focused care, and secondarily on delirium, BPSD, pain, falls, use of tethers, and length of stay; and all of these outcomes (except length of stay and tethers) along with emergency room visits, re-hospitalizations and new long term care admissions at 1, 6 and 12 months post discharge; and at the unit level the aim is to evaluate the impact of FFC-AC-EIT on policies and environments that facilitate function and physical activity at 6, 12 and 18 months post implementation. Hospitals randomized to FFC-AC-EIT will be compared with those randomized to Function Focused Care Education Only (EO). Aim 2 will evaluate the feasibility, based on treatment fidelity (delivery, receipt, enactment)136, and relative cost and cost savings of FFC-AC-EIT versus EO. Findings will address several prioritized areas of research: a focus on ADRD; improving physical function; and training of hospital staff and will demonstrate efficacy of an approach to care for patients with ADRD that can be disseminated and implemented across all acute care facilities.
Detailed description
After hospitals are recruited they will be randomized to cohort and randomly assigned to treatment so that the hospital will receive either FFC-AC-EIT or EO. FFC-AC-EIT is implemented by a Research Nurse Facilitator working with the stakeholder team and unit champions 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. Timing of the intervention activities will be flexible based on the needs of the unit. The first meeting with the stakeholder team will be 1-2 hours and the remaining meetings will be approximately 30 minutes monthly to update the stakeholders on progress and any challenges associated with implementation of FFC-AC-EIT. The majority of the time on the unit by the Research Nurse Facilitator will be spent with the champions helping and assuring that they are engaging staff in function focused care activities via the four steps of FFC-AC-EIT. Once hospitals are randomized we will set up a time to meet with the identified contact to determine the stakeholder team members and champions and organize the first stakeholder team meeting. The first meeting will provide an overview of the implementation of Steps 1 to 4 \[(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families\] and will address the unit challenges to implementing function focused care using a Brainstorming approach. In the first two months the Research Nurse Facilitator completes the environment and policy assessments with the champions and implements appropriate changes on the units and plans and provides staff education and makes available information for patients and families/ caregivers. The education reviews function focused care. Ongoing work between the champions and the Research Nurse Facilitator focuses on motivating staff and patients to work toward achievement of patient goals and established unit goals. The stakeholder team will continue to meet with the Research Nurse Facilitator monthly (approximately 30 minutes) over the 12-month intervention period to review progress and to help champions overcome any identified multilevel challenges. 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. To further facilitate implementation we will give each treatment site: 1) a 100 dollar gift certificate from Nasco (Nasco.com) to buy supplies for the unit to engage patients with ADRD in physical activities (e.g., age-appropriate weights; soft horseshoe toss game); 2) 1000 dollars at the end of the study for each champion to attend a conference and submit an abstract focused on optimizing function and physical activity of hospitalized older adults with ADRD. 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.
Interventions
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.
Sponsors
Study design
Masking description
Participants as hospitals will be randomized to treatment or control
Intervention model description
randomized trial with treatment and control sites. Patients are followed for 12 months. Facilities are worked with for 12 months.
Eligibility
Inclusion criteria
1. are admitted into the hospital from any setting during the 12 month implementation period; 2. are 55 years of age or older; 3. are admitted onto a medical unit for any medical diagnosis; and 4. screen positive for dementia based on two well-validated scales: a score of ≤ 25 on the Montreal Cognitive Assessment (MoCA) and a score of \>2 on the AD8 Dementia Screening Interview; have mild to moderate stage dementia based a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale (CDR); and lastly to differentiate between dementia and mild cognitive impairment eligibility is based on evidence of functional impairment with a score of 9 or greater on the Functional Activities Questionnaire (FAQ).
Exclusion criteria
1. are enrolled in Hospice; 2. have been on the unit for greater than 48 hours; 3. do not have a family member/caregiver that we can contact; 4. anticipate surgery; or 5. have a major acute psychiatric disorder, or significant neurological condition associated with cognition other than dementia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Barthel Index | Scores at hospital admission, hospital discharge, 1,6, and 12 months post discharge | A measure of 10 activities of daily living with scores ranging from 0 to 100 and higher scores indicating better physical function. |
| The Physical Activity Survey | Baseline (hospital admission), hospital discharge (approximately 3 days),1, 6, and 12 months post discharge | 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. |
| The Short Confusion Assessment Method | baseline (hospital admission) ,hospital discharge (approximately 3 days), 1,6, and 12 months post discharge | 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. |
| the Brief Neuropsychiatric Inventory | baseline (hospital admission) , discharge (approximately 3 days),1,6, and 12 months post discharge nb | 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. |
| Pain in Advanced Dementia Scale (PAINAD) | change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FFC-AC-EIT treatment with the intervention FFC-AC-EIT | 220 |
| Education Only Treatment with control for attention with education only | 235 |
| Total | 455 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 91 | 91 |
| Overall Study | Refused | 2 | 2 |
| Overall Study | Unavailable | 12 | 3 |
| Overall Study | Withdrawal by Legally Authorized Representative | 10 | 9 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | FFC-AC-EIT | Education Only |
|---|---|---|---|
| Age, Continuous | 82.5 years STANDARD_DEVIATION 8.5 | 83.6 years STANDARD_DEVIATION 7.8 | 81.4 years STANDARD_DEVIATION 9 |
| Barthel index | 51.5 units on a scale STANDARD_DEVIATION 27 | 49.2 units on a scale STANDARD_DEVIATION 27.3 | 54.9 units on a scale STANDARD_DEVIATION 27.1 |
| Delirium | 1.7 units on a scale STANDARD_DEVIATION 1.7 | 1.5 units on a scale STANDARD_DEVIATION 1.7 | 2.1 units on a scale STANDARD_DEVIATION 1.8 |
| Neuropsychiatric inventory | 1.9 units on a scale STANDARD_DEVIATION 2.5 | 1.4 units on a scale STANDARD_DEVIATION 2.7 | 2.4 units on a scale STANDARD_DEVIATION 3.2 |
| Pain | .11 units on a scale STANDARD_DEVIATION 0.4 | .02 units on a scale STANDARD_DEVIATION 0.2 | .2 units on a scale STANDARD_DEVIATION 0.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 9 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 141 Participants | 49 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 297 Participants | 162 Participants | 135 Participants |
| Sex: Female, Male Female | 285 Participants | 135 Participants | 150 Participants |
| Sex: Female, Male Male | 170 Participants | 85 Participants | 85 Participants |
| The Physical Activity Survey | 8.8 units on a scale STANDARD_DEVIATION 5.5 | 8.2 units on a scale STANDARD_DEVIATION 5 | 9.6 units on a scale STANDARD_DEVIATION 6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 91 / 220 | 91 / 235 |
| other Total, other adverse events | 136 / 220 | 140 / 235 |
| serious Total, serious adverse events | 0 / 220 | 0 / 235 |
Outcome results
Pain in Advanced Dementia Scale (PAINAD)
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.
Time frame: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Population: participants who had data collected at these time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FFC-AC-EIT | Pain in Advanced Dementia Scale (PAINAD) | Discharge | .4 units on a scale | Standard Deviation 1.1 |
| FFC-AC-EIT | Pain in Advanced Dementia Scale (PAINAD) | One month | 1.6 units on a scale | Standard Deviation 1.7 |
| FFC-AC-EIT | Pain in Advanced Dementia Scale (PAINAD) | Six month | 1.5 units on a scale | Standard Deviation 1.6 |
| FFC-AC-EIT | Pain in Advanced Dementia Scale (PAINAD) | twelve month | 6.4 units on a scale | Standard Deviation 1.7 |
| FFC-AC-EIT | Pain in Advanced Dementia Scale (PAINAD) | Baseline | .02 units on a scale | Standard Deviation 0.2 |
| Education Only | Pain in Advanced Dementia Scale (PAINAD) | Baseline | .2 units on a scale | Standard Deviation 0.6 |
| Education Only | Pain in Advanced Dementia Scale (PAINAD) | twelve month | 6.4 units on a scale | Standard Deviation 1.8 |
| Education Only | Pain in Advanced Dementia Scale (PAINAD) | One month | 1.2 units on a scale | Standard Deviation 2 |
| Education Only | Pain in Advanced Dementia Scale (PAINAD) | Discharge | 1.2 units on a scale | Standard Deviation 1.8 |
| Education Only | Pain in Advanced Dementia Scale (PAINAD) | Six month | 1.3 units on a scale | Standard Deviation 1.8 |
The Barthel Index
A measure of 10 activities of daily living with scores ranging from 0 to 100 and higher scores indicating better physical function.
Time frame: Scores at hospital admission, hospital discharge, 1,6, and 12 months post discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FFC-AC-EIT | The Barthel Index | 12 month | 32.0 score on a scale | Standard Deviation 12.1 |
| FFC-AC-EIT | The Barthel Index | Baseline | 49.2 score on a scale | Standard Deviation 27.3 |
| FFC-AC-EIT | The Barthel Index | discharge | 52.0 score on a scale | Standard Deviation 28.5 |
| FFC-AC-EIT | The Barthel Index | one month | 58.2 score on a scale | Standard Deviation 31.7 |
| FFC-AC-EIT | The Barthel Index | six month | 61.1 score on a scale | Standard Deviation 32 |
| Education Only | The Barthel Index | six month | 61.4 score on a scale | Standard Deviation 27.3 |
| Education Only | The Barthel Index | one month | 58.0 score on a scale | Standard Deviation 30.6 |
| Education Only | The Barthel Index | Baseline | 54.9 score on a scale | Standard Deviation 27.3 |
| Education Only | The Barthel Index | 12 month | 30.1 score on a scale | Standard Deviation 10.8 |
| Education Only | The Barthel Index | discharge | 58.7 score on a scale | Standard Deviation 27.6 |
the Brief Neuropsychiatric Inventory
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.
Time frame: baseline (hospital admission) , discharge (approximately 3 days),1,6, and 12 months post discharge nb
Population: Participants who had data collected at these time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FFC-AC-EIT | the Brief Neuropsychiatric Inventory | Discharge | 1.7 units on a scale | Standard Deviation 3.1 |
| FFC-AC-EIT | the Brief Neuropsychiatric Inventory | Six month | 5.7 units on a scale | Standard Deviation 5.2 |
| FFC-AC-EIT | the Brief Neuropsychiatric Inventory | One month | 6.6 units on a scale | Standard Deviation 5.8 |
| FFC-AC-EIT | the Brief Neuropsychiatric Inventory | twelve month | 3.0 units on a scale | Standard Deviation 2.4 |
| FFC-AC-EIT | the Brief Neuropsychiatric Inventory | Baseline | 1.4 units on a scale | Standard Deviation 2.7 |
| Education Only | the Brief Neuropsychiatric Inventory | twelve month | 3.5 units on a scale | Standard Deviation 2.6 |
| Education Only | the Brief Neuropsychiatric Inventory | Baseline | 2.4 units on a scale | Standard Deviation 3.2 |
| Education Only | the Brief Neuropsychiatric Inventory | Discharge | 2.3 units on a scale | Standard Deviation 3.1 |
| Education Only | the Brief Neuropsychiatric Inventory | One month | 6.0 units on a scale | Standard Deviation 5.7 |
| Education Only | the Brief Neuropsychiatric Inventory | Six month | 6.8 units on a scale | Standard Deviation 6.1 |
The Physical Activity Survey
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.
Time frame: Baseline (hospital admission), hospital discharge (approximately 3 days),1, 6, and 12 months post discharge
Population: participants who had data collected at these time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FFC-AC-EIT | The Physical Activity Survey | twelve month | 13.4 score on scale | Standard Deviation 6.2 |
| FFC-AC-EIT | The Physical Activity Survey | Baseline | 8.2 score on scale | Standard Deviation 5 |
| FFC-AC-EIT | The Physical Activity Survey | Discharge | 9.2 score on scale | Standard Deviation 5.7 |
| FFC-AC-EIT | The Physical Activity Survey | one month | 13.6 score on scale | Standard Deviation 6.7 |
| FFC-AC-EIT | The Physical Activity Survey | six month | 13.9 score on scale | Standard Deviation 6.6 |
| Education Only | The Physical Activity Survey | six month | 12.9 score on scale | Standard Deviation 4.6 |
| Education Only | The Physical Activity Survey | one month | 11.9 score on scale | Standard Deviation 5.7 |
| Education Only | The Physical Activity Survey | Baseline | 9.6 score on scale | Standard Deviation 6 |
| Education Only | The Physical Activity Survey | twelve month | 11.7 score on scale | Standard Deviation 4.4 |
| Education Only | The Physical Activity Survey | Discharge | 10.1 score on scale | Standard Deviation 6.4 |
The Short Confusion Assessment Method
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.
Time frame: baseline (hospital admission) ,hospital discharge (approximately 3 days), 1,6, and 12 months post discharge
Population: participants who had data collected at these time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FFC-AC-EIT | The Short Confusion Assessment Method | Baseline | 1.5 score on a scale | Standard Deviation 1.7 |
| FFC-AC-EIT | The Short Confusion Assessment Method | Discharge | 1.2 score on a scale | Standard Deviation 1.7 |
| FFC-AC-EIT | The Short Confusion Assessment Method | One Month | 2.2 score on a scale | Standard Deviation 1.9 |
| FFC-AC-EIT | The Short Confusion Assessment Method | Six month | 2.1 score on a scale | Standard Deviation 1.7 |
| FFC-AC-EIT | The Short Confusion Assessment Method | twelve month | 2.1 score on a scale | Standard Deviation 1.6 |
| Education Only | The Short Confusion Assessment Method | Six month | 2.5 score on a scale | Standard Deviation 1.9 |
| Education Only | The Short Confusion Assessment Method | Baseline | 2.1 score on a scale | Standard Deviation 1.8 |
| Education Only | The Short Confusion Assessment Method | One Month | 2.2 score on a scale | Standard Deviation 1.8 |
| Education Only | The Short Confusion Assessment Method | twelve month | 2.7 score on a scale | Standard Deviation 2 |
| Education Only | The Short Confusion Assessment Method | Discharge | 1.7 score on a scale | Standard Deviation 1.6 |