Alzheimer Disease
Conditions
Keywords
long term care residents, nursing home care
Brief summary
Of the 1.4 million nursing home (NH) residents in long term care facilities, more than half have Alzheimer's disease or dementia. Due to changes in their familiar daily routines, difficulty expressing their thoughts or asking for what they need, and overstimulation (such as noise) or under stimulation (such as lack of activity), individuals with dementia often display disruptive behaviors like resisting help or continually repeating the same phrases. Medications are often prescribed to reduce agitation and aggressive behavior; however, these medications may not be effective and can have a negative impact on the individual. Therefore, families and other stakeholders strongly advocate the use of other types of approaches that focus on minimizing the cause of the behavior. Two facility-based methodologies include the transdisciplinary approach for integrated dementia care, which combines the expertise of all NH staff, who work together to build a common language and approach for each resident, and the multidisciplinary approach for problem-based dementia care, in which each staff member conducts individual assessments and makes discipline-specific recommendations. While prior research suggests that both of these facility-based approaches are useful, the circumstances under which each approach is most effective are not clear. This project will prospectively randomize 80 nursing homes to one of the two treatment arms to compare the effect of the transdisciplinary approach versus the multidisciplinary approach. This study will examine the difference between the two comparators with respect to facility rates of medications dispensed to residents with dementia, leading to enhanced quality of life for the resident. This project is important because it will address a key clinical dilemma NH staff face as they strive to optimize the use of alternative approaches to reduce disruptive behaviors in residents with dementia. Transforming the quality of dementia care in NHs and enhancing the quality of life of residents with dementia are high priorities for families and other advocates.
Interventions
This approach is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability;
This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.
Sponsors
Study design
Masking description
Outcome assessors will be blinded to the treatment arm the facility is randomly assigned to.
Intervention model description
This cluster pragmatic trial randomized eligible nursing homes to one of the two intervention arms according to the predetermined protocol to evaluate the effect of the facility-level intervention on resident (i.e. long term care residents living with Alzheimer's Disease or Related Dementia) and staff outcomes.
Eligibility
Inclusion criteria
Eligible nursing home facilities will * lack any existing dementia program targeting reduction of off-label psychotropic medication use * each serve \>60 long-term care residents with Alzheimer's or dementia * meet Center for Medicare & Medicaid Services' minimum requirements for NHs (e.g., meeting the mandated number of hours of staff training on dementia care, performing regularly scheduled resident assessments).
Exclusion criteria
Facilities will be excluded if they have * less than 60 long-stay residents * an existing formal dementia care program in place * an off-label psychotropic medication reduction program * is located in a state that requires more than the Center for Medicare & Medicaid Services' minimum for staff training requirements on the topic of dementia care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rejection of Care | 6-month period (months 1-6) | Percentage of nursing home residents with dementia who had rejection of care over Months 1-6 of Intervention. |
| Dispensing of Psychotropic Medications | 6-month period (months 1-6) | Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 1-6 of Intervention. |
| Behavioral Symptoms | 6-month period (months 1-6) | Percentage of nursing home residents with dementia who had behavioral symptoms over Months 1-6 of Intervention. |
| Wandering | 6-month period (months 1-6) | Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unintended Weight Loss | 6-month period (months 1-6) | Percentage of nursing home residents with dementia who had unintended weight loss over Months 1-6 of Intervention. |
| Falls | 6-month period (months 1-6) | Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention. |
| Depressive Symptoms | 6-month period (months 1-6) | Percent of nursing home residents with dementia who had depressive symptoms over Months 1-6 of Intervention |
| Physical Restraints Use | 6-month period (months 1-6) | Percent of nursing home residents with dementia who had physical restraint use over Months 1-6 of Intervention. |
Countries
United States
Participant flow
Pre-assignment details
This mixed methods study used quantitative methods to examine nursing home resident outcomes of the two non-pharmacological approaches to dementia care (i.e., the primary study outcomes). Qualitative methods included one-time interviews with family caregivers and nursing home staff intended to understand their experiences with the two non-pharmacological approaches. Flow chart below reflects the participating nursing homes (i.e., units) and their residents with dementia (i.e. participants).
Participants by arm
| Arm | Count |
|---|---|
| Transdisciplinary Approach This approach is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability. | 759 |
| Transdisciplinary Approach This approach is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability. | 17 |
| Multidisciplinary Approach This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. | 1,969 |
| Multidisciplinary Approach This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. | 36 |
| Total | 2,781 |
Baseline characteristics
| Characteristic | Transdisciplinary Approach | Multidisciplinary Approach | Total |
|---|---|---|---|
| Age, Continuous | 84.2 years STANDARD_DEVIATION 8.1 | 84.9 years STANDARD_DEVIATION 8.4 | 84.7 years STANDARD_DEVIATION 8.3 |
| CMS Nursing Home Rating Quality of Care | 3.5 units on a scale STANDARD_DEVIATION 1.1 | 3.6 units on a scale STANDARD_DEVIATION 1.1 | 3.5 units on a scale STANDARD_DEVIATION 1.1 |
| CMS Nursing Home Rating Staffing Levels | 3.1 units on a scale STANDARD_DEVIATION 0.7 | 2.7 units on a scale STANDARD_DEVIATION 1 | 2.8 units on a scale STANDARD_DEVIATION 0.9 |
| CMS Nursing Home Rating State Survey | 2.6 units on a scale STANDARD_DEVIATION 1.2 | 2.7 units on a scale STANDARD_DEVIATION 1.2 | 2.7 units on a scale STANDARD_DEVIATION 1.2 |
| Cognitive Function Scale Cognitively Intact | 80 Participants | 219 Participants | 299 Participants |
| Cognitive Function Scale Mildly impaired | 123 Participants | 369 Participants | 492 Participants |
| Cognitive Function Scale Moderately impaired | 427 Participants | 1138 Participants | 1565 Participants |
| Cognitive Function Scale Severely impaired | 129 Participants | 243 Participants | 372 Participants |
| Number of Nursing Home Beds | 118.6 certified beds STANDARD_DEVIATION 50.2 | 119.9 certified beds STANDARD_DEVIATION 38 | 119.5 certified beds STANDARD_DEVIATION 41.8 |
| Nursing Home Occupancy Rate | 0.87 # of occupied beds/ # of certified beds STANDARD_DEVIATION 0.1 | 0.87 # of occupied beds/ # of certified beds STANDARD_DEVIATION 0.1 | 0.87 # of occupied beds/ # of certified beds STANDARD_DEVIATION 0.1 |
| Quality Measures ability to move independently worsened | 21.2 percentage of long-stay residents STANDARD_DEVIATION 9.9 | 21.3 percentage of long-stay residents STANDARD_DEVIATION 7.8 | 21.2 percentage of long-stay residents STANDARD_DEVIATION 8.4 |
| Quality Measures had catheter inserted and left in bladder | 1.4 percentage of long-stay residents STANDARD_DEVIATION 1.2 | 1.3 percentage of long-stay residents STANDARD_DEVIATION 1.4 | 1.3 percentage of long-stay residents STANDARD_DEVIATION 1.3 |
| Quality Measures had fall(s) with injury | 4.2 percentage of long-stay residents STANDARD_DEVIATION 1.9 | 3.1 percentage of long-stay residents STANDARD_DEVIATION 2.5 | 3.5 percentage of long-stay residents STANDARD_DEVIATION 2.4 |
| Quality Measures had pressure ulcer | 8.8 percentage of long-stay residents STANDARD_DEVIATION 3.7 | 8.3 percentage of long-stay residents STANDARD_DEVIATION 3.7 | 8.5 percentage of long-stay residents STANDARD_DEVIATION 3.7 |
| Quality Measures had urinary tract infection | 2.9 percentage of long-stay residents STANDARD_DEVIATION 2.5 | 2.1 percentage of long-stay residents STANDARD_DEVIATION 1.6 | 2.4 percentage of long-stay residents STANDARD_DEVIATION 1.9 |
| Quality Measures have depressive symptoms | 4.6 percentage of long-stay residents STANDARD_DEVIATION 5.7 | 3.6 percentage of long-stay residents STANDARD_DEVIATION 4.1 | 3.8 percentage of long-stay residents STANDARD_DEVIATION 4.6 |
| Quality Measures increased in need for help with ADL | 18.3 percentage of long-stay residents STANDARD_DEVIATION 6.7 | 17.3 percentage of long-stay residents STANDARD_DEVIATION 5.4 | 17.6 percentage of long-stay residents STANDARD_DEVIATION 5.8 |
| Quality Measures lost too much weight | 5.6 percentage of long-stay residents STANDARD_DEVIATION 2.5 | 7.3 percentage of long-stay residents STANDARD_DEVIATION 3.5 | 6.8 percentage of long-stay residents STANDARD_DEVIATION 3.3 |
| Quality Measures received antianxiety/hypnotic medication | 22.4 percentage of long-stay residents STANDARD_DEVIATION 7.3 | 21.4 percentage of long-stay residents STANDARD_DEVIATION 11.5 | 21.7 percentage of long-stay residents STANDARD_DEVIATION 10.3 |
| Quality Measures received antipsychotic medication | 12.7 percentage of long-stay residents STANDARD_DEVIATION 3.9 | 13.4 percentage of long-stay residents STANDARD_DEVIATION 6.4 | 13.2 percentage of long-stay residents STANDARD_DEVIATION 5.7 |
| Quality Measures were physically restrained | 0.1 percentage of long-stay residents STANDARD_DEVIATION 0.3 | 0.2 percentage of long-stay residents STANDARD_DEVIATION 0.5 | 0.1 percentage of long-stay residents STANDARD_DEVIATION 0.4 |
| Race/Ethnicity, Customized Asian | 9 Participants | 6 Participants | 15 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 45 Participants | 244 Participants | 289 Participants |
| Race/Ethnicity, Customized Hispanic | 69 Participants | 91 Participants | 160 Participants |
| Race/Ethnicity, Customized Other | 14 Participants | 39 Participants | 53 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 622 Participants | 1589 Participants | 2211 Participants |
| Sex: Female, Male Female | 532 Participants | 1469 Participants | 2001 Participants |
| Sex: Female, Male Male | 227 Participants | 500 Participants | 727 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,291 | 0 / 3,206 |
| other Total, other adverse events | 0 / 1,291 | 0 / 3,206 |
| serious Total, serious adverse events | 0 / 1,291 | 0 / 3,206 |
Outcome results
Behavioral Symptoms
Percentage of nursing home residents with dementia who had behavioral symptoms over Months 1-6 of Intervention.
Time frame: 6-month period (months 1-6)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Behavioral Symptoms | 143 Participants |
| Multidisciplinary Approach | Behavioral Symptoms | 334 Participants |
Behavioral Symptoms
Percentage of nursing home residents with dementia who had behavioral symptoms over Months 7-12 of Intervention.
Time frame: 12-month period (months 7-12)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Behavioral Symptoms | 104 Participants |
| Multidisciplinary Approach | Behavioral Symptoms | 299 Participants |
Behavioral Symptoms
Percentage of nursing home residents with dementia who had behavioral symptoms over Months 13-18 of Intervention.
Time frame: 18-month period (months 13-18)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Behavioral Symptoms | 68 Participants |
| Multidisciplinary Approach | Behavioral Symptoms | 232 Participants |
Dispensing of Psychotropic Medications
Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 1-6 of Intervention.
Time frame: 6-month period (months 1-6)
Population: Population includes all nursing home residents with dementia in participating nursing homes with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Dispensing of Psychotropic Medications | 161 Participants |
| Multidisciplinary Approach | Dispensing of Psychotropic Medications | 315 Participants |
Dispensing of Psychotropic Medications
Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 7-12 of Intervention.
Time frame: 12-month period (months 7-12)
Population: Population includes all nursing home residents with dementia in participating nursing homes (NHs) with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Dispensing of Psychotropic Medications | 125 Participants |
| Multidisciplinary Approach | Dispensing of Psychotropic Medications | 289 Participants |
Dispensing of Psychotropic Medications
Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 13-18 of Intervention.
Time frame: 18-month period (months 13-18)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Dispensing of Psychotropic Medications | 107 Participants |
| Multidisciplinary Approach | Dispensing of Psychotropic Medications | 227 Participants |
Rejection of Care
Percentage of nursing home residents with dementia who had rejection of care over Months 13-18 of Intervention.
Time frame: 18-month period (months 13-18)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Rejection of Care | 59 Participants |
| Multidisciplinary Approach | Rejection of Care | 217 Participants |
Rejection of Care
Percentage of nursing home residents with dementia who had rejection of care over Months 1-6 of Intervention.
Time frame: 6-month period (months 1-6)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Rejection of Care | 131 Participants |
| Multidisciplinary Approach | Rejection of Care | 302 Participants |
Rejection of Care
Percentage of nursing home residents with dementia who had rejection of care over Months 7-12 of Intervention.
Time frame: 12-month period (months 7-12)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Rejection of Care | 75 Participants |
| Multidisciplinary Approach | Rejection of Care | 282 Participants |
Wandering
Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention.
Time frame: 6-month period (months 1-6)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Wandering | 88 Participants |
| Multidisciplinary Approach | Wandering | 117 Participants |
Wandering
Percentage of nursing home residents with dementia who had wandering over Months 7-12 of Intervention.
Time frame: 12-month period (months 7-12)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Wandering | 52 Participants |
| Multidisciplinary Approach | Wandering | 116 Participants |
Wandering
Percentage of nursing home residents with dementia who had wandering over Months 13-18 of Intervention.
Time frame: 18-month period (months 13-18)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Wandering | 38 Participants |
| Multidisciplinary Approach | Wandering | 98 Participants |
Depressive Symptoms
Percent of nursing home residents with dementia who had depressive symptoms over Months 1-6 of Intervention
Time frame: 6-month period (months 1-6)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Depressive Symptoms | 37 Participants |
| Multidisciplinary Approach | Depressive Symptoms | 90 Participants |
Depressive Symptoms
Percent of nursing home residents with dementia who had depressive symptoms over Months 13-18 of Intervention.
Time frame: 18-month period (months 13-18)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Depressive Symptoms | 20 Participants |
| Multidisciplinary Approach | Depressive Symptoms | 59 Participants |
Depressive Symptoms
Percent of nursing home residents with dementia who had depressive symptoms over Months 7-12 of Intervention.
Time frame: 12-month period (months 7-12)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Depressive Symptoms | 24 Participants |
| Multidisciplinary Approach | Depressive Symptoms | 95 Participants |
Falls
Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention.
Time frame: 6-month period (months 1-6)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Falls | 326 Participants |
| Multidisciplinary Approach | Falls | 750 Participants |
Falls
Percent of nursing home residents with dementia who had falls over Months 7-12 of Intervention.
Time frame: 12-month period (months 7-12)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Falls | 274 Participants |
| Multidisciplinary Approach | Falls | 700 Participants |
Falls
Percent of nursing home residents with dementia who had falls over Months 13-18 of Intervention.
Time frame: 18-month period (months 13-18)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Falls | 246 Participants |
| Multidisciplinary Approach | Falls | 614 Participants |
Physical Restraints Use
Percent of nursing home residents with dementia who had physical restraint use over Months 13-18 of Intervention.
Time frame: 18-month period (months 13-18)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Physical Restraints Use | 0 Participants |
| Multidisciplinary Approach | Physical Restraints Use | 70 Participants |
Physical Restraints Use
Percent of nursing home residents with dementia who had physical restraint use over Months 1-6 of Intervention.
Time frame: 6-month period (months 1-6)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Physical Restraints Use | 3 Participants |
| Multidisciplinary Approach | Physical Restraints Use | 102 Participants |
Physical Restraints Use
Percent of nursing home residents with dementia who had physical restraint use over Months 7-12 of Intervention.
Time frame: 12-month period (months 7-12)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Physical Restraints Use | 4 Participants |
| Multidisciplinary Approach | Physical Restraints Use | 91 Participants |
Unintended Weight Loss
Percentage of nursing home residents with dementia who had unintended weight loss over Months 1-6 of Intervention.
Time frame: 6-month period (months 1-6)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Unintended Weight Loss | 125 Participants |
| Multidisciplinary Approach | Unintended Weight Loss | 302 Participants |
Unintended Weight Loss
Percentage of nursing home residents with dementia who had unintended weight loss over Months 13-18 of Intervention.
Time frame: 18-month period (months 13-18)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Unintended Weight Loss | 137 Participants |
| Multidisciplinary Approach | Unintended Weight Loss | 294 Participants |
Unintended Weight Loss
Percentage of nursing home residents with dementia who had unintended weight loss over Months 7-12 of Intervention.
Time frame: 12-month period (months 7-12)
Population: Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transdisciplinary Approach | Unintended Weight Loss | 132 Participants |
| Multidisciplinary Approach | Unintended Weight Loss | 395 Participants |