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Optimizing Care for Patients With Dementia

Optimizing Care for Patients With Dementia: A Comparison of Two Non-pharmacological Treatment Approaches

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03442322
Enrollment
53
Registered
2018-02-22
Start date
2018-03-15
Completion date
2022-07-26
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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

OTHERtransdisciplinary 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;

This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

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

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
Rejection of Care6-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 Medications6-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 Symptoms6-month period (months 1-6)Percentage of nursing home residents with dementia who had behavioral symptoms over Months 1-6 of Intervention.
Wandering6-month period (months 1-6)Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention.

Secondary

MeasureTime frameDescription
Unintended Weight Loss6-month period (months 1-6)Percentage of nursing home residents with dementia who had unintended weight loss over Months 1-6 of Intervention.
Falls6-month period (months 1-6)Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention.
Depressive Symptoms6-month period (months 1-6)Percent of nursing home residents with dementia who had depressive symptoms over Months 1-6 of Intervention
Physical Restraints Use6-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

ArmCount
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
Total2,781

Baseline characteristics

CharacteristicTransdisciplinary ApproachMultidisciplinary ApproachTotal
Age, Continuous84.2 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 Participants219 Participants299 Participants
Cognitive Function Scale
Mildly impaired
123 Participants369 Participants492 Participants
Cognitive Function Scale
Moderately impaired
427 Participants1138 Participants1565 Participants
Cognitive Function Scale
Severely impaired
129 Participants243 Participants372 Participants
Number of Nursing Home Beds118.6 certified beds
STANDARD_DEVIATION 50.2
119.9 certified beds
STANDARD_DEVIATION 38
119.5 certified beds
STANDARD_DEVIATION 41.8
Nursing Home Occupancy Rate0.87 # 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 Participants6 Participants15 Participants
Race/Ethnicity, Customized
Black, non-Hispanic
45 Participants244 Participants289 Participants
Race/Ethnicity, Customized
Hispanic
69 Participants91 Participants160 Participants
Race/Ethnicity, Customized
Other
14 Participants39 Participants53 Participants
Race/Ethnicity, Customized
White, non-Hispanic
622 Participants1589 Participants2211 Participants
Sex: Female, Male
Female
532 Participants1469 Participants2001 Participants
Sex: Female, Male
Male
227 Participants500 Participants727 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,2910 / 3,206
other
Total, other adverse events
0 / 1,2910 / 3,206
serious
Total, serious adverse events
0 / 1,2910 / 3,206

Outcome results

Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachBehavioral Symptoms143 Participants
Multidisciplinary ApproachBehavioral Symptoms334 Participants
p-value: 0.108Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachBehavioral Symptoms104 Participants
Multidisciplinary ApproachBehavioral Symptoms299 Participants
p-value: 0.411Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachBehavioral Symptoms68 Participants
Multidisciplinary ApproachBehavioral Symptoms232 Participants
p-value: 0.981Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachDispensing of Psychotropic Medications161 Participants
Multidisciplinary ApproachDispensing of Psychotropic Medications315 Participants
p-value: 0.492Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachDispensing of Psychotropic Medications125 Participants
Multidisciplinary ApproachDispensing of Psychotropic Medications289 Participants
p-value: 0.765Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachDispensing of Psychotropic Medications107 Participants
Multidisciplinary ApproachDispensing of Psychotropic Medications227 Participants
p-value: 0.808Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachRejection of Care59 Participants
Multidisciplinary ApproachRejection of Care217 Participants
p-value: 0.279Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachRejection of Care131 Participants
Multidisciplinary ApproachRejection of Care302 Participants
p-value: 0.389Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachRejection of Care75 Participants
Multidisciplinary ApproachRejection of Care282 Participants
p-value: 0.043Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachWandering88 Participants
Multidisciplinary ApproachWandering117 Participants
p-value: 0.02Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachWandering52 Participants
Multidisciplinary ApproachWandering116 Participants
p-value: 0.299Regression, Linear
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachWandering38 Participants
Multidisciplinary ApproachWandering98 Participants
p-value: 0.389Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachDepressive Symptoms37 Participants
Multidisciplinary ApproachDepressive Symptoms90 Participants
p-value: 0.898Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachDepressive Symptoms20 Participants
Multidisciplinary ApproachDepressive Symptoms59 Participants
p-value: 0.56Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachDepressive Symptoms24 Participants
Multidisciplinary ApproachDepressive Symptoms95 Participants
p-value: 0.217Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachFalls326 Participants
Multidisciplinary ApproachFalls750 Participants
p-value: 0.708Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachFalls274 Participants
Multidisciplinary ApproachFalls700 Participants
p-value: 0.775Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachFalls246 Participants
Multidisciplinary ApproachFalls614 Participants
p-value: 0.584Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachPhysical Restraints Use0 Participants
Multidisciplinary ApproachPhysical Restraints Use70 Participants
p-value: 0.303Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachPhysical Restraints Use3 Participants
Multidisciplinary ApproachPhysical Restraints Use102 Participants
p-value: 0.277Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachPhysical Restraints Use4 Participants
Multidisciplinary ApproachPhysical Restraints Use91 Participants
p-value: 0.4Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachUnintended Weight Loss125 Participants
Multidisciplinary ApproachUnintended Weight Loss302 Participants
p-value: 0.728Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachUnintended Weight Loss137 Participants
Multidisciplinary ApproachUnintended Weight Loss294 Participants
p-value: 0.232Regression, Linear
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transdisciplinary ApproachUnintended Weight Loss132 Participants
Multidisciplinary ApproachUnintended Weight Loss395 Participants
p-value: 0.49Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026