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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transdisciplinary approach | Active Comparator | The transdisciplinary approach that 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 |
|
| multidisciplinary approach | Active Comparator | The multidisciplinary approach that is problem-based and draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transdisciplinary approach | Other | 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; |
| Measure | Description | Time Frame |
|---|---|---|
| Dispensing of Psychotropic Medications | Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 1-6 of Intervention. | 6-month period (months 1-6) |
| Dispensing of Psychotropic Medications | Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 7-12 of Intervention. | 12-month period (months 7-12) |
| Dispensing of Psychotropic Medications | Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 13-18 of Intervention. | 18-month period (months 13-18) |
| Behavioral Symptoms | Percentage of nursing home residents with dementia who had behavioral symptoms over Months 1-6 of Intervention. | 6-month period (months 1-6) |
| Behavioral Symptoms | Percentage of nursing home residents with dementia who had behavioral symptoms over Months 7-12 of Intervention. | 12-month period (months 7-12) |
| Behavioral Symptoms | Percentage of nursing home residents with dementia who had behavioral symptoms over Months 13-18 of Intervention. | 18-month period (months 13-18) |
| Wandering | Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Unintended Weight Loss | Percentage of nursing home residents with dementia who had unintended weight loss over Months 1-6 of Intervention. | 6-month period (months 1-6) |
| Unintended Weight Loss | Percentage of nursing home residents with dementia who had unintended weight loss over Months 7-12 of Intervention. |
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Inclusion Criteria:
Eligible nursing home facilities will
Exclusion Criteria:
Facilities will be excluded if they have
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| Name | Affiliation | Role |
|---|---|---|
| Natalie E Leland, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37501632 | Derived | Piersol CV, Martinez J, Chew F, Perry B, Leland NE. Understanding the Experiences of Family Caregivers of Nursing Home Residents With Dementia: A Grounded Theory Study. Gerontologist. 2024 Apr 1;64(4):gnad102. doi: 10.1093/geront/gnad102. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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; |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This was a nursing home-level analysis, therefore not all participants were in the sample during the baseline period. Participants (i.e., nursing home residents) were included if they met the study criteria based on age, dementia status, and long-term nursing home residence, but could be included in the sample at any point of the study. Thus, there were participants who were in the study sample (and reflected in the flow overview), but were not in the study sample during the baseline period.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Multidisciplinary Approach |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Population includes all nursing home residents with dementia in participating nursing homes with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 6-month period (months 1-6) |
|
This pragmatic clinical trial was embedded into the workflow of the nursing homes. Our intervention was about training staff about dementia knowledge. We were not intervening at patient level, thus adverse outcomes were not relevant.
This pragmatic clinical trial was embedded into the workflow of the nursing homes. Our intervention was about training staff about dementia knowledge. We were not intervening at patient level, thus adverse outcomes were not relevant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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; |
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We were only able to assess post-training outcomes for 6 months prior to COVID-19 and it is possible that nursing homes would have achieved different outcomes after this initial start-up period. Similarly, the comparative effectiveness of the care approaches in 12- and 18-month follow-up period were confounded by the effects of COVID-19. Finally, the use of antipsychotic medication outcome was collected with a 7-day look back period, which may have resulted in underreporting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Leland | University of Pittsburgh | (412) 383-3405 | NEL24@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2021 | Mar 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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Outcome assessors will be blinded to the treatment arm the facility is randomly assigned to.
| multidisciplinary approach | Other | This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. |
|
| 6-month period (months 1-6) |
| Wandering | Percentage of nursing home residents with dementia who had wandering over Months 7-12 of Intervention. | 12-month period (months 7-12) |
| Wandering | Percentage of nursing home residents with dementia who had wandering over Months 13-18 of Intervention. | 18-month period (months 13-18) |
| Rejection of Care | Percentage of nursing home residents with dementia who had rejection of care over Months 1-6 of Intervention. | 6-month period (months 1-6) |
| Rejection of Care | Percentage of nursing home residents with dementia who had rejection of care over Months 7-12 of Intervention. | 12-month period (months 7-12) |
| Rejection of Care | Percentage of nursing home residents with dementia who had rejection of care over Months 13-18 of Intervention. | 18-month period (months 13-18) |
| 12-month period (months 7-12) |
| Unintended Weight Loss | Percentage of nursing home residents with dementia who had unintended weight loss over Months 13-18 of Intervention. | 18-month period (months 13-18) |
| Falls | Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention. | 6-month period (months 1-6) |
| Falls | Percent of nursing home residents with dementia who had falls over Months 7-12 of Intervention. | 12-month period (months 7-12) |
| Falls | Percent of nursing home residents with dementia who had falls over Months 13-18 of Intervention. | 18-month period (months 13-18) |
| Depressive Symptoms | Percent of nursing home residents with dementia who had depressive symptoms over Months 1-6 of Intervention | 6-month period (months 1-6) |
| Depressive Symptoms | Percent of nursing home residents with dementia who had depressive symptoms over Months 7-12 of Intervention. | 12-month period (months 7-12) |
| Depressive Symptoms | Percent of nursing home residents with dementia who had depressive symptoms over Months 13-18 of Intervention. | 18-month period (months 13-18) |
| Physical Restraints Use | Percent of nursing home residents with dementia who had physical restraint use over Months 1-6 of Intervention. | 6-month period (months 1-6) |
| Physical Restraints Use | Percent of nursing home residents with dementia who had physical restraint use over Months 7-12 of Intervention. | 12-month period (months 7-12) |
| Physical Restraints Use | Percent of nursing home residents with dementia who had physical restraint use over Months 13-18 of Intervention. | 18-month period (months 13-18) |
This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. |
| BG002 | Total | Total of all reporting groups |
| Nursing homes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Cognitive Function Scale | Count of Participants | Participants | Participants |
|
| Number of Nursing Home Beds | Mean | Standard Deviation | certified beds | Nursing homes |
|
| Nursing Home Occupancy Rate | Mean | Standard Deviation | # of occupied beds/ # of certified beds | Nursing homes |
|
| CMS Nursing Home Rating | This is the Centers for Medicare and Medicaid (CMS) 5-Star Rating for nursing homes, which is a composite measure of quality reflecting state survey performance, staffing, and quality. The measure ranges from 1 to 5, with a score of 1 indicating low care quality and 5 indicates high care quality. | Mean | Standard Deviation | units on a scale | Nursing homes |
|
| Quality Measures | Mean | Standard Deviation | percentage of long-stay residents | Nursing homes |
|
This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns. |
|
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| 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. | Population includes all nursing home residents with dementia in participating nursing homes (NHs) with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 12-month period (months 7-12) |
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| 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. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 18-month period (months 13-18) |
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| Primary | Behavioral Symptoms | Percentage of nursing home residents with dementia who had behavioral symptoms over Months 1-6 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 6-month period (months 1-6) |
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| Primary | Behavioral Symptoms | Percentage of nursing home residents with dementia who had behavioral symptoms over Months 7-12 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 12-month period (months 7-12) |
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| Primary | Behavioral Symptoms | Percentage of nursing home residents with dementia who had behavioral symptoms over Months 13-18 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 18-month period (months 13-18) |
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| Primary | Wandering | Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 6-month period (months 1-6) |
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| Primary | Wandering | Percentage of nursing home residents with dementia who had wandering over Months 7-12 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 12-month period (months 7-12) |
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| Primary | Wandering | Percentage of nursing home residents with dementia who had wandering over Months 13-18 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 18-month period (months 13-18) |
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| Primary | Rejection of Care | Percentage of nursing home residents with dementia who had rejection of care over Months 1-6 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 6-month period (months 1-6) |
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| Primary | Rejection of Care | Percentage of nursing home residents with dementia who had rejection of care over Months 7-12 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 12-month period (months 7-12) |
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| Primary | Rejection of Care | Percentage of nursing home residents with dementia who had rejection of care over Months 13-18 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 18-month period (months 13-18) |
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| Secondary | Unintended Weight Loss | Percentage of nursing home residents with dementia who had unintended weight loss over Months 1-6 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 6-month period (months 1-6) |
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| Secondary | Unintended Weight Loss | Percentage of nursing home residents with dementia who had unintended weight loss over Months 7-12 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 12-month period (months 7-12) |
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| Secondary | Unintended Weight Loss | Percentage of nursing home residents with dementia who had unintended weight loss over Months 13-18 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 18-month period (months 13-18) |
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| Secondary | Falls | Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 6-month period (months 1-6) |
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| Secondary | Falls | Percent of nursing home residents with dementia who had falls over Months 7-12 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 12-month period (months 7-12) |
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| Secondary | Falls | Percent of nursing home residents with dementia who had falls over Months 13-18 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 18-month period (months 13-18) |
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| Secondary | Depressive Symptoms | Percent of nursing home residents with dementia who had depressive symptoms over Months 1-6 of Intervention | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 6-month period (months 1-6) |
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| Secondary | Depressive Symptoms | Percent of nursing home residents with dementia who had depressive symptoms over Months 7-12 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 12-month period (months 7-12) |
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| Secondary | Depressive Symptoms | Percent of nursing home residents with dementia who had depressive symptoms over Months 13-18 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 18-month period (months 13-18) |
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| Secondary | Physical Restraints Use | Percent of nursing home residents with dementia who had physical restraint use over Months 1-6 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 6-month period (months 1-6) |
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| Secondary | Physical Restraints Use | Percent of nursing home residents with dementia who had physical restraint use over Months 7-12 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 12-month period (months 7-12) |
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| Secondary | Physical Restraints Use | Percent of nursing home residents with dementia who had physical restraint use over Months 13-18 of Intervention. | Population includes all nursing home residents with dementia in participating NHs with valid data in the Minimum Data Set (MDS) assessments. | Posted | Count of Participants | Participants | 18-month period (months 13-18) |
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|
| 0 |
| 1,291 |
| 0 |
| 1,291 |
| 0 |
| 1,291 |
| EG001 | 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. | 0 | 3,206 | 0 | 3,206 | 0 | 3,206 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |