CClinicalTrials.gg
CompletedNCT03442322Updated Aug 19, 2024Results posted

Optimizing Care for Patients With Dementia

An interventional study of transdisciplinary approach and multidisciplinary approach in Alzheimer Disease, sponsored by University of Pittsburgh. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease

Keywords

  • long term care residents
  • nursing home care
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • Active comparator
    transdisciplinary approach

    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

    Other: transdisciplinary approach

  • Active comparator
    multidisciplinary approach

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

    Other: multidisciplinary approach

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;

  • Othermultidisciplinary approach

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

05

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

06

Results

Posted Aug 19, 2024
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestoneTransdisciplinary ApproachMultidisciplinary Approach
Started12913206
6-month outcome7931905
12-month outcome6581693
Completed5261420
Not completed7651786

Outcome measures

PrimaryDispensing 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)
Reported as:
Count of participants · Participants
Dispensing of Psychotropic Medications
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Dispensing of Psychotropic Medications161315
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.492 · Difference-in-difference estimator: 1.25All regressions controlled for resident characteristics and nursing home fixed effects.
PrimaryDispensing 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)
Reported as:
Count of participants · Participants
Dispensing of Psychotropic Medications
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Dispensing of Psychotropic Medications125289
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.765 · Difference-in-difference estimator: -0.73All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
PrimaryDispensing 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)
Reported as:
Count of participants · Participants
Dispensing of Psychotropic Medications
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Dispensing of Psychotropic Medications107227
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.808 · Difference-in-difference estimator: 0.77All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
PrimaryBehavioral 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)
Reported as:
Count of participants · Participants
Behavioral Symptoms
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Behavioral Symptoms143334
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.108 · Difference-in-difference estimator: 3.86All regressions controlled for resident characteristics and nursing home fixed effects.
PrimaryBehavioral 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)
Reported as:
Count of participants · Participants
Behavioral Symptoms
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Behavioral Symptoms104299
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.411 · Difference-in-difference estimator: 2.59All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
PrimaryBehavioral 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)
Reported as:
Count of participants · Participants
Behavioral Symptoms
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Behavioral Symptoms68232
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.981 · Difference-in-difference estimator: -0.08All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
PrimaryWandering

Percentage of nursing home residents with dementia who had wandering over Months 1-6 of Intervention.

Time frame:
6-month period (months 1-6)
Reported as:
Count of participants · Participants
Wandering
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Wandering88117
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.020 · Difference-in-difference estimator: 3.51All regressions controlled for resident characteristics and nursing home fixed effects.
PrimaryWandering

Percentage of nursing home residents with dementia who had wandering over Months 7-12 of Intervention.

Time frame:
12-month period (months 7-12)
Reported as:
Count of participants · Participants
Wandering
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Wandering52116
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.299 · Difference-in-difference estimator: 1.62All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
PrimaryWandering

Percentage of nursing home residents with dementia who had wandering over Months 13-18 of Intervention.

Time frame:
18-month period (months 13-18)
Reported as:
Count of participants · Participants
Wandering
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Wandering3898
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.389 · Difference-in-difference estimator: 1.68All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
PrimaryRejection 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)
Reported as:
Count of participants · Participants
Rejection of Care
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Rejection of Care131302
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.389 · Difference-in-difference estimator: -2.14All regressions controlled for resident characteristics and nursing home fixed effects.
PrimaryRejection 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)
Reported as:
Count of participants · Participants
Rejection of Care
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Rejection of Care75282
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.043 · Difference-in-difference estimator: -5.95All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
PrimaryRejection 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)
Reported as:
Count of participants · Participants
Rejection of Care
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Rejection of Care59217
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.279 · Difference-in-difference estimator: -3.91All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
SecondaryUnintended 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)
Reported as:
Count of participants · Participants
Unintended Weight Loss
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Unintended Weight Loss125302
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.728 · Difference-in-difference estimator: 0.92All regressions controlled for resident characteristics and nursing home fixed effects.
SecondaryUnintended 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)
Reported as:
Count of participants · Participants
Unintended Weight Loss
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Unintended Weight Loss132395
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.490 · Difference-in-difference estimator: -1.75All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
SecondaryUnintended 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)
Reported as:
Count of participants · Participants
Unintended Weight Loss
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Unintended Weight Loss137294
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.232 · Difference-in-difference estimator: 4.44All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
SecondaryFalls

Percent of nursing home residents with dementia who had falls over Months 1-6 of Intervention.

Time frame:
6-month period (months 1-6)
Reported as:
Count of participants · Participants
Falls
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Falls326750
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.708 · Difference-in-difference estimator: 1.11All regressions controlled for resident characteristics and nursing home fixed effects.
SecondaryFalls

Percent of nursing home residents with dementia who had falls over Months 7-12 of Intervention.

Time frame:
12-month period (months 7-12)
Reported as:
Count of participants · Participants
Falls
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Falls274700
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.775 · Difference-in-difference estimator: 1.00All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
SecondaryFalls

Percent of nursing home residents with dementia who had falls over Months 13-18 of Intervention.

Time frame:
18-month period (months 13-18)
Reported as:
Count of participants · Participants
Falls
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Falls246614
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.584 · Difference-in-difference estimator: 1.77All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
SecondaryDepressive 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)
Reported as:
Count of participants · Participants
Depressive Symptoms
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Depressive Symptoms3790
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.898 · Difference-in-difference estimator: -0.25All regressions controlled for resident characteristics and nursing home fixed effects.
SecondaryDepressive 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)
Reported as:
Count of participants · Participants
Depressive Symptoms
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Depressive Symptoms2495
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.217 · Difference-in-difference estimator: -2.79All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
SecondaryDepressive 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)
Reported as:
Count of participants · Participants
Depressive Symptoms
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Depressive Symptoms2059
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.560 · Difference-in-difference estimator: -1.39All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
SecondaryPhysical 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)
Reported as:
Count of participants · Participants
Physical Restraints Use
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Physical Restraints Use3102
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.277 · Difference-in-difference estimator: -3.08All regressions controlled for resident characteristics and nursing home fixed effects.
SecondaryPhysical 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)
Reported as:
Count of participants · Participants
Physical Restraints Use
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Physical Restraints Use491
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.400 · Difference-in-difference estimator: -2.53All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.
SecondaryPhysical 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)
Reported as:
Count of participants · Participants
Physical Restraints Use
ParticipantsTransdisciplinary ApproachMultidisciplinary Approach
Physical Restraints Use070
Statistical analysis
  • Transdisciplinary Approach vs Multidisciplinary Approach · Regression, Linear · p = 0.303 · Difference-in-difference estimator: -3.18All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Transdisciplinary Approach0/1,291 (0%)0/1,291 (0%)0/1,291 (0%)
Multidisciplinary Approach0/3,206 (0%)0/3,206 (0%)0/3,206 (0%)

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)Transdisciplinary ApproachMultidisciplinary ApproachTotal
Mean84.2 ± 8.184.9 ± 8.484.7 ± 8.3
Sex: Female, Male
Sex: Female, Male(Participants)Transdisciplinary ApproachMultidisciplinary ApproachTotal
Female53214692001
Male227500727
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Transdisciplinary ApproachMultidisciplinary ApproachTotal
White, non-Hispanic62215892211
Black, non-Hispanic45244289
Hispanic6991160
Asian9615
Other143953
Cognitive Function Scale
Cognitive Function Scale(Participants)Transdisciplinary ApproachMultidisciplinary ApproachTotal
Cognitively Intact80219299
Mildly impaired123369492
Moderately impaired42711381565
Severely impaired129243372
Number of Nursing Home Beds
Number of Nursing Home Beds(certified beds)Transdisciplinary ApproachMultidisciplinary ApproachTotal
Mean118.6 ± 50.2119.9 ± 38.0119.5 ± 41.8
Nursing Home Occupancy Rate
Nursing Home Occupancy Rate(# of occupied beds/ # of certified beds)Transdisciplinary ApproachMultidisciplinary ApproachTotal
Mean0.87 ± 0.10.87 ± 0.10.87 ± 0.1
CMS Nursing Home Rating
CMS Nursing Home Rating(units on a scale)Transdisciplinary ApproachMultidisciplinary ApproachTotal
State Survey2.6 ± 1.22.7 ± 1.22.7 ± 1.2
Staffing Levels3.1 ± 0.72.7 ± 1.02.8 ± 0.9
Quality of Care3.5 ± 1.13.6 ± 1.13.5 ± 1.1
Quality Measures
Quality Measures(percentage of long-stay residents)Transdisciplinary ApproachMultidisciplinary ApproachTotal
increased in need for help with ADL18.3 ± 6.717.3 ± 5.417.6 ± 5.8
had pressure ulcer8.8 ± 3.78.3 ± 3.78.5 ± 3.7
lost too much weight5.6 ± 2.57.3 ± 3.56.8 ± 3.3
had catheter inserted and left in bladder1.4 ± 1.21.3 ± 1.41.3 ± 1.3
had urinary tract infection2.9 ± 2.52.1 ± 1.62.4 ± 1.9
have depressive symptoms4.6 ± 5.73.6 ± 4.13.8 ± 4.6
were physically restrained0.1 ± 0.30.2 ± 0.50.1 ± 0.4
had fall(s) with injury4.2 ± 1.93.1 ± 2.53.5 ± 2.4
received antipsychotic medication12.7 ± 3.913.4 ± 6.413.2 ± 5.7
ability to move independently worsened21.2 ± 9.921.3 ± 7.821.2 ± 8.4
received antianxiety/hypnotic medication22.4 ± 7.321.4 ± 11.521.7 ± 10.3
07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 1, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03442322
Lead sponsor
University of Pittsburgh
Collaborators
Patient-Centered Outcomes Research Institute
Responsible party
Natalie Leland (Professor, University of Pittsburgh) — Principal investigator
First posted
Feb 22, 2018
Start date
Mar 15, 2018
Primary completion
Jul 26, 2022
Completion
Jul 26, 2022
Results posted
Aug 19, 2024
Last update
Aug 19, 2024

Study contacts

Natalie E Leland, PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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