NCT03442322

Optimizing Care for Patients With Dementia

Completed NA Results posted Last updated 19 August 2024

What this trial tests

NA trial testing transdisciplinary approach in Alzheimer Disease in 53 participants. Completed in 26 July 2022.

Timeline

15 March 2018

Primary endpoint
26 July 2022

26 July 2022

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	53
Start date	15 March 2018
Primary completion	26 July 2022
Estimated completion	26 July 2022
Sites	1 location across United States

Drugs / interventions tested

• transdisciplinary approach
• multidisciplinary approach

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

University of Pittsburgh

Who can join

Eligibility, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dispensing of Psychotropic Medications Primary · 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.

Group	Value	95% CI
Transdisciplinary Approach	161
Multidisciplinary Approach	315

Dispensing of Psychotropic Medications Primary · 12-month period (months 7-12)

Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 7-12 of Intervention.

Group	Value	95% CI
Transdisciplinary Approach	125
Multidisciplinary Approach	289

Dispensing of Psychotropic Medications Primary · 18-month period (months 13-18)

Percentage of nursing home residents with dementia who received one or more antipsychotic medication over Months 13-18 of Intervention.

Group	Value	95% CI
Transdisciplinary Approach	107
Multidisciplinary Approach	227

Behavioral Symptoms Primary · 6-month period (months 1-6)

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

Group	Value	95% CI
Transdisciplinary Approach	143
Multidisciplinary Approach	334

Behavioral Symptoms Primary · 12-month period (months 7-12)

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

Group	Value	95% CI
Transdisciplinary Approach	104
Multidisciplinary Approach	299

Behavioral Symptoms Primary · 18-month period (months 13-18)

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

Group	Value	95% CI
Transdisciplinary Approach	68
Multidisciplinary Approach	232

Wandering Primary · 6-month period (months 1-6)

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

Group	Value	95% CI
Transdisciplinary Approach	88
Multidisciplinary Approach	117

Wandering Primary · 12-month period (months 7-12)

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

Group	Value	95% CI
Transdisciplinary Approach	52
Multidisciplinary Approach	116

Wandering Primary · 18-month period (months 13-18)

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

Group	Value	95% CI
Transdisciplinary Approach	38
Multidisciplinary Approach	98

Rejection of Care Primary · 6-month period (months 1-6)

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

Group	Value	95% CI
Transdisciplinary Approach	131
Multidisciplinary Approach	302

Rejection of Care Primary · 12-month period (months 7-12)

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

Group	Value	95% CI
Transdisciplinary Approach	75
Multidisciplinary Approach	282

Rejection of Care Primary · 18-month period (months 13-18)

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

Group	Value	95% CI
Transdisciplinary Approach	59
Multidisciplinary Approach	217

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluating non-pharmacological approaches to nursing home dementia care: A protocol.
   Leland NE, Shier V, Piersol CV, Lekovitch C, et al · · 2023 · cited 4× · PMID 37347001 · DOI 10.1016/j.conctc.2023.101161