Status:

COMPLETED

Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias

Lead Sponsor:

Hebrew SeniorLife

Conditions:

Dementia

Infection, Bacterial

Eligibility:

All Genders

21+ years

Phase:

NA

Brief Summary

This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an intervention to ...

Detailed Description

The final stage of dementia is characterized by recurrent suspected infections. Research has shown these episodes are widely mismanaged, leading to adverse patient and public health outcomes. Antimicr...

Eligibility Criteria

Inclusion

  • Facility inclusion criteria
  • More than 60 beds
  • Within 60 miles of Boston
  • Resident inclusion eligibility criteria
  • Age \> or = to 60 years
  • A diagnosis of dementia (any type)
  • Global Deterioration Scale (GDS) score of 7
  • NH length of stay \>90 days
  • An individual who can communicate in English has been formally or informally designated as a health care proxy
  • Not comatose GDS stage 7 features include: profound memory deficits (cannot recognize family), total functional dependence, speech \<= 5 words, incontinence, and non-ambulatory. GDS 7 was chosen to define advanced dementia as it has been successfully operationalized and validated in or prior studies, and experts agreed to use this definition in research studies. A 90 day minimum length of stay was chosen to exclude short-stay patients.
  • Provider inclusion criteria
  • Direct care provider of advanced dementia residents (a nurse, nurse practitioner, physician or physician assistant identified by a senior administrator as an individual who cares for residents with advanced dementia)
  • Can communicate in English (because intervention materials are all in English),
  • Over 21 years of age.

Exclusion

  • Residents with cognitive impairment due to causes other than dementia (e.g., head trauma and in short-term, sub-acute SNFs) will be excluded.
  • Residents' whose proxies cannot communicate in English will be excluded from the study, because the information directed to proxies are only in English.
  • Providers that do not provide direct care to residents with advanced dementia or who do not speak English.
  • \-

Key Trial Info

Start Date :

October 15 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 10 2020

Estimated Enrollment :

430 Patients enrolled

Trial Details

Trial ID

NCT03244917

Start Date

October 15 2017

End Date

March 10 2020

Last Update

August 10 2021

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Hebrew SeniorLife

Boston, Massachusetts, United States, 02131