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Clinical Trials/NCT01966523
NCT01966523
Completed
Phase 2

A Pilot Study of an RCT to Improve Infection Management in Advanced Dementia

Hebrew SeniorLife1 site in 1 country62 target enrollmentOctober 2013
ConditionsDementia

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Dementia
Sponsor
Hebrew SeniorLife
Enrollment
62
Locations
1
Primary Endpoint
proportion of suspected infectious episodes for which antimicrobials were initiated appropriately
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

To conduct a pilot study of cluster randomized clinical trial of an practice intervention to improve the quality of care for suspected lower respiratory and and urinary tract infections among 60 nursing home residents with advanced dementia living in 4 facilities (2 matched intervention/control pairs) for 12 months. We hypothesize that 1. In the intervention compared to the control facilities there will be a trend towards a greater proportion of infections for which antimicrobials were initiated appropriately, and 2. in the intervention compared to the control facilities there will be a trend towards higher proxy satisfaction with decision-making, fewer hospital transfers, and lower antimicrobial exposure.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
February 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hebrew SeniorLife
Responsible Party
Principal Investigator
Principal Investigator

Susan Mitchell, MD

Senior Scientist

Hebrew SeniorLife

Eligibility Criteria

Inclusion Criteria

  • Resident eligibility criteria include: 1) Age \> 65, 2) Dementia, 3) Global Deterioration Scale score of 7,59 and 4) a proxy is available who can speak in English. Features of Global deterioration stage 7 include: profound memory deficits (cannot recognize family), total functional dependence, speech \< 5 words, incontinence, and inability to ambulate.
  • Eligibility criteria for providers in the intervention nursing homes include: Medical Doctor,a. nurse, nurse practitioner, physician assistant identified by a senior administrator as an individual who cares for residents with advanced dementia, and is
  • able to communicate in English because on-line course and algorithms are in English., and
  • over 21 years of age.

Exclusion Criteria

  • Residents with cognitive impairment due to causes other than dementia (e.g., head trauma) and in short-term, sub-acute SNFs will be excluded. -

Outcomes

Primary Outcomes

proportion of suspected infectious episodes for which antimicrobials were initiated appropriately

Time Frame: 12 months

The primary outcome will be the proportion of suspected infectious episodes for which antimicrobials were initiated appropriately defined by 2 factors: i. minimal clinical criteria to start antimicrobials are met based on consensus guidelines, ii. treatment was consistent with proxy preferences (based on proxy interview).

Secondary Outcomes

  • hospital transfers(12 months)

Study Sites (1)

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