NCT05950607

Brief Summary

The goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Nov 2023Jun 2026

First Submitted

Initial submission to the registry

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 13, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

July 10, 2023

Last Update Submit

January 2, 2026

Conditions

DementiaAlzheimer DiseaseInfections

Outcome Measures

Primary Outcomes (1)

  • Antimicrobial use in residents with moderate to advanced dementia

    Number of antimicrobial courses/person-year among residents with moderate to advanced dementia.

    12 months

Secondary Outcomes (3)

  • Antimicrobial use in residents with dementia

    12 months

  • Burdensome interventions in residents with moderate to advanced dementia

    12 months

  • Burdensome interventions in residents with dementia

    12 months

Study Arms (2)

TRAIN AD 2.0

EXPERIMENTAL

Nursing homes randomized to the experimental arm will emply a multicomponent intervention among their providers designed to improve the management of suspected infections in residents with dementia. The components include: a.Orientation sessions for providers, b.On-line case based course for providers, c.Infection management algorithms for providers, d. Guidelines for providers to communicate with proxies, and e. Education booklet about infections in dementia for providers.

Behavioral: TRAIN AD 2.0

Usual Care

ACTIVE COMPARATOR

Nursing homes randomized to the conrol arm will employ usual care to manage nursing home residents with dementia with suspected infections.

Behavioral: TRAIN AD 2.0

Interventions

TRAIN AD 2.0BEHAVIORAL

The study intervention is a multi-component training program targeting direct care providers and healthcare proxies for NH residents with moderate to advanced dementia intended to improve the management of urinary tract infections (UTIs) and lower respiratory tract infections (LRIs). The components include: A. Provider Orientation: At NH start-up and q2 months providers will be offered orientations sessions involving two 15-minute presentations, one focused on the background and rationale for the program and one focused on describing the program components. B. A case-based on-line course, "Infection Management in Moderate to Advanced Dementia," C. Posters and pocket cards for providers displaying algorithms guiding appropriate antimicrobial initiation for suspected UTIs and LRIs that integrate patient preferences, and D. Proxies of ALL residents in the facility will be sent a booklet related to infection management for persons with moderate to advanced dementia. .

TRAIN AD 2.0Usual Care

Eligibility Criteria

Age60 Years - 106 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 60
  • A diagnosis of dementia (any type)
  • Cognitive Functional Scale (CFS) \> 1
  • NH length of stay \>90 days
  • The CFS score categorizes cognitive impairment status based on data in the electronic health record into: 1. None, 2. Mild, 3. Moderate, and 4. Severe (advanced). For the primary outcome, the analysis will be restricted to residents with a CFS score of 3 or 4.

You may not qualify if:

  • Less than 60 years of age
  • Living in nursing home for less than 90 days
  • Does not have diagnosis of dementia
  • Does not meet CFS \>1 score

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew SeniorLife

Boston, Massachusetts, 02131, United States

RECRUITING

MeSH Terms

Conditions

DementiaAlzheimer DiseaseInfections

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Susan Mitchell, MD, MPH

    Hebrew SeniorLife

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Mitchell, MD, MPH

CONTACT

16172813669smitchell@hsl.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

November 13, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)