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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01966523
Enrollment
62
Registered
2013-10-21
Start date
2013-10-31
Completion date
2016-02-29
Last updated
2016-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

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.

Interventions

BEHAVIORALIntervention

Provider Training: i. on-line education course and ii. algorithms and checklists. The course consists of 4 cases: 2 for urinary tract infection and 2 for lower respiratory tract infections with multiple choice questions and evidence-based feedback. To reinforce provider learning, posters displaying algorithms guiding appropriate antimicrobial initiation for infections will be placed in all nursing home units. Laminated pocket cards with the algorithms will be given to providers. Providers will complete simple checklists for each suspected infection throughout the study. B. Proxy Information: The printed material explains, in a lay fashion: i. the nature of infection in advanced dementia, ii. treatment options, iii. concerns about antimicrobial overuse, and iv. features of appropriate antimicrobial use.

OTHERControl

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Hebrew SeniorLife
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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 2. able to communicate in English because on-line course and algorithms are in English., and 3. 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. -

Design outcomes

Primary

MeasureTime frameDescription
proportion of suspected infectious episodes for which antimicrobials were initiated appropriately12 monthsThe 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

MeasureTime frameDescription
hospital transfers12 monthsproportion of episodes for which residents were transferred to the hospital,

Other

MeasureTime frameDescription
antimicrobial use12 monthstotal antimicrobial use among residents defined as days of therapy per 1000 resident-days
Decision satisfaction12 monthsproxy satisfaction with decision-making as measured by the Decision Satisfaction Index,

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026