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

Phase 2

Completed

• Conditions: Dementia
• Interventions: Behavioral: Intervention; Other: Control

• Registration Number: NCT01966523
• Lead Sponsor: Hebrew SeniorLife

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-21
• Status Verified: 2015-09
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	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.
Usual Care	Control	Residents will receive usual care for infections

Primary Outcome Measures

Name	Time	Method
proportion of suspected infectious episodes for which antimicrobials were initiated appropriately	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 Outcome Measures

Name	Time	Method
hospital transfers	12 months	proportion of episodes for which residents were transferred to the hospital,

Trial Locations

Locations (1)

Hebrew SeniorLife; 🇺🇸 Boston, Massachusetts, United States