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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966523
• Other study ID #: NIH R21AG042325
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2013
• Last updated: August 19, 2016
• Start date: October 2013
• Est. completion date: February 2016

Study information

• Verified date: September 2015
• Source: Hebrew Rehabilitation Center, Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• 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.

Other:
• Control

Locations

Country	Name	City	State
United States	Hebrew SeniorLife	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Hebrew Rehabilitation Center, Boston	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	antimicrobial use	total antimicrobial use among residents defined as days of therapy per 1000 resident-days	12 months	No
Other	Decision satisfaction	proxy satisfaction with decision-making as measured by the Decision Satisfaction Index,	12 months	No
Primary	proportion of suspected infectious episodes for which antimicrobials were initiated appropriately	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).	12 months	No
Secondary	hospital transfers	proportion of episodes for which residents were transferred to the hospital,	12 months	No