A Pilot Study of an RCT to Improve Infection Management in Advanced Dementia
August 19, 2016 updated by: Susan Mitchell, MD, Hebrew SeniorLife
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02131
- Hebrew SeniorLife
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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 Names:
|
|
Other: Usual Care
Residents will receive usual care for infections
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hospital transfers
Time Frame: 12 months
|
proportion of episodes for which residents were transferred to the hospital,
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
antimicrobial use
Time Frame: 12 months
|
total antimicrobial use among residents defined as days of therapy per 1000 resident-days
|
12 months
|
|
Decision satisfaction
Time Frame: 12 months
|
proxy satisfaction with decision-making as measured by the Decision Satisfaction Index,
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
October 17, 2013
First Submitted That Met QC Criteria
October 18, 2013
First Posted (Estimate)
October 21, 2013
Study Record Updates
Last Update Posted (Estimate)
August 23, 2016
Last Update Submitted That Met QC Criteria
August 19, 2016
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIH R21AG042325
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