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

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ClinicalTrials.gov Identifier: NCT01966523
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : August 23, 2016
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Susan Mitchell, MD, Hebrew Rehabilitation Center, Boston

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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Intervention Other: Control Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Pilot Study of an RCT to Improve Infection Management in Advanced Dementia
Study Start Date : October 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Dementia

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.
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 Name: Infection Management Practice Intervention

Usual Care
Residents will receive usual care for infections
Other: Control



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. hospital transfers [ Time Frame: 12 months ]
    proportion of episodes for which residents were transferred to the hospital,


Other Outcome Measures:
  1. antimicrobial use [ Time Frame: 12 months ]
    total antimicrobial use among residents defined as days of therapy per 1000 resident-days

  2. Decision satisfaction [ Time Frame: 12 months ]
    proxy satisfaction with decision-making as measured by the Decision Satisfaction Index,



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966523


Locations
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United States, Massachusetts
Hebrew SeniorLife
Boston, Massachusetts, United States, 02131
Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
National Institute on Aging (NIA)

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Responsible Party: Susan Mitchell, MD, Senior Scientist, Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier: NCT01966523     History of Changes
Other Study ID Numbers: NIH R21AG042325
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: September 2015

Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Anti-Infective Agents
Anti-Bacterial Agents