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

Sponsor
Hebrew SeniorLife (Other)
Overall Status
Completed
CT.gov ID
NCT01966523
Collaborator
National Institute on Aging (NIA) (NIH)
62
1
2
28
2.2

Study Details

Study Description

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
  • Behavioral: Intervention
  • Other: Control
Phase 2

Study Design

Study Type:
Interventional
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 :
Oct 1, 2013
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

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 Names:
  • Infection Management Practice Intervention
  • Other: Usual Care

    Residents will receive usual care for infections

    Other: Control

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. hospital transfers [12 months]

      proportion of episodes for which residents were transferred to the hospital,

    Other Outcome Measures

    1. antimicrobial use [12 months]

      total antimicrobial use among residents defined as days of therapy per 1000 resident-days

    2. Decision satisfaction [12 months]

      proxy satisfaction with decision-making as measured by the Decision Satisfaction Index,

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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. -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hebrew SeniorLife Boston Massachusetts United States 02131

    Sponsors and Collaborators

    • Hebrew SeniorLife
    • National Institute on Aging (NIA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Susan Mitchell, MD, Senior Scientist, Hebrew SeniorLife
    ClinicalTrials.gov Identifier:
    NCT01966523
    Other Study ID Numbers:
    • NIH R21AG042325
    First Posted:
    Oct 21, 2013
    Last Update Posted:
    Aug 23, 2016
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 23, 2016