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

Primary Purpose

Dementia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
Hebrew SeniorLife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Hebrew SeniorLife

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Usual Care

Arm Description

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.

Residents will receive usual care for infections

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2013
Last Updated
August 19, 2016
Sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01966523
Brief Title
A Pilot Study of an RCT to Improve Infection Management in Advanced Dementia
Official Title
A Pilot Study of an RCT to Improve Infection Management in Advanced Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Residents will receive usual care for infections
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Other Intervention Name(s)
Infection Management Practice Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
proportion of suspected infectious episodes for which antimicrobials were initiated appropriately
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
hospital transfers
Description
proportion of episodes for which residents were transferred to the hospital,
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
antimicrobial use
Description
total antimicrobial use among residents defined as days of therapy per 1000 resident-days
Time Frame
12 months
Title
Decision satisfaction
Description
proxy satisfaction with decision-making as measured by the Decision Satisfaction Index,
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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. - 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. -
Facility Information:
Facility Name
Hebrew SeniorLife
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States

12. IPD Sharing Statement

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

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