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Trial record 1 of 1 for:    NCT03817450
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Daily Mouth Care to Prevent Pneumonia in Nursing Homes

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ClinicalTrials.gov Identifier: NCT03817450
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This project will determine whether an evidence-based, tested, pragmatic, system-level, comprehensive mouth care program provided to nursing home residents can reduce the incidence of pneumonia. It also will examine matters related to implementation, sustainability, and cost. If effective, the investigators expect this program to be widely adopted and sustained, to result in fewer episodes of pneumonia, and to reduce health-care costs.

Condition or disease Intervention/treatment Phase
Aging Nursing Home Pneumonia Behavioral: Daily Mouth Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Daily Mouth Care to Prevent Pneumonia in Nursing Homes: A Systems-Level Approach
Actual Study Start Date : January 2013
Actual Primary Completion Date : May 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Daily Mouth Care
The intervention consists of training in Mouth Care Without a Battle (MCWB) techniques and support in established quality improvement techniques. MCWB is a system-level, evidence based, tested approach to person-centered daily mouth care, which includes tooth-brushing, flossing, care of the gums, and denture care. MCWB provides training to all certified nursing assistants (CNAs) and nursing supervisors, and also supports the designation and specialized training of a CNA to serve as a dedicated, full-time Oral Care Aide (OCA) to provide mouth care to the residents who are at greatest risk for pneumonia and require specialized support to achieve good oral hygiene.
Behavioral: Daily Mouth Care
Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention nursing homes.

No Intervention: Standard Mouth Care
Nursing homes will continue to provide standard mouth care to all residents. Nursing home staff will not receive training or supplies in the control condition.



Primary Outcome Measures :
  1. Incidence of pneumonia over time [ Time Frame: Collected every four months during the 2 year study ]
    The total number of diagnosed cases of pneumonia


Secondary Outcome Measures :
  1. Incidence of hospitalizations over time [ Time Frame: Collected every four months during the 2 year study ]
    The total number of hospitalizations

  2. Mortality [ Time Frame: Collected every four months during the 2 year study ]
    The total number of deaths that occur in the nursing home

  3. Staff self-efficacy to provide mouth care [ Time Frame: Baseline and 24 months ]
    The measure will be administered to all CNAs (age 21 and older) in the intervention sites at baseline and 24 months, and to all CNAs (age 21 and older) in the control sites at 24 months (to avoid a possible Hawthorne effect from pre-administration). In the intervention sites, the 24-month measure will include a retrospective pre-test that asks respondents to reflect on their initial self-efficacy after having learned what they might not have known that they did not know previously. The self-efficacy measure has 35 items (Cronbach's alpha α=0.74-0.92), scored 1 (strongly disagree) to 4 (strongly agree). An increase in post-score shows higher self-efficacy to provide mouth care.

  4. Frequency of mouth care [ Time Frame: Collected during the entire 2 year study ]
    Daily mouth care will be documented on a simple log developed for the MCWB pilot study, on which the certified nursing assistant will record daily, for each resident, whether mouth care occurred. If mouth care did not occur, a reason is documented.

  5. Number of times mouth care products were used [ Time Frame: Collected during the entire 2 year study ]
    Use of mouth care products will be will be documented whenever a certified nursing assistant indicates on the mouth care log that mouth care was provided.


Other Outcome Measures:
  1. Intervention costs [ Time Frame: Collected during the entire 2 year study ]
    In the intervention NHs, costs measured over the two year study period will include the salary of the certified nursing assistants and nurses; staff time for MCWB training, supervision, and quality improvement meetings; time spent providing mouth care; and product costs. In addition, the investigators will track staff turnover. The costs will be added together to determine the total cost of MCWB implementation.

  2. Staff Turnover [ Time Frame: Collected during the entire 2 year study ]
    The total number of staff resignations and terminations during the two-year study period

  3. Change in Plaque Index Score for Long-Term Care (PI-LTC) over time [ Time Frame: Baseline and 24 months ]
    The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.

  4. Change in Gingival Index Score for Long-Term Care (GI-LTC) over time [ Time Frame: Baseline and 24 months ]
    The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Buccal and lingual surfaces scores also are calculated. Lower scores are better.

  5. Change in Denture Plaque Index Score (DPI) over time [ Time Frame: Baseline and 24 months ]
    The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76-100% of area covered). Lower scores are better.



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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:

  • Residents who are at least 21 years of age and who reside in a participating nursing home
  • Residents who have natural teeth and/or dentures and do not require prophylactic antibiotics prior to a dental examination
  • Staff members who are at least 21 years of age and who work in a participating nursing home and speak English

Exclusion Criteria:

  • Residents with no natural teeth or dentures
  • Residents who require prophylactic antibiotics prior to a dental examination
  • Non-English speaking staff members
  • Staff members who do not provide direct care to residents

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): NCT03817450


Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Sheryl Zimmerman, PhD University of North Carolina, Chapel Hill
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03817450    
Other Study ID Numbers: 13-2072
4R01HS022298-03 ( U.S. AHRQ Grant/Contract )
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
Mouth Care
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections