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
|Condition or disease||Intervention/treatment||Phase|
|Aging Nursing Home Pneumonia||Behavioral: Daily Mouth Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1416 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Incidence of pneumonia over time [ Time Frame: Collected every four months during the 2 year study ]The total number of diagnosed cases of pneumonia
- Incidence of hospitalizations over time [ Time Frame: Collected every four months during the 2 year study ]The total number of hospitalizations
- Mortality [ Time Frame: Collected every four months during the 2 year study ]The total number of deaths that occur in the nursing home
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
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
|Principal Investigator:||Sheryl Zimmerman, PhD||University of North Carolina, Chapel Hill|