<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03817450</url>
  </required_header>
  <id_info>
    <org_study_id>13-2072</org_study_id>
    <secondary_id>4R01HS022298-03</secondary_id>
    <nct_id>NCT03817450</nct_id>
  </id_info>
  <brief_title>Daily Mouth Care to Prevent Pneumonia in Nursing Homes</brief_title>
  <official_title>Daily Mouth Care to Prevent Pneumonia in Nursing Homes: A Systems-Level Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will determine whether an evidence-based, tested, pragmatic, system-level,&#xD;
      comprehensive mouth care program provided to nursing home residents can reduce the incidence&#xD;
      of pneumonia. It also will examine matters related to implementation, sustainability, and&#xD;
      cost. If effective, the investigators expect this program to be widely adopted and sustained,&#xD;
      to result in fewer episodes of pneumonia, and to reduce health-care costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each year, almost two million episodes of pneumonia are suffered by nursing home (NH)&#xD;
      residents across the United States, resulting in more deaths than from any other infection.&#xD;
      Further, NH residents acquire pneumonia at a rate 6-10 times higher than older adults in the&#xD;
      community, indicating that characteristics of these individuals and/or the NH settings put&#xD;
      them at increased pneumonia risk.&#xD;
&#xD;
      Pneumonia is an inflammatory condition usually initiated by the introduction of bacteria into&#xD;
      the lung, such as through aspiration. In aspiration, contents from the mouth, throat, or&#xD;
      stomach that are colonized with pathogenic bacteria are inhaled into the lungs. Poor oral&#xD;
      hygiene is therefore a critical risk factor for pneumonia because it increases the volume and&#xD;
      infectious nature of secretions from the mouth and throat.&#xD;
&#xD;
      Considering the high rate of pneumonia in NHs and its relationship to oral hygiene, it should&#xD;
      come as no surprise that mouth care provided in NHs is poor. Almost 90% of residents require&#xD;
      help with tooth brushing, yet only 16% have their teeth brushed regularly. Reasons for&#xD;
      insufficient care include time, other priorities, existing procedures, perceptions that oral&#xD;
      health is not vital to overall health, and fear of resistant residents.&#xD;
&#xD;
      Evidence is emerging that improved oral care can prevent pneumonia. However, no studies have&#xD;
      developed and tested a program designed specifically for widespread adoption and&#xD;
      sustainability. Our research team developed the Mouth Care Without a Battle (MCWB) program,&#xD;
      and in pilot-testing, MCWB significantly improved tooth brushing and flossing, reduced dental&#xD;
      plaque and gingivitis (which harbor the bacteria that can cause pneumonia), and increased&#xD;
      staff knowledge and attitudes related to mouth care.&#xD;
&#xD;
      If MCWB is effective in reducing pneumonia and related hospitalizations and mortality, it&#xD;
      would constitute a major advance in disease prevention. Therefore, the aims of this&#xD;
      evidence-based, tested, matched-pairs cluster randomized trial are:&#xD;
&#xD;
      1a. Compare the incidence of pneumonia in seven mouth care NHs to the incidence of pneumonia&#xD;
      in seven control NHs for two years.&#xD;
&#xD;
      Secondarily:&#xD;
&#xD;
      1b. Compare the case-adjusted incidence of pneumonia in mouth care NHs to the case-adjusted&#xD;
      incidence in control NHs, and evaluate whether the intervention effects for pneumonia&#xD;
      incidence are modified by resident-level risk factors for pneumonia.&#xD;
&#xD;
      1c. Examine the relationship between the overall incidence of pneumonia and change in average&#xD;
      oral health status, as measured by the plaque and gingival indices of cross-sectional random&#xD;
      samples of 60 residents per NH at baseline and at the end of the study.&#xD;
&#xD;
      2. Examine the implementation and sustainability of the mouth care program, including: (a)&#xD;
      staff self-efficacy to provide mouth care; (b) frequency of mouth care and related&#xD;
      supervision; (c) use of mouth care products; (d) barriers and facilitators to implementation;&#xD;
      and (e) cost of the mouth care program.&#xD;
&#xD;
      3. In regard to secondary outcomes of hospitalization and mortality: 3a. Compare differences&#xD;
      in hospitalization and mortality rates (pneumonia and all cause) from baseline through two&#xD;
      years for mouth care and control NHs.&#xD;
&#xD;
      3b. Assess the likelihood that the intervention is cost-saving, and estimate the cost per&#xD;
      hospitalization avoided attributable to the mouth care program.&#xD;
&#xD;
      These aims will be addressed in a two year matched pairs cluster randomized trial will be&#xD;
      conducted in seven pairs of NHs; one half of each pair will be randomly assisted to receive&#xD;
      the intervention (MCWB), and the other half will be assigned to the control condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of pneumonia over time</measure>
    <time_frame>Collected every four months during the 2 year study</time_frame>
    <description>The total number of diagnosed cases of pneumonia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of hospitalizations over time</measure>
    <time_frame>Collected every four months during the 2 year study</time_frame>
    <description>The total number of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Collected every four months during the 2 year study</time_frame>
    <description>The total number of deaths that occur in the nursing home</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staff self-efficacy to provide mouth care</measure>
    <time_frame>Baseline and 24 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of mouth care</measure>
    <time_frame>Collected during the entire 2 year study</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of times mouth care products were used</measure>
    <time_frame>Collected during the entire 2 year study</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intervention costs</measure>
    <time_frame>Collected during the entire 2 year study</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Staff Turnover</measure>
    <time_frame>Collected during the entire 2 year study</time_frame>
    <description>The total number of staff resignations and terminations during the two-year study period</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Plaque Index Score for Long-Term Care (PI-LTC) over time</measure>
    <time_frame>Baseline and 24 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Gingival Index Score for Long-Term Care (GI-LTC) over time</measure>
    <time_frame>Baseline and 24 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Denture Plaque Index Score (DPI) over time</measure>
    <time_frame>Baseline and 24 months</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1416</enrollment>
  <condition>Aging</condition>
  <condition>Nursing Home</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>Daily Mouth Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Mouth Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Daily Mouth Care</intervention_name>
    <description>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.</description>
    <arm_group_label>Daily Mouth Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residents who are at least 21 years of age and who reside in a participating nursing&#xD;
             home&#xD;
&#xD;
          -  Residents who have natural teeth and/or dentures and do not require prophylactic&#xD;
             antibiotics prior to a dental examination&#xD;
&#xD;
          -  Staff members who are at least 21 years of age and who work in a participating nursing&#xD;
             home and speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Residents with no natural teeth or dentures&#xD;
&#xD;
          -  Residents who require prophylactic antibiotics prior to a dental examination&#xD;
&#xD;
          -  Non-English speaking staff members&#xD;
&#xD;
          -  Staff members who do not provide direct care to residents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheryl Zimmerman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>November 11, 2019</last_update_submitted>
  <last_update_submitted_qc>November 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mouth Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03817450
org study id: 13-2072
secondary id: 4R01HS022298-03
nct id: NCT03817450
lead sponsor: 
has dmc: No
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.
Each year, almost two million episodes of pneumonia are suffered by nursing home (NH)
      residents across the United States, resulting in more deaths than from any other infection.
      Further, NH residents acquire pneumonia at a rate 6-10 times higher than older adults in the
      community, indicating that characteristics of these individuals and/or the NH settings put
      them at increased pneumonia risk.

      Pneumonia is an inflammatory condition usually initiated by the introduction of bacteria into
      the lung, such as through aspiration. In aspiration, contents from the mouth, throat, or
      stomach that are colonized with pathogenic bacteria are inhaled into the lungs. Poor oral
      hygiene is therefore a critical risk factor for pneumonia because it increases the volume and
      infectious nature of secretions from the mouth and throat.

      Considering the high rate of pneumonia in NHs and its relationship to oral hygiene, it should
      come as no surprise that mouth care provided in NHs is poor. Almost 90% of residents require
      help with tooth brushing, yet only 16% have their teeth brushed regularly. Reasons for
      insufficient care include time, other priorities, existing procedures, perceptions that oral
      health is not vital to overall health, and fear of resistant residents.

      Evidence is emerging that improved oral care can prevent pneumonia. However, no studies have
      developed and tested a program designed specifically for widespread adoption and
      sustainability. Our research team developed the Mouth Care Without a Battle (MCWB) program,
      and in pilot-testing, MCWB significantly improved tooth brushing and flossing, reduced dental
      plaque and gingivitis (which harbor the bacteria that can cause pneumonia), and increased
      staff knowledge and attitudes related to mouth care.

      If MCWB is effective in reducing pneumonia and related hospitalizations and mortality, it
      would constitute a major advance in disease prevention. Therefore, the aims of this
      evidence-based, tested, matched-pairs cluster randomized trial are:

      1a. Compare the incidence of pneumonia in seven mouth care NHs to the incidence of pneumonia
      in seven control NHs for two years.

      Secondarily:

      1b. Compare the case-adjusted incidence of pneumonia in mouth care NHs to the case-adjusted
      incidence in control NHs, and evaluate whether the intervention effects for pneumonia
      incidence are modified by resident-level risk factors for pneumonia.

      1c. Examine the relationship between the overall incidence of pneumonia and change in average
      oral health status, as measured by the plaque and gingival indices of cross-sectional random
      samples of 60 residents per NH at baseline and at the end of the study.

      2. Examine the implementation and sustainability of the mouth care program, including: (a)
      staff self-efficacy to provide mouth care; (b) frequency of mouth care and related
      supervision; (c) use of mouth care products; (d) barriers and facilitators to implementation;
      and (e) cost of the mouth care program.

      3. In regard to secondary outcomes of hospitalization and mortality: 3a. Compare differences
      in hospitalization and mortality rates (pneumonia and all cause) from baseline through two
      years for mouth care and control NHs.

      3b. Assess the likelihood that the intervention is cost-saving, and estimate the cost per
      hospitalization avoided attributable to the mouth care program.

      These aims will be addressed in a two year matched pairs cluster randomized trial will be
      conducted in seven pairs of NHs; one half of each pair will be randomly assisted to receive
      the intervention (MCWB), and the other half will be assigned to the control condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of pneumonia over time
time frame: Collected every four months during the 2 year study
description: The total number of diagnosed cases of pneumonia
measure: Incidence of hospitalizations over time
time frame: Collected every four months during the 2 year study
description: The total number of hospitalizations
measure: Mortality
time frame: Collected every four months during the 2 year study
description: The total number of deaths that occur in the nursing home
measure: Staff self-efficacy to provide mouth care
time frame: Baseline and 24 months
description: 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.
measure: Frequency of mouth care
time frame: Collected during the entire 2 year study
description: 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.
measure: Number of times mouth care products were used
time frame: Collected during the entire 2 year study
description: 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.
measure: Intervention costs
time frame: Collected during the entire 2 year study
description: 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.
measure: Staff Turnover
time frame: Collected during the entire 2 year study
description: The total number of staff resignations and terminations during the two-year study period
measure: Change in Plaque Index Score for Long-Term Care (PI-LTC) over time
time frame: Baseline and 24 months
description: 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.
measure: Change in Gingival Index Score for Long-Term Care (GI-LTC) over time
time frame: Baseline and 24 months
description: 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.
measure: Change in Denture Plaque Index Score (DPI) over time
time frame: Baseline and 24 months
description: 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.
arm group label: Daily Mouth Care
arm group type: Experimental
description: 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.
arm group label: Standard Mouth Care
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Daily Mouth Care
description: 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.
arm group label: Daily Mouth Care
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Sheryl Zimmerman, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
responsible party type: Sponsor
mesh term: Pneumonia
sharing ipd: No