Oral Care as Prevention for Nonventilator Hospital-Acquired Pneumonia: A Four-Unit

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ORIGINAL RESEARCH

       Oral Care as Prevention
       for Nonventilator
       Hospital-Acquired
       Pneumonia: A Four-Unit
       Cluster Randomized Study
       Findings suggest that daily oral care can play a crucial role.

       H
               ospital-acquired pneumonia (HAP) is now         ity.8, 13, 14 Moreover, within 48 hours of hospitaliza-
               the most common type of hospital-acquired       tion, changes occur in the oral microbiota that are
               infection in the United States, accounting      associated with more virulent pneumonia-caus-
       for 26% of all such infections, according to the        ing organisms.15, 16 Respiratory pathogens such as
       most recent point prevalence survey conducted           Staphylococcus aureus, Klebsiella pneumoniae,
       by the Centers for Disease Control and Preven-          Enterobacter cloacae, and Pseudomonas aerugi-
       tion (CDC).1 It is also the most common hospital-       nosa colonize the dental plaque and can be aspi-
       acquired infection in Europe.2, 3 Of the HAP cases      rated, introducing these organisms into the lungs,
       in the CDC survey, fully 65% were found to be           even in healthy adults.17-19 Studies indicate that
       nonventilator hospital-acquired pneumonia (NV-          patients are up to six times more likely to develop
       HAP).                                                   HAP if the mouth is persistently colonized by
          NV-HAP presents a serious and largely prevent-       such pathogens.15, 20 Several studies have shown
       able threat to patient safety. Compared with all        that improved cleaning of the oral biofilm pro-
       other hospital-acquired infections except ventilator-   vides primary source control of HAP pathogens
       associated pneumonia, NV-HAP is associated with         and reduces HAP incidence.5, 14, 21
       increased morbidity and mortality, longer hospital          Given the relatively high risk of NV-HAP, it’s
       stays, increased ICU utilization, and markedly          imperative that we gain a better understanding of
       higher costs.4-7 One study found that, after control-   effective means of prevention. An emerging body
       ling for multiple comorbidities and other factors,      of literature addresses the role of oral care in pre-
       patients with NV-HAP were at much higher risk for       venting NV-HAP.4, 21-26 An associated reduction in
       death during hospitalization than those without         antibiotic use has also been noted.27 Because oral
       NV-HAP (15.5% versus 1.6%).7                            microbiota is arguably the most modifiable risk
          Pathogenesis. Pneumonia occurs when                  factor for NV-HAP,21, 22 primary source control was
       microbes move from proximal sites such as the           the underlying strategy used in this study.
       oral cavity into the lungs and incite an inflam-            Study aim. The primary aim of this study was
       matory response.8-10 Researchers have found an          to determine the effectiveness of a universal, stan-
       important relationship between the oral micro-          dardized oral care protocol in preventing NV-HAP
       biota and HAP.10-12 For example, bacteria found         in the acute care setting, specifically, four units at
       in the bronchi of patients with HAP have been           an 800-bed tertiary medical center. We hypothe-
       matched with specific flora found in the oral cav-      sized that there would be a significant reduction in

24     AJN ▼ June 2021   ▼   Vol. 121, No. 6                                                                ajnonline.com
By Karen K. Giuliano, PhD, RN, FAAN, Daleen Penoyer, PhD, RN, CCRP, FCNS, FCCM,
                                                             Aurea Middleton, RN, and Dian Baker, PhD, RN, APRN-BC, PNP

   ABSTRACT
   Background: Nonventilator hospital-acquired pneumonia (NV-HAP) presents a serious and largely
   preventable threat to patient safety in U.S. hospitals. There is an emerging body of evidence on the effec-
   tiveness of oral care in preventing NV-HAP.
      Purpose: The primary aim of this study was to determine the effectiveness of a universal, standardized
   oral care protocol in preventing NV-HAP in the acute care setting. The primary outcome measure was NV-
   HAP incidence per 1,000 patient-days.
      Methods: This 12-month study was conducted on four units at an 800-bed tertiary medical center.
   Patients on one medical and one surgical unit were randomly assigned to receive enhanced oral care
   (intervention units); patients on another medical and another surgical unit received usual oral care (control
   units).
      Results: Total enrollment was 8,709. For the medical control versus intervention units, oral care fre-
   quency increased from a mean of 0.95 to 2.25 times per day, and there was a significant 85% reduction in
   the NV-HAP incidence rate. The odds of developing NV-HAP were 7.1 times higher on the medical control
   versus intervention units, a significant finding. For the surgical control versus intervention units, oral
   care frequency increased from a mean of 1.18 to 2.02 times per day, with a 56% reduction in the NV-HAP
   incidence rate. The odds of developing NV-HAP were 1.6 times higher on the surgical control versus inter-
   vention units, although this result did not reach significance.
      Conclusions: These findings add to the growing body of evidence that daily oral care as a means of
   primary source control may have a role in NV-HAP prevention. The implementation of effective strategies
   to ensure that such care is consistently provided warrants further study. It’s not yet known what degree
   and frequency of oral care are required to effect favorable changes in the oral microbiome during acute
   care hospitalization.
      Keywords: hospital-acquired infection, nonventilator hospital-acquired pneumonia, oral care,
   pneumonia

NV-HAP incidence on the intervention units com-            had 26 beds for postoperative cardiac surgery
pared with the control units. Frequency of oral care       patients; the surgical control unit had 32 beds for
in compliance with the new oral care protocol was          postoperative vascular surgery patients. Nurse-to-
used to assess fidelity to the intervention. The pri-      patient ratios were 1:4 on the medical units and
mary outcome measure was NV-HAP incidence                  1:3 on the surgical units. Nursing assistant-to-
per 1,000 patient-days. Our secondary aim was              patient ratios were 1:9 on the medical units and
to learn more about NV-HAP outcomes and add                1:7 on the surgical units. Other nursing care
this to the emerging literature.4, 6, 28 To that end, we   actions that might influence NV-HAP rates, such
also collected data on NV-HAP–associated events,           as head of bed elevation and early mobilization,
including the development of postadmission sepsis,         were not changed and were similar between the
unplanned ICU transfer, 30-day readmission, and            control and intervention units.
mortality.                                                    Sample. To determine the necessary sample
                                                           size, a power analysis was conducted via
METHODS                                                    G*Power 3.1.9.4 freeware.29 Using data from
Study design and setting. The study was                    previous research on NV-HAP incidence and pre-
designed as a single-site cluster randomized trial.        implementation data, we performed the analysis
It involved a total of four clinical units: one medi-      with a target set at 50% reduction in the NV-HAP
cal and one surgical unit were randomized to an            incidence rate from 1.8 per 1,000 patient-days
enhanced oral care protocol; these were matched            (control) to 0.9 per 1,000 patient-days (interven-
to one medical and one surgical unit randomized            tion). Results indicated that 2,580 patients per
to usual care. The study units were selected based         group—a total of 10,320 patients—were needed
on similar patient admission diagnoses and inci-           to power the study, per the typical settings of α
dence of NV-HAP as evaluated over the preceding            = 0.05 and power = 0.8 (α represents the proba-
12 months. Unit randomization was done by sim-             bility of finding significance where there is none;
ple, blind drawing from a container. The medical           power represents true significance).29
intervention and control units had 49 and 38                  Approval for the study was obtained from the
beds, respectively. The surgical intervention unit         organization’s institutional review board prior

ajn@wolterskluwer.com                                                                 AJN ▼ June 2021   ▼   Vol. 121, No. 6   25
to data collection. Signed consent was waived                The kits used in the study were provided by
     because the intervention presented minimal risk to       Medline Industries (Northfield, IL). They were
     participants.                                            chosen because they were the only kits available
        The intervention consisted of the implemen-           that contained all the products in the protocol.
     tation of a standardized oral care protocol (see         (Organizations can also follow the protocol’s rec-
     Figure 1) and targeted education. The protocol,          ommendations by assembling kits using individual
     which was first developed for an earlier study,30        products from a variety of manufacturers.) Unit-
     was adapted by two of us (DB and KKG) for this           level team members (nurses and nursing assistants)
     study. It was approved by the American Dental            were instructed to perform daily oral assessments to
     Association (ADA) Board of Trustees in 2017.             ensure that patients had the correct supplies based
     Before implementation, all nurses and nursing            on their status, which could change. They were
     assistants on the intervention units received edu-       asked to document both these assessments and oral
     cation on the protocol. In individual and group          care in the electronic health record (EHR).
     sessions, the investigators covered topics that              On the control units, all unit-level team mem-
     included the importance of oral care, methods of         bers received refresher training on the hospital’s
     delivery, and assessment of patient needs. Dem-          usual oral care protocol and required documenta-
     onstrations of new oral care techniques and prod-        tion. No special oral care supplies were provided,
     ucts used in the study were given, and regularly         but team members were reminded to document all
     scheduled coaching as well as reinforcement when         oral care performed. In keeping with usual care,
     needed were offered throughout the study period.         patients were not reminded to brush their teeth or
     Patients and family members on the interven-             educated on the importance of doing so. Assistance
     tion units were educated through flyers, signage,        with oral care was provided as needed. No attempt
     teaching that emphasized the importance of oral          was made to inform team members on the control
     care, and demonstrations of oral care techniques         units of the procedures and materials used on the
     and products.                                            intervention units.
                                                                  Determining NV-HAP incidence. All 8,713
                                                              patients discharged from the four study units during
                                                              the study period (a number that includes all those
                                                              who died) were screened for inclusion. Those who
                                                              weren’t at least 18 years of age were excluded.
            NV-HAP prevention is of                           Cases of pneumonia were then identified using the
                                                              International Classification of Diseases, Tenth Revi-
           paramount importance to                            sion (ICD-10) codes, as documented in the hospi-
                                                              tal’s electronic data warehouse. Patients without
                                                              such codes were excluded, as were those who had
                       patient safety.                        been hospitalized less than 48 hours, received a
                                                              pneumonia diagnosis within 48 hours of admission,
                                                              been extubated within 48 hours of pneumonia diag-
                                                              nosis, or been present on a study unit less than 48
                                                              hours before such diagnosis. From the remaining
        The intervention was designed to align with the       cases, NV-HAP was confirmed using the CDC’s cri-
     ADA-approved protocol’s recommendations. It              teria for pneumonia (which involve radiologic
     made use of a kit that included a high-quality soft-     determination, cultures when available, and symp-
     bristle toothbrush, plaque-removing toothpaste, a        tom assessment).31
     nonalcohol-based mouthwash, and lip and mouth                Data collection. After staff education on the new
     moisturizers applied as needed. Target frequency of      oral care protocol was completed, there was a
     oral care was set at four times a day.30 The fre-        30-day run-in period (September 1 through Septem-
     quency and timing were similar whether the patient       ber 30, 2018) to monitor compliance and provide
     was on a regular meal schedule or not. Suction           additional training as needed. Data collection took
     toothbrush kits were used with patients who were         place over a 12-month period, from October 1,
     at risk for aspiration or unable to perform their        2018, through September 30, 2019.
     own oral care. Patients with dentures were given             For all patients in the study, frequency of oral
     special kits that included a high-quality soft-bristle   care was recorded by nurses and nursing assistants
     toothbrush, denture adhesive cream, and a denture        in the EHR. Because the EHR did not permit docu-
     cup and sanitizing tablets for nightly cleaning.         mentation at the level of detail needed to track the
     Every kit came with standard directions for use and      new oral care protocol, randomized audits were
     additional patient education materials developed         conducted weekly via direct patient interviews on
     for the study.                                           all study units. These took place in real time with

26   AJN ▼ June 2021   ▼   Vol. 121, No. 6                                                               ajnonline.com
Figure 1. The Standardized Oral Care Protocol

              • Complete oral care assessment includes a swallow assessment                 • Document oral care in the patient record.
                first. Determine if a bite block is required and if additional              • Disposable oral swabs do not replace tooth brushing. They are for
                swallow assessment is required.                                               comfort care, one-time use only; do not leave oral swabs soaking in
              • Always use Personal Protective Equipment (PPE) when assisting                 a cup for reuse later.
                patients with mouth care and wash your hands before and after               • Maintain adequate oral hydration when possible to maximize
                the procedure per policy.                                                     salivary flow.

                                       EQUIPMENT                                                             PROCEDURE
          Self-care and                • Soft toothbrush, ADA approved                                       1. Set patient up at sink or in bed with all equipment.
          staff-assist.                • Toothpaste and mouth rinse, ADA approved                            2. Instruct patient to brush teeth for 1-2 minutes.
          Able to expectorate          • Mouth moisturizer prn or mouthwash                                  3. Use mouth rinse twice a day, swish for 20 to 30 seconds.
          (spit)                       • Dental floss or interdental cleansers (optional)                    4. If patient is able and supply is available, use floss or
                                       • Lip balm (optional)                                                    interdental cleansers.
                                                                                                             5. May moisturize interior of mouth and lips using an oral
                                       FREQUENCY                                                                swab prn.
                                                                                                             6. Discard disposable equipment/swab in appropriate
                                       • After each meal and before bedtime.                                    receptacle.
                                       • If patient is NPO, oral care should be done 2-4 times daily.

                                       EQUIPMENT                                                             PROCEDURE
                                       • Suction toothbrush with oral cleaning solution packet               1. Moisten suction or regular toothbrush as noted.
          Dependent for                  (as appropriate and available)                                      2. Assist the patient to brush all surfaces of the
          oral care.                   • Soft toothbrush moistened with clean tap water or                      teeth until clean (1-2 minutes).
          Not able to                    alcohol-free mouthwash                                              3. Suction debris from mouth.
          expectorate (spit).          • Mouth moisturizer prn                                               4. Apply mouth moisturizer using an oral swab, to
          At risk for                  • Dental floss or interdental cleansers (optional)                       the interior of the oral cavity and apply lip balm.
          aspiration.                  • Lip balm (optional)                                                 5. Discard disposable equipment in appropriate
                                                                                                                receptacle.
                                       FREQUENCY
                                       • After each meal and before bedtime.
                                       • If patient is NPO, oral care should be done 2-4 times daily.

                                       EQUIPMENT                                                 PROCEDURE
          Dependent on                 • Suction toothbrush/ oral swab                           1. Provide suction prn to remove oropharyngeal secretions that can
                                       • Oral cleansing solution                                    migrate down the tube and settle on top of the cuff.
          oral care.
                                       • Mouth moisturizer                                       2. Obtain suction toothbrush/oral swab and moisten with
          Patient on a
                                       • May consider chlorhexidine oral rinse                      oral cleansing solution.
          ventilator.
                                         per hospital policy — current studies are               3. Connection suction toothbrush to continuous suctions.
                                         unclear as to benefit and harm                          4. If chlorhexidine is used, remove the debris and cleanse the gums,
                                                                                                    tongue, and inside of cheeks with the solution-saturated oral swab.
                                       FREQUENCY                                                 5. Suction debris from mouth
                                                                                                 6. Apply moisturizer using oral swab to the interior of the oral cavity
                                       • Every four hours and pm to remove oral                     and lips.
                                         debris.                                                 7. Discard disposable equipment/swab in appropriate receptacle.

                                       EQUIPMENT                                            PROCEDURE
          Denture care or              • Denture cup, labeled                               1. After removing dentures, place in a labeled denture cup.
          patients with                • Denture brush is preferred when                    2. Brush the palate, buccal surfaces, gums, and tongue with the toothbrush
                                         available, otherwise soft toothbrush                  or swab.
          no teeth.
                                       • ADA approved denture cleanser (for soaking)        3. Patient can swish and spit mouthwash, or use oral swab to apply moisturizer.
          Before the patient goes
          to sleep, remove and         • 2 oral swabs                                       4. Line the sink with paper towel and add water to cushion the dentures in
          clean dentures and place     • Denture adhesive (optional)                           case you drop them. Carefully brush dentures with warm tap water.
          them in a denture            • Mouth rinse                                           Do not use toothpaste as this may scratch the surface of the dentures.
          cleansing solution           • Mouth moisturizer prn or mouthwash                 5. Clean and dry equipment and return to patient’s bedside table.
          once daily.                                                                       6. Assist patient in inserting dentures into mouth.
                                       FREQUENCY                                            7. If patient needs denture adhesive to hold firmly in place, follow
                                                                                               manufacture directions.
                                       • Dentures are removed for cleaning at
                                                                                            8. Soak dentures in a denture cleanser in the denture cup at bedtime.
                                         bedtime. Remove dentures when sleeping

ADA = American Dental Association; NPO = nil per os, or nothing by mouth.
Note: This is the hospital-wide protocol used at the study site. For the purposes of this study, the orange section on care for ventilated patients was not relevant.
Image courtesy of the authors.

ajn@wolterskluwer.com                                                                                                  AJN ▼ June 2021       ▼   Vol. 121, No. 6              27
an average of 63% of patients on a unit, depend-        group (10 patients). See Figure 2 for a flow dia-
     ing on census. An investigator (AM) asked patients      gram describing our process for obtaining this
     and family members about their experience in the        final patient sample.
     last 24 hours: the number of times they’d com-             Regarding age, there were small but significant
     pleted oral care, the level of assistance needed, and   differences between both the medical and surgical
     whether they’d used their own oral care products or     control versus the intervention groups. Patients
     those provided by the hospital.                         in the medical and surgical control groups had
        Data analysis. All data were entered into an         a mean age of 60.9 and 62.6 years, respectively.
     Excel spreadsheet and were audited for accuracy by      Those in the medical and surgical intervention
     two clinical research coordinators (AM and another      groups had a mean age of 62 and 64.9 years,
     coordinator at the hospital) and by the research        respectively. Regarding length of stay, there was
     team. Data were then imported into IBM SPSS, ver-       a significant difference between the surgical con-
     sion 26, for analyses. The NV-HAP incidence rate        trol group (mean, 5.3 days) and the surgical inter-
     per 1,000 patient-days on the intervention units was    vention group (mean, 7.4 days). Regarding race,
     compared with that on the control units. A χ2 anal-     there were no significant differences between the
     ysis was used to determine the relationship between     medical control and intervention units. On the
     units, and the Wald test for logistic regression was    surgical units, there were significantly more white
     calculated to obtain the odds ratio and confidence      patients on the intervention unit (64.5%) than on
     intervals between groups. Means comparisons of          the control unit (50.1%) and significantly more
     continuous variables (age, length of stay) across the   Asian patients on the control unit (27.1%) than
     control and intervention groups were done using         on the intervention unit (12.2%). Demographic
     the independent samples t test. The Mann-Whit-          data for the full sample are provided in Table 1.
     ney U test was used to test for group differences of       Deidentified demographic and general out-
     categorical variables (gender, race). The Cramér V      comes data were retrieved for the 39 identified
     effect size was calculated to assess the strength of    NV-HAP patients. Demographic data included
     association between categorical variables. Monthly      age, gender, length of stay, and hospital day of
     tracking of NV-HAP cases, compliance with oral          NV-HAP onset. Outcomes data included sepsis
     care practice standards, and pneumonia readmis-         diagnosis postadmission, unplanned ICU transfer,
     sion rates on all study units were summarized using     30-day readmission, and mortality. For details, see
     descriptive statistics to compare the control and       Table 2.
     interventional units. For all analyses, statistical        Primary outcome. To determine the effective-
     significance was set at P ≤ 0.05.                       ness of a universal, standardized oral care proto-
                                                             col in preventing the development of NV-HAP, we
                                                             looked at the incidence rate of NV-HAP per 1,000
                                                             patient-days. Logistic regression revealed a signifi-
             Improved oral care was                          cant difference between the medical control and
                                                             intervention groups. Patients on the medical con-
                                                             trol unit were 7.1 times more likely to develop
            associated with NV-HAP                           NV-HAP than those on the medical intervention
                                                             unit. The Cramér V effect size was 0.52, indica-
                            reductions.                      tive of a moderate association between being on a
                                                             control unit and developing NV-HAP. But the dif-
                                                             ference between the surgical control and interven-
                                                             tion groups did not reach significance. For all
                                                             units, the NV-HAP incidence rate per 1,000
     RESULTS                                                 patient-days and the percentage by which this
     Sample. Of the 8,713 patients initially screened,       decreased are shown in Table 3.
     four were excluded because they were under 18              The initial power analysis indicated a requisite
     years of age, leaving a total of 8,709 patients. Dis-   sample size of 2,580 patients per group, for a total
     tribution across the study units was as follows:        of 10,320 patients. While none of the four groups
     medical control, 2,075 patients; surgical con-          reached a sample size of 2,580, post hoc power
     trol, 2,088 patients; medical intervention, 2,709       analyses of the medical control versus the medical
     patients; surgical intervention, 1,837 patients. All    intervention units revealed a moderate Cramér V
     8,709 patients were evaluated for the presence of       effect size of 0.54 and an actual power of 0.99.
     NV-HAP using the criteria described above. At           However, such analyses of the surgical control ver-
     the end of data collection, nearly three times as       sus the surgical intervention units revealed a much
     many NV-HAP cases had been identified in the            smaller Cramér V effect size of 0.02 and a lower
     control group (29 patients) as in the intervention      power of 0.61.

28   AJN ▼ June 2021   ▼   Vol. 121, No. 6                                                              ajnonline.com
Figure 2. CONSORT Flow Diagram: Initial Screening to Final Identified NV-HAP Cases

                                                            Patients screened
                                                                (n = 8,709)

                                              Intervention                            Control
                                               (n = 4,546)                          (n = 4,163)

       Excluded (n = 4,127)                                                                  Excluded (n = 3,735)
       • No ICD-10 PNA code                                                                  • No ICD-10 PNA code

                                        Had ICD-10 PNA code                 Had ICD-10 PNA code
                                              (n = 419)                           (n = 428)

       Excluded (n = 367)                                                                    Excluded (n = 368)
       • < 48 hrs LOS (n = 24)                                                               • < 48 hrs LOS (n = 31)
       • PNA on admission (n = 327)                                                          • PNA on admission (n = 325)
       • < 48 hrs postextubation (n = 16)                                                    • < 48 hrs postextubation (n = 12)

                                          Included (n = 52)                      Included (n = 60)

       Excluded (n = 29)                                                                     Excluded (n = 20)
       • < 48 hrs before PNA diagnosis                                                       • < 48 hrs before PNA diagnosis

                                            PNA diagnosis on                  PNA diagnosis on
                                            study unit (n = 23)               study unit (n = 40)

                              Met CDC criteria (n = 10)                             Met CDC criteria (n = 29)

                        Surgical                          Medical           Surgical                              Medical
                         (n = 7)                          (n = 3)           (n = 13)                              (n = 16)

CDC = Centers for Disease Control and Prevention; CONSORT = Consolidated Standards of Reporting Trials; ICD-10 = International Classification of
Diseases, Tenth Revision; LOS = length of stay; PNA = pneumonia.

ajn@wolterskluwer.com                                                                                        AJN ▼ June 2021    ▼   Vol. 121, No. 6   29
Table 1. Patient Demographics (N = 8,709) by Unit
                                                                    Medical                                             Surgical
                                                      Control        Intervention                       Control         Intervention
         Variable                                   (n = 2,075)       (n = 2,709)          P          (n = 2,088)        (n = 1,837)             P
         Age, mean (SD), years                      60.9 (17.6)            62 (17.7)      0.03         62.6 (16.3)        64.9 (13)          < 0.001
         LOS, mean (SD), days                          5.5 (6.7)            5.4 (6.5)     0.43             5.3 (5.5)       7.4 (6.9)         < 0.001
         Gender, No. (%)
           Female                                   983 (47.4)       1,357 (50.1)         0.74         965 (46.2)        682 (37.1)            0.46
           Male                                    1,092 (52.6)      1,352 (49.9)                     1,123 (53.8)     1,155 (62.9)
         Race, No. (%)   a

           White                                    969 (46.7)       1,237 (45.7)         0.28        1,047 (50.1)     1,185 (64.5)          < 0.001
           Asian                                      18 (0.9)             37 (1.4)                        21 (1)         19 (1)
           Black or African                         668 (32.2)         854 (31.5)                      565 (27.1)        224 (12.2)
           American
           Other                                    410 (19.8)         567 (20.9)                         438 (21)       403 (21.9)
     LOS = length of stay.
     a
         Percentages are based on total number per unit. Some data were missing; thus, not all columns sum to 100%.

     Table 2. Demographic and Outcomes Data for NV-HAP Patients (n = 39)
                                                                 Medical                                               Surgical
                                                   Control                 Intervention                    Control                Intervention
         Variable                                  (n =16)                    (n = 3)                      (n = 13)                  (n = 7)
         Age, years
           Mean (SD)                      61.8 (13.3)                 64 (5)                     65.5 (20)                 70.4 (12.5)
           Median                         63.5                        64                         67                        73
         Gender, No. (%)
           Female                             9 (56.2)                  2 (66.7)                      6 (46.2)                    2 (28.6)
           Male                               7 (43.8)                  1 (33.3)                      7 (53.8)                    5 (71.4)
         LOS, days
           Mean (SD)                      17.1 (11.5)                16.7 (17.6)                 11.6 (5)                   24.2 (13.9)
           Median                         14.8                        7.7                        11                         25
         Hospital day of
         NV-HAP onset
           Mean (SD)                          8 (6)                     5 (1)                         6 (2)                   11 (5)
           Median                             6                         5                             5                       12
                                                         Outcomes for All NV-HAP Cases, No. (%)
                                            Sepsis Diagnosis           Unplanned ICU                    30-Day
                                             Postadmission               Transfer                     Readmission                  Mortality
         Yes                                  8 (20.5)                10 (25.6)                       5 (12.8)                    2 (5.1)
         No                                 31 (79.5)                 29 (74.4)                    34 (87.2)                  37 (94.9)
     LOS = length of stay; NV-HAP = nonventilator hospital-acquired pneumonia.

30   AJN ▼ June 2021         ▼   Vol. 121, No. 6                                                                                             ajnonline.com
Table 3. NV-HAP Rates and χ2 Results by Group
                                                                                                     NV-HAP
                                                                                                                         Incidence Rate per
    Treatment Group                                                   No                     Yes          Total          1,000 Patient-Days
    Medical Control, No. (%)                                  2,059 (99.2)            16 (0.8)        2,075              1.40
    Medical Intervention, No. (%)                             2,706 (99.9)             3 (0.1)a       2,709              0.21
    Total                                                     4,765                   19              4,784              −85 (% difference)
    Surgical Control, No. (%)                                 2,075 (99.4)            13 (0.6)        2,088              1.17
    Surgical Intervention, No. (%)                            1,830 (99.6)             7 (0.4)b       1,837              0.51
    Total                                                     3,905                   20              3,925              −56 (% difference)
CI = confidence interval; NV-HAP = nonventilator hospital-acquired pneumonia; OR = odds ratio.
a
    OR for medical control vs. medical intervention units (OR: 7.1; 95% CI, 2.01-24.1, P = 0.002).
b
    OR for surgical control vs. surgical intervention units (OR: 1.6; 95% CI, 0.65-4.1, P = 0.29).

Table 4. Oral Care Frequency and Type Provided
                                                    Frequency of Daily Oral Care per Month
                                                   Medical Units                                         Surgical Units
    Control, range (mean)                          0.86 –1.03 (0.95)                                     0.9 –1.4 (1.18)
    Intervention, range (mean)                     1.28 – 2.9 (2.25)                                     1.19 – 2.3 (2.02)
    % Difference                                   +135   a
                                                                                                         +70 a
                                                   Type of Oral Care Provided, % of Patients
                                                                                 Required some            Required total assistance and
                                                   Independent                   assistance               use of suction toothbrush
    Medical intervention                           40                            39                       20
    Medical control                                39                            40                       22
    Surgical intervention                          55                            37                           7
    Surgical control                               63                            30                           6
a
    P ≤ 0.05.

    While our goal of achieving an oral care fre-                                   daily oral care frequency improved significantly on
quency of four times daily wasn’t met on any of                                     the intervention units, reaching up to 2.9 times per
the study units, the frequency was significantly                                    day on the medical intervention unit. Although this
higher on both the intervention units compared                                      didn’t meet the target level, improved oral care was
with the control units. On the medical units, the                                   associated with NV-HAP reductions of 85% on the
intervention unit increased the daily oral care                                     medical intervention unit and 56% on the surgical
frequency by 135% compared with the control                                         intervention unit. This finding supports previous
unit. On the surgical units, the intervention unit                                  research that showed a positive relationship
increased the frequency by 70% compared with                                        between increased frequency of daily oral care and
the control unit. For more details on oral care                                     NV-HAP incidence reduction.23
frequency and types of oral care provided, see                                         Studies of implementation science can involve
Table 4.                                                                            a variety of contextual factors that aren’t specif-
                                                                                    ically related to the intervention itself, including
DISCUSSION                                                                          nursing culture and leadership, workload, admin-
This study tested the impact of enhanced oral care                                  istrative responsiveness and support, and level of
on NV-HAP prevention in patients on medical and                                     resistance to change.32-34 We found this to be so in
surgical units. Over the course of the study, the                                   our study. The medical intervention unit embraced

ajn@wolterskluwer.com                                                                                             AJN ▼ June 2021   ▼   Vol. 121, No. 6   31
the oral care intervention and provided more fre-       vention efforts can be substantial.21 But this requires
     quent oral care (135% more than control) com-           a sizable initial investment in such products, which
     pared with the surgical intervention unit (70%          will present a roadblock for many hospitals. In
     more than control)—even though the medical unit         short, changing the clinical mindset will take time,
     had less staffing. Also, more patients on the med-      sustained effort, ongoing involvement of nurses and
     ical than the surgical intervention unit were iden-     nursing assistants, interdisciplinary collaboration,
     tified as partially or entirely dependent on assis-     and buy-in from nursing and hospital leadership.
     tance for oral care (59% versus 44%). There was            Although we collected demographic data on
     a general expectation that patients could perform       age, gender, and race, the small number of NV-
     oral self-care in the first days after cardiovascu-     HAP cases did not permit analyses to assess these
     lar surgery, and this may have accounted for the        data in relation to findings. The influence of age,
     lower frequency of oral care on the surgical inter-     gender, and race on NV-HAP incidence represents
     vention unit compared with the medical interven-        an area for further study. The additional data we
     tion unit. The surgical intervention unit also had a    collected on the development of postadmission
     significantly higher mean length of stay and mean       sepsis, unplanned ICU transfer, 30-day readmis-
     patient age compared with the surgical control          sion, and mortality can help to inform future
     unit; both variables are known risk factors for         research on morbidity and mortality associated
     hospital-acquired infection.                            with NV-HAP.

        Findings suggest that primary source control through improved
                   oral care may be important for NV-HAP prevention.

         Post hoc power analyses showed that the surgical       Limitations. Although units were selected as
     units were underpowered to answer the research          matched pairs for their similarity in diagnoses and
     question, and the effect size was very small. Even      required care levels, we could not check for cluster
     with 12 months of data collection, we were unable       control effects on any of the units. The ideal frequency
     to achieve the full sample of patients.                 of oral care for NV-HAP prevention is unknown. In
         Despite the use of multiple means of education,     this study, accuracy in tracking such frequency was a
     coaching at the point of care, readily available sup-   challenge, as nursing staff didn’t always fully docu-
     plies, and ongoing reports during weekly huddles,       ment each oral care event and may have recorded self-
     oral care frequency remained lower than our target      care that didn’t actually occur. Moreover, because oral
     level. This is consistent with the findings of other    care was performed by both patients and staff, we
     researchers exploring the impact of oral care on        could not control for its quality. Hospitals are
     NV-HAP rates and the challenges of improving            dynamic institutions and it’s not always possible to
     such care.21, 23, 35, 36                                understand all the potential influencers on interven-
         As oral care is solely a nursing intervention—      tions and controls. Therefore, it’s possible that other
     and one critical to patient safety—nurses are           hospital initiatives directly or indirectly affected the
     well positioned to have a strong impact in this         oral care intervention and NV-HAP outcomes. Lastly,
     area. Nursing assistants are also vital to oral care    this study was conducted in a single hospital and find-
     improvement, as they often provide much of this         ings should be interpreted in that context.
     basic care. In order to realize the importance of
     the nursing role in NV-HAP prevention, we must          CONCLUSIONS
     change the mindset of nurses and other health care      Critically ill hospitalized patients are at high risk
     providers from seeing oral care as a comfort mea-       for NV-HAP and the associated increased morbid-
     sure to recognizing oral care as a therapeutic inter-   ity and mortality. NV-HAP prevention is of par-
     vention and oral care products as therapeutic           amount importance to patient safety. Our study
     devices. From an organizational perspective, there      findings suggest that primary source control
     is evidence that the return on investment in higher-    through improved oral care may be important for
     quality oral care products for use in NV-HAP pre-       NV-HAP prevention. Developing and implementing

32   AJN ▼ June 2021   ▼   Vol. 121, No. 6                                                                 ajnonline.com
unit undergoing mechanical ventilation. Clin Infect Dis
effective strategies that foster frequent, consistent                          2008;47(12):1562-70.
oral care for all inpatients warrants further study.                       14. Perry SE, et al. The association between oral bacteria, the
Moreover, it’s not yet known what degree and fre-                              cough reflex and pneumonia in patients with acute stroke
quency of oral care is necessary to favorably influ-                           and suspected dysphagia. J Oral Rehabil 2020;47(3):386-94.
                                                                           15. Abele-Horn M, et al. Decrease in nosocomial pneumonia in
ence changes in the oral microbiome during acute                               ventilated patients by selective oropharyngeal decontamina-
care hospitalization. Questions regarding ideal oral                           tion (SOD). Intensive Care Med 1997;23(2):187-95.
care frequency, best practices, and consistent imple-                      16. Kitsios GD, et al. Dysbiosis in the intensive care unit:
mentation would best be addressed through large                                microbiome science coming to the bedside. J Crit Care
                                                                               2017;38:84-91.
randomized controlled trials. ▼                                            17. Didilescu AC, et al. Respiratory pathogens in dental plaque
                                                                               of hospitalized patients with chronic lung diseases. Clin Oral
Karen K. Giuliano is an associate professor at the College of                  Investig 2005;9(3):141-7.
Nursing and the Institute for Applied Life Sciences, University of         18. Gleeson K, et al. Quantitative aspiration during sleep in nor-
Massachusetts Amherst. Daleen Penoyer is the director of the Center            mal subjects. Chest 1997;111(5):1266-72.
for Nursing Research and Advanced Nursing Practice, Orlando
                                                                           19. Huxley EJ, et al. Pharyngeal aspiration in normal adults
Health, Orlando, FL. Aurea Middleton is the research coordina-                 and patients with depressed consciousness. Am J Med
tor for Orlando Health’s Center for Nursing Research. Dian Baker               1978;64(4):564-8.
is a professor at the School of Nursing, California State University,
                                                                           20. Ewan VC, et al. Dental and microbiological risk factors
Sacramento. Financial support for this study was provided by Med-
                                                                               for hospital-acquired pneumonia in non-ventilated older
line Industries (which supplied the kits used) and Orlando Health.             patients. PLoS One 2015;10(4):e0123622.
Baker and Giuliano have also created a CE program on NV-HAP
sponsored by Medline. An intervention toolkit is available from the        21. Quinn B, et al. Basic nursing care to prevent nonven-
                                                                               tilator hospital-acquired pneumonia. J Nurs Scholarsh
authors. The authors acknowledge Joohyun Chung for her guidance
                                                                               2014;46(1):11-9.
and review of the statistical approach and analyses. Contact author:
Karen K. Giuliano, kkgiuliano96@gmail.com. The authors have dis-           22. Cassidy MR, et al. The I COUGH multidisciplinary periop-
closed no other potential conflicts of interest, financial or otherwise.       erative pulmonary care program: one decade of experience.
                                                                               Jt Comm J Qual Patient Saf 2020;46(5):241-9.
                                                                           23. McNally E, et al. Oral care clinical trial to reduce non-
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ajn@wolterskluwer.com                                                                                       AJN ▼ June 2021    ▼   Vol. 121, No. 6   33
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