Helen Kenedi, M.S., CCC-SLP Jenny Reynolds, M.S., CCC-SLP JoBeth Vance, M.S., CCC-SLP

Helen Kenedi, M.S., CCC-SLP Jenny Reynolds, M.S., CCC-SLP JoBeth Vance, M.S., CCC-SLP

Disclosure Helen Kenedi, Jenny Reynolds, and JoBeth Vance have no financial or nonfinancial disclosures and do not endorse any specific products.

Objectives of our talk Learner will Describe the importance of an oral care program within the context of the water protocol. Summarize preliminary pilot results and interpret their implications. Describe how to initiate, plan and implement collaborative practice-based research.

Jenny Reynolds, MS CCC-SLP

Dirty mouth- what s the risk? CAUSE: Bacteria- Oropharyngeal colonization by flora or pathogens linked to respiratory infection Oral secretions that migrate/ Aspiration of subglottal secretions Colonization of Dental plaque with respiratory pathogens (Fourier 1998) RESULT: VAP Non ventilator acquired pneumonia Increased length of stay Increased expenses

Benefits of Oral Care Benefit: Prevention of VAP (Garcia 2009) Decreased length of stay in ICU (Lloyd 2002) Best Practices from literature : (Lloyd 2002) Daily assessment of oral cavity Brushing every 2-4 hours Alcohol-free, antiseptic oral rinse Suctioning of oral secretions in both the oral cavity and the oropharyngeal area Application of a water-based mouth moisturizer

Oral Care Implementation Process Phase 1 ICU policy created in 2005 for ventilator dependent ICU patients Phase 2 In 2010, SLP team met with RN and RT to discuss need for ORAL CARE POLICY with floor patients that have dysphagia Phase 3 SLP and RN collaboratively reviewed literature and revised current policy to include non-icu patients and patients with dysphagia Phase 4 SLP and RN met with product vendors, SAGE, to discuss products for floor patients Phase 5 Collaborative Education to RN units by RN/SLP/Vendor

Oral Care Products Included in Continue Care package: 1 Covered Yankauer 2 Pkg Suction Toothbrushes with sodium bicarbonate, Antiseptic Oral Rinse, Mouth Moisturizer, Applicator Swab 2 Pkg Suction Swabs with sodium bicarbonate, Antiseptic Oral Rinse, Mouth Moisturizer and Applicator Swab

BUMC Oral Care Protocol

Procedure for Collaborative Education Create education with RN/SLP Provide education to RN floors that were part of the pilot study Initiated oral care pilot study (3 months) Tracked compliance of oral care and documentation

Content of Collaborative Education Creation/Update on policy content Oral Care products Oral Care procedure Patient population that needs oral care Documentation of oral care in EHR

Collaborative Education Educated every RN unit (all shifts) with RN, SLP, and Vendor

Oral care with the FWP Patients on free water are recommended aggressive oral care to decrease possible oropharyngeal colonization of bacteria, a known risk for developing aspiration pneumonia. An oral care protocol was implemented as a precursor to the Free Water Protocol (FWP) research.

JoBeth Vance, MS CCC-SLP

Free Water Guidelines Aggressive oral care encouraged Receive ice/water before or between meals Use of swallowing strategies Water NOT served with medications NOT allowed access to thin liquids other than water Supervision of ice/water intake as deemed appropriate by the SLP and physicians

Method - Study Design Two Randomized Control Pilot Studies Positive and Negative clinical indicators of FWP: Acute Stroke Acute Trauma Approved by Baylor Healthcare System and University of Texas at Dallas Internal Review Boards

Study Design Equally divided by diagnosis and randomly assigned Table 1 Traditional dysphagia therapy Oral care protocol Experimental Group Yes Yes Control Group Yes Yes FWP Yes No

Method Participants Referrals made by attending physicians or SLP s at Baylor University Medical Center (BUMC) Consents/assents obtained from each patient/ caregiver

Method- Participants 45 total participants from BUMC - Acute Care 43 completed the study

Inclusion and Exclusion Inclusion Criteria: Primary diagnosis: Trauma or Stroke Documented evidence of aspiration on thin liquids based on an objective exam Receiving alternate nutrition/modified diet during the study

Inclusion/ Exclusion Exclusion Criteria: Medically complex with CHF Presence of thrush/active oral infection Excessive coughing during/after intake Fluid restrictions Mental status that does not support oral intake Progressive degenerative disease

Time Patient Enrollment : 04/2011 09/2012 Consent/Assent and Initial Data Collection: ~1+ hour Data Collection and Collaboration: ~ 1 hour for each patient

Signage Patient Room Number: Date: Diet: Patient may not have water or ice. Patient Room Number: Date: Diet: Patient will require 100% supervision with ice and water. Patient MAY HAVE ice or water before meals or 30 minutes after meals. Patient may not have ice or water during meals or for 30 MINUTES after meals. Patient must have oral care in the morning prior to any ice or water. Patient must continue using thickener for all liquids except ice and water. Do not give medications with water. Patient Room Number: Date: Diet: Patient MAY HAVE ice or water before meals or 30 minutes after meals. Patient may not have ice or water during meals or for 30 MINUTES after meals. Patient must have oral care in the morning prior to any ice or water. Patient must continue using thickener for all liquids except ice and water. Do not give medications with water.

Statistical Analysis Analyzed using descriptive and inferential statistics Biostatistician blinded Dependent variables: Occurrence of positive or negative clinical indicators

Demographics Control (N=21) Experimental (N=22) p-value Gender Female 4 (19%) 3 (14%) Male 17 (81%) 19 (86%) 0.70 Age Mean ± SD 63 ± 13 56 ± 16 0.15 Diagnosis Stroke 9 9 Trauma 12 13

Positive Clinical Indicators Diet Control (n=21) Experimental (n=22) Downgrade None None --- Significance level (p) No Change 10 (48%) 14 (67%) 0.35 Upgrade 11 (52%) 7 (33%) 0.35 NPO to PO 5/10 (50%) 5/13 (38.5%) 0.69 Length of Stay Median (Range) 23 days (7-42) 21 days (0-71) 0.79

Negative Clinical Indicators Aspiration Pneumonia Control (n=21) Experimental (n=22) None None --- Intubation None None --- Xerostomia Significance level (p) Pre-Tx 14 (70%) 14 (74%) 1.00 Post-Tx 5 (42%) 3 (27%) 0.67 Change: Xero- No Xero 4 (33%) 4 (33%) 1.00 No Change 8 (67%) 4 (36%) 1.00

Data Collection Patient Satisfaction Survey Designed to elicit nonverbal expression of feelings Modification of (Wong, 1997)

Patient Satisfaction Thin Liquids To relieve symptoms of dry mouth 100% To quench thirst 88% Respondents (n=16) Thick Liquids Thick liquid satisfaction ~50%

Results: Summary Negative clinical indicators were NOT observed in either groups No significant difference or change in xerostomia cases/status between both groups None of the participants experienced a diet downgrade Low percentage of participants on FWP initially NPO were upgraded to oral diet post-treatment

Results: Summary Length of Stay No significant differences Satisfaction Surveys completed by 16/43 (37%) 9 - experimental group 7 - control group All indicated thin liquids satisfied dry mouth 14/16 indicated thin liquids quenched thirst ~ 50% reported satisfaction with thickened liquids

Discussions No statistically significant group differences in positive clinical indicators No group difference in rates of negative clinical indicators including aspiration pneumonia or intubation Patient satisfaction surveys of limited use in acute care setting

Challenges Acute Care Hospital Setting Multiple physician coverage Multiple floors Patient requirements Daily shift change/ turn over between nursing staff Frequent, continual education Primary treating SLP not involved in study

Limitations Tracking water intake Short LOS duration Lack of personnel to closely track water intake Covering multiple floors Weekend staff coverage Communication between rotating nursing staff IV-fluids or ANH Notice of patient discharge

Implications Results suggest no contraindications of the FWP for patients similar to those studied

Implications Important factors may account for absence of adverse events: Oral care program Continual education and communication with multiple disciplinary staff Adherence to FWP guidelines (Garon 1997, Carlaw 2012) Additional studies in larger samples are needed

Study Expansion Currently recruiting and observe a larger sample size of patients to better compare positive/negative clinical indicators. Following a subset of patients from acute care to BIR Inpatient- Dallas. Complete patient satisfaction surveys at discharge from inpatient rehabilitation

Helen Kenedi, M.S., CCC-SLP

Collaboration: The Essential Link in Practice-Based Evidence What is research collaboration? Researchers working together with the common goal of producing new scientific knowledge (Katz & Martin, 1997) Why research collaboration? Clinicians lack time for research Academics have limited access to clinical populations

Benefits of Research Collaboration Practice-based research Sharing resources Sharing workload Interdisciplinary input: each professional offers a specific skill set Opportunity to disseminate information via multiple channels

Challenges with Research Collaboration Time costs -IRB paperwork at multiple institutions -Division of workload Management costs -Communication: keeping members informed -Managing differences of opinion

Collaboration Process Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6 Phase 7 Laying the groundwork Developing data collection tools and processes Implementing the pilot study Analyzing the pilot study Developing the principal study Funding the principal study Implementing the principal study

Phase 1: Laying the groundwork ID area of interest Build a Team Formulate/develop research question PICO (Dollaghan 2007) Formulate and Agree on Research Aims Seek Academic and Physician Sponsors

Phase 2: Data collection, Forms, and the IRB Data collection tools: Develop Pilot test Modify Finalize Consent forms: Develop Obtain translations

Phase 2: Data collection, Forms, and the IRB Submit internal review board applications to institutions involved Complete the application Complete financial disclosures Complete required research modules for each institution Obtain administrative approvals Attend full board meeting

Phase 3: Implementing the Pilot Study Recruit patients Consent patients Collect data Code and enter data Stay current on IRB requirements

Phase 4: Analyzing the Pilot Study Consult with UTD faculty sponsor Analyze pilot data Baylor Biostatistician performs data analysis

Phase 5: Developing the Principal Study Modify and finalize data collection tools from pilot studies Modify and finalize methodology from pilot study Modify and finalize consent forms Submit IRB applications for institutions involved

Phase 6: Funding the Principal Study Identify potential funding sources Callier Clinical Research Grant In the process of receiving a grant BIR Research Fund within the Baylor Foundation Apply for funding sources/grants

Phase 7: Implementing the Principal Study Recruit patients Consent patients Collect data Code enter data Stay current on IRB

Successful Collaboration Collaborative research presents benefits and challenges Specific skill sets and resources are necessary to collaborate successfully Successful collaborations have a clear division of technical roles Build trust and respect

Oral Care References Craven DE. (2000). Epidemiology of ventilator-associated pneumonia. Chest. 117:186S-187S. Fourrier, F., Duvivier, B., Boutigny, H., Roussel-Delvallez, M., Chopin, C. (1998). Colonization of Dental Plaque, A Source of Nosocomial Infections in Intensive Care Unit Patients, Critical Care Medicine. 26:301-308 Garcia, R., Jendresky, L., Colbert, L., Bailey, A., Zaman, M., & Majumder, M. (2009). Reducing ventilator-associated pneumonia through advanced oral-dental care: a 48-month study. American Journal of critical care, 18(6), 523-532. Safdar N, Crnich CJ, Maki DG. (2002). The pathogenesis of ventilatorassociated pneumonia: its relevance to developing effective strategies for prevention. Respir Care. 50:725-739, Schleder, B., Stott, K., Lloyd, R. (2002) : Effect of a Comprehensive Oral Care Protocol on patients at risk for Ventilator Associated Pneumonia. Journal of Advocate Health Care 4:1: 27-30

Water Protocol Study- References Carlaw, C., Finlayson, H., Beggs, K., Visser, T., Marcoux, C., Coney, D., & Steele, C. (2012). Outcomes of a pilot water protocol project in a rehabilitation setting. Dysphagia, 27, 297-306. Garon, B. R., Engle, M., & Ormiston, C. (1997). A randomized control study to determine the effects of unlimited oral intake of water in patients with identified aspiration. Neurorehabil Neural Repair,11(3), 139-148. Panther K: Frazier Rehab Center s Water Protocol, Frazier Rehab, Louisville, Kentucky. Wong, D., Baker, C. (1988) Pain in children: comparison of assessment scales. Pediatric Nursing, 14(1):9-17.

Collaboration References Dollaghan, C.A. (2007). The handbook for evidence-based practice in communication disorders. Baltimore, MD: Paul H. Brookes publishing Co. Katz, J. Sylvan, and Ben Martin (1997). What is Research Collaboration? Research Policy, Vol. 26, No. 1: pp. 1-18.