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Running head: END-OF-LIFE ESMO PROTOCOL PROJECT 1 End-of-Life ESMO Protocol Project Jacqueline Degen, Cynthia Snook, Anita M. Stechschulte, and Allison Tayloe Wright State University NUR 7005 April 15, 2013

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Running head: END-OF-LIFE ESMO PROTOCOL PROJECT 1

End-of-Life ESMO Protocol Project

Jacqueline Degen, Cynthia Snook,

Anita M. Stechschulte, and Allison Tayloe

Wright State University

NUR 7005

April 15, 2013

END-OF-LIFE ESMO PROTOCOL PROJECT 2

Abstract

DECREASING PAIN IN THE ACTIVELY DYING PATIENT THROUGH USE OF AN END-OF-LIFE SYMPTOM MANAGEMENT PROTOCOL

Funded by project grants from The American Nurses Foundation and National Institute of Nursing Research

Purpose: The purpose of this evidence based practice change is to determine if ESMO protocol use in an acute care setting decreases pain and adds comfort to the palliative care patients’ life during the last one to two weeks of life expectancy.

Synthesis of Evidence Guiding Change: Although palliative care options are available for patients in the acute care setting, many nurses caring for the actively dying patient have concerns over symptom management related to patient’s inability to communicate their needs. Previous studies have shown that use of clinical pathways, such as ESMO protocols, for the dying patient increased the healthcare teams’ ability to appropriately manage symptoms in various clinical settings, as well as increase comfort to the patient during this time.

Proposed Change: The proposed change for this EBP project will be implementation of an end-of-life symptom management protocol that includes a standardized order set, documentation tool, consent, and non-verbal pain scale for measurement of ESMO protocol effectiveness.

Strategies of Implementation: Strategies for implementation include developing the medical record changes, holding staff meetings to discuss importance and details of pilot project implementation and needed change, sharing successes and concerns during and after pilot implementation, and sharing outcomes following completion of the project. Stakeholders: The active stakeholders in this project include the nurses, physicians, and healthcare team members who are working in the acute care setting in which the project is taking place (med-surg floor of hospital). The passive stakeholders in this project include the hospital wide nursing council, director of nursing research, and director of nursing education.

Method of Evaluation: The method of evaluation for ESMO protocol use will be data analysis of the electronic medical record use for protocol screening. Significance of relationships between decreased pain and increased comfort will be measured by the use of non-verbal pain scale (NVPS) as part of the ESMO protocol. Previous studies have shown improved patient comfort through ESMO protocol use as measured by pain and dyspnea management. Press Ganey surveys will also be used to determine cost-benefit analysis of project implementation following the conclusion of pilot project.

Significance: The significance of this intervention is to have staff feel more comfortable with the care of the nonverbal dying patient. This EMSO will help the care team to be able to provide the best care available and will help the care team address end of life symptoms appropriately in the palliative care patient. ESMO protocol has proven to provide comfort through dyspnea and pain management in previous research. Thus, implementing ESMO protocol as a standardized order set will not only increase comfort to the dying patient, but decrease costs associated with symptom management in the dying patient related to appropriate pain and dyspnea management.

END-OF-LIFE ESMO PROTOCOL PROJECT 3

TABLE OF CONTENTS

Abstract ________________________________________________________________2

Table of Contents _______________________________________________________3-4

EBP Part 1: Statement of the Problem______________________________________5-7

Step 1: Assessing the Need for Change ___________________________________5-7Statement of the problem _______________________________________________5PICOT ______________________________________________________________5Planning the practice team ______________________________________________6Key informants and stakeholders _________________________________________7

EBP Part 2: Critical Appraisal of the Evidence ______________________________8-14

Step 2: Locating the Best Evidence________________________________________9Supporting Material____________________________________________________9

Step 3: Analysis of the Evidence______________________________________11-14 Synthesis__________________________________________________________11

Study 1 Walling et al: Barriers_______________________________________11 Study 2 Walling et al: Symptom Control_______________________________12 Study 3 Walker er al: Medications/Order sets___________________________13 Study 4 Cochrane Review: __________________________________________13Schematic Framework_________________________________________________14

EBP Part 3: Plan a Pilot Test ___________________________________________14-22

Step 4: Designing Practice Change_____________________________________14-15Model: Evidence-Based Practice Change Model_____________________________14Specific Aims/Objectives_______________________________________________15Client/Population/Setting_______________________________________________15Intervention: ESMO protocol____________________________________________15Special Considerations_________________________________________________15

Step 5: Implementation and Evaluation________________________________16-19Katherine Kolbacha’s Care Theory_______________________________________16Timeline: Gantt______________________________________________________16Order Sets/Protocols__________________________________________________16Staff Participation____________________________________________________17Special Accomodations________________________________________________18Outcomes and Measurement/ Data Collection ______________________________19Donabedian’s Outcome Framework______________________________________20Ethical Considerations_________________________________________________20

Step 6: Integrating and Maintaining Change____________________________21-22Dissemination of the Evidence__________________________________________22

END-OF-LIFE ESMO PROTOCOL PROJECT 4

EBP Part 4: Budget Proposal______________________________________________22

Projection/Justification_________________________________________________22Funding/Grants_______________________________________________________22

References/Works Cited________________________________________________23-25

Appendices__________________________________________________________26-31

Appendix I: Gantt Chart: Project Timeline___________________________________26

Appendix II: Non-Verbal Pain Scale (NVPS)________________________________27

Appendix III: Evidence-Based Practice Change Model_________________________28

Appendix IV: Plan for Measuring Success Table______________________________29

Appendix V: ESMO Budget Table_________________________________________30

Appendix VI: Poster For Dissemination_____________________________________31

End-of-Life ESMO Protocol Project

EBP Part 1: Statement of Problem

In today’s world of continued medical advancements, physicians, and hospitals are ready to offer

patients numerous choices on treatment options regarding particular diseases and diagnoses throughout

the country. Furthermore, nurses are trained to use these high technological advancements and treatments

to save their patients found in life threatening situations. However, many health care institutions lack

appropriate protocols for patients approaching death and many nurses feel uncomfortable with caring for

a dying patient and addressing his or her needs when a palliative care approach is chosen (White &

Coyne, 2011). Previous studies have shown nurse’s top two deficiencies regarding end of life care for

patients as lack of proficiency in discussing end of life options with patients and families and appropriate

pain control during the dying process (White, Coyne, & Patel, 2001). For example, Carol is a nurse on an

oncology unit caring for a patient with a terminal pancreatic cancer diagnosis. The patient has suffered

multiple strokes and cannot verbalize her needs. The patient often grunts, groans, and grimaces, but has

no other signs of verbalization of needs. The nurse has pain medication orders every hour, but does not

know when or how much to give. The patient’s family anxiously waits at her bedside, and the nurse is

confused regarding what they are feeling as well.

Step 1: Assessing the Need for Change

The nurse knows there is a protocol for end of life symptom management but not one in place at

her healthcare facility. A protocol, such as this is, needed for this patient during the palliative care phase

of life to help guide the nurses’ decision making. In the actively dying adult patient who is non-verbal,

how does the use of end-of-life symptom management orders (ESMO) protocol compared to those not

receiving ESMO affect the person's overall comfort and symptom management during the last one to two

weeks of life expectancy?

Walling, Brown- Saltzman, Barry, Quan, and Wenger’s (2008) state that during aggressive

treatment in an acute care setting “inadequate time is devoted to developing care plans to address end of

life (EOL) symptom management” (p. 858). Without a plan this lack leads to inadequate symptom

END-OF-LIFE ESMO PROTOCOL PROJECT 6

management when EOL symptoms occur. Their further discussion notes that physicians may be

uncomfortable guiding comfort care if there are no guidelines to direct said care and may be complicated

by diverse views regarding opiate use at EOL. Additionally, according to White, Coyne, & Patel (2001)

nurses have verbalized that they are uncomfortable with those who are actively dying. Thus,

implementation of ESMO would address not only the physician’s discomfort in guiding care but also

provide the nurse with suggestions for symptom management, reminders of requirements for

implementation of the ESMO, and specific orders to address symptom management. Topolovec-Vranic,

et al. (2010) state that “in the presence of life-threatening illness pain assessment and management are

often overlooked or underappreciated by the health care team.” (p. 345) One often hears bedside nurses

express he or she is uncomfortable in caring for nonverbal dying patients as they are unsure as to how to

assess effectively and/or manage that discomfort.

The population or individuals this evidence-based project will focus on are those non-verbal

adults in his or her last days of life. According to Hospice (n.d.), there are two phases a person approaches

with impending death: pre-active phase and the active phase of dying. Those individuals in the active

phase of dying are the individuals whom the intervention will be used. Individuals in his or her last few

days of life may still experience discomfort but cannot verbalize that discomfort.

Changing the way nursing interventions are done involves approaching a problem with the best

evidence available (Melnyk, 2011, p. 9). The options for interventions are to continue ‘as usual’ and

allow each nurse to dictate whether the patient is comfortable or not. Another option would be apply a

pain specific assessment tool, such as the ABBEY assessment tool for pain or the Nonverbal Pain Scale

assessment tool. Another intervention could even be relying on family to dictate whether the patient is

comfortable or not. However, according to Walling et al, (2008) designing an overall comfort plan that

involves the entire end of life symptom management, not just pain control, is the best approach to

optimizing overall comfort at the end of life (p. 858). Using the ESMO protocol, end-of-life symptom

management orders helps guide the use of medications, such as opiates, and other palliative modalities (p.

857).

END-OF-LIFE ESMO PROTOCOL PROJECT 7

The intervention chosen is the implementation of an end of life system management protocol

(ESMO). The protocol would allow the staff on the floors not familiar with the care of a dying nonverbal

patient to feel more at ease and to have the assurance that the patient is getting the best care. The use of

the protocol could be used not just with the floor nurses but with other ancillary departments: social

workers, case managers, respiratory therapy, palliative care team, and pastoral care. The ESMO

incorporates not just pain but also other end of life concerns. As it has been written previously the use of

an ESMO can improve the quality of care given to the nonverbal dying patient.

The need for a protocol to help nurses and other care teams’ respond to the dying patient is

necessary to give the best care available. The key to the implementation of this protocol is educating the

staff and other necessary personal. The protocol helps to bring about continuity of care for both the

patient and his or her family. The ESMO will allow the nurse to feel more comfortable with use of pain

medication and other symptoms. Knowing that the patient will have adequate symptom management is

needed at this stage of life. In planning the practice change, nearly every discipline of the health care team

should collaborate. Administration must support and enable implementation of an evidence-based tool.

Pharmacy will be consulted on adequate dosing of medication. The education department will insure all

members of the interdisciplinary team are aware of how and when to implement the tool. Social work and

pastoral care will facilitate agreement by the family for implementation of the ESMO. Respiratory

therapy, physicians, and nurses must be knowledgeable and comfortable using the ESMO effectively.

Looking within the organization to develop a team, two stakeholders help make a project happen:

active stakeholders and passive stakeholders (p. 55). In the case of implementing end-of-life symptom

management orders (ESMO) protocol the active stakeholders would be those people or councils that

would be actively participating in evidence-based intervention: physicians, nurses, patients, family, and

other ancillary staff such as nurse technicians. Passive stakeholders are not directly involved with the

implementation but still play a part in its success. Passive stakeholders are risk management, education

departments, managers, executive officers, the evidence practice council, and the research board. It can be

END-OF-LIFE ESMO PROTOCOL PROJECT 8

difficult to identify all the stakeholders upon the onset of a project, remaining open to others and sharing

the project plan will help with communication, support, and implementation (Fineout-Overholt, 2011).

EBP Part 2: Critical Appraisal of the Evidence

After addressing the active and passive stakeholders for this evidence-based practice project, it is

important to consider agencies outside the hospital setting that may be important. Agencies such as

outpatient hospice facilities, local cancer outreach support groups, and the American Association of

Critical Care Nurses would all be important to include in implementing the ESMO protocol. Attention to

individuals and groups, such as those needed to improve the outcomes or change practice related to the

project implementation (Melnyk & Fineout-Overholt, 2005). Outpatient hospice facilities in the area may

offer insight into end of life care protocols and ease the implementation of such protocols within the

hospital setting (Kehl, Kirchhoff, Kramer, & Hovland-Scafe, 2009). Local cancer outreach support groups

have two purposes. First, it offers information to clientele regarding the protocol being implemented at

the hospital. Secondly, it offers benefits to both patients and families facing palliative care options and

serve as a resource for hospital setting to reach out to families as part of the ESMO protocol. The

American Association of Critical Care Nurses (AACN) has cited palliative and end of life care as one of

three major initiatives in current health policy agendas and evidence-based practice. Thus, including

AACN as an agency would allow potential research funding and supporting evidence based practice

during planning and implementation of the ESMO protocol in the hospital setting (American Association

of Critical Care Nurses, 2013).

The patient care-team will help implement the new intervention into practice and coordination of

all the disciplines needs to occur to ensure the project is a success. The multitude of information and

expertise available within the team will allow for a smoother transition. Change within the organization is

never easy. However, with proper education and the best available evidence, the new protocol will be

well received. Hopefully sparking a spirit of inquiry for other evidence based projects. Assessing and

addressing the needs of dying patients is difficult for nurses in the health care arena. Fulfillment of these

needs can be especially difficult with the unpredictability of a death and the individuality of end of life

END-OF-LIFE ESMO PROTOCOL PROJECT 9

symptom management (Seow et al, 2010). Many studies have focused on the need for new outcomes,

frameworks, and quality indicators associated with end of life symptom management as well as a push for

ESMO (end of life symptom management order) protocols within practice (Walling, Ettner, Barry,

Yamamoto, & Wenger, 2011).

Step 2: Locating the Best Evidence

Previous studies have shown that comfort is achieved through adequate pain and dyspnea

management, which has been improved with the use of ESMO protocols (Walling et al, 2008). Pain and

dyspnea management in the dying patient may be difficult to assess related to the patients’ inability to

express their needs verbally. Pain is often described as suffering through physical or emotional

discomfort, whereas dyspnea is noted as discomfort in breathing patterns (Seow et al, 2010). Both pain

and dyspnea, although subjective, are indicators that affect a patient’s sense of comfort. ESMO protocol

often includes a non-verbal pain scale that addresses indicators of facial movements and airway

management to control patients’ symptoms in the last weeks of life. Therefore, the focus of this EBP

project centers on the use of ESMO protocols to improve comfort in the form of pain and dyspnea

management in the dying patient compared to standard care.

A systematic and thorough review of multiple databases was conducted and included: CINAHL,

PUBMED, Cochrane Review, and Agency for Health Care Research and Quality (AHRQ). Other

supplemental material was reviewed as well: research studies, patient education materials, benchmarks,

and guidelines. The use of ESMO protocols within health care institutions was evaluated and synthesized

for importance of information.

In 2011 Nottingham University Hospital launched benchmarks “to encourage staff (to take)

ownership and involvement in … raising standards in fundamental care” to improve end-of-life care

(Warren, Freer, & Molinari, 2011, p. 15). Nearly half of all deaths occur in the acute care setting (p. 16),

yet hospital-based nurses, especially those in an acute care setting, do not feel comfortable taking care of

or managing symptoms at end-of-life (White & Coyne, 2011). Developing standards of measurement in

end-of life care raises awareness of the best practices available and gives nurses the confidence to care for

END-OF-LIFE ESMO PROTOCOL PROJECT 10

this challenging population. One of the 12 benchmarks set forth by Nottingham University Hospital is for

“nurses to know how to manage common symptoms” such as pain, secretions, and dyspnea in a dying

patient (Warren, Freer, & Molinari, 2011, p. 17). These benchmarks include that staff should have access

to and know how to use end-of-life symptom management pathways to give the patient comfort through

symptom management.

In addition to these guidelines, the Agency for Health Care Research and Quality (AHRQ) has

proposed a framework centered on end-of-life symptom management in the form of pain, dyspnea, and

delirium management (Seow et al, 2010). Although this framework is focused on end-of-life care for

cancer patients, the assessment of quality indicators that ease the suffering and provide comfort have

generalizability toward any dying patient. This framework was developed from multiple research studies

surrounding end-of-life care. The AHRQ framework contains an assessment and diagnosis category for

symptom management within a five-step process. Thus, it is important to note the nurse’s role in

evaluating patient needs and symptoms during the palliative care stage. Additionally, this framework

includes assessment of factors to gauge appropriate ESMO use in the dying patient during the last one to

two weeks of life expectancy (Seow et al, 2010).

Recently, many hospitals have begun to develop inpatient hospice units and palliative care teams

to address the needs of patients in the last weeks of life expectancy (Caple, 2012). Palliative care teams

focus have evolved based on the World Health Organization’s definition to include management of

patient and families’ physical and psychological needs during the palliative care phase of life. Within

recent years, progress has been made to include development and use of the end-of-life-symptom

management within institutions. As part of that development, palliative care teams have been formed to

provide comfort to the dying patient (Caple, 2012). Thus, the development and support of such studies

and government research agency guidelines is important to address the current findings and to advocate

for ESMO protocol use. Health care facilities need to make it a priority to maintain comfort through

adequate pain and dyspnea management during a patient’s last one to two weeks of life expectancy.

Step 3: Analysis of the Evidence

END-OF-LIFE ESMO PROTOCOL PROJECT 11

The research was evaluated regarding ESMO protocol use compared to standard care in

comforting the dying patient in the last one to two weeks of life expectancy and there is ample evidence

supporting the general use of ESMO protocols within institutions (Walling et al, 2011). However,

whether ESMO protocol improves specific outcomes has not been rigorously studied (Chan & Webster,

2010, 4). Designing such studies is a challenge with the dying population because of potential ethical

issues in conducting controlled studies (p. 9). Although further rigorous research needs to be conducted,

end-of-life care pathways have been shown to be effective in managing certain conditions (p. 9).

In health care facilities where ESMO protocols are available studies have shown that clinicians

use these protocols approximately 50% of the time even though the use has been proven to increase

patient’s comfort (Walling et al, 2011). These finding strengthen the argument that a change is needed in

providing comfort through ESMO protocol use. Such findings support the use of ESMO protocol as the

‘gold standard’ and indicate a need for change regarding ESMO protocol use within health care

institutions to improve comfort in the dying patient in the last one to two weeks of life.

In a study conducted by a research team within a university-center hospital, data and calculations

were gathered on dying patients within the facility to assess use and non-use of the ESMO protocol

(Walling et al, 2011). Analysis of this study’s results concluded that use of the ESMO protocol helped

increase patient comfort in the dying patient. It also concluded that non-use of the ESMO protocol by

physicians and nurses was because of inadequate attention to patient comfort during a time of expected

death (Walling et al, 2011). Barriers exist with the use of ESMO protocol use within this specific

population of dying patients. Such barriers can be types of insurance and diagnoses on admission to the

hospital. This study was both statistically and clinically significant. The confidence interval for this study

was measured at 95%, leaving little room for random error. The confidence interval for this study was

used to evaluate barriers to ESMO use in the inpatient dying population, which was said to be increased

in younger, underinsured, and minority populations (Walling et al, 2011). This study is clinically

significant because the results are reliable and valid. The study addressed barriers to ESMO protocol use

END-OF-LIFE ESMO PROTOCOL PROJECT 12

within healthcare institutions to increase comfort for dying patients in their last one to two weeks of life

expectancy.

The PubMed database search using the keywords “end-of-life symptom management” and

“comfort-care end-of-life symptom management” revealed four studies with two relevant to the PICOT

question. Of the two relevant studies, one was a repeat of a study already included in this appraisal. The

chosen study by Walling et al. (2008), Assessment of Implementation of an Order Protocol for End-Life

Symptom Management, evaluated the implementation of an inpatient end-of-life symptom management

protocol (ESMO). This study’s results are valid because this is a Level IV study with implementation of

the chosen intervention, ESMO (Appendix 1). Over the course of 342 days, 127 in-patients in the final

day(s) of life were given the chosen intervention. The ESMO protocol was to be initiated by physicians

and nurses and evaluated if such a protocol was useful in caring for a dying hospitalized patient. The

study was a controlled study that measured pre and post knowledge and attitudes toward ESMO.

Although these outcomes were not relevant to the PICOT question the EBP research team wanted to

measure, the measurements of pain and dyspnea symptoms were subsequently included in the study and

these were relevant to the PICOT question (p. 860).

The results are reliable because the level of significance was placed at p<0.01 (Walling, Brown-

Saltzman, Barry, Quan, & Wenger, 2008, p. 859) (Appendix 1). The physician and nurse responses were

compared using x2 tests (p. 859). This indicates a probability ratio, 1 out of 100 chances that the result

was an accident or there was a 1% chance the result was obtained by accident. These results would be

considered significant, meaning that the researchers are 99% sure the study variables do have a

relationship (Heavey, 2011). However, the study also measured specific symptom control (comfort) such

as pain and dyspnea so this study was chosen to be a ‘keeper’. Each symptom was measured on how well

the physician or nurse perceived the symptom to be managed. The results will help in caring for patients

because in a majority of cases the clinicians believed patients had adequate symptom control in 82%

(physicians) versus 77% (nurses) (Walling et al., 2008, p. 862). Although the authors of the study

END-OF-LIFE ESMO PROTOCOL PROJECT 13

concluded that a standardized protocol may not fully be sufficient in managing all symptoms, a set

protocol “is a step toward improving care for dying hospitalized patient” (p. 857).

Walker, Nachreiner, Patel, Mayo, and Kerney (2011) retrospectively compared patients over a

six-month time-period and grouped the patients into three groups. The first group was those with standard

care who had no comfort or palliative care orders on the chart. The second was those who had comfort

measure only orders written at the doctor’s discretion. The third was those with a palliative care order set

implemented as ESMO. Their discussions of findings note that in the group with the ESMO, availability

of all types of palliative medications (opioids, anxiolytics, anti-secretory agents, etc.) was significantly

higher. The authors also note they were encouraged by the frequency of use in ESMO orders relatively

soon after implementation of the EMSO protocol even though they were in a smaller community teaching

hospital where staffing and time for palliative care education is often more limited than in larger hospitals

(p. 285). The authors further noted their findings do support previous reports of successful ESMO

implementation at large hospitals (p. 285).

The Cochrane review synthesized multiple studies regarding the use of end-of-life pathways

versus the non-use of critical pathways to improve the care given to the dying patient. Various databases

like MEDLINE and EBASE were used. The criterion for inclusion was the use of end-of-life pathways

versus non-use. It was noted that the pathways were patient-centered and kept the focus on the comfort

needs of the dying patient. The pathways help to lead the health professional to give the best care in the

best amount of time (Chan R, 2010). It can be noted that the Cochrane systematic review is the highest

level of evidence, has homogeneity, and it is the least biased of all the evidence available. Of the 920

studies pulled for review, none of the studies were found to have met the criteria needed for rigorous of a

systematic review. The pathways according to this review of evidence noted that results from pathways in

some disease processes were beneficial and in others it did prove to provide the needed evidence to

encourage the use of the pathways. The review states that even though the pathways were not proven to

support the criteria the pathways are helpful for managing certain issues just not all of them (Chan R,

2010).

END-OF-LIFE ESMO PROTOCOL PROJECT 14

The scheme used to determine the strength of the evidence to make a practice change was based

on the quality, the quantity, and the consistency of the evidence (Melnyk & Fineout-Overholt, 2011, p.

76). The evidence found was a moderate level of evidence, mostly nonrandomized retrospective studies

and case studies. There was a large quantity of studies supporting ESMO in general. The quantity of the

evidence regarding specific outcomes is low as well, with very few making reference to ‘comfort’. The

consistency of the evidence has shown that end-of-life care pathways helped clinicians caring for those in

the active stages of dying. The consistent findings noted in the literature of effective implementation lead

to positive patient outcomes providing reliable support for implementation of ESMO and are summarized

in the synthesis table as noted in Appendix I. Chan says “until there is evidence indicating harms caused

by the end-of-life care pathways, the use of (such) pathways may be continued” (Chan & Webster, 2010,

p. 7). The recommendation from this EBP team will be to implement an end-of-life protocol with the

potential to help increase comfort in the actively dying person.

EBP Part 3: Plan a Pilot Test

The model that this group has chosen is the Model for Evidence- Based Practice Change

developed by Rosswurm and Larrabee. This model looks at quality indicators outside the organization

and links the indicators to interventions (Gawlinski, 2008). It is with this model that will best help

implement the new change protocol to the organization. The concepts are clear and easy to understand.

The chart that organizes the steps, Appendix III, is straightforward and can be followed quickly. This

model takes the nurse from the beginning of the process, with assessing the need for change,

implementing, and maintaining the change into the organization. One of the most important reasons that

this model works well is that it can be used on a variety of patients, projects, departments and programs

(Gawlinski, 2008). The first three steps have already been executed, the team can complete steps four

through six.

Step 4: Designing Practice Change

The specific aim for this evidence-based project is to look at our PICOT question. How does the

use of end-of –life symptom management orders (ESMO) protocol compared to those not receiving

END-OF-LIFE ESMO PROTOCOL PROJECT 15

ESMO affect the person’s comfort and symptom management during the last one to two weeks of life

expectancy? It is from this question that we aim to implement an end of life protocol that will help

inpatient staff better to understand how to care for the nonverbal dying patient. It is also the aim of this

practice change to include multiple disciplines of the organization to incorporate a smooth transition of

the protocol.

The clinical setting for the implementation of the protocol will be a medical surgical floor in the

hospital. The 25-bed unit will be ideal the setting because the nurse patient ratio is low and this will make

it easier to implement the new ESMO. The patient population will be those nonverbal persons toward the

end of life. The protocol will be implemented when the physician has initiated palliative care consult

although the patient can be located on any of the various floors in the hospital. Nurses on the floor where

the patient is located will approach the family and explain the purpose of the study. Consent will be

reviewed and signed. The number of patients involved will be limited due to the nature of the patient that

is needed for the use of the protocol. Attrition could possibly be a problem.

The support needed for the project change from all the nurses, physicians, and administrators as

long as the proper amount of education has been done. The project group will need to make sure that the

staff that will implement the pilot has a good understanding of all components of the protocol. Lack of

communication of a project change will be the first thing that will slow the implementation process.

The ESMO protocol will be measured through use of a nonverbal pain scale that will assess both

pain and dyspnea in the dying patient during the last one to two weeks of life. ESMO protocol, in this

EBP project, functions as a specific order set that will be available via the hospital information system for

use by the physicians working within the unit. The purpose of the ESMO protocol is to manage symptoms

in the palliative care patients during the last one to two weeks of life expectancy (Walling et al, 2008). All

patients within the unit in which the intervention is taking place will be screened for appropriateness of

ESMO protocol use.

Step 5: Implementation and Evaluation

END-OF-LIFE ESMO PROTOCOL PROJECT 16

Katherine Kolcaba’s theory of comfort appropriately explains the use of ESMO protocol in the

dying patient during the last one to two weeks of life expectancy. In Kolcaba’s (1991) theory, a patient

has needs that when addressed through comforting interventions provided by the nurse leads to enhanced

patient comfort (Kolcaba & Kolcaba, 1991). In this scenario, the patient’s needs are both physical and

emotional suffering that the patient is unable to express verbally, which is managed through ESMO

protocol use as the intervention and leads to enhanced comfort, measured by pain and dyspnea

management.

During implementation, an intervention group of eligible dying patients in the last one to two

weeks of life expectancy will receive the new ESMO protocol versus a control group who will not receive

a specific protocol in the last one to two weeks of life expectancy. It is important to note that because the

education for this EBP project will include an online education module, the EBP project will be able to be

reproduced (Melynk & Fineout-Overholt, 2011). Time to conduct the study, potential funding sources,

and potential subject base are all important factors to consider when considering the feasibility of this

EBP change (Melynk & Fineout-Overholt, 2011). For use of the ESMO protocol, educational costs for

the physicians and nurses within the unit of change have been evaluated and cost-benefit analysis of EBP

change has been presented to the IRB and research committee of the hospital. The EBP team has been

established and leadership roles addressed to ensure appropriate amount of time to be lead the change

implementation.

Because change often disrupts the balance of an environment, change is often unwelcome and

resisted by those involved (Stonehouse, 2012). People resistant to the change regarding this EBP project

may include both nurses and physicians on the unit in which the EBP project will be implemented. This

resistance may be related to lack of understanding and challenges faced by implementing as new protocol

within the unit. Resistance to change may also be because it requires acknowledgement that current

practice is not providing the highest quality care to patients (Stonehouse, 2012). Implementing a new

protocol will require education for all members of the health care team, as well as rigorous push for

physicians to appropriately screen and order the ESMO protocol for eligible patients. Following this,

END-OF-LIFE ESMO PROTOCOL PROJECT 17

nurses working on the unit will also need to understand the protocol and the appropriate use of the order

sets. The reason for the orders would be to increase comfort to the patient’s during the last one to two

weeks of life expectancy. It is easy for the hospital to weigh the cost-benefit analysis of implementing

such a protocol; however, nurses and physicians may not be able to see the big picture and will need extra

education regarding why this change is necessary (Stonehouse, 2012).

As noted in the Gantt Appendix I, the first step in EBP implementation for timeline will be to hire

and train the EBP team that will consist of physician, clinical nurse specialist, nurses, respiratory

therapists, and a nurse researcher. Roles and leadership positions within the EBO team will need to be

assigned (Melynk & Fineout-Overholt, 2011). Distribution of the literature review will need to be

completed. The ESMO protocol (order set) will need to be added to the health information computer

system at the facility indicating when the practice change will occur. Training of personnel using the

ESMO protocol will occur and a small pilot study of the intervention will be implemented to trial the

change. This pilot study will conclude after one month, during which appropriate changes will be made

for the implementation unit wide of the ESMO protocol in June 2013. Six months of data collection will

accompany intervention implementation and following this time. Data analysis and evaluation of results

will be finalized. Finally, a final report will be submitted to help disseminate the information.

In order to implement the change, the health information system used by the hospital will need to

be updated with the appropriate and agreed upon ESMO order set. This will require not only a cost

benefit analysis, but a return on investment quote. Special accommodations related to computer system

changes will need to be evaluated in order for not only the unit in question, but the entire hospital should

this practice change go hospital wide. In addition to this, nurses, physicians and social workers who work

in the unit in which the change will be taking place will need to complete online educational modules

regarding the purpose and use of the change in order to be competent and comfortable with the change.

Following staff education and prior to pilot implementation, staff needs time to be able to ask questions

about the ESMO protocol and how why the change is needed. Once staff understands the need for ESMO

END-OF-LIFE ESMO PROTOCOL PROJECT 18

protocol use, physicians and nurses will be able to implement the change more effectively (Stonehouse,

2012).

Lastly, special accommodations may need to be made for the patients who will be affected by the

ESMO project change. Patients have the right to be aware of such change and options at the end of life,

which needs to be considered when implementing a project that is said to promote comfort in the last one

to two weeks of life expectancy. This would mean explaining the use of the ESMO protocol to the

patients and families who are affected by using this EBP change project.

There are many strategies that will help increase the support for the project change within this

intensive care unit. It is important to note that engaging stakeholders is key to a successful

implementation of an EBP project (Ford, Fineout-Overholt, Melnyk, & Stillwell, 2011). Thus, prior to our

project implementation, meetings will be held with the triforce hospital wide council who drives research

and EBP projects throughout nursing units, the director of nursing education, who would be considered

passive stakeholders. The ESMO protocol, needs for use, and timetable for change will all be discussed in

these meetings. This will allow for a trusting environment to be built between the EBP change team and

for key stakeholders. Meeting with active stakeholders such as the nurses, physicians, and managers on

the unit participating in the EBP change project will foster collaboration in decision making which is an

important step in getting stakeholders to buy-in (Ford et al, 2011). In addition to this, evidence from the

literature review will be shared during staff meetings within the unit of change regarding increased

comfort associated with ESMO use. There will be a question and answer poster hung on the unit in the

staff breakroom that the EBP change team can respond to in order to elicit more support for the EBP

change project (Ford et al, 2011 ). Finally, a kick-off meeting will be held between the stakeholders

mentioned above and the EBP change team. This meeting will allow stakeholders the opportunity for the

EBP team to ask for input on the EBP change product and finalize the project timeline. This will also

allow for physicians and nurses on the unit to see how many people are supportive of this change, which

will make them less resistive to the implementation.

END-OF-LIFE ESMO PROTOCOL PROJECT 19

Outcomes will be measured using the Nonverbal Pain Scale (NVPS) as illustrated in the

Appendix II. The ratings of five elements, facial expression, activity, guarding, vital sign changes, and

physiologic indicators, will be measured on a scale of zero to ten (with zero described as no pain and ten

described as the highest level of pain possible). This scale was originally developed by Odhner, Wegman,

Freeland, Steinmetz, and Ingersoll (2003) and has been adapted for adult patients from the FLACC scale

(Merkel, Voepel-Lewis, Shayevitz, & Malviya, 1997). Ratings within the study found internal

consistency and reliability through examining: Face, Legs, Activity, Cry, Consolability. The (FLACC)

pain assessment tool and the NVPS are similar and rely on “reasonable evidence of criterion-related

validity; with the FLACC serving as gold standard for nonverbal pain assessment” (p. 264). Wegman

(2005) later revised the scale for use with ventilated patients and Kabes, Graves, and Norris (2009)

conducted a study comparing the validity and reliability of the original and revised versions. They noted

both versions supported overall construct validity and that reliability was acceptable for scores during and

following painful interventions.

In the proposed pilot study of the practice change, retrospective data withdrawal of electronically

documented pain measurement scores for up to two weeks prior to the patient’s death as rated on the

NVPS for patients who died in the hospital over the six months prior to implementation of the pilot

ESMO protocol will be electronically compiled by the information technology department (IT).

Collection will also include patient demographic information, length of stay, diagnosis, and date of death.

Following development and education regarding the pilot ESMO protocol, the subsequent two-week

adjustment period will provide comfort and aptitude in the use of the protocol. The following six months’

of data will be collected in the same manner and compared to pre-implementation data. Comparisons will

be examined by the authors, all registered nurses, of the proposed change. The frequency of the

preliminary data will be collected at one-month, three-months, and following completion of the six-month

period. If at any time it appears the protocol may be having an adverse or harmful effect on patient pain

measurements the study will be forfeited. If the study process and outcomes are favorable,

implementation of the practice change will move forward.

END-OF-LIFE ESMO PROTOCOL PROJECT 20

Donabedian’s (1987) outcomes framework emphasizes structure, process, and outcomes.

Mitchell, Ferketich, & Jennings (1998) describe structure as “having the right things,” processes as

“doing the right things,” and outcomes as “having the right things happen” (p. 43). Use of this framework

will work well with implementation model being used, the Model for Evidence-based Change, as the

model moves through the beginning of the process with assessing the need for change to implementing

and maintaining the change into the organization that includes the process and outcome framework

elements. The result of the process (doing the right thing = ESMO protocol implementation) will be easily

seen in the outcome (having the right things happen = decreased patient pain as rated by the NVPS) as

compared to pre-implementation of the ESMO protocol.

The collection of data requires the evidence-based team to ensure protection of rights and respect

for those subjects involved in the pilot study (Pollitt & Beck, p. 709). Death can be a difficult and

emotional time and obtaining consent for the intervention, such as ESMO will need to be handled with

care. Consenting to end-of-life protocol might seem like the logical thing to do; however a recent study

by Walling et al., “Missed opportunities: Use of an end-of-life symptom management order protocol

among inpatients dying expected deaths” found that those patients who had no insurance and minorities

tended to refuse such an intervention. It was believed that there was a “lack of trust and an unwillingness

to agree to anything less than full aggressive treatment” (p. 411). Taking these patient preferences into

consideration, a plan that helps the team leader and a spiritual counselor consult with family could help

with obtaining consent.

Implementing change is never easy, but with persistence, patience, and perseverance change can

happen (Melnyk & Fineout-Overholt, 2011). The plan begins with administration leaders and

stakeholders having been informed of the vision. Next, the internal review board would need to ‘clear’ the

project to ensure human subject respect and rights. The EBP team will begin by touching the hearts of

nurses through a video and exemplar experience of a person not receiving ESMO compared to someone

who had received the protocol. Building excitement and an emotional experience will help igniting the

spirit of inquiry among staff. Beginning the project on a small step, involves finding those who are

END-OF-LIFE ESMO PROTOCOL PROJECT 21

‘champions of change’. A kick off meeting that shares the structured protocol, orders, documentation

tool, and procedures will give these staff members the needed tools to implement the project. A mid-

project meeting will be held to monitor change progress. Those staff members involved will be able to

share successes and failures. Most of all, the EBP team will encourage staff and offer incentives when

outcomes have been successfully met. Celebrating successes will give motivation and keep the ‘fire’ alive

when things become difficult.

Step 6: Maintaining Change

Once the pilot project has been completed, the next step is devising a plan to monitor the long-

term effects of the practice change. Listening to feedback from staff members through success sharing

discussions, ESMO documentation tools, and with data collected will determine the success or failure of

this EBP pilot project. Several sources of data will be analyzed such as the electronic medical record

(EMR), NVPS, ESMO documentation tools, staff communication, and family communication. These

sources of data will be analyzed to evaluate whether the project should be adapted, adopted or rejected

(Melnyk & Fineout-Overholt, 2011, p. 257). Collection of post-pilot project data will be compared and

analyzed to the standard care date prior to implementation. This analysis will provide conclusions and

measurable outcomes that administrative leaders and key stakeholders will find valuable in determining

the sustainability of this project. The anticipated outcomes (Appendix IV) along with other outcomes

should be considered. Other outcomes (Appendix IV) to consider are the quality of care improvements,

efficiency of processes, environmental changes, and timeliness of project events also need to be

considered.

Communicating change project outcomes with key stakeholders is the first step in maintaining the

EBP project change. The EBP team will determine success or failure based on whether the outcomes were

achieved, if staff properly used protocol, and if costs stayed within budget. This information will be

presented to those stakeholders through a post-project poster presentation along with scorecards (Melnyk

& Fineout-Overholt, 2011, p. 234). The presentation and scorecard will reinforce operational

performance, quality performances, and staff/family satisfaction score. Continuing communication with

END-OF-LIFE ESMO PROTOCOL PROJECT 22

administration, stakeholders, and staff is crucial in implementing the integration of the project change into

standard practice. The implications of this EBP project will ensure that those persons in the active stage

of dying will receive evidence-based care that improves comfort. Clinical circumstances, patient

preferences, research evidence, and health care resources available were considered when developing this

EBP project. Disseminating the information outside the organization at professional conferences or in

nursing publications will help other nurses to develop and evidence-based practice.

EBP Part 4: Budget Proposal

The end of life system management (ESMO) pilot project will be funded by the use of project

grants. The American Nurses Foundation Nursing Research grant program provides funds for beginners

and experienced nurse researchers to conduct studies that contribute toward the advancement of nursing

science and patient care. Our project, if additional money is needed, also can be funded with the help

from the NIH through the National Institute of Nursing Research. The budget (Appendix V) will consist

of new materials to help with implementation and education. The protocols, order sets, and computer-

based training are a one-time fee and would not require further funding. This would decrease the cost of

sustaining the project. Incentives will be offered to those staff members who have shown successes and

are a ‘champion’ for this evidence-based practice change. All staff completing the pre and post

implementation survey offered through Survey Monkey will receive a T-shirt for participation.

The overall cost of the evidence-based practice change is $7,066.75 with the majority of cost

being attributable to the time personnel will need to spend in obtaining consents for the pilot, in family

counseling, and in data collection. Yet once implemented, the savings in terms of human suffering for the

nonverbal patient are incalculable. As noted earlier, end-of-life care pathways have been found to lead to

positive patient outcomes and will also help clinicians in caring for the dying. Melnyk and Fineout-

Overholt (2011) note evidence-based practice is essential in delivering quality healthcare and outcomes

(p. 3). Additionally, there is no cost associated with continuation of the practice change once

implemented.

END-OF-LIFE ESMO PROTOCOL PROJECT 23

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END-OF-LIFE ESMO PROTOCOL PROJECT 24

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END-OF-LIFE ESMO PROTOCOL PROJECT 26

APPENDIX I

April May June July Aug Sept Oct Nov Dec

Hire and train EBP team. Obtain IRB approval for EBP project

1st

Literature Distribution 15th

Add ESMO order set to HIS 30thTrain physicians and nurses on ESMO protocol 5th

Pilot Implementation in Unit

15th 15th

Implementation/Delivery of Intervention

15th 15th

Collect Data and Measure Outcomes

15th 15th

Analyze Data/Evaluation 15th

Submit Final Report 15th

Im ple

me

nta

tio nProject Timeline

END-OF-LIFE ESMO PROTOCOL PROJECT 27

Appendix II

Non-Verbal Pain Scale (NVPS)

END-OF-LIFE ESMO PROTOCOL PROJECT 28

APPENDIX III

Steps in Model for Evidence-Based Practice Change

Melnyck and Overholt p. 255

APPENDIX IV

Plan for Measuring ESMO Success

Plan for Measuring ESMO SuccessOutcome Measurement Source/Owner

ADP > # of expired persons on unit EMRMortality Rates: >Death rates hospital wide EMR

END-OF-LIFE ESMO PROTOCOL PROJECT 29

HWMR and unit specific MR>per unit

>intervention unit

Discuss at meeting

ESMO >Number of persons receiving

>Number of persons refusing

EMR manager tracking

Comfort: *Pain *Dyspnea

>Scale scores with SC

>Scale scores with ESMO

NVPS EMR Staff

Quality Care >Family communication/response

>Time of initiation

Staff EMR Documentation Tool

Efficiency of Processes >Time from initiation to death

>Order set use

Documentation Tool EMR

Environmental change >Use of order sets

>Use of mentors

>Comfort care supplies

>Staff response

EMR Staff Documentation tool

ROI in ESMO1. Cost of ESMO

*Personnel*Supplies*IT changes

2. Improved PSS

>Personnel time ESMO/SC

>Average LOS

>Cost of supplies

>Cost of IT

>PSS hospital wide

>SC

>ESMO

Billing Data EMR IT Documentation Tool

Press Ganey scores Documentation Tool

ADP=actively dying person HWMR=hospital wide mortality rate MR=mortality rate EMR=electronic medical recordESMO=end-of-life order protocol NVPS=non-verbal pain scale ROI=return on investment SC=standard careIT=information technology department LOS=length of stay PSS=patient satisfaction scores

APPENDIX V

ESMO Budget Plan

END-OF-LIFE ESMO PROTOCOL PROJECT 30

APPENDIX VIPoster for Dissemination

END-OF-LIFE ESMO PROTOCOL PROJECT 31