Running head: RESEARCH PROPOSAL 1

The Effect of Shared Decision Making in Dialysis Therapies

Elaine Dean

Jacksonville University

Nursing Theory 11

520

November 28, 2016

RESEARCH PROPOSAL 2

The Effect of Shared Decision Making in Dialysis Therapies

Introduction

Shared decision-making constitutes a mutual agreement and negotiation around

healthcare choices that lead to action. It is a unique collaboration that enhances the provider-

patient relationship in making healthcare decisions. The process merges together available

healthcare options, healthcare professionals’ knowledge and experiences and patient values and

preferences. The process involves inter-professional interaction, negotiation, communication,

assessment, cultural and ethical knowing, development of patient-provider relationship and

teaching. The Patient Protection and Affordable Care Act PPACA and other professional

initiatives have recommended the integration of shared decision-making into healthcare practice

(Trugilo-Londrigan, 2016).

Background

The natural process of aging can involve multiple chronic disease processes, frequently

end-stage conditions such as renal disease. The combination of complex comorbid and high

mortality has also led to an increase in the initiation of renal replacement therapy among the

elderly. According to U.S. Renal Data (2012), the median age of the patient with chronic renal

failure was 71 years old. The United States Medicare system current expenditure as reported in

2015 for patients sixty-five and older with chronic renal failure exceeded fifty billion which

represents 20% of all Medicare spending in the age group (U.S. Renal Data, 2015). Choosing

dialysis therapy should be individualized, as the common choice of in-center hemodialysis might

not be a viable or valuable option for some older adults. Establishing a shared decision-making

process during pre-dialysis care can provide balanced information about treatment options that

will close the gap for the underutilization of independent home-based therapies.
RESEARCH PROPOSAL 3

Research Problem

Choosing dialysis therapies have been related to increased stress, anxiety, conflict, and

decisional turmoil. The severity of the disease process with its chronic progression of debilitating

symptoms is a source of mental fatigue for many end-stage renal disease (ESRD) patients.

However, significant differences have been seen in patients who are able to manage the disease

based on knowledge and preparation against those who were poorly prepared and not equipped

with the needed skills. Furthermore, new research shows a direct link between quality of life and

self-care. The choice to make value sensitive decisions based on personal factors and preferences

seems to alleviate symptom responses to the unknown. Shared decision-making has not been

adequately integrated into renal care to deliver the significant outcome it can offer to patients.

Moreover, physician biases, gaps in interdisciplinary care, inability to incorporate the patient

values, beliefs, past experiences, lifestyle, family support system and health status have defied

the ESRD patient of high-quality dialysis care ( Harwood & Clarke, 2014).

Statement of Purpose

The purpose of this study is to examine the role of shared decision-making among the

elderly cohort of end-stage renal disease patients, stages 4 and 5 in choosing independent home-

based therapies versus in-center hemodialysis and its influence on the improved quality of life.

Review of Relevant Searches

A search was conducted based on published literature between 2011 and 2016. Databases

searched were CINAHL, Cochrane, and PubMed. The search strategy used the following key

terms: shared decision-making, older adults with kidney disease, independent therapies,

significant other, peritoneal dialysis, in-center hemodialysis, and adult end-stage renal disease

patient on dialysis. The review of literature was conducted with a comprehensive focus on
RESEARCH PROPOSAL 4

synthesis of the data. The result of the synthesis allowed the translation of one study into another,

integrating concepts and ideas across the reviewed studies (See Matrix).

Review of Theoretical Literature

The empirical data shows that 25% of the population on dialysis are elderly seventy-five

years and older (U.S. Renal Data, 2012). This growing segment of the dialysis population is

likely to make the decision for renal replacement therapy based on the perceived life expectancy

and quality of life. It is a highly personalized decision that seeks minimal intrusion and

interruption of life patterns. Acceptance of treatment modality and setting in this cohort is

frequently influenced by knowledge, values, beliefs, experiences and lifestyle (Harwood &

Clark, 2014). The literature determined that this value-sensitive decision is usually not

considered due to the lack of a shared decision-making model to engage patient and healthcare

professional in considering the best therapy for the individual patient (Louiselle, O’Connor &

Michuad, 2011).

The following themes emerged from prior studies supporting the need for evidence-

based application of a shared decision-making process towards the uptake of independent home-

based therapies: personal factors (Harwood & Clark, 2014); the engagement of family and or

significant others (Rosenrool, Higuchi, Dutton, Murray, & Stacy, 2013); social support

(Harwood, Wilson, Sontrop, & Alexander, 2012); stressors and coping (Harwood et al., 2012);

decisional conflict and support ( Louiselle et al., 2011).; paternalistic ideology versus ideology of

participation ( Aasen, Kavangarsness, & Heggan, 2011); self-care (OShaughnessy, 2014);

barriers, facilitators and education (Sondrup & Copland, 2011), Choiu & Chang, 2011),

Harwood & Cark, 2014). A study by Boateng and East (2011) determined that independent

home-based therapy patients rated their quality of life higher than the hemodialysis patient when
RESEARCH PROPOSAL 5

measured using the Kidney Disease Quality of Life (KDQOL) scale. According to Johansson

(2013), a study done in the U.S found that of 1365 dialysis patients 93% were in-center

hemodialysis and only 7% on continuous cycling peritoneal dialysis (CCPD) and of the sample

68-88% had not been presented with the option of dialysis at home. Compared to the U.K 65%

of a sample population of 132 patients had no knowledge of continuous ambulatory peritoneal

dialysis. The study concluded that in the absence of shared decision-making and knowledge, in-

center hemodialysis treatment is selected over independent home-based therapies (Johansson,

2013).

Summary of Review

Shared decision-making constitutes a significant benefit to the patient as it allows the

patient to consult with family and friends prior to making a treatment decision. This is

particularly important when contemplating an independent home-based therapy, as it will require

social support. The family desire to be a part of the dialysis modality decision-making process

can be considered as a network of advocacy and support that will decrease the stressors and

improve the coping mechanism of the patient. The acknowledgment of patients’ values,

preference, and beliefs will act as a catalyst towards the ideology of patient participation and

self-care. Additionally, those who deliver education need to account for the diversity of the

patient, understanding about their condition, individual beliefs and barriers to learning. Finally,

education should be anticipated ahead of time before the treatment modality decision is made.

Framework

The diagnosis of end-stage renal disease ESRD and the treatment of maintenance dialysis

means being dependent on a lifelong treatment. The conceptual framework ( See Framework

Diagram ) was organized to establish a relationship between shared decision-making and quality
RESEARCH PROPOSAL 6

of life. The structural concepts establish that shared decision-making promote self-care, which

facilitates health promotion. The patient is empowered to develop skills towards self-

management, autonomy, independence, and engagement these actions serve as a catalyst to

promote therapeutic self-care. The integration of shared decision-making and choice of the

preferred therapy engages the patient, which positively impact lifestyle and quality of life. Once

there is an improved sense of QOL the individual will perform a deliberate action on their own to

maintain health and wellbeing. It is the responsibility of the provider to provide high-quality

information about each dialysis therapy including risk factors modification, choice of medication

with therapies, explanation of therapies and strategies to help incorporate recommended dialysis

treatment plan in everyday living (Hain & Sandy, 2013). Based on an acute awareness and

knowledge of the different dialysis modalities the patient will apply self-management skills such

as taking their own vital signs and weight, being able to insert their needles through the button

hole technique, initiate and terminate their own treatment and maintain the dialysis equipment

with the awareness of infection control practices. The development of autonomy and

independence will move the relationship from dependent and paternalistic, as is common

practice in the in-center setting to an environment of supportive self-care. The renewed sense of

independence will help the patient to gain control of internal and external orientation thereby

decreasing vulnerabilities and achieve quality of life and positive outcome.

Hypotheses

End stage renal disease patients receiving shared decision-making intervention will

choose independent home-based therapy over in-center hemodialysis treatment than those who

received no shared decision-making intervention.

RESEARCH PROPOSAL 7

End stage renal disease patients receiving shared decision-making intervention will have

improved quality of life with the choice of independent home-based therapy than those who

received no shared-decision making towards the decision of dialysis therapy

Research Question

What is the effect of shared decision making in choosing independent dialysis therapy

compared to in-center hemodialysis in promoting quality of life among the older adults with end-

stage renal disease? The independent variable refers to the intervention of shared decision-

making. The dependent variable refers to the outcome QOL.

Conceptual and Operational Definitions of the Study

Shared decision-making (SDM) is defined as the process in which health care

practitioners and the patient reach decisions relevant to healthcare choices together. SDM has the

potential to benefit the clinicians, the patient and the health care process in general. It is

associated with improved health outcome, reduction in care and cost variances, decreased

anxiety, increased knowledge and the alignment of care models with the patients’ values. The

2001 Institute of Medical report, Crossing the Quality Chasm highlighted the significance of a

care system that encourages SDM and accommodates patient preference (IOM, 2001). The

Ottawa Decision Support Framework (ODSF) can be used to guide the patient decisional needs.

It provides a practical approach in a three-step process, assessment of decisional support needs,

provides a tailored decisional intervention, and outcome evaluation. The key focus is to facilitate

the development of the patients’ decisional capacity towards personal healthcare decision-

making. This framework is suited for the ESRD patients who lack the clarity regarding treatment

choices, conflicted due to changing circumstances and perceives the choice of therapy will have
RESEARCH PROPOSAL 8

a value-laden outcome. The ODSF is specifically instrumental in the deliberative phase of

therapy choice rather than the implementation phase (Loiselle, O”Connor & Michaud, 2011).

Quality of life is the general wellbeing of an individual. It observes life satisfaction

including everything from physical health, family, education, employment, religious beliefs,

finances, and the environment. QOL is interpreted differently in each group and culture, also

aspects of QOL such as the physical and mental are perceived over time, therefore, the

embodiment of QOL as a public health component can create a common theme to collaborate

with and incorporate community partners, social agency and healthcare partners to maximize

QOL. The Ferrans and Powers Quality of Life Index Dialysis Version 111 (QLI-V111) will be

used to measure quality of life.

Definition of Relevant Terms

One of the major constructs in this study is self-efficacy, this refers to the application of

the social, the cognitive, and skill capabilities that an individual uses to form an action. Self-

efficacy is used interchangeably with self-care these are any intentional actions that individuals

uses to take care of themselves physically, mentally and emotionally. A person who is actively

engaged in the process of self-care is known as the self-care agency. The General Self-Efficacy

GSE-10 a self-report measurement scale can be used to measure self-efficacy (Wells &

Anderson, 2011) and Orem’s Self-Care Deficit Nursing theory (SCDNT) can be aptly used to

measure the level of self-care ability (O’Shaughnessy, 2012). The self-care agency is defined as

the individuals’ ability to perform purposeful and deliberate actions to regulate the body’s

function and development. This supports the therapeutic environment by establishing an

environment that promotes life, adaptation, and development. The SF-36 QOL scale and the self-

care agency scale can be used to measure self-care agency (Kalendar & Tosun, 2014). End-stage
RESEARCH PROPOSAL 9

renal disease is defined as the final stage of chronic kidney failure. This means that the kidneys

are functioning below 10% of their functional ability and can no longer support daily life

resulting in the need for dialytic therapies. Independent home-based therapies refer to self-

administration of dialysis therapies in the patient home without direct medical supervision. The

most popular home-based therapy is peritoneal dialysis (PD): a treatment that uses the lining of

the abdomen (peritoneum) and a fluid called dialysate to filter and clean the blood. Two forms of

PD are continuous cycling peritoneal dialysis (CCPD) this uses an automated cycler to perform

multiple exchanges at nights and continuous ambulatory peritoneal dialysis (CAPD), which is

the performance of manual exchanges. To accommodate and support independent home-based

therapies the nursing agency is needed, it is comprised of highly specialized nurses who will

develop specialized education and training founded in theoretical and practical nursing sciences

to deliver care in reality situations.

Methods and Procedure

This is an approximate replication of a study by Nabolsi, Wardam & Al-Halabi (2013).

Design

In the replicated study a descriptive correlation design was used. The design for this

study is a quasi-experimental pretest and posttest nonequivalent comparison design comparing

the quality of life outcome of patients who received shared decision-making intervention with

similar patients who did not receive the care intervention. The classic experimental design will

serve as a model for the study design identifying the implementation of the independent variable

(IV) shared-decision making and the measurement of the dependent variable (DV) quality of life

(QOL) (See Appendix). Both study groups will take the pre and posttest and the Ferrans and

Powers Quality of Life Index Dialysis Version 111 (QLI- V111) will be used to measure the
RESEARCH PROPOSAL 10

DV. The experimental group will meet with the multidisciplinary nephrology team monthly in

the outpatient clinic setting for three months with guided support from the Ottowa Decisional

Support Model. The comparison group will have no intervention. Data will be collected at

beginning of the study and at the end of the three-month period. Two categories of weakness

exist in this study design, one is, the assumption that both groups experimental and comparison

are similar. Secondly, there are several threats to the validity of the study these include testing,

mortality, selection and maturation. However, the strength of the design is that the data collected

at the time of pretest allows for evaluation and comparison of prior variables that exist between

the two groups before the independent variable is introduced.

Population and Sample

The patient population in the replicated study is diagnosed ESRD patients already on

dialysis 18 years and older. A convenience sample was recruited from four major hospitals in

Jordan (two private and two public n = 244). For this study, the population is the elderly cohort

of end-stage renal disease (ESRD) patient stage 4 and 5. The sample will be drawn from a

Veteran Medical Center outpatient nephrology clinic of patients 65 years and older accessing

pre-dialysis care for chronic kidney disease. The recruitment process will include the

presentation of research plans to patients at regular continuity clinic visits and CKD educational

classes. Research flyers will also circulate throughout the hospital for stable ESRD patients that

have longer nephrology appointment span but visit the hospital for other appointments. A cross-

section of participants will be chosen from the 5 full-time nephrologist patient panel.

Demographic information such as gender, ethnicity, age, marital status, and educational level

will be reviewed and compared to the entire sample. Power analysis will be used to determine

the sample size needed in the study for a confidence level of 95% and a level of significance of
RESEARCH PROPOSAL 11

0.05 or less. An additional 5% of participants will be recruited for attrition. The total size of the

sample will then be divided in half, one-half equaling 28 patients will be in the experimental

group and the other half of 28 will be in the comparison group. The renal clinic accumulates at

least 15 new consults each week with a full physician grid of 12-18 patients in the continuity

clinic each day of the week. The percentage of no-show for appointments are about 3%, so, full

recruitment should be accomplished within 2 weeks. Using the electronic record system the

inclusion criteria was refined as determined by following: (a) 65 years and older; (b) diagnosis of

ESRD confirmed by nephrologist; (c) able to communicate verbally; (d) being followed in the

nephrology continuity clinic for 3 months or more; (e) is a veteran receiving care in the

designated Veteran Affairs hospital; (f) stages 4 or 5 end stage renal disease; (g) be willing to

participate in the study. Exclusion criteria will be; (a) inability to communicate; (b) younger than

65; (c) already on other treatment intervention; (d) already a dialysis patient. The strength of the

sample is that there is a high patient count of veterans with ESRD, however, weaknesses include

non-compliance, the presence of significant comorbid, high probability of frequent

hospitalization and death.

Setting

The setting will be the C.W Bill Young Medical Center. The strengths of the setting are:

(a) the participants are accessible; (b) electronic medical records are readily available to assist

with research data collection; (c) the monthly CKD educations classes will include shared

decision-making opportunities. The weaknesses are: (a) HIPAA laws and protected health

information; (b) organizational policies and procedures; (c) consent is also needed for chart

reviews
RESEARCH PROPOSAL 12

Ethical Consideration

Jacksonville University and the Institutional Review Board IRB recommendation for the

protection of human subjects will be followed throughout the study. Strict adherence will be

given to the protection of data and participants’ identity using specified numerical coding and

password protected storage of information. All participants will be given handouts on the right to

be protected as human research subjects. All participants will be given full disclosure and

explanation on the study at the beginning and throughout the study. Participants will have a

chance to ask questions and receive answers to their satisfaction. Informed consent will be

present to each participant (See Appendix), questions will be answered as directed by

participants so they fully understand the process. There will be no data collection on participants

without a signed informed consent.

Intervention

The sample will be divided into two equal groups, each group consisting of 23 patients.

The gender ratio will be equal in both groups 3 females and twenty-five males. The materials

developed for this study include consent forms, data collection forms, interview schedules, study

budget, study time -table and educational materials. A registered nurse assistant will be trained to

assist with data collection, recruitment and to cover for absences, illnesses, and unforeseen

events. The study will be divided into four phases: a) the interview phase; b) theory session,

theory and observation session and, the summary session. Telephone contact will be maintained

with all participants over the life of the study to encourage engagement and participation. After

the initial interview, the timeline will be one session each month for three months. The study will

be scheduled for completion within four months. The interview phase will be done individually

with each participant by the author. At this meeting, all relevant information will be
RESEARCH PROPOSAL 13

disseminated. The participants will be advised of all their rights as study subjects and that the

protection of their privacy and data will be reinforced through numeric coding. Time will be

allowed for questions and concerns and participants will be asked to commit to the duration of

the study but also educated on their rights to terminate participation at any time. Demographic

data, pretest and signed consent will be obtained at this meeting (See Appendix). Participants

will be engaged an open discussion on the background of their illness, knowledge of dialysis

therapies and the impact on their quality of life. Additional information if required will be

obtained from the electronic health records.

The theory session will follow a classroom format with extensive education on all the

dialysis therapies and supporting systems. It will incorporate the current practice guidelines as

recommended by the National Kidney Foundation Kidney Disease Outcome Initiative (NKF –

KDOQI, 2015), and current Association for the Advancement of Medical Instrumentation

(AAMI, 2012) standards. It will be three hours long with a presentation from each of the

multidisciplinary team members. The format will comprise largely of visual aids, interactive

computerized sessions, and breakout group sessions. The volunteer department agreed to

provide light lunch, snacks, and drinks.

The theory and observation session will take place in the dialysis training room where the

participants will visually experience the various dialysis machines. Each machine will be set up

and “dummy” treatment simulated to give the participants a feel of the operational and practical

working of each piece of equipment. They will also be exposed to the advantages and

disadvantages of each treatment options. During this session participants will also have a tour of

the hemodialysis treatment center as agreed ahead of time with the nurse manager, here they can

interact with the actual dialysis patients and see the treatments been performed in real time.
RESEARCH PROPOSAL 14

The summary phase will bring together both groups. Here the post-test and the QLI –

V111 will be completed. After all the relevant data for the study is collected there will be an

informal discussion session with both groups. A Likert questionnaire will be given to all

participants for comparison of dialysis choices at the end of the study. (See Appendix). This data

will be for the dialysis unit focus group to present at the monthly ESRD committee meeting.

Selection of Measurement Method

As in the study being replicated the Ferrans and Powers Quality of Life Index Dialysis

Version 111 (QLI – V111) will be used as the measurement instrument (See Appendix).The

instrument was developed in 1985 by Carol Ferrans and Marjorie Powers. It is a copyrighted

instrument, however, it is made available for use without charge for non-profit research. There

are two parts to this instrument each part is a 35-item section that measures importance and

satisfaction based on various aspects of life. The items are grouped into four subscales: health

functioning, psychological and spiritual, and social and family. Scores from part 1 are weighted

with scores from part 2. A high score indicates a higher quality of life. The highest potential

response will produce a range of scoring from 0-35. Internal consistency reliability coefficient

(Cronbach’s alpha) for each subscale the quality of life index ranged from 0.89 - 0.92. Cronbach

alpha for the total scale was 0.90. The reported Cronbach alpha was 0.90 and 0.93 with dialysis

patient. The QLI – V111 is a well establish instrument with a background of substantial evidence

of reliability and validity. Good construct and discriminate validity have been reported (Nabolsi,

Wardam & Al-Halbi).

Plans for Data Collection

The trained RN assistant will assist with the recruitment of participants and data

collection. The study will follow the sequential steps for completion as outlined in the research
RESEARCH PROPOSAL 15

timeline (See Appendix D). All participants will complete the demographic data and pretest upon

initiation of the study during their regular clinic appointment. The experimental group will have

a three-hour intervention session on shared decision making for three consecutive months, the

Ottawa Decisional Model will be used as a guide and the sessions will include comprehensive

training and information on each dialysis therapy. The comparison group will have no

intervention. At the end of the research participants will complete the Powers and Ferrans

Quality of Life Index Dialysis Version 111 and the post-test. A Likert-style decisional tool will

be utilized as a rating scale for therapy choices (See Appendix).

Plans for Data Analysis

The Statistical Package for Social Sciences GradPack 24 with regression will be used to

analyze the data. The objective is to examine the role of shared decision-making among the

elderly cohort of end-stage renal disease patients stages 4 and 5 in choosing independent home-

based therapies versus in-center hemodialysis and its relationship on quality of life. Hypotheses

testing will be conducted to justify rejection of the null hypothesis and accepting the alternative

hypotheses. The level of significance will be assessed for p – value of 0.05 or less which will

conclude statistical significance. The data will be organized and summarized using the

descriptive function of SPSS to obtain output data including frequency, mean, median, and

standard deviation (SD). To establish clarity of the data and to assist with comparison of

relationship example gender/age the results will be reported as percentages. Inferential statistics,

t-test, will be used to determine the strength of the relationship within the sample.

Limitation of the study

There are several limitations that must be considered when interpreting the results of this

study. The study was designed only to explore the impact of shared decision-making on ESRD
RESEARCH PROPOSAL 16

patient uncertainty, decisional conflict, and decision-making. The needs of dialysis patients are

so vast future studies should incorporate more variables.

2). In light of limited time, manpower, and budget this study only track data for a three

month pretest, posttest period. As patient progress through the disease, they might encounter

different problem levels. Future studies should extend the research intervention and observation

time to capture time effects and evaluate decision-making over a longer term.

3). Due to the limitation of the sample the nephrology outpatient clinic in one Veteran

Hospital and the corresponding limited follow-up period of three months the generalizability will

be limited. Further research will be needed to expand time and location to enhance result rigor.

4). There is a gender inequality, this is not intentional but signifies the population that

uses this VA for care. Future studies should extend to a VA that provides women services to

draw on that population as well (Choi & Chang, 2011).

Communication of Findings

The findings of the research study will be first communicated to peers in the dialysis

specialty. A poster presentation will be the next step at the annual nurses week fair. This visual

method will be seen by a larger number of people in a shorter time span. The poster will contain

an immediate view of the hypotheses, description of the sample, method, findings and major

conclusions. Diagrams, graphs, and tables will be included to adequately explain certain areas of

the study. A journal article presentation opportunity might present itself in the future for this

study to contribute to the body of knowledge in nursing.

RESEARCH PROPOSAL 17

References

Aasen, E. A., Kvangarsnes, M., & Heggan, K. (2011). Perceptions of patient participation

amongst elderly patients with end-stage renal disease in a dialysis unit. Scandinavian

Journal of Nursing, 26, 61-69. http://dx.doi.org/10.1111/j.147-6712.2011.00904.x

Alligood, M. R. (2014). Nursing theorist and their work (8th ed.). St Louis, MO: Mosby

Elsevier.

Boateng, E. A., & East, L. (2011). The impact of dialysis modality on quality of life: A

systematic review. Journal of Renal Care, 37(4), 190-200.

Chiou, C. P., & Chung, Y. C. (2011). The effectiveness of multimedia interactive patient

education on knowledge, uncertainty and decision-making in patients with end-stage

renal disease. Journal of Clinical Nursing, 21, 1223-1231.

http://dx.doi.org/10.1111/j.1365-2702.2011.03793.x

Gonzalo, A. (2011). Theoretical foundations of nursing. Retrieved from

http://nursingtheories.weebly.com/dorothea-e-orem.html

Gonzalo, A. (2011). Theoretical foundations of nursing. Retrieved from

nursingtheories.weebly.com/dorothea-e-orem.html

Groves, S. K., Burns, N., & Gray, J. R. (2013). Practice of nursing research: Appraisal,

synthesis, and generation of evidence (7th ed.). St Louis, MO: Elsevier Saunders.

Hain, D. J., & Sandy, D. (2013). Empowerment through shared decision making. Nephrology

Nursing Journal, 40(2).

Harwood, L., & Clark, A. M. (2013). Understanding pre-dialysis modality decision-making: A

meta-synthesis of qualitative studies. International Journal of Nursing Studies, 50, 109-

120. http://dx.doi.org/10.1016/j.ijnurstu.2012.04.003
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Harwood, L., & Clark, A. M. (2014). Dialysis modality decision-making for older adults with

chronic kidney disease. Journal of Clinical Nursing, 23, 3378-3390.

http://dx.doi.org/10.1111/jocn.12582

Harwood, L., Wilson, B., Sontrop, J., & Clark, A. M. (2012). Chronic kidney disease stressors

influence choice of dialysis modality. Journal of Advanced Nursing, 68(11), 2454-2465.

http://dx.doi.org/10.1111/j.1365-2648.2012.05943.x

Institute of Medicine (2001). Crossing the quality Chasm: A new health system for the 21st

century. Washington, DC: The National Academies Press.

Kalender, N., & Tosun, N. (2014). Determination of the relationship between adequacy of

dialysis and quality of life and self-care agency. Journal of Clinical Nursing, 23, 820-

828.

Loiselle, M. C., O’Connor, A. M., & Michaud, C. (2011). Developing a decision support

intervention regarding choice of dialysis modality. The CANNT Journal, 21(3).

Myoungjin, K., & Mallory, C. (2014). Statistics for evidence based practice in nursing.

Burlington, MA: Jones & Bartlett Learning.

Nabolsi, M., Wardam, L., & Al-Halabi, J. (2013). Quality of life, depression, adherence to

treatment and illness perception of patients on hemodialysis . International Journal of

Nursing Practice, 21, 1-10. http://dx.doi.org/10.111/ijn.12205

O’Shaughnessy, M. (2012). Application of Dorothea Orem’s theory of self care to the elderly

patient on peritoneal dialysis. Nephrology Nursing Journal, 41(5), 495-497.

Petiprin, A. (2016). Nursing theory. Retrieved from http://nursing-theory.org/theories-and-

models/orem-self-care-deficit
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Rosenroll, A. D., Higuchi, K. S., Dutton, K. S., Murray, M. A., & Stacy, D. (2013). Perspectives

of significant others in dialysis modality decision-making: A qualitative study. The

CANNT Journal, 23(4).

Sondrup, B., & Copeland, M. (2011). Supporting patient choice: An intervention to promote

independent dialysis therapies. Nephrology Nursing Journal, 38(6).

Stringer, S., & Baharani, J. (2012). Why did I start dialysis? A qualitative study on views and

expectation from an elderly cohort of patients with end-stage renal failure starting

hemodialysis in the United Kingdom. Nephrology, 44, 295-300.

http://dx.doi.org/10.1007/s11255-011-0045-4

Truglio-Londrigan, M. (2016). Shared decision making through reflective practice: Part 1.

Medsurg Nursing, 25(1), 260-264.

U.S. Renal Data System (2012). Atlas of end-stage renal disease in the United States. Retrieved

from usrds.org/atlas.aspx

Wells, J. R., & Anderson, S. T. (2011). Self efficacy and social support in african american

diagnosed with end stage renal disease. ABNF Journal, 22(1), 9-12.

Winterbottom, A., Bekker, H. L., Connor, M., & Mooney, A. (2012). Choosing dialysis

modality: Decision making in a chronic illness context. Health Expectations, 17, 710-

723. http://dx.doi.org/10.111/j.1369-7625.2012.00798.x
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Article Identifying Purpose of Framework Methods Study Results Level of Practice

Information Study Evidence Implications

Loiselle, M. C., O’Connor To Ottawa Qualitative Comprehensive Level 1V Knowledge of the

A. M., Michaud, C. (2011). propose a Decision decisional support Decision Support
Developing a decision method Support intervention and follow Framework will
support intervention for Framework up is needed for CKD improve the
regarding choice of dialysis develop- patients and their teaching skills of
modality. The CAANT ing and families to manage nurses as they
journal, 21(3). imple- ESRD which will incorporate a
menting a contribute to improved support decision
decision quality of decision framework into their
support regarding renal practice.
inter- replacement therapy
vention. choice and self-
management

Aasen, E. M., Kvangarsnes, To Theory of Qualitative The in-center Level A culture of change
M., & Heggen, K. (2011). explore discourse exploratory hemodialysis 111 is needed for
Perception of patient the and Theory design environment did not healthcare team to
participation amongst perception of promote patient engage patient in a
elderly patients with end- of patient participa- participation. The social dialogue of shared
stage renal disease in a participa- tion practice of dominance, knowledge and
dialysis unit. Scandinavian tion power and imbalance of intellect and change
Journal of Caring science, amongst knowledge facilitates the social practices to an
26, 61-69. elderly paternalistic ideology. ideology of
doi:10.1111/j.1471- patients Patient struggle for SDM participation.
6712.2011.00904.x with and the focus becomes
ESRD in a therapeutic environment
dialysis versus quality of life
unit.
RESEARCH PROPOSAL 21

Article Identifying Purpose of Framework Methods Study Results Level of Practice

Information Study Evidence Implications

Rosenroll, A. D., Higuchi, To Inter- Qualitative The significant other Level Including the
K. S., Dutton, K. S., explore profess- interpretive plays a very important 111 significant other
Murray, M. A., & Stacey, the ional descriptive role in both home based who is usually the
D. (2013). Perspective of experience Shared study and in-center therapy caregiver in the
significant others in of the Decision options. Significant deliberate choice of
dialysis modality decision- dialysis Model others need to be treatment modality
making: A qualitative modality included in the shared can improve patient
study. The CANNT decision- decision making process and significant other
Journal, 23(4). making to meet the need of the outcome.
process as family unit. Support
perceived should also be offered to
by the meet the emotional and
significant physical need of the care-
other. giver.
Harwood, L., Wilson, B., To N/A Perspective The CKD patients Level 1V The plan of care
Sontrop, J., & Clark, A. M. evaluate Correla- experience a lot of stress need to involve
(2012). Chronic kidney whether tional including psychosocial, intervention to help
disease stressors influence CKD physiological and patients to deal with
choice of dialysis modality. stress logistical. There is a stressors to promote
Journal of Advanced levels and direct link between stress positive health
nursing, 68(11), 2454- coping and choice of modality behaviors and
2465. doi:10.11111/j.1365- strategies selection. This ultimately increase
2648.2012.05943 influence population of patients choice in home
the will need decisional based dialysis
decision support intervention therapy. The stress
to initiate included in the shared inventory scale can
treatment decision making process a be a valid tool.
with HD to prevent decisional
vs. PD conflict from occurring.
RESEARCH PROPOSAL 22

Article Identifying Purpose of Framework Methods Study Results Level of Practice

Information Study Evidence Implications

To Dorothea Literature Orem’s Theory of Self- Level The nursing agency

O”Shaughnessy, M. provide an Orem Review Care can be adapted into V11 will support the
(2014). Application of overview Theory of the home based therapy patient to meet self-
Dorothea Orem’s theory of of the use Self-Care dialysis setting, The care needs, facilitate
self-care to the elderly of Orem’s integration of patient decision-making
patient on peritoneal Theory of centered care, high and independence.
dialysis. Nephrology Self-Care quality patient education, A sense of
Nursing Journal, 41(5) to guide implementation of autonomy will
the care emotional and supportive promote positive
for elderly measures and assessment health outcome and
patients of the patient cognitive adjustments to
on and physical abilities can changing quality of
peritoneal empower the process of life needs.
dialysis self-care.
To The Qualitative The study determines Level To provide effective
Sondrup, B., & Copland, explore Interaction exploratory that independent 111 care the nurse need
M. (2011). Supporting the Model of therapies are aligned with to understand the
patient choice: An process to Client improved patient patient lifestyle and
intervention to promote educate Health outcome when compared medical needs.
independent dialysis patients Behavior with the conventional in- Comprehensive
therapies. Nephrology with center HD model. education is
Nursing Journal, 38(6). ESRD However the education essential in. When
regarding need to begin in pre patient are involved
indepen- dialysis CKD care. in the decision
dent Appropriate education is making process
dialysis needed to aid patient in increase of home
therapies opting for home based based dialysis
renal replacement therapies will occur
therapy.
RESEARCH PROPOSAL 23

Article Identifying Purpose of Framewo Methods Study Results Level of Practice

Information Study rk Evidence Implications
APA reference)
Harwood, L., & Clark, A. To examine Social Qualitative The largest barriers were Level Promote quality
M. (2014). Dialysis the theory ethno- support and money. 111 intervention that
modality decision making facilitators graphy Personal factors will improve
for older adults with and barriers including knowledge and delivery of renal
chronic kidney disease. of home individual lifestyle, services to enhance
Journal of Clinical Nursing, dialysis values, life experiences benefits of home
23,3378-3390. decision and preferences were the dialysis to the older
doi:10.1111/jocn.12582 making for main facilitators. The adults and in so
older CHD gender disparity was that doing reduce the
patients women were more cost of this
willing to seek out expensive therapy.
information and learn

Testing the N/A Quasi- The experimental group Level The educational
Choiu, C. P., & Chung, Y. efficacy of Experi- demonstrated increased 111 process should be
C. (2011). Effectiveness of interactive mental knowledge, less started early. As
multimedia interactive multimedia design. uncertainty and reduced soon as kidney
patient education on DVD as an Quanti- decision regret with the injury is determined
knowledge, uncertainty and educational tative interventional interactive and continued
decision-making in patients tool for multimedia DVD through
with end-stage renal patients educational tool. In the maintenance
disease. Journal of Clinical with ESRD control group it was dialysis therapy.
Nursing, 21,1233-1231. to enhance determined that simple Close monitoring of
doi:10.1111/j.1365- knowledge educational leaflet was kidney disease
2702.2011.03793.x and an inadequate tool to usually starts with
decision- provide full scope eGFR <60 more so
making and education on the in comorbids such
decrease complicated therapy as HTN and
uncertainty. options. diabetes.
 RESEARCH PROPOSAL 24
ESRD

Diagram 1. Framework

Shared Decision

Self-Management and Lifestyle

Quality of Life Autonomy and Independence

Therapeutic Self-Care
Diet – Renal diet, fluid Health Requisites
restriction. Compliance with treatment regimen
Elimination – decrease in Knowledge of potential
urinary output, adequate bowel complication with treatment
movement regimen example infection.
Health
Nursing Safety - access care Acceptance of changes in self Promotion
Medication –identification of
Agency renal medication
image to facilitate progression of
chronic disease process example
Recreation – modification of skin and body changes.
exercise. Accommodate and incorporate
dialysis therapy into lifestyle.
Tolerates treatment plan.

Support Well Being Health

 Demographic Questionnaire

APPENDIX Department Nursing

A

Organizatio Jacksonville University

n

Date Elaine Dean RN

12/01/201
6

Read each question then circle the answer that applies

1. Age
______

2. Years of Education

______

3. Marital Status

a. Married

b. Single

4. Gender

a. Male

b. Female

5. Ethnicity

a. African-American

b. White

c. Other ______
Appendix
Test Name: Shared decision-making Name:

Test Level: Pre/post Date:

1. I have a through understanding of continuous  TRUE  FALSE

cycling
Peritoneal dialysis
2. I have a through understanding of in-center  TRUE  FALSE
hemodialysis
3. I have a through understanding of ambulatory  TRUE  FALSE
peritoneal dialysis
4. I have a through understanding of home therapies  TRUE  FALSE
5. I have a through understanding of transplant  TRUE  FALSE
6. I know what is conservative treatment  TRUE  FALSE
7. I have a through understanding of home  TRUE  FALSE
hemodialysis
8. I would prefer to control my treatment  TRUE  FALSE
9. I want to minimize lifestyle changes  TRUE  FALSE
10. Flexibility is important to me  TRUE  FALSE
11. I prefer qualified staff to manage my treatment  TRUE  FALSE
12. I want the ability to make decisions concerning my  TRUE  FALSE
treatment
13. I discuss my therapy decision with my nephrologist  TRUE  FALSE
14. I know all the dialysis accesses  TRUE  FALSE
15. I know what my current eGFR  TRUE  FALSE
16. I am planning to attend chronic kidney disease  TRUE  FALSE
classes

26
Appendix
Ferrans and Powers
QUALITY OF LIFE INDEX©
DIALYSIS VERSION - III

PART 1. For each of the following, please choose the answer that best describes how satisfied you are with that
area of your life. Please mark your answer by circling the number. There are no right or wrong answers.

Moderately Dissatisfied

Slightly Dissatisfied

Moderately Satisfied
Very Dissatisfied

Slightly Satisfied

Very Satisfied
HOW SATISFIED ARE YOU WITH:

1. Your health? 1 2 3 4 5 6

2. Your health care? 1 2 3 4 5 6

3. The amount of energy you have for everyday activities? 1 2 3 4 5 6

4. Your ability to take care of yourself without help? 1 2 3 4 5 6

5. The likelihood you will get a kidney transplant? 1 2 3 4 5 6

6. The changes you have had to make in your life because

of kidney failure (such as diet and need for dialysis)? 1 2 3 4 5 6

7. The amount of control you have over your life? 1 2 3 4 5 6

8. Your chances of living as long as you would like? 1 2 3 4 5 6

9. Your family’s health? 1 2 3 4 5 6

10. Your children? 1 2 3 4 5 6

11. Your family’s happiness? 1 2 3 4 5 6

12. Your sex life? 1 2 3 4 5 6

13. Your spouse, lover, or partner? 1 2 3 4 5 6

14. The emotional support you get from your family? 1 2 3 4 5 6

15. Your friends? 1 2 3 4 5 6

(Please Go To Next Page)

© Copyright 1984 & 1998 Carol Estwing Ferrans and Marjorie J. Powers (Do not use without permission).

Page 1
Appendix

Moderately Dissatisfied

Moderately Satisfied
Slightly Dissatisfied
Very Dissatisfied

Slightly Satisfied

Very Satisfied
HOW SATISFIED ARE YOU WITH:

16. The emotional support you get from people other

than your family? 1 2 3 4 5 6

17. Your ability to take care of family responsibilities? 1 2 3 4 5 6

18. How useful you are to others? 1 2 3 4 5 6

19. The amount of worries in your life? 1 2 3 4 5 6

20. Your neighborhood? 1 2 3 4 5 6

21. Your home, apartment, or place where you live? 1 2 3 4 5 6

22. Your job (if employed)? 1 2 3 4 5 6

23. Not having a job (if unemployed, retired, or disabled)? 1 2 3 4 5 6

24. Your education? 1 2 3 4 5 6

25. How well you can take care of your financial needs? 1 2 3 4 5 6
26. The things you do for fun? 1 2 3 4 5 6

27. Your chances for a happy future? 1 2 3 4 5 6

28. Your peace of mind? 1 2 3 4 5 6

29. Your faith in God? 1 2 3 4 5 6

30. Your achievement of personal goals? 1 2 3 4 5 6

31. Your happiness in general? 1 2 3 4 5 6

32. Your life in general? 1 2 3 4 5 6

33. Your personal appearance? 1 2 3 4 5 6

34. Yourself in general? 1 2 3 4 5 6

(Please Go To Next Page)

© Copyright 1984 &1998 Carol Estwing Ferrans and Marjorie J. Powers (Do not use without permission).

Page 2
Appendix
PART 2. For each of the following, please choose the answer that best describes how important that area of your
life is to you. Please mark your answer by circling the number. There are no right or wrong answers.

Moderately Unimportant

Moderately Important
Slightly Unimportant
Very Unimportant

Slightly Important

Very Important
HOW IMPORTANT TO YOU IS:

1. Your health? 1 2 3 4 5 6
2. Your health care? 1 2 3 4 5 6

3. Having enough energy for everyday activities? 1 2 3 4 5 6

4. Taking care of yourself without help? 1 2 3 4 5 6

5. Getting a kidney transplant? 1 2 3 4 5 6

6. The changes you have had to make in your life because of

kidney failure (such as diet and need for dialysis)? 1 2 3 4 5 6

7. Having control over your life? 1 2 3 4 5 6

8. Living as long as you would like? 1 2 3 4 5 6

9. Your family’s health? 1 2 3 4 5 6

10. Your children? 1 2 3 4 5 6

11. Your family’s happiness? 1 2 3 4 5 6
12. Your sex life? 1 2 3 4 5 6

13. Your spouse, lover, or partner? 1 2 3 4 5 6

14. The emotional support you get from your family? 1 2 3 4 5 6

15. Your friends? 1 2 3 4 5 6

16. The emotional support you get from people other

than your family? 1 2 3 4 5 6

(Please Go To Next Page)

© Copyright 1984 & 1998 Carol Estwing Ferrans and Marjorie J. Powers (Do not use without permission).

Page 3
Appendix

Moderately Unimportant

Moderately Important
Slightly Unimportant
Very Unimportant

Slightly Important

Very Important
HOW IMPORTANT TO YOU IS:
17. Taking care of family responsibilities? 1 2 3 4 5 6
18. Being useful to others? 1 2 3 4 5 6

19. Having no worries? 1 2 3 4 5 6

20. Your neighborhood? 1 2 3 4 5 6

21. Your home, apartment, or place where you live? 1 2 3 4 5 6

22. Your job (if employed)? 1 2 3 4 5 6

23. Having a job (if unemployed, retired, or disabled)? 1 2 3 4 5 6

24. Your education? 1 2 3 4 5 6

25. Being able to take care of your financial needs? 1 2 3 4 5 6

26. Doing things for fun? 1 2 3 4 5 6

27. Having a happy future? 1 2 3 4 5 6

28. Peace of mind? 1 2 3 4 5 6

29. Your faith in God? 1 2 3 4 5 6

30. Achieving your personal goals? 1 2 3 4 5 6

31. Your happiness in general? 1 2 3 4 5 6

32. Being satisfied with life? 1 2 3 4 5 6

33. Your personal appearance? 1 2 3 4 5 6

34. Are you to yourself? 1 2 3 4 5 6

© Copyright 1984 & 1998 Carol Estwing Ferrans and Marjorie J. Powers (Do not use without
permission).

Page 4
 Appendix
Data Collection Spreadsheet
Educational Marital Decisional Tool
Nunerical ID Age Gender Pretest QLI Scores Post Test
Level Status Outcome

Page 5
Appendix
Research Timeline

Month Objective Activity Completion Person

Date Responsible
1 Recruitment and Enlisting End of month Elaine Dean
interviews participants. 1 Sandy Armstrong
Conducting
initial interviews
and pre-test
2 Meeting shared- Visual aids, End of month Elaine Dean
decision goals (theory interactive 2 And
presentation) learning. Open Multidisciplinary
discussion, small Team-
groups. Social Worker
Dissemination of Dietician
information Nephrologist
materials Dialysis
Educator

3 Meeting shared- Dialysis training End of month Elaine Dean and

decision goals room field trip. 3 Dialysis Educator
practical/observation Outpatient unit
session observation visit
Practical
demonstration
4 Summary of Open forum End of month Elaine Dean
intervention. Rap up discussion 4
session Post test Completion of
Completion of study
Quality of Life
Index Dialysis
Version 111.

Page 6
 Appendix
Data Analysis Shells

Demographic Variables Level of Measurement Reason for Inclusion Descriptive Statistics

Age Interval Information is Frequency, mean,
necessary for standard deviation,
generalizability of mean
population
Gender Nominal Information is Frequency, percent
necessary for
generalizability of
population
Education Level Ordinal Is there a relationship Frequency, percent ,
between education and median
therapy choices
Marital Status Ordinal Is there a relationship Frequency, percent
between marital status
therapy choices and
quality of life
Ethnicity Nominal Information is Frequency, percent
necessary for the
generalizability of the
population

Study Variables Level of Measurement Descriptive Data Inferential Statistics

Quality of Life Ratio Mean, standard t-test
deviation, percentages
Shared Decision Nominal Frequency, t-test
Making percentages

Page 7
Appendix
Likert Scale Decision tool
What matters Strongly Disagree Strongly Not
to me for this disagree agree applicable
decision
1. Having
someone else in
charge of doing
my dialysis
2. Seeing my
health care
team more often
3. Having ability
to go to work or
school
4. Having
flexible daily
dialysis
5. Providing care
for myself at
home
6. Having set
schedule at
dialysis center
7. Having the
ability to travel
8. Avoiding
needles

Page 8
Appendix
JACKSONVILLE UNIVERSITY

CONSENT TO PARTICIPATE IN SCIENTIFIC INVESTIGATIONS

SUBJECT’S NAME:

TITLE OF INVESTIGATION: Shared decision making and its effects on the upyake of
independent home-based therapies versus in-center hemodialysis and its influence on quality of
life

PRINCIPAL INVESTIGATOR’ NAME: Elaine A. Dean BSN, RN, CDN

PURPOSE OF THE STUDY:

The purpose of this study is to see if more individuals will choose dialysis at home if allowed to
make that choice with the doctor. You qualify to participate in this study because you have
kidney disease and will possibly need dialysis in the future. If you choose to participate in this
study you will be provided with information and decisional making training. You have a right
not to participate in this study and if you exercise that right you will not be treated differently for
doing so.

BENEFITS OF THE STUDY:

The benefits of study are to help us understand if making a decision with the doctor would help
more patients choose dialysis in the comfort of their homes than going to a clinic three days per
week, and would it improve their quality of life. You may not benefit directly from this study
over and above the benefits normally associated with your continuity of care in the nephrology
clinic.

RISKS OF THIS STUDY:

I do not anticipate any risk to you participatig in this study. If at any point you do not wish to
continue, you have the right to withdraw from the study, without penalty, at any time.

ALTERNATIVES:

There are no alternatives to participating in this study. Your clinic appointments and treatment
prescribed by the nephrologist will remain the same.

COSTS / COMPENSATION:
There are no cost to you participating in this study. You will obtain valuable information and
training for your time.

Page 9
Appendix

CONFIDENTIALITY:

Your privacy and your participation in this study will be protected under HIPAA Laws. All
information will be kept confidential and anonymous. By anonymous, that your name will not
appear anywhere and no one except me will know about your specific answers. By confidential, I
will assign a number to your response, and only I will have the key to indicate which number
belong to which participant. In any article I write or any presentation that I make, I will use a
made-up name for you, and I will not reveal details or I will change details about where you
work, where you live, and ant other personal information about you.

CONFLICT OF INTEREST:

There are no current or foreseeable conflict of interest.

RIGHT TO PARTICIPATE OR WITHDRAW:

Your participation in this study is completely voluntary. You may refuse to participate or
withdraw at any time. If you choose to withdraw from this study your care will not be affected.

CONSENT TO PARTICIPATE:

I have discussed my participation in this study with (investigator

obtaining consent) and all of my questions have been answered satisfactorily. I understand the
purpose, benefits, risks, and alternatives associated with participating in this study. I further
understand that I am participating voluntarily and that I may withdraw at any time without
prejudice. I also understand that no representations or guarantees of any type have been made
concerning my participation in this study. Signing this form does not waive any of my legal
rights.

You may contact Elaine Dean at Elaine.Dean@va.gov if you have any questions or concerns
regarding this study. If you have questions about your rights as a research volunteer, you may
contact Dr. Mike Nancarrow, IRB Chair, mnancar@ju.edu or Dr. Adele Hanlon, IRB Assistant
Chair, ahanlon@ju.edu at Jacksonville University, 2800 University Boulevard North,
Jacksonville, FL 32211.

______________________________________ ____________________
Subject or Parent if Subject is a Minor Date

______________________________________ ___________________
Investigator Obtaining Consent Date

Page
10
Appendix
Nursing Theory and Research 11

PI Name: Elaine Dean RN BSN CDN

Proposal Title: The Effect of Shared Decision Making in Dialysis Therapies

Item Amount
Personnel
1.
2.
3.
4.
5.
Category Total: $0.00
Personnel Justification:

Equipment
1.
2.
3.
4.
Category Total: $0.00
Equipment Justification:

Supplies/Expenses
1.
2.
3.
4.
5.
6.
7.
Category Total: $0.00
Supplies/Expenses Justification:

Page
11
Appendix
Travel
1.
2.
3.
Category Total: $0.00
Travel Justification:

TOTAL $0.00

Page
12
Appendix

Classic Experimental Design

Pretest and Posttest with Comparison Group

Measurement of Measurement of Measurement of

Dependent Independent Dependent
Variable Variable Variable
(DV) (IV) (DV)
Experimental Pretest Intervention Posttest
group of elderly Quality of Life Shared Decision- improved
end-stage renal QOL Making Model QOL
disease patients
Nonequivalent Pretest Posttest
comparison group Quality of Life Improved
of elderly end- QOL QOL
stage renal disease
patients

Intervention- Experimental group

Comparison group received no intervention

Approach to analysis – Examine the difference between pretest and posttest scores
Comparison of experimental and comparison group
Identify differences between the two sample groups.

Uncontrolled treats to validity – Testing

Mortality
Sample
Maturation

Page
13