HEP 456 Module 7 Final Evaluation Plan

HEP 456: Health Promotion Program

7th December 2022

Living Well With Dialysis Intervention Plan

Abstract/Executive Summary

Introduction

The intervention program ‘Living Well With Dialysis’ is an intervention plan aimed at helping dialysis patients manage hypertension. This program will focus on the needs of people aged 25–40 who are undergoing dialysis. This is because these individuals are most likely not to follow the laid down procedures for managing hypertension. The priority population for this program will be newly diagnosed dialysis patients at Memorial Hospital Gulfport. The program will have a total of 150 participants i.e., dialysis patients. In addition, the program will also encompass a total of 15 staff members. The main goal of this project is to prevent complications for patients on dialysis and promote long-term healthy habits for patients who have been admitted to Gulfport Memorial Hospital. The stakeholders of the program will work together to make it a success.

Methods

The data collection methods will be designed to answer the process and impact evaluation questions. Some of the questions that will be directed to the program evaluators will be regarding the execution of the program. Was it executed as expected? Was it well managed? The type of issues that were experienced during delivery of the program?

Conclusions

The evaluation plan is expected to last for a period of around 3 years. The different stakeholder representatives as well as an analytical team will lead the evaluation. Print formats including one-page descriptions, brochures, executive summaries, newsletters, and technical reports will be utilized to disseminate information to the general public, attendees of conferences and workshops, and decision-makers in government and the nonprofit sector.

Background Literature on Program Need

Dialysis patients have much higher rates of hypertension than the general population. As is for the general population, hypertension is one of the major causes of cardiovascular mortality in dialysis patients. Since there have been so few high-quality clinical trials conducted, there are still numerous unanswered questions and concerns about managing hypertension, making it difficult to treat hypertension in dialysis patients.

Hypertension in hemodialysis patients is diagnosed when blood pressure is more than 140/90 mmHg before dialysis or greater than 130/80 mmHg after dialysis, as outlined by the Kidney Disease Outcomes Quality Initiative recommendations published in 2004 by the National Kidney Foundation (Sarafidis et al., 2019). Seventy percent or more of dialysis patients have high blood pressure, and only around 20% of those with high blood pressure have it well controlled (BP). Hypertension is also common among those undergoing peritoneal dialysis (PD), with estimates ranging from 30 to 90 percent. The wide range of hypertension diagnostic methods and terminologies is primarily to blame. Epidemiological studies conducted in Gulfport, Mississippi, indicated that 72%-88% of the people examined had high blood pressure (BP), depending on the definition of hypertension (Ashby et al., 2019). Antihypertensive medicine was more commonly used by patients with high blood pressure, however only 30–50% of patients in those trials had their blood pressure under control. Dialysis patients with renal failure nearly always take medication to reduce their blood pressure. Many of these people have hypertension due to an excess of fluid in their bodies; however, regular dialysis can help eliminate some of this fluid. Nevertheless, medication for excessive blood pressure is still required for about 60% of hemodialysis patients and 30% of peritoneal dialysis (PD) patients. Studies have linked both low blood pressure and high blood pressure, such as the U-shape, to an increased risk of death in dialysis patients, although arrhythmia and cardiac arrest account for around 25% of deaths in the United States.

In most cases, hemodialysis patients will have three sessions each week. The patient’s weight and amount of excess fluid often increase just before dialysis and decrease after it. Naturally, the systolic blood pressure is highest just before hemodialysis, and the diastolic pressure is lowest just after (Heerspink et al., 2009). It’s usual for patients to experience low blood pressure after undergoing hemodialysis. Constipation, dizziness, fainting, nausea, and vomiting are some of the negative symptoms. Keeping fluid consumption under control is essential for maintaining normal blood pressure. This program will focus on the needs of people aged 25–40 who are undergoing dialysis. This is because these individuals are most likely not to follow the laid down procedures for managing hypertension. In addition, dialysis patients often have excessive blood pressure due to obesity. Adults are urged to be mindful of their foods, limit their sodium intake, and choose healthful options.

The intended outcome of the new program is to enhance the quality of life for those who will be participating in it. Dietitians will monitor the patients' diets and fluid intake as part of the advantages they receive. To complement this, patients will participate in activities designed to maintain healthy blood pressure and heart rates. The hospital will also offer transportation services to help patients get to and from the facility. The initiative will be a huge success and a forerunner to similar programs.

Several programs have been designed so far to help dialysis patients with hypertension. The Chronic Kidney Disease (CKD) Initiative was launched by the CDC in 2006 to promote public health measures for enhancing kidney health (Bragg-Gresham et al., 2019). Several US dialysis patient hypertension initiatives have benefited from this task force’s efforts. The CKD Initiative works with the Making Dialysis Safer Coalition Program to fund hypertension management options for hemodialysis patients.

Introduction to the Program

The priority population for this program will be newly diagnosed dialysis patients at Memorial Hospital Gulfport. As aforementioned, the target population for this program will be patients suffering from high blood pressure aged between 25 and 30. Patients in this age bracket take many things for granted and do not follow the correct procedure for dialysis to avoid having high blood pressure issues. New patients diagnosed with ESRD at Memorial hospital will be given top priority. The gender of the patients will not determine the eligibility of the patients, but we expect that more women will be enrolled in the program since they comprise of a bigger percentage of the hemodialysis population in Mississippi. The program will have a total of 150 participants i.e., dialysis patients. In addition, the program will also encompass a total of 15 staff members i.e., a charge nurse, 3 floor nurses, a patient advocate, 3 social workers, a dietician, 5 therapists, and a CHES. The program will consist of dialysis activities, physical activities, therapy sessions, and education and interaction sessions. Dialysis will take place on the left-wing of the Gulfport Memorial hospital, the physical activities will take place on the rooftop, the therapy sessions will take place next to the psychiatric facilities, and the interactions and education will take place in the nurse’s cafeteria.

The main goal of this project is to prevent complications for patients on dialysis and promote long-term healthy habits for patients who have been admitted to Gulfport Memorial Hospital. The program is expected to improve the health of its participants, reduce the risk of one having complications during dialysis, equip its participants with additional knowledge on how to be on dialysis and still be healthy, and educate its participants on the need for one to take care of their bodies and eating habits.

Logic Model of the Program

Gap- Dialysis patients aged 25-30 around Mississippi are going through a lot of trouble managing their hypertension.

Engaging The Stakeholders

The intervention plan which is aimed at helping diabetic individuals manage hypertension will incorporate a couple of stakeholders namely financiers and insurers, health professionals, the management at Gulfport Memorial Hospital, diabetic patients, and their caregivers. The engagement of stakeholders in healthcare is very important. By working together, they are able to weigh the merits of competing viewpoints and interests, improving both the quality of care and patient outcomes. Stakeholder involvement is, thus, a crucially vital duty in aiding CMS in its efforts to learn about future measurement requirements and to carry out its measurement operations openly.

Stakeholders, Their Roles and the Importance of Engagement

Program Financiers and Insurers

The program will be grant-funded. The American Kidney Association will be responsible for acquiring the grants for the project. These program financiers will provide the resources necessary for the execution of the project in terms of money to pay salaries to the staff and the procurement of resources e.g., hospital beds. Engaging the program financiers will improve accountability within the intervention program. Transparency as to how the plan intends to use the grants will improve the trust between the financiers and the executors of the plan. This will augment the chances of even receiving more grants and helping more individuals than intended.

Medicare is the main insurance program for diabetic patients. The program can cover everyone, individuals from any age group, undergoing dialysis. Again, the engagement of Medicare will improve transparency and trust. This will help in the timely disbursement of funds from Medicare to the program.

Health Professionals and Supporting Staff

These are the individuals who will be actively engaging the patients. The program will encompass a total of 15 staff members i.e., a charge nurse, 3 floor nurses, a patient advocate, 3 social workers, a dietician, 5 therapists, and a CHES. Each of these members needs to know their roles and also any contribution from these members is important as they are foot soldiers. The engagement of these individuals is important as they can help identify some probable errors in the intervention plan and suggest some remedies.

The Management at Gulfport Memorial Hospital

As previously stated, this intervention plan will be executed in Gulfport Memorial Hospital, Mississippi. New patients diagnosed with ESRD at Memorial hospital will be given top priority. Dialysis will take place on the left wing of the Gulfport Memorial hospital, the physical activities will take place on the rooftop, the therapy sessions will take place next to the psychiatric facilities, and the interactions and education will take place in the nurse’s cafeteria. This means that the hospital is directly involved and is part of the plan. Engaging the management at Gulfport Memorial Hospital is important in order to get the necessary clearance to execute the plan on their premises. The management needs to know that the plan is serious before letting us execute it.

Dialysis Patients

As previously stated, new dialysis patients at the Gulfport Memorial Hospital will be the top priority. The whole plan revolves around these patients. Involving the patient population via committees and focus groups may be a successful technique for gaining support, increasing program awareness, and improving program results.

Dialysis Patient’s Caregivers

These are the friends and family members of dialysis patients. Their support is very vital in patient recovery. They need to understand their roles and also their suggestions are very important and need to be incorporated in the plan. In primary care settings, patient and family engagement in decision-making has been linked to lower pain and suffering and quicker recovery. Patients, their families, and other caregivers provide firsthand information about the appropriateness — or lack thereof — of various therapies for the patient’s conditions and preferences. Input from both sources is required to choose the best care choice.

Evaluation Questions

Impact evaluations assess the effectiveness of a program in producing change while process evaluations help stakeholders see how a program outcome or impact was achieved.

Evaluation Questions for Process Evaluation

Process evaluation information is helpful for understanding how program impact and outcomes were accomplished, as well as for program replication (Hieu & Nwachukwu, 2019). Looking at outcomes without considering how they were obtained fails to account for the human capital (overworked employees) required in achieving strong outcomes as well as the genuine expenses of the program.

Process evaluation questions

a) Was the plan executed as expected? Why or Why Not?

b) What are the specific kind of interventions that was put into place? Have the interventions worked or not? If not why have they not worked?

c) Did all the planned activities go as planned? If not, why dis some activities not go as planned?

d) Was the target population reached as earlier planned?

e) Was the program able to maintain an active and diverse stakeholder community? If not, why did some stakeholders pull out of the plan before termination?

f) What types of issues did you experience when delivering the program – did you have adequate resources from the start to perform it well?

g) Was the program well-managed?

h) Were employees taught or educated to the appropriate degree of program design? Is there skill in enabling the program procedures from start to finish?

i) Was the program well-supported?

Evaluation Questions for Impact Evaluation

The most prevalent form of assessment sought by foundations is impact evaluation. Impact assessments analyze a program’s ability to impact change (Sadare et al., 2020). Impact assessments concentrate on the challenging issues of what happened to enrollees and how much of an impact the program made for them. Impact or outcome assessments are conducted when it is necessary to determine whether or not the goals of a project or program were accomplished.

Impact evaluation questions

a) Is the community around Gulfport Memorial Hospital happy regarding the project?

b) Has the project being able to meet the community’s needs?

c) What was the completion rates of the enrolled individuals? If not 100%, why were some individuals unable to complete the program?

d) Is there evidence that the wellbeing of dialysis patients involved in the program is improving?

e) Has the’ Living Well in Dialysis’ plan met its objectives? These objectives are stated below.

Program Goal: Prevent complications for patients on dialysis and promote long-term healthy habits for patients that have been admitted to Gulfport Memorial Hospital.

Process Objective Statement 1: By August 2023, 150 newly diagnosed ESRD patients will be set up for long-term success on dialysis at Memorial Hospital Gulfport.

Process Objective Statement 2: By July 2022, The Case Manager will distribute 2500 pamphlets on healthy lifestyle and long-term success to 150 newly diagnosed ESRD patients at Memorial Hospital Gulfport.

Impact Objective Statement 1: By August 2023, 150 newly diagnosed ESRD patients on dialysis will have completed 12 group counseling sessions at Memorial Hospital Gulfport.

Outcome Objectives Statement: Five years after the program implementation, patient success on dialysis at Memorial Hospital Gulfport will increase by 80%.

Additional Impact Objectives:

• At the end of the educational workshop, all 150 patients will be able to list three foods high in potassium and three foods low in potassium.

• After completing 12 months of group counseling sessions, 95% of the patients will be able to list four coping techniques verbally.

Evaluation Design and Measures

Months 1 Months 2-11 Months 12

Process Evaluation

Questions Was the target population reached as earlier planned?

Was the plan executed as expected? Why or Why Not?

What types of issues did you experience when delivering the program – did you have adequate resources from the start to perform it well

Was the program well-supported?

Was the program well-managed?

Were employees taught or educated to the appropriate degree of program design? Is there skill in enabling the program procedures from start to finish?

Did all the planned activities go as planned? If not, why did some activities not go as planned?

What are the specific kind of interventions that was put into place? Have the interventions worked or not? If not why have they not worked?

Impact Evaluation

Questions Is the community around Gulfport Memorial Hospital happy regarding the project?

Has the’ Living Well in Dialysis’ plan met its objectives?

Is there evidence that the wellbeing of dialysis patients involved in the program is improving?

What were the completion rates of the enrolled individuals? If not 100%, why were some individuals unable to complete the program?

Gaining Consent From Individuals

No one will be forced to take part in the study. Furthermore, anyone willing to quit the study before its completion will also be allowed to do so. Participants will receive the consent form 3 months prior to the start of the study. They will be required to review the form in 1 month, ask questions in 3 weeks and email back the form to the program evaluators a month before the start of the program. Anyone who will have not submitted the form within the stipulated time will be regarded as unwilling to take part in the study. The evaluation team will follow-up on the individuals to make sure that everyone is able to ask questions regarding the study as well as that everyone understands what is contained in the consent document. The locations for private meetings will be disclosed to the individual interviewees on enquiry.

Data Collection Plans

Data Collection Methods for Process and Impact Evaluation.

These data collection methods will be designed to answer the process and impact evaluation questions.

Some of the process evaluation questions include:

j) Was the plan executed as expected? Why or Why Not?

k) What are the specific kind of interventions that were put into place? Have the interventions worked or not? If not, why have they not worked?

l) Did all the planned activities go as planned? If not, why did some activities not go as planned?

m) Was the target population reached as earlier planned?

n) Was the program able to maintain an active and diverse stakeholder community? If not, why did some stakeholders pull out of the plan before termination?

o) What types of issues did you experience when delivering the program – did you have adequate resources from the start to perform it well?

p) Was the program well-managed?

q) Were employees taught or educated to the appropriate degree of program design? Is there skill in enabling the program procedures from start to finish?

r) Was the program well-supported?

Some of the impact evaluation questions include:

f) Is the community around Gulfport Memorial Hospital happy regarding the project?

g) Has the project been able to meet the community’s needs?

h) What were the completion rates of the enrolled individuals? If not 100%, why were some individuals unable to complete the program?

i) Is there evidence that the well-being of dialysis patients involved in the program is improving?

j) Has the’ Living Well in Dialysis’ plan met its objectives? These objectives are stated below.

During the process assessment, both quantitative and qualitative data will be employed. Here are a few data collection strategies that will be used:

• Questionnaires and Surveys.

Questionnaires and surveys will collect data from participants by asking them both open-ended and closed-ended questions. Some of the questions that will be directed to the program evaluators will be regarding the execution of the program. Was it executed as expected? Was it well managed? The type of issues that were experienced during delivery of the program? Participants in surveys of the program will include patients, care providers, or other entities. Staff and volunteer training effectiveness will be assessed by in-person surveys. The vast majority of the questions on these questionnaires will be at the nominal or ordinal level, allowing for quick and easy classification of respondents into three categories: well-trained, somewhat well-trained, and not well-trained. Clear written and verbal guidelines on how to fill out the questionnaire will be provided to all program employees and volunteers.

• Post and Pre Program Knowledge and Attitude test.

These will help keep track of any new knowledge gained or perspective altered as a consequence of program participation. The attitude tests will be used to assess whether the community around Gulf Memorial Hospital is happy about the project and

• Interviews and Focus Groups.

In order to conduct an effective assessment, focus groups will be comprised of a representative sample of the target audience. Interviews related to certain questions or concerns will also be used. Both approaches include talking to grantees or other stakeholder groups to glean information about their experiences with program implementation and evaluating both intended and unanticipated policy effects.

• Expert panels.

Professionals will evaluate policies, provide suggestions, weigh the benefits and drawbacks, and think about both the program’s intended and unforeseen impacts. Expert panels will be used to assess whether the program has met it objectives and whether the interventions that were put into place worked.

• Direct Observations.

In order to maintain tabs on the progress of the training of both staff and volunteers, program administrators will use direct observation. This will be done prior to implementation on January 2023. Direct observations will be used in assessing questions like has the well-being of the participants improved, whether all participants completed the program, whether all shareholders reached the final stages of the program or some pulled out along the way and whether all the planned activities went as planned.

Measurement Approaches

The ‘Living Well On Dialysis’ program will be evaluated using a variety of measures. The measures include how many participants were present as well as whether or not the project was presented to them. These measures will be assessed via program records, structured interviews with staff, and observations.

1. Direct Observation

Direct observation will be utilized to evaluate if the program was applied and offer descriptive details of the study and the participant’s behavior.

2. Structures Interviews With The Program Staff

Staff members' impressions of how well the program was adhered to in practice will be recorded via these interviews. Any problems that arise during program implementation may be discovered via the use of structured interviews with program employees.

3. Program Records

They’ll be put to use explaining the results of program. Information such as participant numbers, demographics, services provided, and programm implementation can be gleaned from program records. The results will help establish whether or not the program’s content was effectively delivered to the targeted audience.

Data Collection Procedures

Participants in the “Living Well On Dialysis” program will be provided with a consent form that details the goals of the program, any potential hazards, and the participant’s involvement in making decisions about the program throughout enrolment. Participants will be able to understand the evaluation procedure and provide their informed permission for evaluators to access their personal information via this agreement, including results from age and prior knowledge surveys. The evaluator will begin by collecting program records.

It will likely take two or three days to finish reviewing all of the program’s records. The program implementation process will be observed. The evaluator will be the only one involved and will have received training in indirect observation. There will be a one-hour observation session. The evaluator will conduct formal interviews with program employees to gather data. Depending on the complexity of the questions and the answers given, an interview might span anywhere from thirty to sixty minutes.

Planning For Data Analysis and Interpretation

Expertise Needed for The Collected Data

Data analysis will be performed by experienced and well-qualified health professionals. Health professionals are qualified clinicians who provide community health services. Knowledge, qualities, and abilities for evaluating the impact of health services are critical to their successful implementation. As a result, the capacity to conduct program assessment is a valuable addition to the knowledge base of all health professionals. While it has long been assumed that health professionals can organize and carry out evaluations of small-scale initiatives, support and training for this group has been limited. That is why, for this study, we insist on hiring health experts who have received extensive training as program evaluators. These specialists must be skilled in any of the following areas: interviews, focus groups, surveys, observation, and documentation analysis.

List of Data for Process Evaluation

• Attendance lists.

• Stakeholder meetings attendance lists.

• Counts of number of people participating in the ‘Living Well on Dialysis’ intervention program.

• Observations of whether all activities of the program went as planned.

• Counts of the number of stakeholders who pulled out before the end of the program.

• Counts of the number of posts and adverts made on social media regarding the program.

• Counts of the number of staff involved in the project and their designation.

• Number of participants in the program.

List of data for impact evaluation

• Number of deaths occurring from high blood pressure.

• Number of individuals aware of how much water they should take in a day.

• Counts of the number of people who continue with the workout routine.

• Counts of the number of people who changed their diet to the better.

• Counts of the number of people who expressed their gratitude and promised to in future donate towards the cause of improving the well-being of patients.

• Counts of the number of people who restocked their pantries and fridges with quality food.

Discussion of data interpretation - who will interpret the results and what is the process you will use to do this?

The data gathered will be interpreted by program evaluators who took part in the data assessment as well as skilled statisticians. The survey results will be statistically examined. A t-test will be used to compare pre- and post-intervention replies. The evaluator will be searching for where on the scale participants evaluate the program’s services in this analysis. The scale will reveal if participants find these services useful, allowing the program to make adjustments to improve in areas that are not serving the stated aim of ‘Living Well With Dialysis.’

Drawing and Verification of Conclusions

The analyzed data (or descriptive research “facts”) will be evaluated via an evaluation reasoning process in order to create evaluative conclusions. Drawing conclusions is the process of making the project’s values apparent in determining program effectiveness (Bougie & Sekaran, 2019). The emphasis of values is a fundamental element of program assessment that distinguishes it from research. Holding a sensemaking session or “data party” is an important stage in forming evaluative conclusions (Adams & Neville, 2020). This is a collaborative approach that involves stakeholders and evaluators in analyzing results and developing shared understandings. The “mapping” of agreed understandings of the data to the rubric to establish and agree on the degree of performance is essential to this process. All this will be observed in drawing conclusions.

Timeline/Gantt Chart

Communication and Dissemination Plan

Dissemination

The term “dissemination” refers to the process of making information accessible and useable to many different groups by means of many different channels or forms (CDC, 2019). Whether it’s a press conference or a series of posters, they are all examples of channels. The term “format” describes the structure of the information itself (CDC, 2019). Both oral and written forms of communication may be used to disseminate information.

Reasons to Disseminate

There are several benefits to sharing details about your program with a wide range of people. You may be able to influence change in programs, policies, or practices by raising awareness about the health issues your program addresses and the types of support that would be most helpful, generating positive publicity, and making your organization more competitive when seeking financial and in-kind resources.

Individuals To Receive the Findings

i. General public

ii. Stakeholders i.e., financiers, program personnel, patients, the Gulfport Memorial Hospital Board, Gulfport Community, etc.

iii. Decision-makers in the government and NGO sector.

iv. Workshops and Conferences attendees.

v. Interested parties.

Information to Be Disseminated

i. Introduction to the Program- The ‘Living Well With Dialysis’ program is a program aimed at helping dialysis patients manage hypertension. The priority population for this program will be newly diagnosed dialysis patients at Memorial Hospital Gulfport. As aforementioned, the target population for this program will be patients suffering from high blood pressure aged between 25 and 30. New patients diagnosed with ESRD at Memorial hospital will be given top priority. The gender of the patients will not determine the eligibility of the patients, but we expect that more women will be enrolled in the program since they comprise of a bigger percentage of the hemodialysis population in Mississippi. The program will have a total of 150 participants i.e., dialysis patients. In addition, the program will also encompass a total of 15 staff members i.e., a charge nurse, 3 floor nurses, a patient advocate, 3 social workers, a dietician, 5 therapists, and a CHES. The program will consist of dialysis activities, physical activities, therapy sessions, and education and interaction sessions.

ii. Location of The Program-The program is set to be carried out at the Gulfport Memorial Hospital in Mississippi. Dialysis will take place on the left wing of the Gulfport Memorial hospital, the physical activities will take place on the rooftop, the therapy sessions will take place next to the psychiatric facilities, and the interactions and education will take place in the nurse’s cafeteria.

iii. Impact evaluation findings e.g.,

a) Is the community around Gulfport Memorial Hospital happy regarding the project?

b) Is the project able to meet the community’s needs?

c) The completion rates of the enrolled individuals.

d) Evidence that the well-being of dialysis patients involved in the program is improving?

iv. Process evaluation findings e.g.,

a) Whether the plan was executed as expected.

b) The specific kind of interventions that were put into place.

c) Whether all the planned activities went as planned?

d) Whether the program was able to maintain an active and diverse stakeholder community.

e) The types of issues experienced when delivering the program.

f) Whether the program was well-managed.

Channels and Formats to Be Used For ‘Living Well With Dialysis’ Plan

When deciding how to disseminate information, it’s important to think about whom you’re trying to reach, what kind of information you’re sharing, and why. Selecting the appropriate channels and format is important for the success of the dissemination process.

A list of channels and formats to be used in dissemination include

i. One-page descriptions

ii. Brochures

iii. Executive summaries

iv. Newsletters

v. Technical reports

vi. Slide presentations

vii. News releases or press conferences.

viii. Radio and television coverage

ix. Public meetings

x. Email listservs

Print formats including one-page descriptions, brochures, executive summaries, newsletters, and technical reports will be utilized to disseminate information to the general public, attendees of conferences and workshops, and decision-makers in government and the nonprofit sector. Channels such as slide presentations, news releases or press conferences, radio and television coverage, and public meetings to educate attendance are all effective channels for conveying assessment findings to the general public. We will also take into account the potential value of oral presentations, videos, and displays, which are typically more memorable and powerful than written reports and may also inspire extensive conversation. Stakeholders and others who have the same interests and concerns as your program personnel will be reached through email listservs and other web-based resources.

References

Adams, J., & Neville, S. (2020). Program Evaluation for Health Professionals: What It Is, What It Isn’t and How to Do It. International Journal of Qualitative Methods, 19, 1609406920964345.

Bougie, R., & Sekaran, U. (2019). Research methods for business: A skill building approach. John Wiley & Sons.

CDC. (2019, August). www.cdc.gov. Retrieved November 30, 2022, from Evaluation Briefs: https://www.cdc.gov/healthyyouth/evaluation/pdf/brief9.pdf

Ashby, D., Borman, N., Burton, J., Corbett, R., Davenport, A., Farrington, K., Flowers, K., Fotheringham, J., Andrea Fox, R. N., Franklin, G., Gardiner, C., Martin Gerrish, R. N., Greenwood, S., Hothi, D., Khares, A., Koufaki, P., Levy, J., Lindley, E., MacDonald, J., … Wilkie, M. (2019). Renal Association Clinical Practice Guideline on Haemodialysis. In BMC Nephrology (Vol. 20, Issue 1). https://doi.org/10.1186/s12882-019-1527-3

Bragg-Gresham, J., Morgenstern, H., McClellan, W., Saydah, S., Pavkov, M., Williams, D., … & Centers for Disease Control and Prevention CKD Surveillance System. (2018). County-level air quality and the prevalence of diagnosed chronic kidney disease in the US Medicare population. PloS one, 13(7), e0200612.

Heerspink, H. J. L., Ninomiya, T., Zoungas, S., de Zeeuw, D., Grobbee, D. E., Jardine, M. J., Gallagher, M., Roberts, M. A., Cass, A., Neal, B., & Perkovic, V. (2009). Effect of lowering blood pressure on cardiovascular events and mortality in patients on dialysis: a systematic review and meta-analysis of randomised controlled trials. The Lancet, 373(9668). https://doi.org/10.1016/S0140-6736(09)60212-9

Hieu, V. M., & Nwachukwu, C. (2019). Strategy Evaluation Process And Strategic Performance Nexus.

Sadare, O., Williams, M., & Simon, L. (2020). Implementation of the Health Equity Impact Assessment (HEIA) tool in a local public health setting: challenges, facilitators, and impacts. Canadian Journal of Public Health, 111(2), 212-219.

Sarafidis, P. A., Mallamaci, F., Loutradis, C., Ekart, R., Torino, C., Karpetas, A., … & Zoccali, C. (2019). Prevalence and control of hypertension by 48-h ambulatory blood pressure monitoring in haemodialysis patients: a study by the European Cardiovascular and Renal Medicine (EURECA-m) working group of the ERA-EDTA. Nephrology Dialysis Transplantation, 34(9), 1542-1548.

Appendix

Appendix 1

ARIZONA STATE UNIVERSITY

CONSENT TO BE PART OF A RESEARCH STUDY

1. INFORMATION REGARDING RESEARCHERS AND THIS STUDY

Study title: Living Well on Dialysis

Principal Investigator: Reggie Stewart, Student, Arizona State University.

Faculty Advisor: Helitzer Irvin, Dean, Arizona State University

Study Sponsor: American Kidney Association.

You have been invited to participate in a research project. This form provides information that will assist you in deciding whether or not to participate in the research. The reason you are being asked to complete a consent form is to acknowledge that you understand that this study is an evaluation project

1.1 Key Information

Things you should know:

• The aim of this study is to Prevent complications for patients on dialysis and promote long-term healthy habits for patients that have been admitted to Gulfport Memorial Hospital.

• If you choose to participate, you will be asked to join our team of staff and other 149 new ESRD dialysis patients at the Gulf Memorial Hospital between January 2023 and December 2023. Some of the discomforts of this study include committing lots of time to the program. A time commitment of three hours every Monday, Wednesday, and Friday will be required for the entity of the program, which is 52 weeks. Adoption of healthy eating habits might also be uncomfortable for some time. The program will also involve physical activities like Yoga which might be uncomfortable for a few days for individuals who are not used to physical activity.

• The direct benefits of this study will be being educated and prepared as a dialysis patient for long-term success during your treatment through a holistic approach to your care which encompasses dietary recommendations, case management, behavioural health services, and other social services.

Taking part in this research project is voluntary. You do not have to participate and you can stop at any time. Please take time to read this entire form and ask questions before deciding whether to take part in this research project.

2. PURPOSE OF THIS STUDY

Seventy percent or more of dialysis patients have high blood pressure, and only around 20% of those with high blood pressure have it well controlled (BP). Hypertension is also common among those undergoing peritoneal dialysis (PD), with estimates ranging from 30 to 90 percent. Epidemiological studies conducted in Gulfport, Mississippi, indicated that 72%-88% of the dialysis patients examined had high blood pressure (BP), depending on the definition of hypertension. The main goal of this project is to prevent complications for patients on dialysis and promote long-term healthy habits for patients who have been admitted to Gulfport Memorial Hospital. The program is expected to improve the health of its participants, reduce the risk of one having complications during dialysis, equip its participants with additional knowledge on how to be on dialysis and still be healthy, and educate its participants on the need for one to take care of their bodies and eating habits.

3. WHO CAN PARTICIPATE IN THIS STUDY

3.1 Who can take part in this study?

The priority population for this study will be newly diagnosed ERSD dialysis patients at Gulf Memorial Hospital.

3.2 How many people are expected to take part in this study?

The study will encompass a total of 150 newly diagnosed ERSD dialysis patients. In addition, the program will also encompass a total of 15 staff members i.e., a charge nurse, 3 floor nurses, a patient advocate, 3 social workers, a dietician, 5 therapists, and a CHES.

4. INFORMATION REGARDING PARTICIPATION

4.1 What will happen to me in this study?

You will fisrt be required to visit the leftwing of Gulf Memorial Hospital where the program activities will be based. After enrollment you will be required to commit three hours every Monday, Wednesday, and Friday for the entity of the program, which is 52 weeks. The program will consist of dialysis activities, physical activities, therapy sessions, and education and interaction sessions. Dialysis will take place on the left-wing of the Gulfport Memorial hospital, the physical activities will take place on the rooftop, the therapy sessions will take place next to the psychiatric facilities, and the interactions and education will take place in the nurse’s cafeteria.

The Social Workers will be responsible for your arrival to and from the hospital. There will be a sign-in sheet for you to sign in upon arrival at the group counseling session.

4.2 How much of my time will be needed to take part in this study?

This study will take a total of one year i.e., 52 weeks. You will be required to attend therapy sessions of 3 hours every Monday, Wednesday, and Friday for the entity of the program. After finishing the 1 year program successfully, you will be contacted again in the future for outcome assessment.

4.2.1 When will my participation in the study be over?

The participation will be between January 2023 and December 2023. However, as aforementioned, after finishing the program successfully in December 2023, you will be contacted again in the future for outcome assessment.

4.3 If I decide not to take part in this study, what other options do I have?

If you decide not to be part of this study, you will still be able to access treatment from Gulf Memorial Hospital. The participation is voluntary. If you choose to participate in the program, you will also be automatically legible for participating in the program evaluation.

5. STUDY’S RISK AND BENEFITS

5.1 What risks will I face by taking part in the study? What will the researchers do to protect me against these risks?

The psychological risks that might be witnessed due to the fatigue of attending the therapy sessions will be addressed in the counseling sessions.

The drastic change of diet might also cause some embarrassing bloating and lightheadedness, headaches, and a hangry temper for some individuals. This will be addressed by our program physicians.

5.1.1 What happens if I get hurt, become sick, or have other problems because of this research?

If you get sick from this experiment, our health experts will link you with Gulf Memorial Hospital for treatment. They will assist you in obtaining treatment but your insurance company will be responsible for the cost. By signing this form, you do not give up your right to seek payment if you are harmed because of being in this study.

5.2 How could I benefit if I take part in this study? How could others benefit?

The direct benefits of this study will be being educated and prepared as a dialysis patient for long-term success during your treatment through a holistic approach to your care which encompasses dietary recommendations, case management, behavioural health services, and other social services.

5.3 Will the researchers tell me if they learn of new information that could change my willingness to stay in this study?

One of the aims of this study is to educate the participants, i.e, dialysis patients on a helathy living. Yes, the researchers will tell you if they learn of important new information that may change your willingness to stay in this study.

6. QUITTING THE STUDY

6.1 If I want to stop participating in the study, what should I do?

You may exit the study at any moment. There will be no penalty if you abandon the study before it is completed. If you decide to quit the research before it is completed, please notify one of the people indicated under “Contact Information.” If you want to inform the researchers why you’re quitting the study, your reasons may be included in the study record. Unless you ask us to erase it from our database, the researchers will preserve the information obtained about you for the study. If the researchers have already utilized your information in a study analysis, we will be unable to erase it.

7. FINANCIAL INFORMATION

7.1 Will I be paid or given anything for taking part in this study?

You will not receive any compensation for your participation in the study. You will only be eligible for any of the stated incentives i.e., 20$ Gift Cards, 20$ BP Curfs, and 15$ Glucose Monitors.

7.1.1 Will I need to pay anything to be part of the study?

As a participant, you will not incur any costs. The program will also cater for your transportation cost.

7.2 Who could profit or financially benefit from the study results?

The program will be grant-funded by the American Kidney Association.

8. PROTECTING AND SHARING RESEARCH INFORMATION

8.1 How will the researchers protect my information?

The information collected from this study will be stored in encrypt computer-based files, and any personal identifiers will be removed from the study documents as soon as the research is over.

8.2 Who will have access to my research records?

• University, government officials, study sponsors or funders, auditors, and/or the Institutional Review Board (IRB)- They may need the information to make sure that the study is done in a safe and proper manner.

• Federal or State law- It may require the study team to give information to government agencies.

8.3 What will happen to the information collected in this study?

We will save the information we acquire about you throughout the study for future research initiatives or study records. Your name and other personally identifiable information will be erased from the research data as soon as the study is completed. We will not retain your name or any other information that may be used to identify you personally. The research findings may be published in an article or presentation, but no information identifying you will be included.

8.4 Will my information be used for future research or shared with others?

Your study data may be used or shared in future research investigations. If we share your information with other researchers, it will be de-identified, which means it will not include your name or any other information that may be used to identify you personally.

9. CONTACT INFORMATION

Who can I contact about this study?

Please contact the researchers listed below to:

• Obtain more information about the study

• Ask a question about the study procedures

• Report an illness, injury, or other problem (you may also need to tell your regular doctors)

• Leave the study before it is finished

• Express a concern about the study

Principal Investigator:

Email: rrstewa2@acu.edu

Phone: 855-653-2273

Study Cordinator

Email: helitzerirvin@acu.edu

Phone: 504-512-8190

Study Sponsor

Email: kidneyfund@kidney.org

Phone:800-638-8299

If you have questions about your rights as a research participant, or wish to obtain information, ask questions or discuss any concerns about this study with someone other than the researcher(s), please contact the following:

Arizona State University

Health Sciences and Behavioral Sciences Institutional Review Board (IRB-HSBS)

1151 S Forest Ave Tempe

AZ 85281

Telephone: 855-278-5080

Fax: 855-278-5080

E-mail: customerservice@asu.edu

10. YOUR CONSENT

Consent/Assent to Participate in the Research Study

By signing this form, you agree to participate in this research. Before you sign, be sure you understand the study’s purpose. We will provide you a copy for your records and maintain another copy with the study records. If you have any concerns regarding the study after signing this consent, please contact the research staff using the details given in Section 9 above.

I understand the study’s purpose, and my inquiries have so far been addressed. I accept to participate in this research.

Print Legal Name: _____________________________________________________

Signature: ___________________________________________________________

Date of Signature (mm/dd/yy): ___________________________________________

11. OPTIONAL CONSENT

Consent to be Contacted for Participation in Future For Outcome Assessment or Research

Researchers may desire to retain your contact information on file in order to invite you to participate in future research projects that are similar to or entirely different from this one. The researchers may also desire to keep your contact information in order to ask you questions during outcome assessment.

_____ Yes, I agree to be contacted in the future

_____ No, I do not agree to be contacted in the future.

Appendix 2

‘Living Well on Dialysis’ Intervention Program Survey

This intervention program targets dialysis patients between the age of 25-40. The aim of this survey is to help the program evaluators learn how the participants feel about their perceived susceptibility, barriers, severity, benefits, self-efficacy, and cues action.

Each question has 5 levels of answers marked as 1,2,3,4, and 5.

Their representations are listed below:

1- Strongly Agree

2- Agree

3- Neutral

4- Disagree

5- Strongly Disagree

‘LIVING WELL ON DIALYSIS’ PROGRAM QUESTIONNAIRE

PERCEIVED SEVERITY

1 2 3 4 5

1. I am cognizant of the risks associated with hypertension in dialysis patients.

2. I am aware that unmanaged high and low blood pressures are fatal to dialysis patients.

3. I am aware that among those dialysis patients struggling with hypertension, only 30-50% have it in control.

PERCEIVED SUSCEPTIBILTY

1 2 3 4 5

4. I am aware that most of dialysis patients in my age group are not keen on hypertension management.

5. I am aware that 70-80 % of dialysis patients are also struggling with hypertension.

PERCEIVED BENEFITS

1 2 3 4 5

6. I will be able to live well on dialysis.

7. My diet will improve.

8. I will have self-awareness on hypertension.

9. I will learn the hypertension’s coping techniques.

10. I will live longer and healthier.

CUES TO ACTION

1 2 3 4 5

11. I would like to know more about this intervention program.

12 I am interested in meeting other patients and staff and will work together for a better tomorrow.

13. I am ready to follow the laid program schedule.

PERCEIVED BARRIERS

1 2 3 4 5

14. The change in diet will be uncomfortable.

15. The program is time-consuming.

16.The location of the program i.e., Gulf Memorial Hospital is a bit far from my residence.

SELF EFFICACY

1 2 3 4 5

17. I can make commitment and attend the dialysis program as planned.

18. I do not mind getting calls after completion for outcome evaluation.

19. I can take time off from work to participate in the program

DEMOGRAPHIC QUESTIONS

20. What is your birth date? Write in, month, day, year _ _ / _ _/ _ _ _ _

21. What is your highest level of education? Middle school High school or GED Associate’s degree College Graduate school

22. What is your race? BLACK HISPANIC AMERICAN

INDIAN ASIAN WHITE

23. What is your ethnicity? Hispanic Non-Hispanic

24. What is your gender? Male Female Transgender None of these

This section is for you to give your thoughts on the aforementioned questions and anything else you feel like highlighting.