Assignment 3

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School

Maryville University *

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705

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Health Science

Date

Jun 12, 2024

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docx

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21

Uploaded by DrArtVulture16

IRB RESEARCH PROTOCOL APPLICATION 1. What is the purpose and significance of this study? a. Explain the purpose and/or research questions/hypotheses of the study. At an outpatient substance abuse treatment clinic, patients with substance use disorder (SUD) receive detoxification treatment, but nutritional aspects of substance use treatment is not being currently addressed. To address this gap in treatment the author will implement a nutrition education intervention as a quality improvement project. The purpose of the project is to determine if the implementation of nutrition education for a select period of time will improve retention rate of patients with SUD seen for detoxification, compared to the retention rate from a similar period of time in the previous year when patients did not receive nutrition education. The overall aim of the project is to improve the quality of care and patient outcomes at the author’s clinic by implementing individualized one-on-one nutrition education by a registered nurse and providing customized nutrition recommendations to patients with SUD. b. Indicate how the purpose of the study relates to previous research by including a of the literature. It is especially important to indicate how experts in this area have previously studied the topic/construct so that the multidisciplinary Board has a clear indication of the appropriateness of the intervention. If the design is highly experimental, a more exhaustive literature review is required. Malnutrition is a prevalent problem among individuals with SUD and can lead to poor recovery from substance abuse. Incorporation of nutrition interventions is instrumental to patient recovery and rehabilitation (Cowan & Devine, 2013; Neale et al., 2012; Li et al., 2016). Reduced food intake and poor absorption of essential macro- and micronutrients result in nutritional deficiencies among individuals with substance use disorder (Ross et al., 2012). Micro and micronutrient deficiencies can also increase an individual's risk for depression, anxiety, and mood and can potentially contribute to relapse (Rao et al., 2008). The prevalence of nutritional deficiencies and subsequent negative consequences are the impetus for creating nutrition intervention programs for individuals with SUD. The interventions range from individual to group nutrition education classes, and most interventions were adopted from the food pyramid (Barbadoro et al., 2011; Cowan & Devine, 2013; Juel et al., 2017; Sason et al., 2018). In theory, nutrition intervention can lead to improvement in a variety of patient outcomes. Nutrition education by trained professionals, including nurses and registered dieticians, based on healthy eating principles from nationally recognized nutrition guidelines such as SNAP-Ed can have effects on patients’ nutrition intake, nutrition knowledge, Body Mass Index (BMI), Waist-Hip Circumference (WHC), relapse rate, cravings, mood, behavior, and sleep (Angeles-Agdeppa et al., 2021; Barbadoro et al., (2010); Cowan & Devine, 2013; Grant et al., 2004; Juel et al., 2017; Martinotti et al., 2010; Sason et al., 2018; Waddington et al., 2015). Based on these studies, multiple outcomes can result from nutrition interventions. Angeles-Agdeppa, I., Santos Arias, F., Pascual Sy, J., & Pabustan Garingo, R. (2021). Nutrition care processes can improve the nutritional status and quality of life of persons who use drugs .
International Journal of High-Risk Behaviors and Addiction, 10 (1), 5-14 https://doi.org/10.5812/ijhrba.114975 Barbadoro, P., Ponzio, E., Petrosa, M., Aliotta, F., D'Errico, M., Prospero, E., & Minelli, A. (2010). The effects of educational intervention on nutritional behavior in alcohol dependent patients. Alcohol and Alcoholism, 46 (1) , 77–79 . https://doi.org/10.1093/alcalc/agq075 Cowan, J. A., & Devine, C. M. (2013). Diet and body composition outcomes of an environmental and educational intervention among men in treatment for substance addiction.  Journal of Nutrition Education and Behavior, 45 (2), 154–158. https://doi.org/10.1016/j.jneb.2011.10.011 Grant, L. P., Haughton, B., & Sachan, D. S. (2004). Nutrition education is positively associated with substance abuse treatment program outcomes.  Journal of the American Dietetic Association, 104 (4), 604–610. https://doi.org/10.1016/j.jada.2004.01.008 Juel, A., Kristiansen, C. B., Madsen, N. J., Munk-Jørgensen, P., & Hjorth, P. (2017). Interventions to improve lifestyle and quality-of-life in patients with concurrent mental illness and substance use . Nordic Journal of Psychiatry, 71 (3), 197–204. https://doi.org/10.1080/08039488.2016.1251610 Li, S. S., Ryan, L., & Neale, J. (2016). Diet and nutrient intake of people receiving opioid agonist treatment (OAT): Implications for recovery. Drugs and Alcohol Today, 16 (1), 59-71. Martinotti, G., Reina, D., Di Nicola, M., Andreoli, S., Tedeschi, D., Ortolani, I., Pozzi, G., Iannoni, E., D, I. S., & Janiri, L. (2010). Acetyl-L-Carnitine for Alcohol Craving and Relapse Prevention in Anhedonic Alcoholics: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial. Alcohol
& Alcoholism, 45(5), 449–455. https://doi-org.proxy.library.maryville.edu/10.1093/alcalc/agq039 Neale, J., Nettleton, S., Pickering, L., & Fischer, J. (2012). Eating patterns among heroin users: A qualitative study with implications for nutritional interventions.  Addiction (Abingdon, England), 107 (3), 635–641. https://doi.org/10.1111/j.1360-0443.2011.03660.x Rao, T. S., Asha, M. R., Ramesh, B. N., & Rao, K. J. (2008). Understanding nutrition, depression, and mental illnesses.  Indian Journal of Psychiatry ,  50 (2), 77. Saeland, M., Haugen, M., Eriksen, F. L., Wandel, M., Smehaugen, A., Böhmer, T., & Oshaug, A. (2011). High sugar consumption and poor nutrient intake among drug addicts in Oslo, Norway. The British Journal of Nutrition, 105 (4), 618–624. https://doi.org/10.1017/S0007114510003971 Sason, A., Adelson, M., Herzman-Harari, S., & Peles, E. (2018). Knowledge about nutrition, eating habits and weight reduction intervention among methadone maintenance treatment patients.  Journal of Substance Abuse Treatment, 86, 52–59. https://doi.org/10.1016/j.jsat.2017.12.008 Waddington, F., Naunton, M., Kyle, G., & Cooper, G. (2015). Nutritional intake of opioid replacement therapy patients in community pharmacies: A pilot study. Nutrition & Dietetics, 72 (3), 276-283. 2. Who will be the participants in this study? a. Identify all participant groups (e.g., teachers, college students, elementary school students, district administrators, pediatric patients, patients, care givers). The data for the project will be extracted from electronic medical records (EMRs) of patients who are 18 years and older and who have been admitted into the outpatient detoxification program at the targeted outpatient substance abuse treatment clinic. It is anticipated that 154 patient records in the clinic’s EMR will meet the inclusion criteria. All patients who were seen at the clinic during project implementation from DATE through DATE and participated in the nutritional education intervention will be reviewed. In addition, all records of patients who were seen at the
clinic during a similar period in the prior year from DATE through DATE who did not participate in the nutrition education will also be reviewed retrospectively for potential inclusion. b. For each participant group, describe the basic characteristics of potential participants (e.g., anticipated number of subjects, age range, gender, racial/ethnic background) and indicate any special criteria for including or excluding individuals from participation (specific diagnosis necessary, etc). If the researcher will exclude individuals with certain criteria (e.g., under 18, too many falls in 3-month period), indicate HOW the researcher will determine whether or not the participants meet the inclusion or exclusion criteria (e.g. inclusion/exclusion items at the beginning of questionnaire). The author anticipates reviewing 154 patient records for the project to yield a power of 0.080. The abstracted data from the EMR will consist of patients who are 98% Caucasian and 2% from other ethnic groups and who have a documented diagnosis of substance use and are admitted to the outpatient detoxification program. The age of the patients will be 18 years or older. All genders will be included in the data collection. Inclusion criteria for the participants’ EMRs to be included in the data collection are the following: 1. The participant is 18 years or older with an upper limit of 89 years. 2. The EMR has documentation that patient is enrolled in the clinic’s detoxification program. 3. The EMR has documentation of patient having a diagnosis of substance use including alcohol, opioids, and amphetamines. 4. The EMR has documentation that the patient was seen at the clinic between DATE through DATE and participated in the nutrition education intervention, OR the EMR has documentation that the patient was seen at the clinic between DATE through DATE in the previous year but did not participate in the nutrition education intervention. 5. The EMR has documentation of whether nutrition education was provided to patient, and will be coded as 1=yes or 2=no. 6. The EMR has documentation that the patient has completed the detoxification treatment and will be coded as 1=yes; 2=no. 7. The EMR has documentation that the patient was seen at the clinic one to two months post detoxification for long term follow up and will be coded as 1=yes and 2=no. The EMRs of potential participants will be excluded in a specific order. The exclusion of the EMR will be carefully examined in the following order: 1. If the patient is less than 18 years of age or over 89 years of age, the EMR will be closed, and no data will be retrieved. 2. If the patient did not complete the nutrition education during the period between DATE through DATE when the nutrition education was delivered to patients, the EMR will be closed, and no data will be retrieved. 3. If the EMR has documentation that the patient was enrolled in the detoxification program for less than three consecutive days, the EMR will be closed, and no data will be retrieved. 4. If the EMR has no documentation of a diagnosis of substance use, the EMR will be closed, and no data will be retrieved. 5. If the EMR has no documentation that the patient was enrolled in the detoxification program, the EMR will be closed, and no data will be retrieved.
c. If this research involves vulnerable populations (e.g., children, the mentally disabled, prisoners) or others who cannot fully give informed consent, justify their inclusion in this research study. N/A- Not Applicable. d. Describe any relationship that currently exists between the researcher and potential participants (e.g., teacher-student; OT-patient; nurse-patient; administrator-teacher) and how that relationship will be delineated for purposes of this research. The author of the project currently works on an as-needed basis as a Registered Nurse at the clinic. The author has complete access to the clinic’s EMR system. The clinic’s owner has permitted the author to carry out the project and to review charts retrospectively for data collection to prove usefulness of implementation of nutrition education (See Appendix A). The author will provide education to all the Registered Nurses at the clinic who will then be providing the nutrition education to all patients. The author will not participate in providing nutrition education to the patients as the author will not be on the schedule to work during the months the nutrition education will be implemented at the clinic. 3. How will potential participants be identified and recruited? a. Describe how the researcher will gain access to potential participants/participant groups, how participants will be contacted, and what information will be given to them as part of the recruitment process. A letter of approval has been obtained from the clinic’s owner to provide evidence for permission to release the EMRs of adult patients who were seen at the clinic with a diagnosis of substance use disorder and participated in the quality improvement project from DATE through DATE (See Appendix A). In addition, the clinic owner has provided the author permission to access records of patients from the previous year who did not receive nutrition education from DATE through DATE (See Appendix A). Therefore, patient records from DATE through DATE of current and past years will be retrospectively reviewed by the author of the study. The author has access to the clinic’s EMR due to employment status and has completed required HIPAA training from clinic. The author will adhere to the clinic’s policies regarding accessing patient records. The abstracted data will constitute the minimum necessary data to accomplish the goals of the project (See Appendix B). b. If participants will be compensated in any way (monetary, gifts, course credit), indicate the nature of the compensation and the source of the funds to be used. N/A- Not Applicable c. Attach copies of all materials in the appendices that will be used to recruit participant (e.g., letters, advertisements, announcements, script). N/A- Not Applicable
d. If participants will be identified and/or assessed through a cooperating institution/ agency/school/business or other location (not Maryville University), provide documentation that the study has been reviewed and approved by the appropriate official, ethics committee or IRB of the institution. N/A- Not Applicable. The clinic does not have an IRB. e. If participants will be selected from a school, hospital, or other organization, and that location DOES NOT have a separate IRB process, provide documentation that the study has been reviewed and approved to be conducted at that organization. A letter of approval granting support for the project has been issued by the clinic administrator/owner allowing the author full access to the EMR (See Appendix A). 4. What methodology will be used to answer the research question(s)? Please describe all interventions, treatments, assessment procedures, or other sources of data that will be used / collected in the study. [The reviewer should be able to follow the proposed procedure exactly from the response to the various parts to this question.] a. Describe what each participant (or group of participants) will be asked to do, including any interventions or educational programs, and all testing, observation, interviewing or laboratory procedures utilized to collect data. If observing or interviewing participants, please explain how all data will be recorded (video/audio recordings, field notes, etc.). Note the expectations for participants’ total time engaged in the study for data collection. A quantitative, exploratory design using retrospective chart review will be used for this quality improvement project. None of the study participants will be engaged during the study and patient identifying information will not be abstracted from the EMRs. The electronic medical records from the clinic will be used to collect minimum necessary data to meet the goals of the project and recorded on the data collection sheet, as indicated in Appendix B. A step-by-step outline of the project’s protocol is as follows: Step 1: The project will involve a retrospective chart review, with no direct engagement of clinic participants. Patient identifying information will not be abstracted from the electronic medical records (EMRs). Step 2: Upon obtaining IRB approval from Maryville University, the data collection process will commence. The author will review patient records from the clinic’s electronic medical records (EMRs), for DATE through DATE of current year, and DATE through DATE of previous year. The review will include records from two periods: those who received nutrition education during the current study period and those who did not receive nutrition education during the same period in the previous year. Step 3: The data will only be extracted for EMRs that meet the inclusion criteria. This will include demographic information, diagnosis of substance use disorder, participation in the nutrition education intervention, completion of detoxification treatment, and long-term follow up post detoxification. The data collection sheet (Appendix B) will be used to ensure that all relevant information is accurately documented and coded for analysis. Only minimum necessary data required to accomplish the goals of the project will be abstracted.
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