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NR 505 Week 5 Research Literature Assignment
It is not a secret that opioid abuse is a rapidly growing public health issue in the United States. Providing appropriate healthcare for a patient who abuses opioids is a complex process. There are not many treatment options available for these patients to choose from. One of the most popular treatments is the prescription medication Buprenorphine. Often times patients are torn between beginning treatment and continuing their current lifestyle. This research study is designed to determine if Buprenorphine treatment is effective in reducing the number of patients who are opioid dependent. This paper will discuss the study’s specifications, including the research literature support, the research approach, sampling, and the proposed implementation with a change model.
Every research study aims to answer the research question that caused its initiation. For this particular research study, the research question is, “Does Buprenorphine reduce the number of patients who are opioid dependent in comparison to patients who are receiving no treatment?”
Lintzeris et al. (2013 NR 505 Week 5 Research Literature Assignment) performed a study to determine the effectiveness of Buprenorphine tablets compared to buprenorphine films. The researchers approached the study with a quantitative design via a randomized controlled trial (Lintzeris, Leung, Dunlap, Laranoe, White, Rivas, & Ali, 2013). The study was performed in four outpatient clinics that treat opioid-dependent patients. The participants were already receiving Buprenorphine treatment at the clinics.
They were randomly assigned to groups via block randomization by a random number list on a computer program. It was conducted in three stages. The first stage consisted of continuing the use of Buprenorphine tablets, the second stage consisted of a ten-day period of administering the tablet or the film according random assignment in double-blind conditions. The third stage consisted of fourteen days of continuing the medication administration according to the random assignment under open-label conditions. Researchers at the National Drug and Alcohol Research Centre conducted Independent data monitoring.
Data were analyzed via a mixed model design. The results of the research study provided evidence that Buprenorphine sublingual films are comparable to sublingual tablets in most clinical measures that were examined throughout the study. It is concluded that patients should be able to utilize either form of Buprenorphine without little to any effects. One strength of this research study is the decreased chance of bias due to the randomization and double-blind approach. One limitation of the research study is that the participants were volunteers; therefore, they were keen to assist in the testing (Lintzeris et al., 2013 NR 505 Week 5 Research Literature Assignment).
Abrahamsson et al. (2016) conducted a study regarding the utilization of interim Buprenorphine treatment. The study aimed to determine the feasibility and effectiveness of interim Buprenorphine treatment with successful transitioning into full-scale treatment. An effective cohort study without a control group is applied. Data is collected by utilizing weekly urine drug tests to determine if any opioid abuse is occurring during the interim phase.
A logistic regression analysis revealed was conducted on the urine samples once the data was collected. The study concluded that in places where office-based Buprenorphine treatment is not easily available, interim treatment could be feasible and effective. One strength of this study is its ability to investigate the rare use of interim Buprenorphine treatment. One limitation is the limited amount of baseline data included with each patient, along with a small sample size (Abrahamsson et al., 2016).
Stein, Herman, Moitra, Hecht, Lopex, Anderson, and Brown (2015) performed a study that presents the implementation of distress tolerance (DT) treatment when Buprenorphine treatment is initiated to increase retention rates, thus increasing the effectiveness of the drug. A mixed-method research approach was utilized for this study. The subjects who met the inclusion criteria began Buprenorphine at the beginning of the study.
The subjects were placed in two groups. One group received DT treatment, while the other group received health education (HE) intervention. Self-report and drug screening via urinalysis were completed at each physician visit. Descriptive statistics were utilized to present the collected data. The results of the study showed that DT treatment was more slightly more effective than HE treatment. It also concluded that Buprenorphine was an effective treatment for opioid dependence if the patient maintained enrollment in a program. One strength of the research study is the unreliability of self-report.
One of the limitations is a small sample size (Stein, Herman, Moitra, Hecht, Lopex, Anderson, & Brown 2015 NR 505 Week 5 Research Literature Assignment). Liebschutz, Crooks, Herman, Anderson, Tsui, Meshesha, and Stein (2014) conducted a study that discussed Buprenorphine treatment for hospitalized opioid-dependent patients. This study aimed to determine whether receiving buprenorphine during hospitalization and linkage to office-based buprenorphine opioid antagonist treatment (OAT) after discharge increase entry into office-based OAT, increases sustained engagement in OAT, and decreases illicit opioid use six months after hospitalization.
This study also used a mixed-method research approach via self-reporting validated by urinalysis. The qualifying participants are separated into two groups, the detoxification group and the linkage group. The detoxification group was administered Buprenorphine only throughout their hospital stay. The linkage group was given Buprenorphine throughout their hospital stay, as well as enrolled in the hospital’s outpatient clinic.
Descriptive statistics were also used to summarize the findings of this study. A random-effects logistic model allowed the researches to evaluate the consistency of self-report and the urinalysis result. The results showed that although there was a low retention rate of patients in the outpatient clinic, those who remained in outpatient therapy showed significant decreases in their opioid dependency. One strength of the study was the decreased opportunity for bias to be present because it was a randomized clinical trial. One limitation of the research study was that the follow-up rates on the participants were low for several reasons. This could have easily altered the data (Liebschutz et al., 2014 NR 505 Week 5 Research Literature Assignment).
Bhatraju et al. (2017) conducted a research study based in a New York City public hospital primary care office over seven years. The population in the study area was considered underserved and heavily affected by opioid abuse. The purpose of the study was to determine the induction-related adverse events, treatment retention and to assess the level of dependency of the patients in the clinic over the seven years. The research approach that was used was a prospective clinical registry cohort design. All individuals enlisted in the program over the seven years were included in the study.
Initial clinical assessment data, visit attendance, and prescriptions were periodically pulled from the patient chart to compile a dataset. A retrospective chart review was conducted if there were missing data. The results concluded that the retention rates for all patients over the given time span were 57%. It was also concluded that opiate-positive urine tests declined with longer treatment retention. This proves that the presence of easily accessible treatment programs is needed in underserved areas that are heavily affected by opioid dependence. One strength of the study was the limits of the confounding variables are limited.
One limitation was the lack of randomization which presents the opportunity for there to be an imbalance in patient characteristics (Bhatraju et al., 2017).
Mokri et al. (2016) performed a study comparing the use of Buprenorphine/naloxone and naltrexone. The purpose of the study was to determine which medication is more effective in treating opioid dependency. A quantitative research approach was used via a single-site, two-group parallel randomized, double-blind clinical trial.
The participants were separated randomly into two groups via a computer-generated stratified randomization program. One group received Buprenorphine/naloxone, and the other received naltrexone over a period of twelve weeks. The medications were administered three times per week, double-blind and double-dummy. The groups were given weekly urine drug tests. Both groups also received weekly drug counseling.
The results of the research study concluded that the group who received Buprenorphine/naloxone had a greater number of opioid-negative urine tests and higher retention rates than the group who only received naltrexone. One strength of the research study was that the high level of randomization will help eliminate any bias present in the study. One limitation of the research study was the relatively small sample size (Mokri et al., 2016 NR 505 Week 5 Research Literature Assignment).
Singh, Mishra, and Tiwari (2018) presented a study that discussed patient satisfaction with addiction treatment and the effect it has on positive outcomes and greater program retention. This study aimed to determine the patients’ satisfaction with opioid substitution therapy (OST), the correlation between satisfaction scores and patient characteristics, and patients’ expectations from OST and care providers. The research approach utilized in this study was a mixed methods approach. A questionnaire was used with both closed-ended and open-ended questions. The results were then categorized into quantitative and qualitative data.
The questionnaire consisted of eight questions with a scoring range from 1 to 4. It was then summed based on the response. At the end of the questionnaire, the patients could make comments or suggestions. The results showed that all participants were either satisfied or delighted with OST. The results were positively skewed. One strength of the research study was the utilization of mixed methods with closed and open-ended questions created a wide range view approach for the researches. One limitation of the study was that the limited sample size could have resulted in statistically insignificant correlation between patient characteristics and satisfaction scores (Singh et al., 2018 NR 505 Week 5 Research Literature Assignment).
Goren et al. (2014) conducted a study that took place in a clinic in Israel. The purpose of the research study was to determine the efficacy of Buprenorphine treatment for opioid treatment evidenced program retention. A quantitative research approach was used to determine the retention rates of patients in the clinic. The data was collected based on the patient’s visits to the clinic at appropriate times over a seven-year span.
A retrospective evaluation of the numerical data was conducted once it was collected. The results concluded that the one-year retention rate is 66.5%, the three-year retention rate is 46.1%, and the five-year retention rate is 33.5%. One strength of this research study was that the retrospective evaluation allows the presents findings from a naturalistic environment. One limitation of the study was the assumption that program retention implies being free of illegal opioid abuse without a definite proof (Goren et al., 2014 NR 505 Week 5 Research Literature Assignment).
Esamaeili et al. (2014) performed a research study that compared the effectiveness of Buprenorphine and Methadone in normal clinical conditions in Iran. The research approach that was used is a mixed method. Interviews, an index, questionnaires, and urine drug tests are used to collect data. The participants were random separated into two groups. One group received Buprenorphine treatment, while the other received Methadone treatment. The groups were evaluated three times throughout the study: before treatment, two months after treatment, and six months after treatment.
They were evaluated via an interview using the Opioid Treatment Index, the WHOOL-BREF questionnaire that assesses the quality of life, a general health questionnaire, and a urine test. The results showed that there was higher retention in the Methadone group compared to the Buprenorphine group. However, the authors attribute this to the low dose of Buprenorphine utilized in the study. They conclude that positive results provide support for continuing the maintenance programs. One strength of the study was the utilization of randomization in group selection. One limitation of the study was the small sample size (Esmaeili, 2014).
Turner et al. (2015 NR 505 Week 5 Research Literature Assignment) conducted a study that explored the trends of Buprenorphine use in ambulatory care throughout the United States. The purpose of this study was to learn more about the adoption of Buprenorphine treatment in clinical practice. The research approach was quantitative. A cross-sectional, descriptive analysis of Buprenorphine utilization over ten years using the IMS Health National Disease and Therapeutic Index (NDTI) was used. The NDTI provides estimates of office-based physicians on a national scale via a two-stage stratified sampling method. Descriptive statistics were used to examine the trends.
The results of the study predicted that the utilization of Buprenorphine to treat opioid dependency would continue to grow rapidly throughout the United States and eventually replace the traditional Methadone maintenance therapy. One strength of this study was its ability to recognize the burden of opioid dependence on health care and predict the amount of resources that will be needed to care for these patients in the future. One limitation of this study was the lack of consideration pertaining to the effectiveness, quality of care, and appropriateness of clinical interventions (Turner, Kruszewski, & Alexander, 2015 NR 505 Week 5 Research Literature Assignment).
The research above provides solid support for the foundation of answering the research question for this study. In this particular study, the research approach will be quantitative. The selected quantitative research design for this study is quasi-experimental. A quasi-experimental research design is an observational study with an exogenous explanatory variable that the investigator does not control (Barnighausen, 2017). This design is best suited for this research study due to the intervention group being patients who are opioid dependent and receiving Buprenorphine treatment, while the comparison group is patients who are choosing to receive no treatment. Therefore, the investigator has no control over the comparison group.
One advantage to utilizing the quasi-experimental approach is the avoidance of the threats to external and internal validity that can arise in randomized controlled trials. The quasi-experimental can also produce casual results at a low cost on long-term outcomes (Barnighausen, 2017). One disadvantage of the quasi-experimental research design is the lack of randomization of the participants into test groups. The lack of randomization creates the potential for bias (Barnighausen, 2017). Overall, the quasi-experimental research design is best suited to assist in answering the proposed research question.
The target population for this research study is opioid-dependent patients receiving primary care at a primary care clinic. The sampling type that will be utilized is nonprobability sampling. A sample size of 150 patients will be invited to participate in the research study. The inclusion criteria will be as follows: must be between ages 18-55 and dependent on opioids. The exclusion criteria will be as follows: enrollment in any other opioid treatment program, presence of mental illness, suicidal ideation, or high-risk physiological health issues. One advantage of non-probability sampling is that it is cost-effective. It is also time effective and easy to utilize if a small population sample is being used (Sedgwick, 2013). One disadvantage is the inability to properly represent the population (Sedgwick, 2013).
As with any research study, it is essential to ensure that the participants’ rights be protected. The participants’ confidentiality will be protected by removing any form of identification from the collected data before processing. The participants will remain anonymous throughout the entire research process. Anonymity will be protected by not collecting identifying factors from the participants. The participants will have a choice in whether or not they choose to receive Buprenorphine treatment or receive no treatment.
The participants who chose Buprenorphine treatment will be protected by ensuring proper dosing, assessment, and symptom management. Those participants who choose no treatment will receive continued support and primary healthcare services from the clinic that include close monitoring for health problems. Prior to participating in the study, participants will be informed of all of the details surrounding the study. They will then be asked to sign informed consent before entering the study.
The PDSA Change Model is a model for learning and change movement. It comprises four steps: plan, do, study, and act (Donnelly, 2015). It is challenging to implement change in any area of healthcare. However, it is essential to successfully integrate change for advancements in patient care to be made. This change model is best suited to assist in answering the research question because it provides an organized process that is easy to follow. It is simple to apply the change solution to the change model by developing each stage individually. It is a time-effective way to improve the quality of patient care. The first step in the PDSA change model is “plan.” The plan is to conduct a study and collect data to determine if Buprenorphine treatment is effective in decreasing the amount of patients who are opioid dependent.
The next step is “do.” In this step, the participants will be observed to determine if buprenorphine is effective. They will be provided with closed-ended questionnaires along with weekly urine tests. They will also be assessed by a healthcare provider weekly throughout the study. The next step is “study.” In this step of the change model, the data that was collected from the do step will be analyzed. The results of the questionnaires, urine drug screenings, and weekly urine tests will be compiled and reviewed. The data collection process and overall study design will be evaluated.
The next step of the PDSA Change Model is “act.” In this step, a conclusion will be made about the analysis that occurred in the previous step. This is the most essential step in the change model. The findings from the study will be implemented in this step. For example, if the findings of the research study prove that Buprenorphine is effective in treating opioid dependency, then educational material regarding the effectiveness of Buprenorphine could be provided to the patients encouraging them to seek treatment. Overall, the change model effectively initiates and implements learning and change (Donnelly, 2015 NR 505 Week 5 Research Literature Assignment).
One barrier to the use of evidence-based practice (EBP) that results from the use of this project is proper education. Change is often feared due to the discomfort and lack of knowledge it brings. It is difficult to change perspectives and routines. The first step to ensuring a change plan is followed it to explain the importance of the change via proper education. Educational training sessions, handouts, and real-life examples are all great ways to provide education for change.
Primary care clinics can foster an environment that supports EBP by ensuring that the staff understands the importance of EBP and its effect on patient outcomes.
Education can also be used for the clinic staff to ensure that there is a complete understanding of why the change needs to be implemented. A transition period for the change should be set up to ensure there are plenty of help and people available should questions arise. A smooth transition during the implementation phase is essential in ensuring a change is continued. Overall, a supportive staff, proper education, and appropriate resources are critical to ensuring that a primary care clinic fosters an environment supporting EBP.
In conclusion, opioid abuse is an ever-growing problem across the United States. It is obvious that effective treatment is necessary to slow the progression of this epidemic. Although there is a great need, treatment options are limited. Buprenorphine is gaining recognition as a treatment option for opioid addiction. This research study is designed to determine if Buprenorphine treatment decreases the amount of patients who are opioid dependent. The results of the study have the potential to be life-changing for people who battle opioid addiction in their daily life.
Abrahamsson, T., Widinghoff, C., Lillebladh, A., Gedeon, C., Nilvall, K., & Hakansson, (2016). Interim buprenorphine treatment in opiate dependence: A pilot effectiveness study. Substance Abuse, 37(1), 104-109. https://doi.org/10.1080/08897077.2015.1065541
Barnighausen, T., Tugwell, P., Jon-Arne, R., Shemilt, I., Rockers, P., Geldsetzer, P., … Atun, R. (2017). Quasi-experimental study designs series-paper 4: Uses and value. Journal of Clinical Epidemiology, 89(1), 21-29.
Bhatraju, E. P., Grossman, E., Tofighi, B., McNeely, J., DiRocco, D., Flannery, M., & Lee, J. D. (2017). Public sector low threshold office-based buprenorphine treatment: Outcomes at year 7. Addiction Science & Clinical Practice, 12(1), 7.
Donnelly, P., & Kirk, P. (2015). Use the PDSA model for effective change management. Education for Primary Care, 26(4), 279-281.
Esmaeili, H., Ziaddinni, H., Nikravesh, M., Baneshia, M., & Nakhaee, N. (2014). Outcome evaluation of the opioid agonist treatment in Iran. Drug & Alcohol Review, 33(2), 186-193.
Goren, L. , Carmel, Z., & Marchevsky, S. (2014). Buprenorphine for opiate dependence: Clinic based therapy in Israel. The Israel Journal of Psychiatry and Related Sciences, 51(4), 281-284.
Liebschutz, J. M., Crooks, D., Herman, D., Anderson, B., Tsui, J., Meshesha, L. Z., & Stein, M. (2014). Buprenorphine treatment for hospitalized opioid-dependent patients: A randomized clinical trial. JAMA Internal Medicine, 174(8), 1369-1376.
Lintzeris, N., Leung, S., Dunlap, A., Larance, B., White, N., Rivas, G., & Ali, R. (2013). A randomized controlled trial of sublingual buprenorphine-naloxone film versus tablets in the management of opioid dependence. Drug and Alcohol Dependence, 131(1-2), 119-126.
Mokri, A., Chawarski, M. C., Taherinakhost, H., & Schottenfield, R. S. (2016). Medical treatments for opioid use disorder in Iran: A randomized double-blind placebo-controlled comparison of buprenorphine/naloxone and naltrexone maintenance treatment. Addiction, 111(5), 874-882. https://doi.org/10.1111/add.13259
Your Research Literature, Design, Sampling and Implementation assignment is due this week no later than Sunday 11:59PM MT. You can find the guidelines and rubric (an explanation of how you will be graded) listed below as well in the Documents section of Course Resources. This is a required Turnitin Assignment for this course.
This assignment provides the opportunity for the student to continue development of a MSN EBP scholarly project that started with the identification of a nursing concern and PICOT/PICo question from Week 2. The focus of this assignment is to discuss the research-based literature support for the selected concern, identify an appropriate research design, explain the sampling method, and discuss implementation through the use of a change model.
This assignment enables the student to meet the following course outcome:
CO 1. Integrate evidence-based practice and research to support advancement of holistic nursing care in diverse healthcare settings. (PO 1)
CO 2. Integrate knowledge related to evidence-based practice and person-centered care to improve healthcare. (PO 2, 5)
CO #4. Develop knowledge related to research and evidence-based practice as a basis for designing and critiquing research studies. (PO 1, 2, 3, 5)
CO #5. Analyze research findings and evidence-based practice to advance holistic nursing care initiatives that promote positive healthcare outcomes. (PO 1, 2, 5)
Due Date Sunday 11:59 PM MT at the end of Week Five
Total Points Possible: 250 points
Description of the Assignment:Â This continues the development of a MSN EBP scholarly project by requiring the student to identify the additional elements of the process. The required elements are noted to be:
Criteria for Content
2. Research Approach and Design: In this section, the student will identify the research approach that he/she plans on using for the EBP project as being either quantitative or qualitative. In addition, if the selected approach is quantitative, the student needs to identify if the design is experimental, quasi-experimental, or descriptive. If the selected approach is qualitative, the student needs to identify if the design is phenomenological, ethnography, grounded theory, or historical. A description of the selected design is to be provided as well as rationale for its selection. In addition one advantage and one disadvantage to the selected design is to be identified and discussed. Required content includes:
3. Sampling: In this section, the student will identify the sampling method to be used in order to obtain the necessary participants for the proposed EBP project. Discussion of participants’ rights as research subjects is also included. Required content includes:
4. Proposed Implementation with a change model:Â In this section, the student will apply the PDSA Change Model as the method to implement the proposed EBP practice solution/change. The required content includes:
Criteria for Format and Special Instructions