Running head: EARLY IMPLEMENTATION OF CAPSULE ENDOSCOPY Chambers 1. A Cost-Benefit Analysis. Winde R. Chambers. Texas Woman's University

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1 Running head: EARLY IMPLEMENTATION OF CAPSULE ENDOSCOPY Chambers 1 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia: A Cost-Benefit Analysis Winde R. Chambers Texas Woman's University

2 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 2 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia: A Cost-Benefit Analysis Contact information: Winde R. Chambers, APRN, FNP 156 Kingston Road Benton, Louisiana Capsule endoscopy has revolutionized the diagnosis and management of iron deficiency anemia and obscure gastrointestinal bleeding over the past decade. It allows visualization of areas of the small bowel that are not reached with conventional endoscopic procedures. In 2005, the International Conference on Capsule Endoscopy published a consensus statement that delineates the use capsule endoscopy as part of the initial evaluation for patients with obscure gastrointestinal bleeding (Pennazio, Eisen & Goldfarb, 2005). Regardless of this consensus, initial evaluation with capsule endoscopy in patients without gross gastrointestinal bleeding is debatable (Rockey, 2005). Standard management is often to treat with iron supplementation, followed by observation and/or repeat endoscopy (Rockey, 2010). The purpose of this study is to evaluate the efficacy of early intervention with capsule endoscopy compared to standard management, using cost effectiveness and time to diagnosis as quality outcome measures for care of patients with iron deficiency anemia related to obscure gastrointestinal bleeding. Context Iron deficiency anemia is most frequently caused by chronic occult gastrointestinal bleeding in men and postmenopausal women therefore the standard of care is investigation of the gastrointestinal tract (Rockey, 2010).

3 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 3 Obscure bleeding is characterized by bleeding that persists or recurs without identification of a source on initial evaluation with esophagogastroduodenoscopy (EGD) or colonoscopy (American Gastroenterological Association [AGA], 2007b). Obscure occult bleeding is distinguished by patients with iron deficiency anemia and documented evidence of positive fecal occult blood test and obscure overt bleeding is differentiated by recurrent melena, hematemesis or hematochezia (Rockey, 2010). OGIB represents approximately 5% of all gastrointestinal bleeding with small bowel sources identified in 75% of these cases (AGA, 2007a). Capsule endoscopy has a positive impact on health outcomes, although evidence is lacking regarding outcomes of interventions following capsule endoscopy (AGA, 2007b). It has been estimated that the average cost associated with diagnosing obscure gastrointestinal bleeding is $33,630 (Goldfarb, Phillips, Conn, Lewis & Nash, 2002), however more recent literature asserts that these figures are significantly underestimated (AGA, 2007b). Diagnosing the cause of obscure gastrointestinal bleeding may take a significant amount of time which contributes to substantial medical cost (AGA, 2007b). It takes from one month to eight years to diagnose patients with obscure gastrointestinal bleeding with a median of two years (AGA, 2007b). Medicare and private insurers require documentation of normal EGD and colonoscopy within six months to one year prior to capsule endoscopy approval (AGA, 2007b). Project Description Goal/Objectives The goal of this clinical inquiry is to investigate the efficacy of early capsule endoscopy compared to conventional diagnostic evaluation based on cost effectiveness for patients with iron

4 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 4 deficiency anemia. Objectives include (a) developing a timely and cost effective practice protocol for the management of patients with iron deficiency anemia; (b) and increasing available evidence to support the development of a clinical practice guideline. Research Question The research question guiding this project is: What is the efficacy of early implementation capsule endoscopy compared to conventional diagnostic evaluation for cost effective care management in patients diagnosed with iron deficiency anemia? The intervention is conceptually defined as the diagnostic approach for identifying the source of obscure gastrointestinal bleeding and operationally defined as early implementation of capsule endoscopy (immediate use following initial non-definitive scopes) compared to conventional diagnostic evaluation (trial of iron therapy, repeated endoscopy). The conceptual definition for the outcome variable is cost effective care management operationally defined as incurred procedural cost and time between initial and problem resolution. Methodology A retrospective chart review of patients diagnosed with iron deficiency anemia will be conducted in order to answer the proposed research question. Patients evaluated for iron deficiency anemia from April 2007 to April 2008 will be identified data collected in the practice electronic medical record (EMR). Inclusion criteria include men and postmenopausal women ages 50 to 70 diagnosed with iron deficiency and obscure gastrointestinal bleeding. Patients with history of gastric bypass, cases involving obscure overt gastrointestinal bleeding and those with contraindications for capsule endoscopy will be excluded. Premenopausal women with documentation of abnormal menstrual bleeding will be eliminated from the study. The intervention group will be defined as patients diagnosed with iron deficiency anemia who

5 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 5 underwent capsule endoscopy within 6 months of initial EGD and colonoscopy. The conventional group will be defined as patients diagnosed with iron deficiency anemia that did not have capsule endoscopy following normal EGD and colonoscopy (Appendix C). Data collection tools (Appendix E) developed by the researcher will be used to collect anonymous data from the patients' medical records. Demographics and pre-procedure hemoglobin, mean corpuscular volume, serum iron, total iron binding capacity will be recorded for both groups. Results of fecal occult blood testing and prior blood transfusions will be documented if available. Information regarding use of non- steroidal anti-inflammatory drugs, antiplatelets and anticoagulants will be obtained for both groups. For the intervention group, capsule endoscopy date, findings and recommendations will be recorded. Follow-up laboratory data and clinical outcomes will be recorded. A positive outcome will be defined as identification of the source of bleeding and/or resolution of anemia. A negative outcome will be defined as retained capsule, persistent anemia and/or no definite source of bleeding identified on capsule endoscopy. For the conventional group, the length of time from negative EGD and colonoscopy to date of symptoms resolution or capsule endoscopy will be recorded. The number of endoscopic procedures, radiological images, follow-up visits, laboratory test (including CBC, iron studies) and blood transfusions between these dates will be collected. Timeline and Duration The study is projected to last approximately six months. An exempt application will be submitted to the Texas Woman's University (TWU) Institutional Review Board in September The written document will be submitted to the capstone committee by March Specific dates and activities are illustrated in Table 1.

6 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 6 Table 1 Projected Timeline Date September 1-31, 2010 October 1-7, 2010 October 8- November 31, 2010 December 1-31, 2010 January 1- March 15, 2011 Activity TWU IRB approval Educate data collectors Data collection Statistical analysis Complete project/paper Sites, Support and Personnel Required for Project The study will be conducted a private gastroenterology practice in the Southern United States. No financial support will be needed from the practice. The researcher will require assistance from the health information manager at the practice to obtain the sample from the EMR. The researcher will be responsible for data collectors and statistician. Deliverables to Institution The results of the study will be discussed with the health care providers and personnel at the gastroenterology practice. These findings will aid in the development of a timely and cost effective practice protocol for the management of patients with iron deficiency anemia. A copy of the written documented will be provided by the researcher. Benefits/Anticipated outcomes Findings from this study will increase available evidence to support the development of clinical practice guidelines. The placement of capsule endoscopy immediately after conventional endoscopic evaluation in diagnostic algorithms for iron deficiency anemia will be beneficial for all stakeholders. Patients will reduce losses in productivity and quality of life as

7 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 7 evident by decreasing time off from work for unwarranted testing and preparation for endoscopic procedures. Providers will improve diagnostic precision and enhance patient satisfaction in care provided.

8 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 8 References American Gastroenterological Association Institute. (2007a). American Gastroenterological Association Institute medical position statement on obscure gastrointestinal bleeding. Gastroenterology, 133, doi: /j.gastro American Gastroenterological Association Institute. (2007b). American Gastroenterological Association Institute technical review on obscure gastrointestinal bleeding. Goldfarb, N., Philips, A., Conn, M., Lewis, B., & Nash, D. (2002). Economic and health outcomes of capsule endoscopy: Opportunities for improved management of the diagnostic process for obscure gastrointestinal bleeding. Disease Management, 5(3), Pennazio, M., Eisen., & Goldfarb, N. (2005). ICCE consensus for obscure gastrointestinal bleeding. Endoscopy, 37, Rockey, D. (2005). Occult gastrointestinal bleeding. Gastroenterology Clinics of North America, 31, doi: /j.gtc Rockey, D. (2010). Occult and obscure gastrointestinal bleeding: causes and clinical managment. Natures Reviews: Gastroenterology and Hepatology, 7(5), doi: /nrgastro

9 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 9 Appendix A August 7, Kingston Road Benton, Louisiana GastroIntestinal Specialist, AMC 3217 Mabel Street Shreveport, Louisiana Attn: Linda Ray, Administrator Dear Mrs. Ray: As you know, I am currently pursuing my Doctor of Nursing Practice degree at Texas Woman's University and will be starting my professional capstone project in September. I am seeking approval to conduct a retrospective chart review in order to determine the efficacy of early capsule endoscopy in patients with iron deficiency anemia. The practice has performed thousands of capsule endoscopies since the development of this innovative diagnostic tool. Findings from this study will contribute to the delivery of high quality gastroenterology endoscopic services in an professional and cost effective manner. I have attached my concept paper that describes elements of the proposed research. If any other information is needed you can contact me by phone at (318) or at windechambers@att.net Sincerely, Winde R. Chambers, APRN, FNP-BC

10 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 10 Appendix B Research Project Overview Research Questions and Hypothesis Research Question: What is the efficacy of early implementation capsule endoscopy compared to conventional diagnostic evaluation for cost effective care management in patients diagnosed with iron deficiency anemia? PICO Question: In patients with iron deficiency anemia, is early implementation of capsule endoscopy more cost effective than conventional diagnostic evaluation? Null Hypothesis: There is no difference in cost of early implementation of capsule endoscopy compared to conventional diagnostic evaluation in patients diagnosed with iron deficiency anemia. Proposed Statistical Analysis of Project Simple frequencies will be obtained on demographics such as age, gender, ethnicity as well as capsule endoscopy findings and recommendations. Chi-square test for independence or the Fisher's Exact Probability Test will be used in order to explore the relationship between categorical variables. For example, the relationship between interventions based on capsule endoscopy findings and clinical outcomes will be examined. Cost-Analysis

11 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 11 Appendix C Sample IDA Exclude Patients with: Overt GI bleeding History gastric bypass Capsule endoscopy contraindicated Pre-menopausal women EGD/Colon (Negative findings) Exclude: EGD/Colon positive findings Intervention Group: Capsule endoscopy within 6 months Conventional Group: Second look iron trial

12 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 12 Appendix D SPSS Code Book FULL VARIABLE NAME SPSS VARIABLE NAME CODING INSTRUCTIONS Identification number ID Number assigned to each subject. Last four numbers of subjects medical record number. Group Group 1= Intervention group 2=Conventional group Age Age Age in years Gender Gender 1= Male 2= Female Ethnicity Ethnicity 1=White/Caucasian 2= Black/African American 3= Asian 4=Hispanic 5= American Indian 6= Not indicated Hemoglobin HgB Total in grams/dl Mean corpuscular volume MCV Total in femtoliters/cell Serum iron Iron Total in nanograms/ml Total iron binding capacity TIBC Total in ng/ml Ferritin Ferritin Total in ng/ml Fecal occult blood test FOBT 1= Negative 2= Positive 3= Not available Blood transfusion Blood 1= No 2= Yes Medications Medications 1= No risk medications 2= NSAIDS 3= Plavix 4= Coumadin Capsule endoscopy findings CE findings 1= Normal 2= AVM/Angiodysplasia 3=Tumor 4= Stricture 5= Ulcer 6= Erosion Complications Complication 1= No complications 2= Capsule failure 3= Retained capsule Recommendations Recs 1= Monitor laboratory data/cbc 2= Medication 3= Endoscopy 4= Surgery

13 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 13 Source identified on capsule endoscopy SourceID 1= Yes 2=No Anemia resolved after capsule endoscopy AnemiaResolved 1=Yes 2=No Capsule retained during capsule endoscopy CapsuleRetained 1=Yes 2=No 3= Not Performed/conventional group Clinical Outcome following capsule endoscopy Outcome 1=Positive 2=Negative ER visits ERVisits Number of ER visits for conventional group Established Outpatient Followup Visits 99211/99212/99213/99214/99215 Number of specific follow-up visits Complete blood count CBC Number of CBC's performed Iron Profile IronProfile Number of Iron Profiles Performed EGD Number of EGD's performed Colonoscopy Colon Number of colonoscopies performed Blood Transfusions PRBC Number of blood transfusions Iron Transfusion IronTrans Number of iron transfusions Capsule Endoscopy performed CapsuleEndo 1= Yes 2=No

14 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 14 Appendix E Data Collection Tools

15 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia Chambers 15

Running head: EARLY IMPLEMENTATION OF CAPSULE ENDOSCOPY 1. Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia:

Running head: EARLY IMPLEMENTATION OF CAPSULE ENDOSCOPY 1 Early Implementation of Capsule Endoscopy in Iron Deficiency Anemia: A Cost-Benefit Analysis Winde R. Chambers Texas Woman's University Author