NK4EO: Describe and demonstrate nursing research studies from the past 2
years, ongoing or completed, generated from the structure(s) and process(es) in
NK 4. Provide a table including:
Principal investigator name(s)
Principal investigator credential(s)
Role(s) of nurses in the study
Study scope (internal to a single organization, multiple organizations
within a system, independent organizations collaboratively)
Study type (replication – yes or no; qualitative, quantitative, or both)
The table with the information above follows.
Pis and investigators (direct care RNs and Managers)
The Director of PS/EH was on-site coordinator and
Select one (1) completed research study and respond to the four (4) criteria listed
in the EO guidelines provided in this chapter (page 34):
Describe the purpose and the background
Describe how the work was done (methods or approach)
Discuss who (CNO, staff RNs, CFO, APRNs, pharmacists, physicians, etc.)
was involved and what units participated.
Describe the measurement used to evaluate the outcomes and the impact
(show results and significance of the results).
The study titled, “Effectiveness of Colon Preparation for Optimal Visualization during Colonoscopy Exams: Ful Study” will be described.
The purpose of this quantitative, cause-effect study is to determine if there is a relationship between the type of colon prep used and the visualization outcome of the prep. Relationships between prep type and prep outcome, and gender and age will also be explored.
On December 11, 2008, the U.S. Food and Drug Administration (FDA) recal ed the Fleets Phospho-soda prep solution, an over-the-counter preparation, which had been widely used for bowel preps prior to colonoscopies (FDA, 2008). This solution was the preparation of choice of physicians for optimal bowel cleansing prior to colonoscopies. Consumers preferred this prep type because lesser amounts of solution had to be ingested, compared to other types of bowel preps.
The FDA had become aware of reports of acute phosphate nephropathy, which is an acute kidney injury associated with use of oral sodium phosphate products. Product names containing the sodium phosphate and included in the FDA recall were prescription products, Visicol and OsmoPrep, and over-the-counter preparations such as Fleet Phospho-soda (FDA, 2008). In some cases, patients who had no underlying, identifiable, risk factors for developing acute kidney injury experienced serious adverse events after taking the products for procedural preparation. Acute phosphate nephropathy occurs when calcium-phosphate crystals deposit in the renal tubules, resulting in permanent renal function impairment and the need for chronic kidney dialysis.
Over-the-counter preparations were removed from the market. The FDA further mandated manufacturers of prescription solutions with phosphate sodium develop and implement a risk evaluation and mitigation strategy (REMS), which included a medication guide explaining the risks versus benefits of using preps with phosphate sodium.
Currently, in the Special Procedures Lab (SPL) at Riverside Medical Center, multiple prep solutions and techniques are being used with varying bowel cleansing results (see table below for types of preps currently used in the Riverside SPL).
Prep Products Used in Riverside SPL
Dulcolax (Bisacodyl) SuppositoryDulcolax (Bisacodyl) TabletsFleet Prep Kit 3 - Fleets Phospho Soda 45 ml, Bisacodyl Delayed Release Tabs (5 mg) X 4; Bisacodyl enema 10 mg.)Fleets Phospho Soda - 1/2 doseGolytely HalflytelyMag CitrateMiralaxMoviprepTrilytelyOther - Wil be excluded from the study
When bowel cleansing results are not optimal, physicians may not be able to visualize anomalies of the large intestine. Further bowel cleansing may be needed and procedures might be delayed. Delays are inconvenient for patients, nurses, and physicians. Patients might need to repeat bowel cleansing procedures and reschedule their procedures, resulting in loss of work time, increased costs, and delayed diagnoses.
SPL nurses and physicians had noticed current preps do not result in optimal bowel cleansing for colonoscopies, compared to use of over-the-counter preps such as Fleets Phospho Soda EZ Prep. Patient compliance with the prescribed prep techniques also may be a factor contributing to sub-optimal colon cleansing. For example, patients preferred the Fleets Phospho-soda prep because the total oral intake of the prep solution was only 3 oz. in split doses.
To address this possible extraneous variable, SPL nurses added a section to their pre-procedure assessment form to confirm with patients if they had fol owed the prescribed prep regimen. Any patient record which indicated the patient did not fol ow the prescribed prep – in timing of the prep (such as time started and time completed), amount of water or fluid to be ingested with the prep solution, or any other deviation from prescribed prep – was excluded from the study. Additional variables, which may affect optimal visualization, and which may have changed the planned data collection technique for this study, were not identified in a pilot study. Therefore, the data col ection form for the study and the information from the patient record were assumed valid and reliable.
The study was a quantitative study using audits of patient records from colonoscopy procedures. A quantitative research method was the most applicable method and
design for the study because the purpose of the study was to explore the relationships and/or cause and effect among prep types, prep outcomes, and patient age and gender. The SPL group used information from Burns & Grove (2005) and our Rush University College of Nursing consultants to determine the method and design and the type of statistical analyses used for the study.
Preparation for Study
Prior to the study, SPL nurses had obtained letters of support from all 12 physicians who perform colonoscopies at Riverside Medical Center. All investigators had completed required education on HIPAA and Protection of Human Subjects for Research. Investigators submitted al required paperwork and forms to the hospital Institutional Review Board (IRB). The study was presumed by investigators to be an exempted study, and the form to apply for this type of IRB review was submitted to the IRB and approved. Other required documents included the full IRB application, a narrative document the IRB calls the protocol, and investigator agreements that were signed by each of the five study investigators.
All colonoscopy records from November 1, 2009, through February 28, 2010, were eligible for inclusion in the ful study. Exceptions were 20 records from November 1, 2009 to November 30, 2009, which were used for a pilot study. Only records of patients 18 years and older were included in the sample. Only records of patients who indicated compliance with the colon prep regime were included. Patient records showing a prep different from the 8 being studied were excluded from the full study.
Data was collected from patient records, which reflected colonoscopies that occurred at the Riverside Special Procedures Lab in the 4-month period between November 1, 2009 and February 28, 2010. Patients who underwent colonoscopies during the study period were male and female adults of varying ages. Patient co-morbidities such as diabetes and kidney failure were collected from the patient record for demographic purposes: to describe the study sample.
Data col ection included the following steps:
1. Prior to data col ection, the Director of Riverside Medical Center’s Health
Information Management department was sent an email notification of the start of the study and the names of the 5 study investigators. This step was necessary to address Riverside’s compliance with new, federal HIPAA and privacy laws, which prohibit any employee from accessing any patient records not needed to perform the employees’ regular job functions. Auditing patient records for the colon prep research study was considered a part of the study investigators’ job functions.
2. A report of colonoscopies for the study period, November 1, 2009 through
February 28, 2010 was accessed via the SPL electronic documentation system.
3. Patient records were screened for inclusion, according to the inclusion/exclusion
criteria for the full study, as described previously.
4. Records were sorted according to physician, and then by prep type.
a. If the prep type reported on the SPL documentation form differed from the
prep type usually
ordered by the physician, the prep, which was reported by the patient and reflected on the SPL documentation form, was used.
Fleet Prep Kit 3 - Fleets Phospho Soda 45 ml, Bisacodyl Delayed Release Tabs (5 mg)
X 4; Bisacodyl enema 10 mg.)Halflytely, Dulcolax (Bisacodyl) Tablets
b. If the prep type reported by the patient differed from the 8 prep types in
the study, those patient records were excluded from the ful study.
5. The goal was to select 160 prep records, 20 for each of 8 prep types.
a. These numbers were based on statistical calculations for effect size
performed by our statistician for the Rush University Col ege of Nursing. If one assumes an obtained effect size of .94, and a two-tailed alpha of .05, a sample of 20 patient records per prep type (160 total records) obtains a power of .82.
b. Random selection included choosing every other case for each of the 8
prep types until a total of 160 records were selected. The goal was 20 records for each of the eight prep types. However, one prep type, MD, was not used during the study period. We did not reach our goal of 20 charts per colon prep type for three additional prep types (MM, H, and F) because patient volumes were lower than anticipated during the 4-month study period. Therefore, we included more than 20 of four prep types (T,
TM, M, and G). Total sample size was 134. Sample sizes for each prep type were:
T: 27TM: 23M : 25G: 21MM: 16H: 7 (Physician using this prep type became semi-retired.)F: 15
c. Only records with complete information on the prep taken by the patient
6. Investigators accessed the selected patient records via McKesson HPF Web.
7. Investigators entered data from the selected records into the audit form (see
below: SPL Colonoscopy Prep Audit Tool), using the patient account number.
Data Collection Form - Colon Prep Study
Other patient conditions, co-morbidities,
8. The prep result rating was accessed from physician notes in the patient chart,
and was based on the fol owing criteria, which nurses confirmed with all physicians.
Prep Rating Scale
Able to complete colonoscopy, lots of formed stool left in colon, gross exam only
Able to complete colonoscopy, little formed stool left in colon, some irrigation needed intra-op
Able to complete colonoscopy, no formed stool left in colon
9. When al information was entered in the audit tool, one of the principal
investigators replaced the patient account with a code using the prep code and number (for example, T1 for Trilytely).
a. All investigators may have had access to the patient account number. b. Once the patient account number was replaced with the prep code, the
original form with the patient account number was placed in a file cabinet in a locked office until the study was completed.
c. The original form will be destroyed via shredding no more than 3 years
from the completion date of the study.
10. The collection form was then sent to Dr. Louis Fogg, Rush University statistician,
11.Dr. Fogg sent results via email file to Vicki Haag, co-principal investigator. 12.Dr. Fogg also provided assistance with data interpretation.
13.Results were shared with the rest of the SPL research team, nursing leaders,
direct care nurses (via announcements in meetings), physicians, and the IRB.
14.The SPL will display the project and results at Riverside’s 2010 EPBR Poster
Fair in November of 2010, and possibly at other conferences in 2010.
Departments and Persons Involved in the Study
The study took place in the SPL department. Investigators included the following:
Michele Hanson, Direct Care RN, SPLVicki Haag, RN, MSN, Magnet Coordinator
Jeanne James, RN, BSN (SPL Direct Care RN at start of study, now SPL
Julianne Post, RN (SPL Team Leader at start of study, now O.R. Manager)Sonyia Crawford, RN (SPL Direct Care RN at start of study, now OPS/PACU
Dave Duda, RN, MSN, Senior Vice President, COO, and CNO approved and signed the IRB proposal. Allen Kelly, RN, BSN, MSHA, Vice President of Perioperative and Procedural Services and Mary Kohl, RN, Director of Perioperative Services gave verbal approval for the study. Investigator time spent on the study was paid from the Magnet Office labor budget, which was allocated and approved for 2008 and 2009.
One member of the IRB reviewed the exempted proposal. The proposal was also shared at an IRB meeting, where Vicki Haag, IRB member and hospital representative answered questions.
Our PhD, RN consultant, who is a nursing department professor at Rush University College of Nursing, provided guidance on the study design. Our Rush statistician from
Rush University performed the statistical analyses and provided assistance with interpretation of results.
Measurement and Results
The data analyses addressed three questions concerning the effects of colon prep type, gender, and age on colon prep result. The sample was 134 chart audits of patients who had colonoscopies between November 1, 2010 and February 28, 2010. The sample was predominantly female (58%, 78 of 134) and the mean age was 60.93 years with a standard deviation of 14.57. The ages ranged from 18 to 90.
Type of colon preparation had no impact on clinical outcome. The results are shown in Table 1. The data were analyzed using a one-way analysis of variance. The F-ratio was 0.63 with (6,27) df, p=.70.
Table 1: Effect of Colon Prep
The second set of analyses examined the effects of gender on clinical outcome. Males tended to have a slightly better outcome than females, but the difference was not significant. The means are displayed in Table 2. The t-statistic associated with this analysis was 1.02 with 132 df, p=.31.
Table 2: Group Statistics
Finally, we examined the effects of age on prep outcome. Age was found to predict clinical outcome, with older participants experiencing worse outcome (r
This suggests that clinical outcomes may decrease over the life span, and that older patients may be at greater risk for poorer visualization when undergoing colonoscopy.
The overall sample size and length of the study could have affected the results. In addition, the sample size for each prep type was not achieved. One prep type was not used at al by any physician during the study period.
Significance of Results
The benefits of the study will benefit patients undergoing colonoscopies, nurses caring for these patients, and physicians.
Benefits to Patients
Results from the proposed full study on the effectiveness of colon preps did not provide evidence of an optimal bowel preparation product. The results did suggest that age has an effect on the prep outcome: older patients may be less likely to benefit from having a colonoscopy due to poorer visualization.
Benefits to Nurses
Results of the full study has provide nurses with new information that is being used to improve pre-procedure instructions and perioperative assessments of patients undergoing colonoscopies. The results of the proposed ful study resulted in a redesign of the Preoperative Assessment form used in the SPL. Nurses in physician offices may use the results to better counsel patients on prep procedures.
Benefits to Physicians
Physicians have benefited from the study because they have preliminary data on the success of various bowel prep types. Physicians may use the results to change colonoscopy prep orders for procedures. They may experience better visualization during colonoscopy procedures.
The relationships between age, gender, colon prep type, and prep outcome may require further study. One idea for future research is to study only the elderly population. The group would also increase the sample size and lengthen the study period. The research team assumed physician techniques would have no impact on visualization. Other factors, such as the amount of fluid ingested before the exam, could affect prep outcomes. A qualitative study to assess patient’s perceptions regarding preps could reveal other factors. Studies on physicians’ prep type preferences, patients’ prep preferences, and patients’ rating of the prep experience could provide nurses with
information to improve the experience for the patient. These studies could also prompt nurses to change care protocols during the assessment and/or during the procedure and post-procedure recovery period.
The colon prep study was one of the first forays into research by Riverside direct care nurses. The experience has stimulated ideas for future research by the SPL nurses. The Director of the Office for Research Affairs and the IRB Coordinator claimed the SPL proposal was one of the best they had seen. It was complete, detailed, and written at the desired level for IRB members. Throughout the study, physicians who perform colonoscopies in the SPL anticipated the results. This project supported nurse-physician col egiality and collaboration on patient care in the SPL.
Burns, N., & Grove, S. K. (2005). The practice of nursing research: Conduct, critique, and utilization
(5th ed.). St. Louis, MO: Elsevier Saunders.
U.S. Food and Drug Administration. (2008). Oral Sodium Phosphate (OSP) Products for
Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription).
Retrieved November 4, 2009, from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094900.htm
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Microscopic colitisChris J. J. Mulder1, Ivar M. Harkema2, Jos W. R. Meijer31 Department of Gastroenterology, Vrije Universiteit Medisch Centrum / Free University Medical Centre, Amsterdam, the Netherlands2 Department of Gastroenterology, Ziekenhuis Rijnstate / Rijnstate Hospital, Arnhem, the Netherlands3 Department of Pathology, Ziekenhuis Rijnstate / Rijnstate Hospital, Arnhem, the Netherlands