Project Title: Assessment and Reduction of Catheters in Hemodialysis, ESRD Network 9, The Renal Network, Inc., Michael Brier, Ph.D. and Jeannette A. Cain, B.S.R.N., M.S.M.
Background: At year-end 2000, ESRD Network 9 reported 15,900 hemodialysis patients on dialysis for greater than 90 days (28% IN, 16% KY, 56% OH). December 2000 vascular access data showed 28% were catheter, 26% fistula, and 47% graft. Reported reasons for catheter use were 32% No fistula/graft created a surrogate for no permanent access created. An estimated 9% of the adult hemodialysis patients, greater than 90 days ESRD had a catheter and no permanent access created. Data trended from 1997 through 2000 showed catheter use with no permanent access created increasing.
Primary Objectives: This quality improvement project addressed the topic of hemodialysis vascular access catheters (inappropriate catheters), as prescribed by the Centers for Medicare and Medicaid Services (CMS). The objectives of the project were to increase the referral of catheter patients to a surgeon for placement of fistula/graft, assessment of patients with catheters, and the employment of appropriate clinical processes to ensure appropriate and timely referral for an access (graft or fistula). The objectives included decreasing patients with catheters as the primary vascular access for 90 days or greater. The projects long-range objective was to lower the number of catheters in the selected facilities and the percentage of patients with catheters in this sample towards the KDOQI? guideline of 10% (per facility).
Methods: A rank order (high to low) was calculated of 192 facility December 2000 catheter rates to select the intervention group. Pediatric units, facilities with fewer than 30 in-center HD patients, and facilities with fewer than 5 catheter patients were excluded, n=46. The top-half of facilities was divided into three categories, average, middle-high and high. A power analysis was conducted to determine catheter sample size needed to see a 10% effect in process indicator 1: Increase referral to surgeon for placement of fistula/graft, where the numerator was the actual referral of catheter patients to surgeon in denominator of all patients with a catheter dialyzing in the unit was conducted using Power and Precision 2 for paired proportions. Fourteen facilities were selected based on category (7 average, 2 middle-high, 5 high), number of catheter patients, and the Cleveland-Youngstown and Indianapolis location. Network staff abstracted January- March 2002 baseline data and facility staff abstracted April-December data and entered into an ExcelTM spreadsheet. Intervention facilities participated in an Institute for Healthcare Improvement collaborative model that included a change kit with educational material for professionals and patients, as well as vascular access management tools (VAMT). Univariate analysis of variance was performed on the slope and intercept of the proportions in the following way. Proportions were divided into 3 test periods of 3 months each. Period 1 was Jan, Feb, Mar and is the control period. Period 2 was Apr, May, Jun and was the initial treatment effect. Period 3 was Oct, Nov, Dec and was the final treatment effect. A student-newman-keuls post-test was performed to distinguish the treatment periods from control. The process quality indicators were calculated for each month and these data were imported into SPSS version 11 for analysis.
Main Findings: Process indicator- referral rate to surgeons showed an increase from a mean of 0.08 in the control period to a mean of 0.53 at the end of the study (p=0.05). The intervention facilities met the primary improvement goal by increasing by 10% the proportion of patients referred to surgeon for placement of fistula/graft from baseline.
The process indicator of scheduling rate showed no difference between treatment periods 1-3 with means of 0.59, 0.48, and 0.41. However, there is a trend for a decrease in the rate (p=0.08). The process indicator VAMT use showed no significant difference in the early and late use of this tool.
Outcome indicator of inappropriate use of catheter showed that the proportion of inappropriate catheter use decreased from a mean of 0.53 in the control period to a mean of 0.03 at the end of study (p=0.05). Outcome indicator of 90-day catheter use showed no effect of the treatment with a mean in the three periods of 0.25, 0.21, and 0.23. Outcome indicator of catheter use in hemodialysis patients showed no effect of the treatment on catheter rate for those catheters with a mean in the three periods of 0.32, 0.31, and 0.31. These indicators showed a decreasing trend.
Principle Conclusion: Facilities can impact referral rates and as a result decrease inappropriate catheter use. The collaborative model intervention strategy fostered facility ownership of improving vascular access care and change.
ESRD NETWORK 9 FINAL PROJECT REPORT
Assessment and Reduction of Catheters in Hemodialysis, ESRD Network 9, The Renal Network, Inc., Michael Brier, Ph.D. and Jeannette A. Cain, B.S.R.N., M.S.M.
Network 9 Introduction and Objectives
Network 9 includes the states of Indiana, Kentucky and Ohio. At the end of 2000 there were approximately 15,900 hemodialysis patients on dialysis greater than 90 days, 28% Indiana, 16% Kentucky, and 56% Ohio. December 2000 vascular access data showed 28% were catheter, 26% fistula, and 47% graft. In addition to type of hemodialysis vascular access, reasons for catheter use were collected. Figure 1 shows the percentage of catheter use by state from December 1997-2000. Figure 2 shows the reasons for catheter use in Illinois, Indiana, Kentucky, and Ohio from December 1997-2000.Catheter use rate has increased in all states. No fistula/graft created reason for catheter use has increased. (This was surrogate data for no permanent access created.) An adult hemodialysis patient estimate, greater than 90 days ESRD with a catheter and no permanent access created, was 1425 or 9% of HD patients.
The Network had a four-year quality activity targeting vascular access that included catheter reduction. Interventions included annual data collections, facility and regional comparison and trend data feedback reports, correspondence, vascular access literature, and Network-sponsored educational symposia. With annual attention to vascular access, catheter rate increased 10%, fistula rate increased 8% and graft rate decreased 9% (Silver, 2000). The Network vascular access surveillance process showed that while catheter use rate increased in adult HD patients on dialysis greater than 90 days, there was an increase in catheter patients with a fistula/graft maturing and fewer prevalent patients categorized as having no sites left for the creation of a fistula or graft.
This quality improvement project addressed the topic of hemodialysis vascular access catheters (inappropriate catheters), as prescribed by the Centers for Medicare and Medicaid Services (CMS). The objectives of the project were to increase the referral of catheter patients to surgeon for placement of fistula/graft, assessment of patients with catheters, the employment of appropriate clinical processes to ensure appropriate and timely referral for an access (graft or fistula). The objectives included decreasing patients with catheters as the primary vascular access for 90 days or greater. The projects long-range objective was to lower the number of catheters in the selected facilities and the percentage of patients with catheters in this sample towards the KDOQI? guideline of 10% (per facility).
Network 9 Methods
A rank ordering (high to low) of 192 facility December 2000 catheter rates was conducted. See Figure 3. Pediatric units, facilities with fewer than 30 in-center HD patients, and facilities with fewer than 5 catheter patients were excluded, n=46. The top-half of facilities was divided into three categories, average, middle-high and high. A power analysis was conducted to determine the size of the catheter sample needed to see a 10% effect in process indicator 1: Increase referral to surgeon for placement of fistula/graft, where the numerator was actual referral of catheter patients to surgeon in denominator of all patients with a catheter dialyzing in the unit was conducted using Power and Precision 2 for paired proportions. From Figure 2 an estimate of the proportions of the population that might contribute to the numerator was calculated. A total of fourteen facilities were selected based on category (7 average, 2 middle-high, 5 high), number of catheter patients, and the Cleveland-Youngstown and Indianapolis location.
January, February and March 2002 baseline facility catheter patient data was abstracted from charts onsite by Network quality improvement staff registered nurses with dialysis experience. This data was entered into the data collection tool. See Appendix A.
For the purposes of this project, all patients were assessed and categorized as to type of vascular access in the baseline data collection, Table 1. Patients dialyzing via catheter were further categorized into patients with catheter < 90 days or catheter 90 days. All patients with a catheter were further assessed by facility personnel using a Vascular Access Management Tool (VAMT) the sample algorithms to determine the reason why the catheter use continues (Appendix B).
Network 9 Interventions
The projects interventions conducted followed the Institute for Healthcare Improvement's (IHI) Collaborative Model (Figure 4). An expert vascular access faculty was assembled that included, 3 nephrologists (2 medical directors and 1 interventional nephrologist), 1 vascular access surgeon, 2 corporate quality specialists with administration experience, and 1 vascular access advanced practice nurse. Facility interventions included identification of a vascular access team, monthly catheter patient tracking, 3 learning sessions, educational and resource and materials, facility developed action plans, monthly telephone conference calls reporting updates on the action plans, reasons for catheters and facilitys next action plans. Contents of the resource kit/ tool kit are in Appendix C. The interventions began April 1, 2002 and concluded February 2003 with facility data collection beginning April 2002 and ending December 2002. Interventions, facility and physician participation rates are shown in Table 2.
The intervention package combined organizational, social influence, behaviorist, and educational approaches. The learning sessions and conference calls used respected peers and/or opinion leaders to promote participation and change strategies. The educational approaches included patient and professional materials, workshops, and discussions of the individual facilitys needs and experiences. The intervention contained multiple approaches that brought together expertise, data, feedback, education, and individual facility responsibility for improving care.
The intervention model focused facilities to address their particular root causes and implement projects of their own design. Ownership of the process was a key agent in changing the process. The root causes that the Network addressed in the interventions were (1) lack of awareness catheter problems and solutions, (2) lack of professional and patient education materials and resources, and (3) lack of facility accountability to implement change. The collaborative model combined both the Network and facility interventions.
The project used the proportion of catheter patients (1) referred to surgeon for placement of fistula/graft, (2) referred to surgeon and scheduled for placement of fistula/graft, (3) with vascular access management tool documented and referral to surgeon for placement of fistula/graft, (4) patients with no documentation of a vascular assess plan or reason for catheter use after 90 days post catheter insertion. Additional indicators included (5) proportion of HD patients with catheters in use 90 days, and (6) proportion of HD patients with catheters. The quality indicators for this project consisted of 3 process and 3 outcome indicators. They are listed below with the rationale and the indicators numerators and denominators.
This projects primary improvement goal was process measure indicator 1 to increase by 10% the proportion of patients referred to surgeon for placement of fistula/graft from baseline. Additional goals included increases in (1) proportion of catheter patients referred to surgeon and scheduled for placement of fistula/graft and (2) proportion of catheter patients with documentation of a vascular access management tool and surgical placement of fistula/ graft. Outcome measure indicator goals were a decrease in the (1) proportion of catheter patient with no documentation of a vascular access plan and no reason for catheter, (2) proportion of HD patients with chronic catheters 90 days, and (3) the proportion of HD patients with catheters in use.
Network 9 facilities routinely collect and send electronically patient demographic, ESRD event information, and Clinical Performance Measures (CPM). For this project, the patient tracking information and the CPM data was used for case ascertainment and facility/Network catheter rates. This is an on going, network-wide data collection tools/systems. In addition, a catheter vascular access data collection/assessment tool was used. Catheter patient data was entered into an Excel? worksheet at the facility and sent to the Network office for management and analyzes. A Catheter Reduction Data Collection Tool was developed by a CMS-ESRD Network national workgroup.
A copy of the facility and patient data elements to be collected are in Appendix D.
Network staff conducted the pre-project measurements for the three months prior to the intervention start date. These measurements established the baseline rates. Facility staff collected monthly data on catheter patients during the intervention. The post intervention rate will be the last three months of the intervention. Based on the data from the data collection tool and the patient tracking system, process and outcome indicators were measured.
Data Quality Assessment
Catheters are viewed as negative outcomes; because there may have been a bias to under-report an assessment between two databases was done. The two databases for catheter reporting are the Network CPM and the projects data collection tool. Based on a previous network data validation project, 90% of the hemodialysis patients had a reported adequacy measurement (vascular access is reported with adequacy measurement). For this assessment, more catheters should be reported on the projects data collection tool and exceed the number of catheters reported in CPM database. As expected, a higher number of catheter patients were reported on the catheter data collection tool (Table 3). In addition, facilities completed the brief survey to address initial data collection; those with existing protocols or processes provided a copy to the network office for review.
Data was received as a data download from The Renal Network with patient specific identifiers removed as an Access Database for each of the facilities in the study separated by month. These data were imported into SPSS version 11 for analysis. Using the catheter insertion date and the first day of the month, the number of days that the catheter has been in place was calculated. Those catheters in place for more than 90 days were identified.
Univariate analysis of variance was performed on the slope and intercept of the proportions in the following way. Proportions were divided into 3 test periods of 3 months each. Period 1 was Jan, Feb, Mar and is the control period. Period 2 was Apr, May, Jun and was the initial treatment effect. Period 3 was Oct, Nov, Dec and was the final treatment effect. A student-newman-keuls post-test was performed to distinguish the treatment periods from control. The process quality indicators were calculated for each month of 2002.
Fourteen facilities were targeted for the intervention. The measured indicator averages are shown below in Tables 4 - 9.
Process Indicator Q1: Process Quality Indicator Q1: Referral to surgeon for placement of fistula/graft was calculated for all catheter patients that were referred to a surgeon from the patients that were referred, refused, had other, and had no reason for the catheter. Statistical analysis of the referral rate to surgeons shows an increase from a mean of 0.08 in the control period to a mean of 0.53 at the end of the study (p=0.05). The results are shown in Table 4.
Process Indicator Q2: Surgical placement of fistula/graft was calculated as the proportion of patients referred to a surgeon that have access surgery scheduled. Statistical analysis of the scheduling rate shows no difference between treatment periods 1-3 with means of 0.59, 0.48, and 0.41. However, there is a trend for a decrease in the rate (p=0.08). The results are shown in Table 5.
Process Indicator Q3: Documentation of vascular access management tool use and referral to surgeon. The proportion of patients that were assessed with the VAMT and referred to a surgeon was calculated. Statistical analysis of the use of the VAMT shows no significant difference in the early and late use of this tool. The results are shown in Table 6.
Outcome Indicator Q1: Inappropriate use of catheter was calculated as all catheters in use for greater than 90 days with no vascular access management plan and no documented reason for the catheter. Statistical analysis shows that the proportion of inappropriate catheter use decreased from a mean of 0.53 in the control period to a mean of 0.03 at the end of study (p=0.05). These results are shown in Table 7.
Outcome Indicator Q2: Use of catheters as chronic dialysis access was calculated as the proportion of catheter patients with catheters in for greater than 90 days. Statistical analysis of catheter use in chronic dialysis shows no effect of the treatment on catheter rate for those catheters greater than 90 days with a mean in the three periods of 0.25, 0.21, and 0.23, respectively although there is a trend for a decrease. These results are shown in Table 8.
Outcome Indicator Q3: Catheter use in hemodialysis was calculated as the proportion of hemodialysis patients in each facility that used catheters. Statistical analysis of catheter use in chronic dialysis shows no effect of the treatment on catheter rate for those catheters with a mean in the three periods of 0.32, 0.31, and 0.31, respectively although there is a trend for a decrease. These results are shown in Table 9.
Network 9 Summary of Results
This catheter reduction quality improvement project targeted facilities that had poor catheter rates and had room for improvement. Three process indicators were identified in the project. The first indicator was referral to surgeon for placement of fistula/graft. These data are shown in Table 4 and show a significant increase in rate from the control period to the end of the study. Process indicator two was surgical placement of fistula/graft and these data are shown in Table 5. This indicator showed no significant change in rate from the control period to the end of study, but there was a trend for this indicator to decrease during the year, which would be a negative result. The third process indicator was documentation of vascular access management tool use and referral to surgeon and these data are shown in Table 6. Since this was an intervention used in the study there were no data for this rate in the control period and the rate did not change between the initial study periods and the end of the study.
Three outcome indicators were identified in the project. The first outcome indicator was inappropriate use of catheter and these data are shown in
Table 7. Documentation of inappropriate catheter use decreased significantly and in a positive direction from the control period at a mean of 0.53 to a mean of 0.03 at the end of the study. The second outcome indicator was use of catheter as chronic dialysis access greater than 90 days and these data are shown in Table 8. Catheter use during the study did not significantly change from the control period of 0.25 but did decrease slightly to 0.21 and 0.23 during the study. The third outcome indicator was use of catheter in hemodialysis and these data are shown in Table 9. Catheter use during the study did not significantly change from the control values of 0.32 and there was no trend in the data to either increase or decrease this rate.
The outcome of inappropriate catheter use shows a dramatic and statistically significant improvement during the study. This is likely due to the attention placed on the reasons for catheter by the QIP in each of the facilities. The catheter rate for catheters in for greater than 90 days shows signs of improvement but were not statistically different. This effect might be explained by facilities attempting to get patients off of catheters that had maturing grafts and fistulas at the time the study began.
There was no improvement in the overall catheter rate in the facilities studied in this network.
Of the process indicators, referral to surgeon showed dramatic changes following initiation of the study increasing from about 8% to 53%. These results may be due to a combination of poor documentation of the process in the facility and a true increase in referrals. The proportion of catheter patients that have surgery scheduled fell steadily during the study. Finally, the vascular access management tool was not widely accepted by the study facilities.
The projects primary improvement goal was defined as 10% increase over baseline in the referral catheter patients to surgeon for placement of fistula/graft. The intervention group rate increased from the baseline in January-March 2002 of 8% to 53% in October - December 2002. The project goal was achieved.
Network 9 Discussion of the Results
The projects primary improvement goal was process measure indicator 1 to increase by 10% the proportion of patients referred to surgeon for placement of fistula or graft from baseline. This measure increased from a control period low of about 0.08 to an end of study rate of 0.53. Therefore, the improvement project met its stated goal. However, the subsequent placement of fistula and grafts fell over time and appears to contradict the positive results of the first process indicator. This decline may be due to shrinkage of the available pool of patients from which catheters are being replaced. If the pool of patients with catheters is composed of those patients that could have a fistula or graft placed and those that cannot not, as those patients that can have permanent access placed are removed from the pool and are not replaced by similar patients, this rate would have to decrease and this change could have been expected. Documentation of vascular access and its processes was a very important part of this project. Only half of the facilities documented use of a VAMT but all facilities documented the reason of the catheter access after the project started. Documentation of catheter reason provided a root cause analysis for facilities to develop improvement plans. The data supports facilities used catheter information to refer patients to surgeon. On the conference calls and at the learning sessions, facility accountability for vascular access was challenged. Early project adopting facilities reported to their peers that changes in the facility could be implemented. Access documentation was the key.
Ultimately, one would like to see a decrease in the number of catheters being used for chronic hemodialysis in this patient population. This was a secondary, but important goal of this project. However, the project failed to demonstrate a decrease in this rate but there was a slight trend for a decrease in the catheter rate for those patients with catheters in for greater than 90 days. We can speculate that the decrease in this rate might be study related in that facilities may have made a greater effort to get patients switched to permanent access sooner.
The report of inappropriate catheter use fell dramatically during the study from approximately 0.53 to 0.03. Facilities were asked to identify which catheter patients did not have a valid reason for having and using a catheter for hemodialysis. The results of this portion of the project are probably the most important. The K/DOQI guideline of having a 10% catheter rate in facilities may be unobtainable. If a facility reports that they have a legitimate reason for its patients to be using catheters and these reasons are truly valid, you will not be able to effect a change in the catheter rate.
All facilities had physicians named on the team roster. However, physician involvement on the conference calls and learning sessions was low. The project did not directly measure on-site physician involvement but the documentation data seems to indicate there was a lack of physician involvement in the project.
The project emphasized referral to surgeon. The facility teams reported that the referral to surgeon process was addressed. Facilities documented catheter patients for: surgeon appointments, surgery scheduled, and missed appointments. The data supports referral rates can be impacted by facilities.
Patient education was an important part of the results. The referral data suggests catheter patients made decisions to have surgical appointments made.
The quality improvement project used a vascular access management tool kit, conference calls, and learning sessions to increase the number of patients referred to a surgeon for placement of permanent access and ultimately decrease the catheter rate. In general, only about 75% of facilities in the intervention utilized the vascular access management tool and even in the facilities that used the tool, they did not consistently use it resulting in a decrease in the percent utilization over time. Despite the low number of facilities using this tool, the primary goal of the project was accomplished. What we found to be important, in retrospect, was the interaction of the network staff and the facilities through conference calls and learning sessions. We felt that the facilities targeted in this improvement project had poor processes in place which did not accurately track the progress of patients in obtaining permanent access and when we examined this with them they decreased the number of unexplained catheters from about 50% to less than 5% and increased the number of documented referrals to surgeon from about 10% to about 50%. Finally, the time frame over which the project was performed and the time it would take to see a positive result may be different and we might not fully see the results of our effort for several more months.
Lessons for the Future
The collaborative model made communication, resource sharing, attention to tasks and goals well organized. The communication between facilities in this project was addressed at a high level; it was fundamental to this project. Monthly opportunity to share and discuss individual facility processes was done in a quality forum. Successful strategies were shared and allowed facilities to move faster and farther. The expert panel faculty provided resources to assist facilities in implementing changes in facility process.
The learning sessions were platforms that made facilities accountable for their progress. Each facility in the collaborative made formal and informal presentations to the group. Poster presentations were an important part of the learning sessions. These posters fostered intervention documentation. Facility presentations showed creativity and their ownership. Several presentations will be shared by the collaborating facilities in a larger regional forum at the Networks annual conference.
Data collection and feed back reports were integrated into an Excel spreadsheet. Not all facilities were able to use this tool easily. There was difficulty in printing it on a standard sheet of paper. Facility abstractors did not have internal data checks, i.e. date fields and text fields. Some of the data had to be reentered. The data entry system in the future should have internal checks to avoid data entry problems.
Monthly data collection for 9 months and limiting the project time line to one year was important. Facilities committed to the project knowing that it had limited time to accomplish the goal. This created a sense of urgency and monthly results provided timely data. The 9-month time frame limited the results. In previous studies facilities accomplished a catheter use reduction to the 10% level in two years, significantly longer than the 9 months in this study.
The definition of chronic catheter of greater than 90 days conflicted with fistula maturation period which averaged 6 months. Fistulas are the vascular accesses of choice and facilities with high fistula rates have corresponding catheter rates because of the maturation period. Future indicators need to consider an adjustment if a catheter patient has a fistula maturing.
Rapid PDSA cycles were documented in 12 facilities. This is a standard continuous quality improvement method to tract process changes and the results of changes. This process was not familiar to many of the participants and required additional instructions. In the future, this part of the project will need more time and emphasis.
Facility team evaluations were done at each learning session and covered the many aspects of the collaborative model. The facility participants gave average to excellent responses. The common theme reported was: facilities can influence catheter rates by putting catheters on the quality agenda, documenting vascular access information, targeting catheter patients for referrals and follow-up.
In conclusion, this project and the interventions recognized the barriers of reducing catheters. The Network implemented a collaborative model that fostered facility ownership and change. Overall, this project met its goal and was a success.