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Facilitating the achievement of optimal wellness for renal disease patients
EXECUTIVE SUMMARY
Project Title: Improving the Adequacy of Hemodialysis in In-Center Hemodialysis Facilities in Indiana, Kentucky and Ohio, ESRD Network 9, The Renal Network, Inc., Michael Brier, Ph.D., Carlton A. Hornung, Ph.D., M.P.H., Ashwini Sehgal, M.D., and Jeannette A. Cain, B.S.R.N., M.S.M.
Background: At year-end 1999, ESRD Network 9 contained 8% of the national in-center hemodialysis (HD) population; the Network area includes the states of Indiana, Kentucky and Ohio. Network 9 Clinical Performance Measures (CPM) from the 4th quarter of 1999 showed 80% of the in-center HD patients had an average urea reduction rate (URR) 65%. Data trended from 1996 through 1999 showed the rate of improvement in URR-K/DOQI had been declining.
Primary objectives: This quality improvement project addressed the topic of improving hemodialysis adequacy, as prescribed by the Centers for Medicare and Medicaid Services (CMS). The primary objective was that 85% or more of adult, in-center HD patients in Network 9 would meet or exceed the URR target of 65%. A secondary objective was to measure and improve components of adequacy (blood flow rates, treatment time, use of dialyzer with Kuf 20, and decrease the use of catheters as vascular access). The third objective was to evaluate the facility interventions and the effect on URR.
Methods: A rank order was calculated of Network 9 facilities for the 4th quarter 1999 to select the intervention group. This ordering was accomplished by using the percentage of patients with URR 65% to select the intervention group. The 46 facilities in the lowest quartile were designated as the intervention group. The remaining 188 facilities in the sample were assigned to the non-intervention group. Both groups were provided with data feedback reports based on CPM data from April, July and the 4th quarter of 1999. In addition, intervention facilities attended educational meetings, received a Quality Improvement Kit of educational materials, were required to develop individualized intervention action plans for improving adequacy, received specific facility Needs Assessment Report, and received individualized communications through Medical Review Board letters and telephone conference calls during the course of the QIP. The rate of progress was measured for the percentage of patients with a URR 65% in both groups during the year 2001. As a follow-up, URR measurements were compared for the 4th quarter 1999, 2000 and 2001.
Main findings: In the 4th quarter of 2001, the overall Network 9 rate of URR 65 was 85% ( 6.9%). The Network goal of 85% of facilities with a URR 65 was achieved with a mean URR 65% of 85.2 ( 6.7%) in the non-intervention facilities but fell slightly short in the intervention facilities with a mean URR 65% of 84% (7.93).
The intervention facilities met project goals for improving treatment time and use of dialyzers with Kuf 20.
A secondary analysis of the data using analysis of variance with repeated measures found a significant effect of years (p<0.001), intervention (p<0.001) and the interaction years* intervention (p<0.001). The rate of increase in URR was greater in the intervention group.
An analysis was performed of the interventions used at the facility level to increase the rate of URR. These interventions included policy and procedure, prescription, personnel, patient, physical equipment, and vascular access. Once again there was a significant effect of year on the reported URR (p<0.001). There were no significant between-subject effects. There was a significant interaction between year and those facilities that targeted vascular access (p=0.041) but not in the desired direction.
Principle conclusion: The selection of the lowest performing facilities for this project was an efficient method to improve the overall Network adequacy rate. Facility reported action plans did not show benefit. Facility interventions that targeted vascular access were not beneficial to improving adequacy rates. Directed conference calls to facilities not meeting intermediate goals were beneficial. Adequacy rates were improved by targeting low performing facilities.
ESRD NETWORK 9 FINAL PROJECT REPORT
Project Title: Improving the Adequacy of Hemodialysis in In-Center Hemodialysis Facilities in Indiana, Kentucky and Ohio, ESRD Network 9, The Renal Network, Inc., Michael Brier, Ph.D., Carlton A. Hornung, Ph.D., M.P.H., Ashwini Sehgal, M.D., and Jeannette A. Cain, B.S.R.N., M.S.M.
Network 9 Introduction and Objectives.
At year-end 1999, ESRD Network 9 contained 8% of the national in-center hemodialysis (HD) population; the Network area includes the states of Indiana, Kentucky and Ohio. Network 9 Clinical Performance Measures (CPM) from the fourth quarter of 1999 showed 80% of the in-center HD patients had an average urea reduction rate (URR) 65%. Data trended from 1996 through 1999 showed the rate of improvement in URR had been declining.
Past quality improvement projects for Network 9 had targeted improvement in HDadequacy K/DOQI and decreasing the use of central catheters for vascular access. These projects were directed at all facilities in the Network. Interventions included educational workshops, adequacy literature, project correspondence and annual feedback reports. Despite these efforts, Network outcomes showed a slowing in improvement. With the URR QIP, the Network aimed for improvement by targeting low performing facilities and setting specific performance goals. The improvements would be achieved through Network-mandated improvement plans to be developed by the facilities themselves.
This quality improvement project addressed the topic of improving HD adequacy, as prescribed by the Centers for Medicare and Medicaid Services (CMS). The primary objective was that 85% or more of adult, in-center HD patients in Network 9 would meet or exceed the URR target of 65%. The second objective was to measure and improve components of adequacy (blood flow rates, treatment time, use of dialyzer with Kuf 20, and decrease the use of catheters as vascular access). The third objective was to evaluate the facility interventions and their effect on URR. The fourth objective was to decrease dialysis related morbidity and mortality for in-center HD patients and to assist ESRD provider to modify practice patterns or processes of care in order to improve patient outcomes.
Network 9 Methods.
A rank ordering was conducted of Network 9 facilities for the 4th quarter 1999 by the percentage patients with URR 65%, (see Exhibit 1). The facilities in the lowest quartile were designated as the intervention group. The remaining facilities in this sample were assigned to the non-intervention group.
The rate of progress was measured for the percentage of patients with a URR 65% in both the intervention and the non-intervention groups. There were differences in the historical rates of progress in the targeted and non-targeted facilities (Exhibit 2). Comparisons to the historical rates of progress were conducted in order to determine if the rate of increase in the targeted group was greater than in the non-targeted group. These comparisons were conducted through repeated measures design using 4th quarter 1999, 2000 and 2001 data.
A secondary analysis to determine the effect of the intervention was conducted. The data used in the analysis were the URR collected the 4th quarter of 1999, 2000 and 2001. The URR used was the average URR for each patient in the 4th quarter; the measurement consisted of one to three data points. In-center HD patients were divided into two groups based on the percentage of patients in their facility that have achieved a URR 65%.
Additional factors investigated in an intent-to-treat analysis were the facility-specific quality improvement project interventions. These factors were prescription, policy and procedure, vascular access, patient related, personnel related, physical equipment, and other (Exhibit 3).
A summary of information was calculated for all combinations of factors.
Using analysis of variance with repeated measures, the change in URR between 1999 and 2001 was compared between the intervention and non-intervention groups. A sub-analysis in the intervention group looked at the effect of the facility-level interventions to identify those that were most effective in increasing URR.
The observed increase in the intervention group was tested to see if the increase was greater than expected based on historical increases in this group, and in comparison to the observed increase in the non-intervention group.
Interventions.
The interventions conducted by the Network for this project included educational meetings and materials, facility developed action plans for improving adequacy, data feedback reports, and communication in the form of Medical Review Board letters and telephone conference calls. Each facility was required to develop and implement a plan to improve adequacy outcomes to achieve the project goals (see Table 1).
The project began with notification letters to the facilities in the intervention group. The letters outlined the scope of the project, including goals and activities. Attendance was required at two educational workshops. The first workshop focused on the DOQI Clinical Practice Guidelines for Hemodialysis and Barriers to Inadequate Delivery of Hemodialysis Study. Participation on a conference call was encouraged but not required. The conference call was entitled RPA & The Forum of ESRD Networks: The Nephrologist as Leader and Team Member for Quality Improvement. A "tool kit" containing resources for patients and care providers was also given to the intervention facilities.
By July 2001,an additional intervention was triggered by a facility if the facility URR rate 75%. Facilities with URR rates 5% below the project goal were singled out for more intensive, individualized attention. Conference calls were conducted between intervention facility staff, Network Quality Improvement Director and Medical Review Board chairman to discuss facility plans for improvement. The conference calls covered the project purpose, facility outcome data, facility process of adequacy care, how to achieve desired outcomes, assistance and revision of facility action plan and timeline.
Finally, the intervention facilities submitted CPM data and received feedback reports for the 4th quarter, April and July. A specific facility Needs Assessment Report was distributed which compared facility rates to the top 20 performing facilities
(Appendix C 6,7,8).
Non-intervention facilities submitted 4th quarter, April and July CPM data and received feedback reports. These were the same reports that the intervention facilities received and are standard reports in Network 9. These facilities did not receive the Needs Assessment Report.
Indicators.
The project used the proportion of the average URR, average treatment time in minutes, blood flow rate (BFRK/DOQI) @ 1 hour, dialyzer type, and catheter vascular access type. The time frames were 4th quarter 1999, October, November and December 1999, CPM data (as in the national CPM project) as a baseline.2 Data from the 4th quarter 2000 were used as the project beginning data. Facility interim progress data used April and July 2001 data. Final data was the 4th quarter 2001, October, November and December 2001.
The quality indicators for the project consisted of one outcome and four process indicators. They are listed below with the rationale and the indicators numerators and denominators.
Improvement Definitions.
The primary goal of this QIP was defined as an increase in the Network 9 URR from the 4th quarter 1999 baseline rate of 80% to 85% in the 4th quarter of 2001 for percentage of HD patients with an average URR 65%. Additional goals for the intervention facilities included increases in (1) the proportion of patients with an average URR 65% from 63% to 85%, (2) the average BFR at 60 minutes from 357 mL/minute to 382 mL/minute, (3) the average treatment time from 215 minutes to 219 minutes, (4) the proportion of HD dialyzer type with Kuf 20 from 44% to 56%, and a decrease in (5) the proportion of HD patients with a HD vascular access catheter from 35% to 26%. Improvement goals in the process indicators were based on baseline 4th quarter 1999 non-intervention facility rates.
Data Collection.
Facilities in Network 9 routinely report patient status information on the NephTrak software. April, July, October, November and December CPM data are collected routinely on 100% of the patients. The CPM data includes first monthly adequacy measurements: (1) pre/post serum urea nitrogen (BUN), (2) treatment time blood flow @ 1 hour, (3) dialyzer type, (4) pre/post weights, and (5) vascular access type. The data collection format is the same as the National CPM project. See Appendix B for data collection structure and forms.
At the dialysis facility, patient information is entered initially at the beginning of ESRD therapy and updated as needed by facility abstractors into the NephTrak software. The data are then transmitted via electronic file on diskettes to The Renal Network Data System (TRNDS). Patient status information updated and transmitted monthly and CPM outcome data is transmitted for the months of April, July, October, November, and December. This process of data collection and transmission is routine for dialysis facilities in Illinois, Indiana, Kentucky, and Ohio.
Facility interim progress data used April and July 2001 data. Intermediate results for the intervention and non-intervention patient samples were reported for April 2001, and July 2001.
Data Validation.
The data collection process in Network 9 dialysis facilities has been stable and ongoing since October 1996. In 2000, a URR Validation Study compared the Network 9/10 database with a three-percent random patient sample. Network 9/10 nurse abstractors collected pre/post BUN values from primary source documents for December 1998. The results showed an exact URR value match in 95% of the cases.
Data Compliance Activity.
Facilities in this quality improvement project were required to submit a 100% facility patient sample in April, July, October, November and December. Network staff assessed the number of active in-center hemodialysis patients and compared it to the number of paired pre/post BUN measurements submitted for the project. Facilities were contacted if fewer than 90% of their active in-center hemodialysis patients were reported (see Table 2). Intervention facilities resubmitted data on missing pre/post BUN measurements. The top three reasons for non-reporting of the pre/post BUN measurements were (1) patient was not in the unit when the pre/post BUN measurements were drawn, (2) missed collection of the blood specimen, and (3) missed data entry into the database (see Table 3).
Facility interim progress data used April and July 2001 data.
Data.
The data were received as facility-specific data for all patients showing (1) URR, (2) average blood flow rate, (3) average time on dialysis, (4) number of patients dialyzing with a high flux dialyzer, and, (5) number of patients dialyzing with a catheter. This information was transferred to a statistical program where further analysis was performed (SPSS version 11). The raw data were obtained for the months October, November, and December. Averages over these three months, by facility, were calculated for the percentage of patients in the facility with a URR 65%, average blood flow rate, average time on dialysis, percentage of patients dialyzing with a high flux dialyzer, and percentage of patients dialyzing with a catheter.
The primary outcome for the study was to achieve a Network average of 85% of facilities with an URR 65%. This outcome was determined by calculating the overall rate for the Network in the 4th quarter of 2001. A secondary analysis was performed to look at the non-intervention and intervention facilities using analysis of variance with repeated measures with the repeated measure year (1999, 2000, 2001) and the factor intervention (non-intervention, intervention). These data were further analyzed using the between-subject factors identified by the facilities in their local QIP. These factors were categorized as policy and procedure, prescription, personnel, patient, physical equipment, and vascular access (see Table 4).
Results.
Forty-six facilities were targeted for intervention in Network 9 (Indiana, Kentucky, and Ohio) leaving 188 facilities as non-intervention facilities. The measured parameter averages are shown below in tables 5-9.
As part of the QIP, facilities were required to design their own internal quality improvement plans targeting hemodialysis adequacy. They were then asked to categorize their interventions as to policies and procedures, prescription, personnel, patient, physical equipment and vascular access. There were a total of 46 facilities in the intervention. Eight facilities targeted one area, 11 facilities targeted two areas, nine facilities targeted three areas, 12 facilities targeted four areas, three facilities targeted five areas, and three facilities targeted all six areas. Prescription was most often targeted and occurred in 34 facilities. Next were personnel at 28, policies and procedures at 25, and the patient at 23. Vascular access was targeted in 19 facilities while physical equipment was only targeted in nine facilities.
The primary goal of the QIP was to achieve a Network goal of 85% of facilities with a URR 65%. In the 4th quarter of 2001 this goal was achieved with a mean URR 65% in 85.2 6.7% of the non-intervention facilities but failed in the intervention facilities with only a mean URR 65% of 84.0-7.93. The overall Network 9 rate was now 85.0 6.9%.
A secondary analysis of the data using analysis of variance with repeated measures found a significant effect of years (p<0.001), intervention (p<0.001) and the interaction: years by intervention (p<0.001). These results can best be seen in Figure 1.
Further repeated measures analysis examined the interventions used at the facility level. The between subject effects were policy and procedure, prescription, personnel, patient, physical equipment, and vascular access and all were entered into the model. Once again there was a significant effect of year on the reported URR (p<0.001). There were no significant between-subject effects. There was a significant interaction between year and those facilities that targeted vascular access (p=0.041). The results of these interactions can be seen in Figure 2 where each of the interventions targeted by the facilities is shown.
Seven facilities were found to be below the 75% of patients with a URR 65% and received an additional intervention with the Network, i.e. conference call. The descriptive statistics for this group can be seen in Table 10.
Network 9 Summary of Results.
The improvement goal for this project was defined as an increase in the Network 9 rate from the 4th quarter 1999 baseline rate of 80% to 85% in the 4th quarter of 2001 for percentage of HD patients with an average URR 65%. In the 4th quarter of 2001 this goal was achieved with a mean URR 65% in 85.2% ( 6.7%) of the non-intervention facilities but failed in the intervention facilities with only a mean URR 65% of 84% (7.93). However, the primary outcome indicator was achieved. The overall Network 9 rate was 85% ( 6.9%). Targeting the lowest performing facilities for improvement was an efficient method to improve the overall Network rate.
Additional goals were set for the intervention facilities, as follows:
(1) Increase the proportion of patients with an average URR 65% from 63% to 85%; this was not achieved.
(2) Increase the average BFR at 60 minutes from 357 mL/minute to 382 mL/minute; this was not achieved. The intervention facilities did not achieve the average BFR improvement goal of 382 mL/min; the average BFR increased from 357 mL/min to 374 mL/min.
(3) Increase the average treatment time from 215 minutes to 219 minutes; this was achieved. The average treatment time goal of 219 minutes was met; the intervention patient sample increased the average treatment time from 215 to 224 minutes, five minutes more than the goal.
(4) Increase the proportion of HD dialyzer type with Kuf 20 from 44% to 56%; this was achieved in the patient sample but not in the facility sample.
(5) Decreases in the proportion of HD patients with a HD vascular access catheter from 35% to 26% were not achieved. The catheter use rate did not meet the project goal of 26%; the rate increased rather than decreased in proportion, 35% to 38%. While this increase in catheter use was not in the desired direction, the non-intervention patient sample had the same increase. In the facility sample the non-intervention group had a two-percentage point increase in catheters and the intervention group stayed the same.
Network 9 Discussion of the Results.
In this quality improvement project we attempted to increase the URR delivered in Network 9 to 85% of patients with an URR 65%. The approach used was one that targeted facilities in the lowest 20% of delivered URRs for intervention. Our rationale for selecting these facilities was based on the relationship shown in Exhibit 1 where the largest drop in URR in facilities occurs in those facilities in the lowest quartile. A further consideration in making this decision was one of resource utilization. We considered what portion of the population could we intervene in with our limited resources and still see the desired outcome. We feel that the project was successful in two ways: 1) we were able to achieve the overall goal of 85% of patients with a URR 65% and 2) we were able to do this by targeting a specific, and well defined sub-population of facilities.
As part of the intervention, facilities were required to develop their own quality improvement project to address the barriers of delivering an URR 65%. The facility QIP information sent to the Network was divided into 6 broad topics by which we performed an additional statistical analysis. What one might expect from this analysis is that those facilities that had identified a problem within their facility and developed a QIP based on this problem would, on general, have a lower URR than those facilities that did not have a problem in this area. For instance, a facility has identified that they have a higher proportion of catheters than the rest of the network. They realize that this could yield a lower average URR for that facility and they develop a QIP based on catheters. When we analyze the data on these broad categories we would expect that facilities that targeted access would have a lower URR than those that did not. What the data actually show is that those facilities that targeted access had a higher URR than those facilities that did not (figure 2). One possible explanation for this observation is that facilities, in responding to the Network QIP, responded with already implemented internal QIPs or did not assess the reasons for their lower delivered URR. This would indicate that more guidance might be necessary for the facilities to develop individualized QIP that address the specific problem. In fact, the data support the statement that on a whole that facilities were ineffective in developing internal QIPs that addressed these barriers to providing adequate dialysis.
After the April 2001 data collection, we evaluated the needs assessment report for all the facilities in the intervention. Those facilities that did not have 75% of their patients with an URR of 65% received an additional intervention that consisted of a conference call with Network staff and members of the Medical Review Board. From this intervention, we learned that there was a lack of attention paid to the operation of the facilities in regard to the barriers of adequate dialysis. This intervention was particularly effective with facilities. Prior to the intervention these facilities showed only a 2.5% increase in the percent of patients with an URR of 65% with 61.4% in 1999 increasing to 63.9% in 2000. Following the intervention, the percent of patients with an URR of 65% increased 16.9% going from 63.9% in 2000 to 80.8% in 2001.
In general, facilities may not always recognize what their barriers are to delivering an adequate dialysis and that periodic external review might be one method of providing this help. Certainly, facility policies on what the prescription should be in terms of time on dialysis, standard blood flow rates, etc are areas that could prove useful in increasing the percentage of patients that have an URR 65%.
Limitations of the Project.
The main limitation of the project was resources. Only 20% of the Network facilities were in the sample. The intervention facilities did not self-select themselves for participation into the project, rather, they were selected by a rank ordering scheme. Their mandatory enlistment may have curtailed the willingness of the participants to implement a sustaining change. Since all projects will have limited resources, selecting and targeting the lowest performing facilities did result in an increase of the Network 9 URR 65% rate to 85%.
Data collection and feedback reports were limited to five months for the intervention. Variation between monthly results may have delayed some of the facilities recognition of the need for change. This limitation was negated somewhat by the data collection methodology and the Needs Assessment Report which drilled the adequacy data down so facilities could change action plans if needed.
Lessons for the Future.
The communication between facilities in this project was not widely addressed. At the second workshop, three facilities shared with the intervention group what strategies worked and which ones did not work. This session received high evaluation marks. Facilities can learn from their peers and experiences could have been better shared. In the future, increased frequency of facility strategies and outcome information would be beneficial. In addition to conference calls for discussion and information sharing, an electronic form of communication could be used to improve type of communication and learning.
APPENDICES
A References
B Data Collection Instruments: NephTrak (formerly VisionPlus)/ National CPM Facility Collection Forms, Facility Intervention Categorization Form
C Needs Assessment Communication Report
D Workshop Agendas
E Tool Kit Contents
F Time Line