Department of Health and Human Services 

OFFICE OF


INSPECTOR GENERAL


“KNOW YOUR N(JMBER” BROCHURE


PERSPECTIVES OF DIALYSIS PATIENTS 

JUNE GIBBS BROWN 

Inspector General 

JANUARY 1997 

OEI-06-95-O0320 
OFFICE OF INSPECTOR GENERAL 

The mission of the OffIce of Inspector General (OIG), as mandated by Public Law 95-452, is to 

protect the integrity of the Department of Health and Human Services programs as well as the 

health and welfare of beneficiaries served by them. This statutory mission is carried out through a 

nationwide program of audits, investigations, evaluations, sanctions, and fraud alerts. The 

Inspector General informs the Secretary of program and management problems and recommends 

legislative, regulatory, and operational approaches to correct them. 

OFFICE OF EVALUATION AND INSPECTIONS 

The OIG’S OffIce of Evaluation and Inspections (OEI) conducts short-term management and 

program evaluations (called inspections) that focus on issues of concern to the Department, the 

Congress, and the public. The inspection reports provide findings and recommendations on the 

efficiency, vulnerability, and effectiveness of departmental programs. 

OEI’S Dallas Regional Oftlce prepared this report under the direction of Chester B. Slaughter, 

Regional Inspector General. 

Project staff included: 

DALLAS REGION 

Michelle Adams, Ph. D. 

Ruth Ann Dorrill 

Karen Erickson, Intern 

Sarah Taylor 

Judy Tyler 

Nancy Watts 

HEADQUARTERS 

Mary Beth Clarke 

Brian Ritchie 

Barbara Tedesco 

For additional copies of this report, please contact the Dallas Regional OffIce at (800) 848-8960. 
Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

“KNOW YOUR NUMBER” BROCHURE


PERSPECTIVES OF DIALYSIS PATIENTS 

$‘o +	 JUNE GIBBS BROWN 

Inspector General 

‘+4b 

dza #	 J~ARY 1997 

OEI-06-95-O0320 
EXECUTIVE SUMMARY 

PURPOSE 

This study describes the perspectives of end stage renal disease (ESRD) patients regarding 

the effectiveness of the Health Care Financing Administration’s (HCFA) “Know Your 

Number” brochure in educating them about a way to monitor the adequacy of their 

dialysis. 

BACKGROUND AND METHODOLOGY 

By Medicare’s definition, ESRD is “that stage of renal impairment that appears 

irreversible and permanent, and requires a regular course of dialysis or kidney 

transplantation to maintain life. ” Concern has grown over the adequacy of hemodialysis 

with the recent release of the ESRD Core Indicators Workgroup’s report, conducted as 

part of HCFA’s and the 18 contracting ESRD Network Organization’s quality assurance 

and continuous improvement efforts. Their report found that only 43 percent of patients 

were receiving adequate hemodialysis. 

The 13SRD brochure “Know Your Number” was developed out of this concern. Its 

purpose is to educate the approximately 156,000 in-center hemodialysis patients so they 

may better determine the adequacy of their dialysis and become more proactive in the 

treatment process. 

We surveyed two separate random samples of 800 hemodialysis patients in late October 

1995 and mid-February 1996, to test both early and later dissemination of the brochure. 

FINDINGS 

Overall, we found the brochure was somewhat successful in increasing patient awareness 

of information about adequate dialysis, how it is measured, how patients know if they 

have achieved it, and what they can do to improve their dialysis. Additionally, it appears 

the brochure has helped to enhance the dialogue between facilities and patients about 

adequate dialysis and the use of URR or KT/V numbers to monitor adequacy of dialysis 

treatment. 

Nevertheless, there were problems with dissemination of the brochure. The majority of 

patients did Wt receive it; and most of those who did were ~t familiar with their 

facility’s use of URR or KT/V tests and had no idea what the appropriate target number 

for either of these tests should be. 

i 
Following are more specific findings. 

DISSEMINATION. Only one-third of ESRD hemodialysis pm”ents repotied receiving 

the brochure. 

GENERAL EFFECT. Generally, patient awareness of URR or KT/V was low but 

improved somewhat over h-me. 

Less than half of surveyed patients reported the URR or KT/V test(s) as being used by 

their facility to measure adequacy, with about one-quarter of all patients saying they did 

not know which test(s) were used; nevertheless, patient awareness of URR and/or KT/V 

has increased somewhat over time. 

However, only one-quarter of all patients, whether they received the brochure or not, 

could correctly identify either the target URR or KT/V number(s). Many patients who 

said the brochure was easy to understand and/or that it was very helpful still could not 

identify the correct URR or KT/V target number. Even among college educated patients, 

only 43 percent successfully identified the correct target URR or KT/V number. 

SPECIFIC EFFECT. Overall, pdients receiving the brochure reported it easy to 

understand, ve~ usefil, and had a better understanding of adequate dialysis. 

Eighty-four percent of brochure recipients reported the brochure’s content was very or 

somewhat easy to understand, and over two-thirds reported the brochure was very helpful. 

Patients receiving the brochure were almost 1.5 times more likely to identify URR or 

KT/V as the test(s) used to measure adequacy in their dialysis facility, 2.3 times more 

likely to also know the correct target URR or KT/V number, and 1.3 times more likely to 

track this information over time, compared to those ~ receiving the brochure. Patients 

receiving the brochure were also more likely to have been told by the dialysis staff what 

they could do to improve the adequacy of their dialysis. 

PATIENTISTAFF RELATIONSHIP. ZJze pa&”ent/staff relationship emerged as a most 

important element in p&”ent understanding of adequate dtiysis and the success@ use 

of the brochure. 

Among patients receiving the brochure, less than half reported receiving an explanation of 

the brochure’s content or having it read to them by diaJysis staff. However, dialogue 

between patients and facility staff regarding the adequacy of patients’ dialysis and/or their 

test results appears to have increased somewhat over time. 

ii 
RECOMMENDATIONS 

Overall, HCFA’s strategy to educate patients and enlist them in monitoring the adequacy 

of their dialysis shows promise. The educational brochure has the potential to serve as an 

effective part of a broader strategy of improving patients’ understanding and pursuit of 

adequate dialysis. However, the brochure’s dissemination and its use by facilities need to 

be refined and improved before this can fully occur. 

Based on our findings, we recommend that HCFA: 

Assure future paiient brochures are received by &l Medicare dialysis patients. 

Severe dissemination problems occurred with this patient brochure, either because 

facilities did ~t distribute the brochure to ~ patients, and/or patients received no staff 

explanation when receiving the brochure, and therefore did ~ recall receiving the 

brochure. 

Build on the patient/staff relationship in order to improve patient understanding of URR 

and KT/V and the importance of achieving adequate dialysis. 

It was also clear that the patient/staff relationship was critical in increasing patient 

understanding of the brochure’s content and of dialysis adequacy. Facility staff should be 

encouraged to engage in two-way communication with patients about the adequacy of their 

dialysis, specifically, informing them about URR and KT/V and the appropriate target 

number. Additional Iy, facility staff should actively participate in the dissemination of 

future educational brochures by providing explanations about the brochure’s content, along 

with stressing the importance of the material. 

Additional Office of Ins~ector General Work 

A companion report by the Inspector General’s office (OEI-06-95-O0321 ) provides 

information about how individual facilities disseminated the “Know Your Number” 

brochure to their patients. The report describes what adequacy information is being given 

to patients by facilities, such as patients’ URR or 

highlights educational strategies used by facilities 

recommendations on the creation and distribution 

as facility activities to educate and involve patients 

dialysis. 

... 

111 

KT/V numbers. Additionally, it 

to better inform patients, and provides 

of future educational brochures, as well 

in monitoring the adequacy of their 
AGENCY COMMENTS


The Health Care Financing Administration (HCFA) concurred with all the report’s


recommendations. We appreciate their responsiveness to our proposals. However, we


have a new concern that has arisen since we issued our draft report.


We originally recommended that HCFA encourage facilities to calculate dialysis adequacy


monthly and share these numbers with patients on a regular basis. HCFA informed us


that they had no requirement for facilities to measure the adequacy of dialysis at


prescribed intervals but that their revised ESRD Conditions for Coverage will require


facilities to calculate the adequacy of dialysis quarterly. This is in marked constrast to the


upcoming National Kidney Foundation’s Dial ysis Outcome Quality Initiative guidelines


which recommend a standard practice guideline of a monthly URR or KT/V calculation,


not quarterly calculations. We are concerned that facilities will interpret HCFA’s


Conditions for Coverage as the acceptable standard and conduct adequacy testing only


quarterly.


In our view, this could pose a severe health risk for ESRD patients whose dialysis could


go three months before needed corrections could be made to their treatment. We are


convinced that facilities should be required to calculate adequacy numbers monthly and we


urge HCFA to reconsider or amend the Conditions for Coverage according y.


iv 
TABLE OF CONTENTS


EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i


INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1


mINGs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5


Dissemination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5


General Effect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6


Specific Effect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13


Patient/StaffRelationship . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18


RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22


AGENCY COMMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23


ENDNOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24


APPENDICES


A: Response Rates and Non-Respondent Analysis . . . . . . . . . . . . . . . . . . . . . A-1


B: Coni3dence IntervalsandTests for Significance . . . . . . . . . . . . . . . . . . . . .B-l


C: Text ofAgencyComments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..C-l 
INTRODUCTION 

PURPOSE 

This report assesses the effectiveness of HCFA’s “Know Your Number” brochure in 

reaching end stage renal disease (ESRD) patients by determining 1) if brochures were 

successfully disseminated, 2) if patients understood the content, and 3) the extent of 

interaction between patients and providers as a result of the brochure’s distribution. 

BACKGROUND 

By Medicare’s definition, ESRD is “that stage of renal impairment that appears 

irreversible and permanent, and requires a regular course of dialysis or kidney 

transplantation to maintain life.”’ Although some Americans with chronic kidney failure 

receive kidney transplants, the majority receive either hemodialysis or peritoneal dialysis 

treatment. 2’3Over 186,000 ESRD patients currently receive some form of dialysis 

therapy in the United States. Although dialysis is expensive and is not a cure, the 

treatments can greatly prolong an ESRD patient’s life. 

As a result of the Social Security Amendments of 1972 (P.L. 92-603), ESRD patients may 

qualify for Medicare under the renal disease provision which pays for 80 percent of the 

cost of the treatment no matter how old they are. To qualify for Medicare a person must: 

1) have worked long enough to be insured under the Social Security program, or be the 

spouse/child of someone who has; or 2) already be receiving Social Security benefits. If a 

person isn’t eligible for Medicare, they may qualify for Medicaid if their income is below 

a certain level. 

As part of its oversight to assure the appropriateness of services for ESRD patients,


Congress passed the ESRD Amendments of 1978 (P.L. 95-292) which authorized the


establishment of ESRD Network Organizations. Currently, the Health Care Finance


Administration contracts with 18 ESRD Network Organizations throughout the United


States. In striving for quality assurance and continuous improvement, the ESRD


Networks, together with HCFA and the renal community, worked to implement the ESRD


Health Care Quality Improvement Program. This program allows the ESRD Networks


and HCFA to track improvements in health care provided to renal Medicare beneficiaries


through the development of quality indicators.


ESRD Core Indicators Proiect


In 1994 the ESRD Health Care Quality Improvement Progmm conducted the


National/Network ESRD Core Indicators Project to assist providers of ESRD services in


assessing and improving the care provided to ESRD patients. The first phase of this


project targeted adult in-center hemodialysis patients receiving care in the last quarter of


1993. The project’s focus was on establishing a consistent clinical database of key


components of care. Such clinical measures included the determination of the adequacy of


1 
dialysis using the pre- and post-dialysis blood urea nitrogen (BUN) levels to calculate the 

urea reduction ratios (uRR) .4 Baseline estimates were then used to identify opportunities 

for improvement in ESRD care across the United States. 

The project’s data was compared to standard medical levels of adequate hemodialysis 

developed by the Renal Physicians Association and a National Institute of Health (NIH) 

Consensus Development Conference Panel (URR >0.65 or KT/V > 1.2).5’7 Only 43 

percent of the study’s patients met these new standards, with significant differences 

existing by gender, race, age, and region. The percent of patients in particular network 

areas who received adequate hemodialysis ranged from 29 to 57 percent, accounting for 

differences by race and gender. 

The ESRD Core Indicators Workgroup produced a report in late 1994, along with an 

analysis of the project’s results, and is currently conducting an evaluation of the impact of 

the Health Care Quality Improvement Program on patient care and outcomes. Networks 

will also prepare summary reports of their intervention and follow-up activities on an 

annual basis. 

ESRD Brochure 

The ESRD brochure “Know Your Number” was developed out of concern for the large 

percent of hemodialysis patients not receiving adequate treatment. With the development 

of a consensus medical standard for adequate hemodialysis, patients now have a 

benchmark against which to compare their own test results. 

The brochure’s purpose is to educate the approximately 156,000 in-center hemodialysis 

patients so they may better determine the adequacy of their treatment and become more 

proactive in the treatment process. The brochure focuses on heightening patients’ 

awareness of the following: 1) there is a recommended level of dialysis associated with a 

number; 2) why achieving this level is important; and 3) how patients would know if the 

recommended level of dialysis was achieved. The brochure also seeks to inform patients 

on what they can do to track and improve their dialysis test results. 

A total of 350,000 brochures were initially printed in English, with an additional 50,000 

brochures printed in Spanish for a later distribution. The brochures were sent directly to 

approximately 2,500 dialysis facilities for dissemination to ESRD patients. Distribution of 

the brochure to patients at the facility-level is intended to improve communication between 

providers and patients, in addition to increasing patients’ understanding of their treatment 

and progress. 

SCOPE 

Since the goal of the ESRD “Know Your Number” brochure is to increase patient 

awareness about the adequacy of their dialysis, this study examined whether patients 

received the brochure and understood its content and facilities’ experience in using the 

brochure. In addition, we determined how brochures were disseminated and the extent of 

2

interaction between patients and providers as a result of the brochure’s distribution. We 

did not aim to measure any broad-based changes in patient behavior resulting from the 

brochure due to the difficulty of making such causal inferences. 

METHODOLOGY 

Sample selection 

This study was comprised of three separate samples: 

The fwst sample surveyed in-center hemodialysis patients about their familiarity with 

adequate dialysis, their relationship with facility provider(s), and whether or not they 

received the brochure. We randomly selected a sample of patients and administered a 

brief mail questionnaire the last week of October 1995, shortly after the brochure was 

disseminated to dialysis facilities. 

Although we had originally hoped our surveys for the first sample would arrive prior to 

the brochure’s distribution, thus serving as a baseline, this was not possible. Shipping of 

the brochures to facilities occurred early to mid-October by an independent contractor 

hired by HCFA. The results of our first sample indicated the brochure had already 

reached our sampled patients; therefore, we used this sample’s findings to represent time 

period one. 

�	 A total of 800 in-center hemodialysis patients out of an eligible universe of 

113,475 patients were selected from HCFA’S Medical Information System using 

simple random sampling. Eligible adult patients received hemodialysis between 

1/94 and 6/95 from a staff facility. Anticipating less than a 50 percent response 

rate from this population, we oversampled to obtain a representative sample of 385 

respondents. The actual response rate for this sample was 48 percent (see 

Appendix A). 

The second sample randomly surveyed another group of in-center hemodialysis patients 

almost four months after the brochure’s dissemination to dialysis facilities. Speciilcally, 

this survey was mailed during the second week of February 1996 and assessed in greater 

detail whether patients received the brochure and also measured the brochure’s 

effectiveness. Patients were asked questions about the readability of the brochure, its’ 

usefulness, and whether they could identify URR or KT/V as a test of adequacy or knew 

the target levels for either of these tests. Additionally, patients were asked to recall what 

type of explanation they received regarding the brochure, and their interaction with the 

dialysis facility staff regarding the adequacy of information about their own dialysis. 

�	 Using simple random sampling, another 800 in-center hemodialysis patients were 

selected from a universe of 119,311 eligible patients from the database. Eligible 

adult patients received hemodialysis between the 4/95 and 9/95 from a staff 

facility. Of the 800 patients randomly selected, seven patients were excluded from 

the sample because they were also surveyed in our first sample, leaving 793 

3

eligible patients. Allowing for non-respondents, weexpected to obtaina 

representative sample of 385 respondents. The actual response rate for this sample 

was 50 percent (see Appendix A). 

A third sanmle mailed during the first week of April 1996, surveyed staff in randomly 

selected in-center facilities to further assess how well the brochure achieved its desired 

goals. We analyzed specific actions taken in using the brochure, such as: 1) how was the 

brochure distributed; 2) did they explain the brochure to patients; 3) did they put the 

information in a newsletter; and 4) how did/does the brochure fit into their broader 

educational outreach? The findings from this survey are included in a separate OIG report 

(OEI-06-95-O0321). 

�	 A total of 150 out of 2,847 dialysis facilities in operation prior to 10/1/95 were 

selected from HCFA’s database using simple random sampling. Of the 150 

ditdysis facilities selected, we surveyed 132 facilities with hemodialysis patients in 

April 1996. Our response rate for this sample was 86 percent, with 113 facilities 

responding to our survey. 

Non-Response Analym”s 

A complete analysis of non-response bias from our f~st and second sample, along with 

our findings from a separate survey of 60 non-respondents from our second sample are 

included in Appendix A. 

Tests of Significance 

Tests of signitlcance for key survey questions were performed using either t-tests or Chisquare tests. For the majority of findings in this report we only highlight statistically 

significant differences between our fwst and second sample. Additionally, Chi-square 

tests were used to capture signitlcant differences among those patients receiving the 

brochure vs. those not receiving it, along with those patients understanding URR and/or 

KT/V tests and the target number associated with them vs. those patients not 

understanding these tests of adequacy. Confidence intervals are also included for key 

survey findings in Appendix B. 

This inspection was conducted in accordance with the Quulity Standards for Inspections 

issued by the President’s Council on Integrity and Efficiency. 

4

FINDINGS


OVERVIEW 

Overall, we found the brochure was somewhat successful in increasing patient awareness 

of information about adequate dialysis, how it is measured, how patients know if they 

have achieved it, and what they can do to improve their dialysis. Additionally, it appears 

the brochure has helped to enhance the dialogue between facilities and patients about 

adequate dialysis and the use of URR or KT/V numbers to monitor adequacy of dialysis 

treatment. 

Nevertheless, there were severe problems with dissemination of the brochure, with the 

majority of patients w receiving it. Also, the majority of patients who did receive the 

brochure were ~t familiar with URR or KT/V as tests used by their dialysis facility to 

measure adequacy and had no idea what the appropriate target number for either of these 

tests should be. 

DISSEMINATION 

Only one-third of ESRD hemodialysis p~”ents reported receiving the brochure, 

The majority of patients in both samples stated they had ~t received or did not remember 

receiving the brochure (see table 1). In our first random sample conducted shortly afier 

the brochure was mailed to facilities, only 33 percent of patients reported receiving the 

brochure, while 52 percent had not received it and another 15 percent did not remember. 

We found similar results in another random sample conducted several months after the 

brochure’s dissemination. Thirty-two percent of our second sample reported receiving the 

brochure, 52 percent did not, and 16 percent did not remember. Seventy-six percent of 

patients in this sample reported receiving the brochure from their dialysis center, 19 

percent thought they had received it in the mail, two percent received it some other way, 

and 3 percent did not remember. 

Table 1: PATIENTS RECEIVING BROCHURE 

Comparison of first and second sample results 

Received brochure First Sample Second Sample 

Yes 33% 32% 

(120) (126) 

No 52% 52% 

(193) (202) 

Don’t Remember 15% 16% 

(54) (64) 

5

No significant differences existed, among patients receiving the brochure compared to 

those w receiving it, based on patients’ primary language or by their education level. 

In a separate facility survey (OEI-06-95-O0321 ), 76 percent of facilities reported receiving 

the brochure. However, only half of facilities said they distributed the brochure to every 

patient. 

GENERAL EFFECT 

In order to determine if the brochure led to an increased focus on adequacy of dialysis 

among facility staff and patients, we asked all patients surveyed a number of questions 

about adequate dialysis and the tests used to measure it. The majority of the results 

reported in this section reflect the responses from all respondents to our survey, not just 

those patients receiving the brochure. 

Generally, pah”ent awareness of URR or KT/V was low but improved modestly over time. 

Patient familiarity with URR or KT/V tests. 

Fewer patients idenh~ed the important U. or KT/V tests as being used by their facility 

to measure adequaq, thun other tests, such as potassium and phosphorous. About onequurter of all patients said they did not know which test(s) were used by their dialysis 

facilig. 

When queried about which tests were used by their dialysis facility to measure the


adequacy of their dialysis, patients from both samples marked a wide-assortment of tests


other than the URR or KT/V number (see table 2). The potassium test was most


commonly identified, with 60 and 61 percent of patients selecting this test from a list of


possibilities. The phosphorous test and BUN test were also frequently selected by


patients. Fifty-five and 58 percent of patients in our first and second sample identified the


phosphorous test, while 53 and 55 percent of patients selected the BUN test.


Forty-five percent of our frost sample and only 35 percent of our second sample


respondents identifkd the URR number as a test used by their dialysis facility to measure


adequacy, while 37 and 36 percent of patients selected the KT/V number. Clearance, a


term often used by facility staff, was selected by 32 and 29 percent of patients.


Significantly, about one-quarter of all patients sampled said they did not know which


test(s) were used by their dialysis facility to measure adequacy. Several patients from


both samples (11 and 9 percent) said other tests, besides the ones included on the survey,


were used to measure adequacy in their dialysis facility. The most frequently identifkd


additional tests included albumin (12 patients) and calcium (11 patients). A few patients


mentioned cholesterol (4 patients), glucose (4 patients), and hematocrit (3 patients).


6

Table 2: TESTS IDENTIFIED BY PATIENTS AS THOSE USED BY THEIR 

DIALYSIS FACILITY TO MEASURE ADEQUATE DIALYSIS 

Comparison of first and second sample results 

FirstSample 

Potassium test	 60% 

(23 1) 

Phosphorous test	 55% 

(212) 

BUN	 53% 

(204) 

Urea Reduction Ratio (URR)	 45% 

(171) 

KT/V 37% 

(143) 

Clearance 32% 

(122) 

Seeond Sample 

61% 

(193) 

58% 

( 182) 

55% 

(173) 

35% 

(111) 

36% 

(113) 

29% 

(90) 

Don’t Know 23% 26% I (89) I (82) 

Other	 11% 9% 

(42) (29) 

Most patien~s in both samples said they knew their own dialysis was adequate or were 

aware there was a recommended level of adequate dialysis, however, far fewer reported 

their facility used the 7-RR or KT/V number to measure adequacy. 

Seventy-three percent of all patients from our first sample reported knowing there was a 

recommended level of adequate dialysis. However, only 36 percent of these patients 

correctly identil%xi the URR or KT/V number as the test(s) used in their dialysis facility 

to measure adequacy, even when these tests were included on a list of possible choices 

(see table 3). 

Patients unaware of the recommended level of adequate dialysis were much less likely (13 

percent vs. 36 percent) to identify the URR or KT/V number as a test used by their 

dialysis facility to measure adequate dialysis. 

If all patients were given their URR or KT/V test results by facilities, we would have 

expected far more patients to have identii%d one of these tests as a measure of adequate 

dialysis. However, the lack of patient familiarity with the URR or KT/V tests suggests 

@ all facilities are providing patients with this information as part of their test results. 

Based on the results from our facility survey (OEI-06-95-00321), just over 50 percent of 

facilities surveyed said they give patients their URR or KT/V numbers all the time, while 

7 
27 percent give these numbers 75 percent of the time, 16 percent give them between 25-

50 percent of the time, and four percent don’t ever give patients their test results. 

However, facilities giving patients URR or KT/V numbers all of the time were more 

likely to have distributed the brochure to every patient and to report a higher percent of 

patients are interested intheadequacy of their dialysis. 

Table 3: PATIENTS KNOWING THERE WAS A RECOMMENDED LEVEL 

OF ADEQUATE DIALYSIS 

by those reporting URR or KT/V used at their dialysis facility 

First Sample 

Reported URR or KT/V Used Reported URR or KT/V Mt Used 

by their Dialysis Facility by their Dialysis Facility 

Yes 36% 64% 

(97) (171) 

No 13% 87% 

(13) (84) 

While 94 percent of patients in our second sample reported knowing their own dialysis 

was adequate, far fewer of these patients (52 percent) identified the URR or KT/V number 

as the test used by their dialysis facility to measure adequacy (see table 4). 

Table 4: PATIENTS KNOWING THEIR DIALYSIS IS ADEQUATE 

by those identi@ng URR or KT/V test used at their dialysis facility 

Second Sample 

Reported URR or KT/V Used Reported URR or KT/V M Used 

by their Dialysis Facility by their Dialysis Facility 

Yes 52% 48% 

(147) (136) 

No 24% 76% 

(4) (17) 

Reasons for patients’ lack of familiarity with their dialysis facility’s use of URR or KT/V 

number(s) are unclear. However, this could suggest facility staff do Ut provide the URR 

or KT/V number on a regular basis to patients, but instead just inform them their dialysis 

is “good” or “adequate.” 

Awareness of the URR or KT/V number(s) among patients knowing there is a 

recommended level of adequate dialysis and those knowing their dialysis is adequate does 

8

appear to have increased from 36 to 52 percent between the first and second sample (see 

tables 3 and 4).8 

Although patients reported receiving test results about the adequacy of their dialysis j?om 

their facility, the majority of patients were unable to identifi the URR or KT/V test as one 

used by their dialysis facility to measure adequacy. 

Of patients who asked the dialysis staff for test results, 51 and 37 percent of patients from 

our-first and second sample were unable to identify the URR or KT/V test as one used by 

their facility to measure adequacy (see table 5). 

Additionally, 56 percent of patients who were Wd their test results by facility staff from 

our first sample and 47 percent from our second sample were also unable to identify the 

URR or KT/V test as one used by their dialysis facility to measure adequacy. 

As previously discussed, to some extent, this inability of patients to identify the URR or 

KT/V tests reflects the fact that facilities are not giving adequacy numbers to patients all 

the time. 

Table 5: PATIENTS ASKING OR BEING TOLD TEST RESULTS 

by those identi@ing the URR or KT/V as being used at their dialysis facility 

Comparison of first and second sample results. 

FirstSample Seeond Sample 

Reported URR or KT/V Reported URR or KT/V 

Used by Dialysis Facility Used by Dialysis Facility 

Yes No Yes No 

Patients asked dialysis staff 49% 51% 63% 37% 

for test results (70) (74) (91) (54) 

Patients told test results by 44% 56% 53% 47% 

dialysis staff (60) (77) (120) (106) 

Nevertheless, patient awareness of 77.. and/or KT/V hus increased over time, with 

sizeable increases occum”ng in the percent of patients identifying these tests as a measure 

of adequate dialysis. 

Among patients asking the dialysis staff for their test results, there were sizeable increases 

in patients identifying either the URR or KT/V as a test used by their dialysis facility to 

measure adequacy, with increases from 49 percent in our fnst sample to 63 percent in our 

second sample (see table 5). Additionally, among patients ~ their test results, the 

percent reporting their facility uses the URR or KT/V number to measure adequacy 

increased from 44 to 53 percent between the two samples. This increase in the number of 

patients familiar with URR or KT/V as a test(s) of dialysis adequacy suggests an overall 

9 
increase in patient inquiries and staff communication about patients’ URR or KT/V 

numbers. 

Patient familiarity with Target URR or KT/V numbers. 

Only one-quarter of all patients, whether they received the brochure or not, could 

correctly identl~ either the target URR or KT/V number(s). 

When patients from our second sample were asked to select how much the urea in their 

blood should go down after their treatment, only 25 percent of all patients were able to 

identify either a URR of at least 65 percent or a KT/V of 1.2, even when given a list 

including these as possible options. Regarding URR, 21 percent of all patients knew the 

correct URR target number, with four percent giving an incorrect number, and 75 percent 

saying they did not know. 

As expected, even fewer patients (14 percent) knew the correct KT/V target number, 

wbile six percent gave an incorrect answer and 80 percent did not know this information. 

Patients keeping track of their personal URR or KT/V numbers were somewhat more likely 

to know the correct URR or KT/V target number(s) than those not keeping such records. 

Fifty-seven percent of patients from our second sample that reported keeping track of their 

personal URR or KT/V number(s) knew the correct target number for at least one of these 

tests (see table 6). However, a large number of patients (43 percent) personally recorded 

this information but still did ~t know the correct target range for either of these numbers. 

This suggests that even those patients who are actively involved in their dialysis care need 

further instruction on what level their URR or KT/V number should be for adequate 

dialysis. 

Table 

Yes 

No 

6: PATIENTS KEEPING TRACK OF PERSONAL 

by	 those knowing URR or KT/V target 

Second Samde 

Knew URR or KT/V 

Target Number 

57% 

(27) 

48% 

(40) 

URR OR KT/V NUMBER 

number 

D]d Not KIIOW 

Correct Target Number 

43% 

(20) 

52% 

(43) 

10 
Even among college educated patients or those with a professional degree, only 43 percent 

were able to correctly identtjj the URR or KT/V target number. 

Although patients with a college degree were the most likely to know the correct URR or 

KT/V target number, still, a majority of this group (57 percent) did q know this 

information (see table 7). Additionally, only about one-quarter of patients with some 

college, a high school diploma, or less were able to correctly identify the target level for 

adequate dialysis. 

Table 7: PATIENTS KNOWING URR or KT/V TARGET NUMBER 

by patient’s education level 

Second Sample 

College Degree 

Less than High High School or Professional 

School Diploma Diploma Some College Degree 

Knew correct 23% 22% 28% 43% 

target number (31) (24) (17) (16) 

Did ~t know 

correct target 77% 78% 72% 57% 

number (104) (85) (43) (21) 

Many pa~ients who said ~he brochure was easy to understand andlor that it was very 

helpjid still could not identify the correct URR or KT/V target number. 

Of the patients finding the brochure easy to understand, only 55 percent knew the correct 

URR or KT/V target number, while 45 percent did not know (see table 8). This finding 

highlights the apparent difficulty patients had in really understanding the brochure’s 

content, which focused on patients being able to track whether their URR or KT/V 

number(s) were at the appropriate level for adequate dialysis. 

However, patients who reported the brochure easy to understand were more likely (55 

percent) to know the correct URR or KT/V target number compared to those ~ finding 

the brochure easy to understand (31 percent). Similarly, 69 percent of patients ~t finding 

the brochure easy to understand could ~t correctly identify the target URR or KT/V 

number. 

. 

11

Table 8: PATIENTS RATING OF BROCHURE 

by those knowing URR or KT/V target number 

Second Sample 

Knew Target URR or Did Not Know 

KT/V Number 

Patients finding brochure easy to understand 

Yes 55% 

I (33) 

No 31% 

(15) 

Patients finding brochure very useful 

Yes 52% 

I (36) 

No 28% 

(9) 

Likewise, patients finding the brochure very helpful, more 

identified the URR or KT/V target number than those ~ 

percent, see table 8). Signtilcantly, an even higher percent 

Correct Target Number 

I 45% 

(27) 

69% 

(33) 

I 48% 

(33) 

72% 

(23) 

often (52 percent) correctly 

finding the brochure helpful (28 

(72 percent) of those I@ 

rating the brochure as very useful could not correctly identify the correct URR or KT/V 

target number. 

12

SPECIFIC EFFECT 

Overall, pti”ents receiving the brochure repotied it easy to understand, very usefil, and 

had a better understanding of adequale dialysis. 

Patient rating of brochure 

Eighty-four percent of brochure recipients reported the brochure’s content was very or 

somewhat easy to understand. 

Fifty-eight percent of patients from our second sample found the information in the 

brochure easy to understand, while another 26 percent found it somewhat easy to 

understand (see table 9). Only four percent thought it was somewhat or very hard to 

understand. 

Table 9: PATIENTS UNDERSTANDING OF BROCHURE’S INFORMATION 

Second Sample 

Very easy to understand 58% 

(68) 

Somewhat easy to understand 26% I (31) 

Neither easy nor hard to understand 12% I (14) 

Somewhat hard to understand 3% I (4) 

Very hard to understand I II 1%

Over two-thirds of brochure recipients reported the brochure was very helpfil.


Sixty-seven percent of patients receiving the brochure found it very helpful in increasing


their understanding of the URR or KT/V number (see Table 10). The following


comments illustrate their responses: 1) “The pamphlet gave me a chunce to ask questions


about something I had no idea about;” 2) “They twpkdned it (URR or KT/V number) to


me before, so it wa all information I had already heard, but it was useji.d to go over il


again. “


13


II 
Another 23 percent said the brochure was somewhat helpful, but 10 percent found it Ut 

helpful. The following comments are typical of patients finding the brochure less helpful: 

1) “(1) needed a practical application of it. Had there been a follow-up or encouragement 

to record the KT/V numbers, on the part of the nurses, the pamphiet would huve been very 

helpfil; ” 2) “(Thepamphlet was) over my head;” 3) “(I) don ‘t understand how (the) 

number is obtained;” 4) “Our unit does not do urea reduction. Too much information is 

con@sing. “ 

Table 10: PATIENT RATINGS OF BROCHURE’S HELPFULNESS 

Second Sample 

Very Helpful 67% 

(77) 

Somewhat Helpful 23% 

(26) 

Not Helpfid 10% 

(11) 

Patient familiarity with URR or KT/V tests. 

Patients receiving the brochure were more likdy to identijj U. or KT/V as the test(s) 

used to measure adequaq in their dialysis facili~. 

Fifty-eight percent of patients receiving the brochure from our first sample and 43 percent 

of patients from our second sample identified URR as a test used by their dialysis facility 

to measure adequacy, compared to 39 and 31 percent of patients ~t receiving the 

brochure (see table 11). Similar patterns were found with patients selecting the KT/V 

number as the test used to measure adequacy. Ten percent more patients receiving the 

brochure correctly identilled KT/V from a list of possible test(s), compared with those @ 

receiving it. 

Only 13 and 23 percent of patients from our first and second sample who reported 

receiving the brochure said they did @ know which tests were used by their facility, 

compared to 29 and 28 percent of patients who reported ~t receiving the brochure. 

14

4 

Table 11: TESTS 

DIALYSIS 

Potassium test 

Phosphorous test 

BUN 

Urea Reduction Ratio (l-RR) 

KT/V 

Clearance 

Don’t Know 

Other 

IDENTIFIED BY PATIENTS AS THOSE USED BY THEIR 

FACILITY TO MEASURE ADEQUATE DIALYSIS 

Comparison of first and second sample results 

by brochure receipt 

First 

No 

Brochure 

58% 

(144) 

54% 

(134) 

55% 

(135) 

39% 

(95) 

34% 

(84) 

32% 

(79) 

29% 

(72) 

9% 

(23) 

Sample 

Brochure 

63% 

(75) 

56% 

(67) 

50% 

(60) 

58% 

(69) 

44% 

(53) 

31% 

(10.1) 

13% 

(16) 

13% 

(16) 

Second Sample 

No 

Brochure Brochure 

64% 54% 

(128) (60) 

62% 48% 

( 124) (53) 

57% 51% 

(114) (56) 

31% 43% 

(62) (48) 

32% 43% 

(63) (48) 

29% 26% 

(57) (29) 

28% 23% 

(56) (26) 

8% 12% 

(15) (13) 

Patient familiarity with target URR or KT/V numbers. 

Al~hough the mujority of patients receiving the brochure did not know the correct URR or 

KT/V ~arget number, patien~s who received the brochure were much more likely to know 

this information thun those Ut receiving the brochure. 

Fifty-seven percent of patients receiving the brochure from the second sample were unable 

to correctly identify either the target URR number of at least 65 percent or KT/V number 

of 1.2 (see table 12), even when given a list including the target numbers as possible 

options from which to choose. 

15

Table 12: PATIENTS RECEIVING 

by those knowing URR or KT/V 

Second Sample 

Knew Target URR 

or KT/V Number 

43% 

(47) 

19% 

(34) 

9% 

(5) 

BROCHURE 

target number 

Did Not know 

Correct Target Number 

57% 

(62) 

81% 

(147) 

91% 

(51) 

Reeeived Brochure 

Yes


No


Don’t Remember


Specifically, 35 percent of patients receiving a brochure in our second sample knew the 

correct URR target number, compared to only 15 percent of those ~t receiving the 

brochure (see table 13). Patients receiving the brochure were also less likely (56 percent) 

to say they did ~t know the correct URR target number than those @ receiving it (84 

percent). 

Fewer patients were expected to be familiar with the KT/V target number since KT/V is 

used less frequently in dialysis facilities. Thirty-one percent of patients receiving the 

brochure selected the correct KT/V target number, compared with only 7 percent of those 

not receiving the brochure. Eighty-nine percent of patients ~t receiving the brochure told 

us they did not know the correct KT/V target number, contrasted with 57 percent of those 

receiving it. 

Table 13: PATIENTS RECEIVING BROCHURE 

by those knowing URR or KT/V target number 

Second Sample 

URR Number KT/V Number 

Seketed Seleeted 

Correct Incorrect Didn’t 

Received Know ==l?=l= 

Brochure Target # Target # Target # Target # Target # Target # 

I I 

Yes 35% 9% 56% 31% ] 12% I 57% 

(38) (lo) (60) (32) ! (13) ! (59) 

No 

or Didn’t 15% 1% 84% 7% 4% 89% 

Remember (35) (4) (200) (16) (9) (215) 

16

Patient traclcimz of ~ersonal URR or KT/V numbers. 

Although only 35 percent of patients, overall, tracked their persorud W/R or KT/V 

number, patients who received the brochure were more likely to keep such records than 

those wt receiving it. 

Although not statistically significant, of patients from our second sample who kept track 

of their URR or KT/V number, 56 percent received the brochure compared to only 44% 

of patients who did m (see table 14). However, we cannot tell whether patients started 

tracking their URR or KT/V numbers as a result of receiving the brochure. 

Table 14: PATIENTS KEEPING TRACK OF PERSONAL URR OR KT/V NUMBER 

by brochure receipt 

Second %umde 

Overall No Brochure Brochure , 1 

Yes 35% 44% 56% 

(48) (21) (27) 

No 65% 46% 54% 

(91) (42) (49) 

Patient recei~t of information about immovin~ dialysis. 

Patients receiving the brochure were also more likzly to have been told by the dialysis 

staf whut they could do to improve the adequacy of their dialysis. 

Ninety-one and 95 percent of patients from our first and second sample receiving the 

brochure were given advice on improving their dialysis, contrasted with only 81 and 75 

percent of patients Ut receiving the brochure (see table 15). 

17

Table 15: DIALYSIS STAFF TOLD PATIENTS WHAT THEY COULD DO TO MAKE 

DIALYSIS WORK BETTER


Comparison of first and second sample results


by brochure receipt


First Sample Second Sample 

No 

Brochure 

Yes 81% 

(198) 

No	 19% 

(47) 

PATIENT/STAFF RELATIONSHIP 

E%epatient[staff relationship emerged 

of adequate dialysis and the successful 

Staff discussions of adecmate dialvsis. 

, 

No 

Brochure Brochure Brochure 

91% 75% 95% 

(106) (184) (111) 

9% 25% 5% 

(11) (63) (6) 

as an impotiant element in pati”ent understanding 

use of the brochure. 

Most patients learn whether their own dialysis is adequate by the dialysis stafl telling them 

it is adequate or by being told their test results. 

Regardless of whether patients received the brochure or not, 73 percent of all patients 

from our frost sample reported knowing there was a recommended level of adequate 

dialysis. Eighty-one percent of patients from the second sample said they knew their 

dialysis was adequate. 

Sixty-three percent of patients from our fwst sample and 72 percent of patients from our 

second sample were Md their dialysis was adequate by facility staff (see table 16). Fiftythree and 76 percent of patients from our first and second sample reported learning about 

the adequacy of their dialysis from test results given to them by the facility staff. 

Over the four month period between our first and second sample, noteworthy increases, 

from 63 to 72 percent, occurred in patients reporting the dialysis staff ~ them their 

dialysis was adequate. Similarly, the number of patients being LOJ their test results 

increased from 53 to 76 percent from our fust and second sample. Patients from the later 

sample were more likely to ask if their dialysis was adequate, suggesting patient and 

facility interest in improving understanding of dialysis adequacy and in releasing patient 

test results had increased over time. 

18

II Table 16: HOW PATIENTS KNOW IF THEIR DIALYSIS IS ADEQUATE 

Com~arison of first and second samDle results. 

FirstSample Second Sample 

I I 

Dialysis staff tell patients dialysis is adequate 63% 72% 

(219) (218) 

Patients ask staff for test results 55% 50% 

(189) (152) 

Dialysis staff tell patients test results 53% 76% 

(181) (232) 

Patients ask staff if dialysis is adequate 48% 55% 

(165) (166) 

Two-way communication exists between over half of patients and facili~ stafl regarding 

patients’ test results and the adequacy of their dialysis. 

Patients learned about the adequacy of their dialysis or their individual test results through 

a variety of ways (see table 17). The majority (51 percent) of patients from our first 

sample and 57 percent from our second sample relied on both asking for and being told 

this information by facility staff, suggesting two-way communication exists between 

patients and facility staff. 

However, 25 and 31 percent of patients from our first and second sample counted on the 

dialysis staff telling them this information and did ~t ask about it. Thirteen percent of 

patients from our fwst sample and 10 percent of patients from our second sample obtained 

this information by asking the dialysis staff, but were @ provided this information unless 

they asked. A few patients from both our first sample (1O percent) and our stiond sample 

(2 percent) said they were neither asked nor were told about the adequacy of their dialysis 

or their test results by dialysis staff. 

19

Table 17: METHOD USED BY PATIENTS TO DETERMINE 

IF DIALYSIS IS ADEQUATE OR LEARN THEIR TEST RESULTS. 

Comparison of first and second sample results. 

METHOD USED IN DETERMIIWNG 

ADEQUACY OR NUMBER First Sample Second Sample 

Asked facility staff about information, but 13% 10% 

were ~t told. (47) (32) 

Told information by facility staff, without 25% 31% 

asking. (85) (93) 

Both asked for and told this information I 51% I 57% 

(178) (172) 

I I 

None of the above occurred I 11% I 2% 

(37) I (6) 

Dialogue between patients and facility stafl regarding the adequacy of patients’ dialysis 

andlor their test results appears to have increased somewhut over time. 

Patients were more likely to ask @ be told information on whether their dialysis was 

adequate from facility staff in the later sample. An increase in patient inquiries and staff 

communication about adequacy information and/or patients’ test results occurred between 

our first and second sample, increasing from 51 percent to 57 percent. Additionally, the 

percent of patients Wt asking or being told information about the adequacy of their 

dialysis and/or their test results decreased from 11 to two percent between the two 

samples. 

Over 80 percent of patients reported receiw”ngadvice jlom facili~ stafl about what they 

couki do to make their dialysis work better. 

Eighty-four percent of patients in our first sample and 81 percent of patients from our 

second sample reported they were told what they could do to make their dialysis better. 

Seventy-seven percent of patients from our second sample wem told this information by 

the dietitian, 74 percent by the nurse, 62 percent by the doctor, 18 percent by another 

member of the dialysis staffi and 5 percent of patients by someone else; such as the social 

worker. 

20

Exdanations of the brochure by facilitv staff. 

Nevertheless, among patients receiving the brochure, less thunhalfofpatients who 

received the brochure reported receiving an explanation of the brochure’s content or 

having it read to them by dialysis stafi 

Of the patients receiving the brochure, 49 percent of the first sample reported receiving an 

explanation of the brochure’s content from the dialysis staff. Forty-two percent of the 

second sample who received the brochure reported the brochure was either read or 

explained to them by someone; such as the dialysis staff, a family member or friend. 

Speciilcally, 23 percent of patients received an explanation of the brochure, 11 percent 

reported it was read to them, and eight percent said it was ~h explained and read to 

them. 

Fifty-two percent of the patients in our second sample reported they read the brochure 

themselves, but received m explanation from the facility staff or anyone else. Another 

six percent admitted throwing the brochure away without reading it. 

Men explanations of the brochure’s content did occur, they most commonly came j-em 

the dialysis facility nurse or dietitian. 

When the dialysis facility staff provided explanations of the brochure or at least read it to


patients, this was most commonly done by the facility nurse (47 percent). The dietitian


provided an explanation of the brochure for 24 percent of patients and the doctor for six


percent of patients. Other members of the dialysis staff, such as the social worker,


provided an explanation for 14 percent of patients. Another 13 percent of patients


received an explanation from a friend or someone else.


The following describes the experiences of those patients receiving an explanation from


the dialysis facility staff


� 54 percent reported the staff answered questions.


� 52 percent reported the staff spent enough time with them.


� 49 percent reported they understood the staff’s explanation.


� 43 percent reported the staff just explained the brochure.


� 6 percent reported they did ~t understand the staff’s explanation.


21

RECOMMENDATIONS 

Overall, we found the HCFA strategy to educate patients and enlist them in monitoring 

the adequacy of their dialysis shows promise. The educational brochure has the potential 

to serve as an effective part of a broader strategy of improving patients’ understanding and 

pursuit of adequate dialysis. However, the brochure’s dissemination and its use by 

facilities need to be refined and improved before this can fully occur. 

Clearly, the brochure achieved some impact on patients’ understanding of adequate 

dialysis, and more specifically, about URR and KT/V and the target numbers associated 

with these tests. Additionally, the brochure appears also to have influenced dialysis 

facility staffs by increasing their discussion with patients of URR and/or KT/V, and 

dialysis adequacy, in general. An increase in such discussions should result in more 

patients knowing about adequate dialysis and how to measure and monitor it, which, in 

turn, should lead to healthier patient outcomes. 

Based on our findings, we recommend that HCFA: 

Assure jizture pah”ent brochures are received by &l Medicare dialysis p~”ents. 

Severe dissemination problems occurred with this patient brochure, either because 

facilities did ~t distribute the brochure to Al patients, and/or patients received no staff 

explanation when receiving the brochure, and therefore did Dt recall receiving the 

brochure. 

Build on the patient/staff reldonship in order to improve p~”ent understanding of URR 

and KT/V and the importance of achieving adequate dtiysis. 

It was also clear that the patient/staff relationship was critical in increasing patient 

understanding of the brochure’s content and of dialysis adequacy. Facility staff should be 

encouraged to engage in two-way communication with patients about the adequacy of their 

dialysis, specifically, informing them about URR and KT/V and the appropriate target 

number. Additionally, facility staff should actively participate in the dissemination of 

future educatiomd brochures by providing explanations about the brochure’s content, along 

with stressing the importance of the material. 

22

AGENCY COMMENTS 

The Health Care Financing Administration (HCFA) concurred with all the report’s


recommendations. We appreciate their responsiveness to our proposals. However, we


have a new concern that has arisen since we issued our draft report.


We originally recommended that HCFA encourage facilities to calculate dialysis adequacy


monthly and share these numbers with patients on a regular basis. HCFA informed us


that they had no requirement for facilities to measure the adequacy of dialysis at


prescribed intervals but that their revised EN2D Conditions for Coverage will require


facilities to calculate the adequacy of dialysis quarterly. This is in marked constrast to the


upcoming National Kidney Foundation’s Dialysis Outcome Quality Initiative guidelines


which recommend a standard practice guideline of a monthly URR or KT/V calculation,


not quarterly calculations. We are concerned that facilities will interpret HCFA’s


Conditions for Coverage as the acceptable standard and conduct adequacy testing only


quarterly.


In our view, this could pose a severe health risk for ESRD patients whose dialysis could


go three months before needed corrections could be made to their treatment. We are


convinced that facilities should be required to calculate adequacy numbers monthly and we


urge HCFA to reconsider or amend the Conditions for Coverage accordingly.


Discussion of Technical Comments


HCFA suggested we assess whether some of the comprehension issues might be attributed


to a lack of cultural sensitivity in the brochure. We did analyses looking at both a


patient’s race and primary language. However, we found no statistically significant


differences on key questions related to comprehension based on these two variables.


Additionally, HCFA called attention to the Spanish version of the brochure. We were


happy to mention that 50,000 brochures would be printed for later distribution in the


background section of both reports. Of course this study examined only the English


version; at the time of our facility survey the Spanish version had not been distributed.


See Appendix C for a full text of HCFA’S comments.


23

EN DNOTES


1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

Title 42 CFR 405.2102, Conditions for Coverage of Suppliers of FWH3 Services, 

October 1993; pg. 127. 

Hemodialysis therapy cleans and filters a patient’s blood with a dialyzer. This 

procedure can be done at home or in-center by nurses or trained technicians. 

Hemodialysis is usually performed about three times a week, with treatments 

lasting 2 to 4 hours each. Through this treatment and a proper diet, ESRD patients 

can greatly reduce the amount of wastes building up in their blood. 

Peritoneal Dialysis replaces the work of the kidneys by removing extra water, 

wastes, and chemicals from the body. A cleansing solution, called dialysate, helps 

facilitate a patient’s peritoneal membrane of the abdomen to filter their blood, 

requiring a catheter to be permanently placed into their abdomen. Wastes are 

filtered from a patient’s body once the dialysate is drained. There are three types 

of peritoneal dialysis, with Continuous Ambulatory Peritoneal Dialysis (CAPD) 

being the most common. 

The Urea Reduction Ratio (URR) informs patients how well hemodialysis is 

working by telling them the percentage of urea (waste products) removed from 

their body during their treatment. Baseline estimates were then used to identify 

opportunities for improvement in IZSRD care across the United States. 

Some dialysis facilities calculate a KT/V ratio instead of URR. This urea kinetic 

model or index is defined as the dialyzer urea clearance (K) multiplied by the 

patients’ treatment time (T) divided by the volume of urea distribution (V). 

Consensus Development Conference Panel. Morbidity and mortality of renal 

dialysis: An N_Ill consensus conference statement. Ann Intern Meal, 1994; 121: 

62-70. 

Renal Physicians Association. Clinical practice guideline on adequacy of 

hemodialysis: Clinical practice guideline, number 1. December, 1993 

Although our fwst sample surveyed the extent patients knew there was a 

recommended level of dialysis and our second sample inquired whether patients 

knew their dialysis was adequate, both samples asked patients to identify which 

test(s) are used by their dialysis unit to measure if their dialysis is adequate. 

24

APPENDIX A 

RFSPONSE RATES AND NON-RESPONDENT ANALYSIS 

Our first sample resulted in an overall response rate of 48 percent, with 386 of 800


patients responding. Of the non-respondents, 25 surveys were mailed back to us but were


unusable for a variety of reasons. Fifteen patients either moved or had incorrect


addresses, seven patients were deceased, and three patients were not physically competent


to complete the survey.


There was ~ response bias among patients with just ESRD, as compared with aged or


disabled ESRD patients. There was also no bias by gender in our first sample. However,


response bias existed by race for the first sample. Black respondents were over two times


more likely ~t to respond to our survey compared to white respondents, with only 36


percent of blacks patients responding as compared to 59 percent of white patients. Only


a few statistically significant differences existed by race among our respondents in the first


sample. White respondents were 1.4 times more likely to list the URR test and 1.3 times


more likely to list the KT/V test as ones used by their dialysis facility to measure


adequacy, compared to black respondents. Nevertheless, no statistically significant racial


differences existed by education level or for other key questions, such as those receiving


the brochure or an explanation of it.


Our second samDle resulted in an overall response rate of 50 percent, with 395 of 793


patients responding. Of the non-respondents, 46 surveys were mailed back to us but were


unusable for the following reasons: 22 patients had invalid addresses; ten patients were


deceased; nine patients refusedor just didn’t complete the survey; three patients were


incompetent; and two patients were off dialysis.


No response bias existed by age or among patients with just ESRD vs. aged or disabled


ESRD patients. However, response bias also existed by race for our second sample, with


only 42 percent of Blacks responding to our survey compared to 56 percent of Whites.


Although no response bias existed by race for key survey questions, such as;


understanding of the brochure’s concept, differences did exist in the educational levels of


respondents. Sixty-seven percent of White respondents had a high school diploma or less,


compared to 74 percent of Blacks and 87 percent of non-Black, non-White respondents.


White respondents were two times more likely to have a college or professional degree


compared to Black respondents.


The implications of the response bias by race are unclear. However, our greatest concern


is the potential bias created by non-respondents not receiving the brochure. We


anticipated those ~ receiving the brochure would be less likely to respond to our survey.


Although we have no information about the educational level of our non-respondents, it is


also likely our respondents had higher education levels and/or better reading abilities than


our non-respondents. If bias by education does exist, our estimates will be more


A-1 
conservative estimates of the true population, resulting in higher percentages of patients 

understanding the brochure’s content compared to the actual population. 

Non-res~onse survey 

Addressing concerns about potential bias because of the low response rates from our two 

samples, we conducted a separate phone survey of non-respondents from our second 

sample. Of the 398 non- respondents from our survey, we randomly selected 60 patients 

from the remaining 350 patients ~t completing our survey or having it mailed back to us 

as undeliverable. Patients selected for our non-response analysis were surveyed briefly by 

telephone in May 1996. Since we originally had no phone numbers for our sampled 

patients, phone numbers were obtained through directory assistance. Of the 60 patients 

sampled for this analysis, current phone numbers were @ available for 24 patients. Of 

the 36 patients with valid phone numbers, we successfully surveyed 28 patients via the 

telephone. Patients contacted were asked if they had received our original mail survey, 

knew about adequate dialysis, got the “Know Your Number” brochure, and why they had 

not completed our mail survey. 

Findings @om non-response anulysis: 

Sixty-four percent (18) of patients we telephoned had received our mail survey, while 29 

percent (eight patients) reported they had ~ received it and another seven percent (two 

patients) did not remember receiving it. It is unclear why these patients did not recall 

getting the survey since their mailed survey was ~t returned to us marked undeliverable 

by the mail service. However, it is possible these patients disregarded our survey without 

even opening the envelope to determine its’ contents. 

Ninety-six percent (27) of patients stated that they knew about adequate dialysis, while 

just one patient admitted they did ~t. 

Only 15 percent (four) of patients reported they had received the brochure; 63 percent (17 

patients) did ~t receive it, and 22 percent (six patients) did ~t remember receiving it. 

Patients’ reasons for @ returning our survey included the following: 1) six patients had 

been very ill and had been in the hospital, thus they were either unsure they had even 

received our survey in the mail or were unable to complete it due to health problems; 2) 

six patients were blind and said they were unable to complete our survey by themselves; 

3) ten patients admitted they just hadn’t gotten around to completing the mail survey; and 

4) four patients didn’t complete our survey because they had ~t received the brochure 

and thought they didn’t need to complete the survey. 

A-2

Conclusions: 

The results from our non-response analysis of patients receiving the brochure, compared 

to our respondents, suggest our sample over-estimates the number of patients really 

receiving the brochure. Almost one-third of respondents from our second sample stated 

that they received the brochure, compared to only 15 percent of our non-respondents. 

A-3

APPENDIX B 

ESTIMATES AND CONFIDENCE INTERVALS 

The chart below summarizes the estimated proportions and the 95 confidence intervals for 

key statistics presented in this report based on this simple random sample. 

Table 1: FIRST SAMPLE 

95’% CONFIDENCE 

QUESTION POLNT ESTIMATE INTERVAL 

Proportion of patients receiving the brochure. 

I 33% I 28.1% - 37.9% 

Proportion of patients who knew about the URR test. 

45% 40.1% - 49.9% 

Proportion of patients who knew about the KT/V test. 

I 37% I 32.1% -41.9% 

Proportion of patients who knew there was a recommended level of dialysis.


By Patients who:


Knew URR or KT/V used 36% 30.3% - 41.7%


Proportion of Patients who knew about URR or KT/V test.


By Patients who: 

. Asked dialysis staff about 

about adequacy. 49% 40.8% - 57.2% 

� Told about adequacy by 

dialysis staff. 44% 35.6% - 52.4% 

Proportion of patients receiving the brochure. 

I 

BY patients who: 

� Knew URR used 58% 49.2% - 66.8% 

� Knew KTIV used 44% 39.5% - 48.5% 

� Told what they could do to 

improve their dialysis. 91% 85.9% - 96.1% 

B-1

Table 2: SECOND SAMPLE 

95% CONFIDENCE 

QUESTION POINT ESTIMATE INTERVAL 

Proportion of patients receiving the brochure. 

32% 27.3% - 36.7% 

Proportion of patients who knew about the URR test. 

35% 29.7% - 40.3% 

Proportion of patients who knew about the KT/V test. 

36% 30.7% -41.3% 

Proportion of patients who knew their dialysis was adequate.


BY patients who:


� Knew URR or KT/V used 52% 46.1% - 57.9%


� Didn’ t know tests used 24% 19.1% - 28.9%


Proportion of Patients who knew either their target URR or KT/V number.


Overall 25% 20.5% - 29.5% 

By patients who: 

. Kept track of their number 57% 47.6% - 66.4% 

. Found brochure usefid 52% 40.2% - 63.8% 

� Found brochure easy to 

understand 55% 42.5% - 67.5% 

Proportion of patients who found the brochure. 

� Very easy to understand 58% 49.2% - 66.8% 

� Very helpful 67% 58.4% - 75.6% 

Proportion of patients who received the brochure. 

BY patients who: 

. Were told how they could 

make their dialysis better 95% 91.1% - 98.9% 

. Knew their URR or KT/V 

target number 35% 26.0% - 44.0% 

� Kept track of their number 56% 41.9% - 70.1% 

Proportion of patients who reported that the URR or KT/V test was used. 

By patients who: 

� Asked or were told their test 

results 63% 55.2% - 70.8% 

B-2

TESTS FOR SIGNIFICANCE 

Differences between the first and second sample of patients were tested for significance 

for several questions. The table below shows the difference between the two groups and 

the resulting value when a t-test was performed. 

Table 3: DIFFERENCES BETWEEN FIRST & SECOND SAMPLE FOR KEY OUESTIONS. 

FIRST SAMPLE SECOND SAMPLE 

QUESTION T VALUE 

Reported URR or KT/V Used by 

Dialysis Facility 

1 

Patients asked dialysis staff for test results 

49% 63% -2.42-

Patients told test results by dialysis staff I 44% I 53% -1.72” 

Did Not Receive Brochure 

Dialysis staff told patients what they could


do to make dialysis work better 81% 75% 1.68”


How Patients Know if Their Dialysis 

is Adequate 

Dialysis staff tell patients test results 53% 76% -6.18-

* Indicates significance at the 90% confidence level. 

* Indicates significance at the 95% confidence level. 

- Indicates significance at the 99% confidence level. 

B-3

APPENDIX C 

TEXT OF AGENCY COMMENTS 

c-1 
DEPARTMENT OF HEALTH & HUMAN SERVICES Health Care finaw!n~ Administrat~-n 

— 

The Admlnlstrator 

Washington. 0 C, 20701 

DATE: 0EC22B33 

TO: June Gibbs Brown 

FROM 

Administrator 

SUBJECT:	 Of%w of kuq)ccToftied (OIG) thaft Rqmrts: “klOW your ?+mdw” 

Brnchum - Perspectives of Did@s Patients (OE?-&5-gS-00320) snd 

“Know Your Numbcf Brochure - Ex@cn~ of Diniysis Facilities 

(OH-06-9$00321] 

We reviewed the rnbo-ve-rtferenccdreports w&% examine&c cf&ctiveness of the #caIth 

Care Fmcing Adminimra!ion’s End Stage Renal Disease pram -

. 

Our detilui commen& on the _ recommendations am attached fur your 

consideration. Thank you for the oppcamity to review and comment cm theserqmts. 

Artachmmt 
Comments of the Health Care Financing Admkistration (HCFA) on


Office of Insuector General (OIG) Draft Re~orts:


“how Your Number” Brochure - Perspectives of


Dialwis Patients. (OEI-06-95-00320) ~d ‘Know Your Number” Broch~e ­


~xueriences of Dialysis Facilities. (OE1-06-95-0032 1)


“Know Yow Number” Brochure - Perspectives of Dialvsis Patients. (OEI-06-95-00320) 

.OIG Recommendation 1 

HCFA should ensure future patient brochures are received by all Medicare dialysis 

patients. 

HCFA Res~onse 

We concur. Direct mailing of brochures to patients was considered for our initial 

brochure distribution. However, the American Association of Kidney Patients 

recommended that the brochure be distributed through facilities where questions can be 

asked and explanations provided. If possible, future distributions willbe a combination 

of direct mailing to patients and bulk mailing to facilities. 

OIG Recommendation 2 

HCFA should build on the patientkiff relationship in order to improve patient 

understanding of urea reduction ratios and the urea kinetic model and the importance of 

achieving adequate dialysis. 

HCFA Resr)ons~ 

We concur. The patientistaff relationship is critical to the improvement of a patient’s 

understanding of end-stage renaJ disease @SR.W. Most patients rely on their care givers 

for necessary information and encouragement in order to be active participants in the 

health care decisions that involve them. Facility guidelines that provide the staff with 

additional background materials and suggestions on successful ways to use the brochm e 

in patient education would support paticntist~ff dialogue as well as patient empowerment 

However, it will not guarantee that the brochure will be distributed or that dialogue will 

occur. 
Page 2 

<<Know Your Number” Brochure - Ex~eriences of Dialvsis Facilities, (OEI-06-95-0032 1) .. 

OIG Recommendation 1 (’Dissemination) 

HCFA should ensure that all facilities receive an ample supply of brochures and 

encourage them to distribute a brochure to every patient. HCFA might also consider 

providing guidelines to facilities on effective dissemination approaches. 

HCFA Response 

We concur, The initial distribution was intended to provide all ESRD dialysis facilities 

with enough brochures for 100-percent patient distribution plus extra brochures for 

anticipated new patients. The mailing labels and distribution amounts were pr&ided long 

before the brochures were actually mailed. Consequently, some new facilities were not 

on the list, To the extent possible, fiture mailings will be done from the most ~ument 

roster of facilities. Additional brochures will be sent to the Networka with a request that 

they send an ample supply to a.11facilities added to their Network rolls after the mailing 

list was created, 

HCFA worked closely with the renal community (Renal Physicians’ Association% 

Amezican Association of Kidney Patients, National Kidney Foundatio& American 

Nephrology Nurses Associatio~ National Renal Administrators’ Association, ESl?~ 

Network Forum and National Association of Nephrology Technicians) in the 

development and distribution of the brochure, M well as alerting the renal community m 

the brochure distribution. The national associations were most helpful in promoting the 

brochure at theti national meetings and in their newsletters, as well as distributing 

brochures to their membership. The initial bu~ mailing to facilities was accompanied bv 

a letter of introduction that described the brochure development and encouraged facilities 

to use the brochures for patient education. We realize tlmt continued and addition~l 

facility support arc needed and that facilities which need the most support with the 

utilization of the brochure do not belong to or attend the various national meetings 

provided by the renal community. We wili consider developing facility guidelines 

describing brochure distribution to patients and staff for patient education. The 

guidelines, if developed, will be included in future brochure bulk mailings to dialysis 

facilities. 
Page 3 

OIG Recommendation 2 (!Brochure Content and Format) 

HCFA should simpIi& the language and concepts as much as possible in any subseque~lt 

or.revised patient brochures. Consideration might be given to developing alternate 

versions of the brochure for d~erent reading levels and to add greater use of color mud 

graphics to gain interest and promote patient understanding 

~CFA Resvonse 

We concur. We appreciate the concern expressed regarding the hmguage and concepts


presented in the brochure The National Renal Physicians’ Association has a professional


level brochure. There is also a high school level brochure on the topic. It is important for


stafVpatient dialogue to occur if a patient has difficulty understanding this brochure and


needs the concepts explained tier. Consideration can also be given to developing


alternate versions of the brochure for different reading levels if needed and resources


permit, Development of nymerous versions of the brochure does not guarantee that all


patients wdi get a copy, that the facility will educate their patients, or that all patients will


be interested in learning about ESRD. Carcfu.1distribution plans would need to be


developed to enable a variety of versions of the brochure to be cffectivdy distributed so


that the brochure supply and the need would coincide.


In considering reaching renal patients with information about adequacy of dialysis. the


need for a Spanish version of the brochure became apparent, We have, therefore, had the


brochure translated into Spanish and distributed to facilities with Spanish-speaking


patients. Since all facilities were supposed to receive copies of the English version of the


brochure with the introduction letter, we included information about the availability of


the Spanish translation in the letter. As a result we have had a number of requests for the


Spanish version from facilities who were not on the original Spanish brochure


distribution list.


We originally designed the brochure to have larger print and brighter, more varied colors.


However, the Government Printing Office only allows a two-color process for printing


brochures, and budgetary considerations reduced the size of the brochure. Future


printings of the brochure will be mom sensitive to the visuaI1y-impaired and more


visually stimulating if at all possible.

Page 4 

(NGRecomm ndation 3 (Conlinuing Pab‘ent Education) 

HCFA should encourage continuing efforts by facilities to educate patients and rein.force 

the importance of patient understanding and monitoring of the adequacy of their dialysis. 

A training video to introduce and/or retiorcc the brochure concepts might also prove 

effective, based on the suggestions and experiences of some facilities. 

I+CFAR eSQQW2 

We concur. If fimding permits, a training video to educate patients and reinforce the 

brochure concepts would probably be very helpfid and well received. Having the 

brochure information on video would allow the visually-impaired to either better seethe 

concepts or at least hear the concepts. Supporting patienthff dialogue would still be 

needed, 

In additiom since faciIity staff, in con~ction with the patient are required to 

periodically review and update the patient’s care pla% perhaps staff can be encouraged to 

take this opportunity to explain the information to patients and answer questions or 

address any concerns about the information in the brochure, 

Recommendation 4 (We QfAdeauacv Mea sures) 

HCFA should encourage facilities to calculate dialysis adequacy measures on a monthly 

basis and share these numbers with patients on a regular basis in order for the brochure to 

achieve its intended impact on patients and facilities. 

kKFA RcSPQELe 

We. concur, At this time there is no requirement for facilities to measure the adequacy of 

dialysis at prescribed intervals. Although the revised ESR.DConditions for Coverage, 

scheduled for release in early 1997, will require dialysis facilities to calculate the 

adequacy of dialysis quarterly, we encourage more fiequcnt calculations as part of the 

facilities coxltiuuous quality improvement program. 

The Facilities of Achievement Initiative will demonstrate, in volunteer ESRD dialysis 

facilities with existing computer capacity, the possibility of collecting medical indicators 

on 100 percent patient sample, then collating and analyzing the data and returning it to 

the ptulicipating facility for use in developing quality improvement interventions. The 

clinical indicators of the care received w-illbe submitted to HCFA on a quarterIy basis. 
Page 5 

Technical Comments 

The report should assess whether some of comprehension issues of the beneficiaries 

might be attributed to a lack of cultural sensitivity in the presentation. Not only is there 

the relatively large number of Hispanics in the ESRD prograrq but also American Im%ns 

and African-Americans are represented in the population disproportionately, 

We also note that the report failed to mention that there was a Spanish edition of this 

publication, This is particularly important considering the Iarge Hispanic community 

affected by ESRD.