Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

“KNOW YOUR N(JMBERrr BROCHURE 

EXPERIENCES OF DIALYSIS FACILITIES 
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 cf 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 eftlciency, 

vulnerability, and effectiveness of departmental programs. 

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

Regional Inspector General. 

Project staff included: 

DALLAS REGION


Michelle Adarns, 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


EXPERIENCES 

+W 

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NUMBER” BROCHURE


OF DIALYSIS FACILITIES 

‘-i 

JUNE GIBBS BROWN 

Inspector General 

JANUARY 1997 

OEI-06-95-O0321 
EXECUTIVE SUMMARY 

PURPOSE 

This study describes the experiences of renal dialysis facilities in using the Health Care 

Financing Administration’s (HCFA) “Know Your Number” brochure to educate end stage 

renal disease (ESRD) patients on how to monitor the adequacy of their dialysis treatment. 

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 

EMU.1 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. This report found that only 43 percent of patients were receiving adequate 

hemodialysis. 

The ESRD brochure “Know Your Number” was developed out of this concern. It’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. To ascertain the experience with and obtain the perspectives of facilities’ staff 

regarding the brochure, we randomly surveyed 132 facilities treating hemodialysis patients. 

FINDINGS 

Facilities who received the brochure overwhelmingly reported the brochure includes useful 

information and most said it is somewhat or very easy for patients to understand. These 

facilities said the brochure allows staff to help patients become actively involved in their own 

dialysis, encourages patient compliance with their recommended treatment, and its’ content is 

sometimes being used or will be used in facilities’ educational outreach materials. 

However, 22 percent of facilities reported ~t receiving the brochure. Some who got it, 

didn’t fully disseminate it to patients. Furthermore, we found 21 percent of facilities do ~t 

calculate patients’ URR or KT/V numbers on a monthly basis. Facilities calculating these 

numbers on a monthly basis were much more likely to also distribute the brochure and have 

patients who participate more proactively in their dialysis. This finding clearly highlights an 

important interaction between facility practice and the effectiveness of the brochure. 

i 
DISSEMINATION 

Seventy six percent of facilities repotied receiving the brochure, 22 percent said they did 

not. All but 13 percent of receiving facilities distributed the brochure, half to every patient 

and half to an average of 69 percent of their p~”ents. Brochures were frequently (74 

percent) personally handed to pti”ents, ofien accompanied by an explanation from a 

registered nurse (84 percent). 

Facilities @ fully distributing the brochure said many patients wouldn’t understand the 

brochure’s content or they didn’t receive enough brochures to distribute it more extensively, 

Facilities distributing the brochure most commonly handed the brochure to patients and/or 

placed it somewhere accessible in their facilities. 

Registered nurses provided the majority of brochure explanations, with almost all facilities 

saying at least half or more of their patients appeared alert during their explanations. 

BROCHURE’S EFFECTIVENESS 

Seventy-two percent of facilities rated the brochure’s effectiveness as a patient educti”onal 

tool as either excellent or good, and 66 percent said the brochure was somewhat, or very, 

easy for their pti”ents to understand. 

Forty-six percent of facilities reported most or all of their patients wanted to know their own 

URR or KT/V number after receiving the brochure, and 47 percent said half or more of their 

patients asked questions about the brochure’s content. 

Almost all facilities (98 percent) said patients need to know the information in the brochure. 

Eighty-two percent said a brochure was an appropriate method for communicating this 

information. 

DIALYSIS ADEOUACY 

Facilities sazii at least 50 percent of their patients are interested in the adequacy of their 

dhzlysis, with 29 percent tnzcking their numbem month-to-month. 

Clearly, the brochure’s effectiveness cannot be assessed without considering facilities’ 

practices, and in the process of conducting our study, we found not all facilities calculate 

dialysis adequacy measures on a monthly basis or routinely share them with their patients. 

Only 77 percent of facilities calcukhte p~”ents’ numbers at least monthly, with 21 percent 

doing this only quatierly. Futiher, only 53 percent of facilities ~“ve pti”ents their numbens 

all the time; many do so far less, 16 percent do this less than half the time. 

Facilities who give patients their numbers monthly, or more often, were much more likely to 

have distributed the brochure to every patient and to have patients who track their numbers. 
RECOMMENDATIONS 

Overall, we found the brochure has the potential to serve as an effective part of a broader


strategy of improving patients’ understanding of adequate dialysis and enlisting their support


in monitoring the adequacy of their dialysis. The “Know Your Number” brochure was given


a positive assessment by facilities receiving it. However, the brochure was not received by


all facilities nor was it fully distributed or explained to all patients by all receiving facilities.


It seems clear that the brochure’s effectiveness in educating patients and involving them in


monitoring dialysis still is heavily dependent upon facility practices and the quality of staff-


patient relationships.


Based on our findings, we recommend that HCFA take the following actions to improve


kidney dialysis:


DISSEMINATION. Assure all facilities receive an ample supply of brochures and


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


providing guidelines to facilities on effective dissemination approaches.


BROCHURE CONTENT & FORMAT. Simplify the language and concepts as much as


possible in any subsequent or revised patient brochures. Consideration might be given to


developing alternate versions of the brochure for different reading levels, and to adding


greater use of color and graphics to gain interest and promote patient understanding.


CONTINUING PATIENT EDUCATION. Encourage continuing efforts by facilities to


educate patients and to reinforce the importance of patient understanding and monitoring of


the adequacy of their dialysis. A training video to introduce and/or reinforce the brochure


concepts might also prove effective, based on the suggestions and experiences of some


facilities.


USE OF ADEQUACY MEASURES. Encourage facilities to calculate dialysis adequacy


measures on a monthly basis and to share these numbers with patients on a regular basis, in


order for the brochure to achieve its intended impact on patients and facilities.


Additional OffIce of InsmXtor General Work


A companion report by the Inspector General’s office (OEI-06-95-O0320) provides


information about perspectives of dialysis patients regarding the “Know Your Number”


brochure. The report describes how successful the brochure was 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


highlights how the brochure has helped 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. The report also addresses problems with brochure dissemination, lack of


patient familiarity with dialysis tests used by their facility and with target numbers indicating


dialysis adequacy, even among patients receiving the brochure.


... m 
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 on] y 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. 

iv 
4 

TABLE OF CONTENTS 

PAGE


EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1


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


FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,4


Dissemination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4


Brochure’s Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,8


Dialysis Adequacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14


RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19


AGENCY COMMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20


ENDNOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21


APPENDICES


A: Profiles: Respondent Facility Information and Patient Demographics . . . . . . . A-1


B: Confidence Intervals and Tests for Significance . . . . . . . . . . . . . . . . . . . . . B-1


C: Text ofAgency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-l 
INTRODUCTION 

PURPOSE 

This study describes the experiences of renal dialysis facilities in using the Health Care 

Financing Administration’s (HCFA) “Know Your Number” brochure to educate end stage 

renal disease (EM?D) patients on how to monitor the adequacy of their dialysis treatment. 

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.”3 Over 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.


To conduct oversight activities assuring the appropriateness of services for ESRD patients,


Congress passed the ESRD Amendments of 1978 (P.L. 95-292) authorizing 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 quaMy


indicators.


ESRD Core Indicators Proiect


In 1994 the IZSRD Health Care Quality Improvement Program 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 fwst 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 dialysis using the pre-


and post-dialysis blood urea nitrogen (BUN) levels to calculate the urea reduction ratios


1 
(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) .5’6’7Only 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. 

EM?D 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 EXD “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 also facilities’ experience in using the brochure. In 

addition, we determined how brochures were disseminated and the extent of interaction 

between patients and providers as a result of the brochure’s distribution. We did not aim to 

2

measure any broad-based behavior changes by patients resulting from the brochure due to the 

difficulty of making such causal inferences. 

METHODOLOGY 

Sample selection 

Using the HCFA’s Medical Information System (PMMIS) database, we used simple random 

sampling to obtain two separate samples of 800 hemodialysis patients each in late October 

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

The findings from this survey will be included in a separate OIG report (OEI-06-95-00321 ). 

Using HCFA’s Online Survey Certification and Reporting System (OSCAR) and Medical 

Information System (PMMIS) databases, we used simple random sampling to obtain a sample 

of 150 dialysis facilities in operation prior to October 1995. We surveyed the 132 facilities 

with hemodialysis patients in April 1996. Our response rate for this sample was 86 percent, 

with 113 facilities responding to our survey. Four additional completed surveys came in 

several months after the survey deadline and were not analyzed for this report. 

An analysis of non-respondents versus respondents, based on key facility characteristics, such 

as ownership type, location of facility, number of hemodialysis stations, and the number of 

years with Medicaid/Medicare certification, showed no differences between the two groups. 

A profile of responding facilities and facility staff completing our survey is provided in 

Appendix A. Confidence intervals for specific frequency estimates are provided in 

Appendix B. 

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

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

3

FINDINGS


Facilities who received the brochure overwhelmingly reported the brochure includes useful 

information, and most said it is somewhat, or very, easy for patients to understand. These 

facilities said the brochure allows staff to help patients become actively involved in their own 

dialysis, encourages dialysis time compliance among patients, and its’ content is sometimes 

being used, or will be used, in facilities’ educational outreach materials. 

However, 22 percent of facilities reported ~t receiving the brochure. Some who got it, 

didn’t fully disseminate it to patients. Furthermore, we found 21 percent of facilities do ~t 

calculate patients’ URR or KT/V numbers on a monthly basis. Facilities calculating these 

adequacy numbers on a monthly basis, were much more likely to also distribute the brochure 

and have patients who participate more proactively in their dialysis. This finding clearly 

highlights that there is an important interaction between facility practice and the effectiveness 

of the brochure. 

DISSEMINATION 

Seventy six percent of facilities repotied receiving the brochure, allhough 22 percent said 

they did not. All but 13 percent of receiving facilities distributed the brochure, half to 

every pah”ent and half to an average of 69 percent of their palients. Brochures were 

@equently (74 percent) personally handed to p~”ents, often accompanied by an explan~”on 

from a registered nurse (84 percent). 

A large majority (76 percent) of facilities reported receiving the brochure, while 22 percent 

said they did not receive it and another two percent did not remember receiving it. There 

were significant differences in facilities receiving the brochure based on facility location and 

type. Ninety-three percent of rural facilities reported receiving the brochure compared to 

only 81 and 64 percent of suburban and urban facilities (see table 1). 

Table 1: FACILITIES RECEIVING BROCHURE 

by locationof facility 

Urban area Suburban area Rural area 

Yes 64% 81% 93% 

(30) (25) (28) 

No/Didn’t 36% 19% 

Remember (17) (6) (7; 

4

Additionally, facilities attached to hospitals were more likely (88 vs. 72 percent) to have 

received the brochure than free-standing facilities (see table 2). However, there were no 

differences in the brochure’s distribution based on the size of the facility or the number of 

patients treated. 

Table 2: FACILITIES RECEIVING BROCHURE 

by type of facility 

Free-standing Attached to hospital 

Yes 72% 88% 

(54) (30) 

No/Didn’t 28% 12% 

Remember (21) (4) 

The head nurse and/or dialysis facility administrator most commonly determined whether the 

brochure would be disseminated to patients. Fifty-nine percent of head nurses and 25 

percent of dialysis facility administrators determined whether the brochure would be 

distributed. Additionally, 17 percent of medical directors, along with nine percent of both 

dietitians and social workers, determined the brochure’s dissemination. 

Most facilities hunded the brochure to patients and/or placed it somewhere accessible in their 

facility. 

Seventy-four percent of facilities said they personally handed the brochure to patients, and 13 

percent gave it to family members or a signiilcant other. Although 47 percent of facilities 

reported placing the brochure somewhere accessible in the facility, only seven facilities relied 

exclusively on this method of dissemination. Brochures were most commonly placed in the 

patient waiting room or lobby area, and/or placed on the patient bulletin board. Twelve 

facilities used several of the above methods of distributing the brochure, three facilities let 

the staff decide how it would be distributed, and one facility translated it into Spariish first. 

i%irteen percent of facilities did Et distribute the brochure for a variety of reasons. 

Of the thirteen percent of facilities (11 facilities) not distributing the brochure, two facilities 

didn’t do so because they were either not calculating URR numbers at the time or were 

changing the measure of adequacy reported to patients. Another three facilities mentioned 

planning to distribute the brochure in the future. One facility reported not receiving enough 

copies of the brochure, one needed the Spanish version of the brochure, two facilities were 

still evaluating the brochure, and two facilities reported having tb.eir own “report card” or 

method of reporting URR or KT/V numbers to patients. 

5

Hay of the facilities reported distributing the brochure to every patient, while the other half 

said they distributed it to an average of 69 percent of patients. 

Facilities were split evenly on whether they distributed the brochure to every patient or to 

only a portion of patients. Facilities not distributing the brochure to every patient, reported 

distributing it to an average of 69 percent of their patients. The modal distribution of the 

brochure was 78 percent of patients with a median distribution of 75 percent. 

In two separate patient surveys reported in a companion OIG report (OEI-06-95-O0320), only 

one-third of patients reported receiving the brochure. The discrepancy between the number 

of facilities receiving the brochure (76 percent) and the much lower number of patients 

saying they received- the brochure could be explained, at least in part, by the fact that half of 

the facilities surveyed did not distribute the brochure to every patient. 

For-profit facilities were almost three times as likely (74 vs. 26 percent) to distribute the 

brochure to every patient compared to non-profit or government-owned facilities (see table 

3). There were significant differences in brochure distribution based on the type of facility 

administration. Hospital administered facilities were much less likely (18 vs. 82 percent) to 

distribute the brochure to every patient, compared to non-hospital administered facilities. 8 

Table 3: FACILITIES OWNERSHIP STATUS: 

Facility ownership 

Non-profit/Government 

For-profit 

Facilitv administration 

Hospital administered 

Non-hospital administered 

by distribution 

Distributed to 

every patient 

26% 

(lo) 

74% 

(28) 

18% 

(7) 

82% 

(31) 

PROFIT OR NON-PROFIT/GOVERNMENT 

of brochure 

Dktributed to Brochure not 

some patients distributed 

48% 73% 

(14) (8) 

52% 27% 

(15) (3) 

38% 45% 

(11) (5) 

62% 55% 

(18) (6) 

Among facilities not distributing the brochure to every patient, the most commonly reported 

reasons were: 1) their belief that many patients wouldn’t understand the brcchure’s content 

(54 percent), and 2) they did not receive enough brochures to give one to every patient (37 

percent). Time constraints prevented the distribution of the brochure to every patient 

according to five facilities, while four facilities said they didn’t distribute it because they 

used other education materials instead. Other facilities not distributing brochures to each 

6

patient reported the brochures were placed in the waiting area, they had already discussed the 

material with patients, or said disseminating the brochure was not a staff priority. 

Eighty-four percent of facilities reported they personally expkzined the brochure to patients, 

with registered nurses providing the majon”ty of these explanations. 

Most facilities (84 percent) reported their staff personally explained the brochure to patients.


Eighty percent of facilities said registered nurses provided these explanations. Thirty percent


of dietitians, 18 percent of licensed vocational nurses (LVNS), and 17 percent of social


workers in facilities also provided such explanations. Fifteen percent of doctors and 12


percent of technicians also provided explanations of the brochure to patients. Although


several staff members might have provided these explanations, RNs had the greatest


responsibility.


Facilities reported patients were usually alert but didn’t always ask questions or didn’t appear


to understand staff explanations of the brochure. Almost all facilities (97 percent) said at


least half or more of their patients appeared alert during their explanations. However, only


67 percent of facilities reported patients asked questions during these staff explanations, of


which, 34 percent said only half of patients did so, and 33 percent said only a few.


In our patient surveys (OEI-06-95-O0321), only 49 percent of patients from our first sample,


and 42 percent from our second sample, remembered receiving an explanation of the


brochure’s content, although 84 percent of facilities reported giving explanations of the


brochure to patients. This discrepancy suggests some patients may not have actively listened


to the explanation, or the explanation may have been cursory or low key, and thus


forgettable.


Seventy-three percent of facilities said a few patients didn’t appear to understand the


explanation, while another nine percent said most, or about half, of patients didn ‘t


understand.


The majority of patients, reportedly, were listening during staff explanations, with only 59


percent of facilities saying a few patients weren’t listening. Seven facilities reported a few or


more patients slept through the staff explanation. Additionally, 87 percent of facilities


reported no patients objected to having the information explained to them, while only three


facilities said that about half or more of their patients objected to such an explanation.


Facilities with at least 50 percent of their patients interested in finding out about how


adequate their dialysis is were also significantly more likely to explain the brochure to


patients. Ninety-two percent of facilities with over half of their patients interested in their


adequacy information also explained the brochure, compared to 77 percent of facilities with


fewer than half of their patients interested in adequacy information.


7

BROCHURE’S EFFECTIVENESS 

Seventy-two percent of facilities rated the brochure’s effectiveness as a pti”ent educm”onal 

tool as either excellent or good, and 66 percent said the brochure was somewhat, or very, 

easy for their p~”ents to understand. Almost all facilities (98 percent) said pti”ents need to 

know the informti”on in the brochure, and 82 percent considered a brochure to be an 

approptie method for communicating d to patients. 

Facilities’ ratinm of brochure’s effectiveness.


Twenty-one percent of facilities rated the brochure’s overall effectiveness in educating


patients as excellent, and another 51 percent rated it as good. Twenty-four percent of


facilities felt the brochure did a fair job of achieving this goal, while only two facilities rated


the effectiveness of the brochure in educating patients as poor or very poor.


Typical comments from facilities judging the brochure’s effectiveness as excellent or good


include the following: 1) “(It) was easy to understand with excellent and direct information;”


2)	 “Makes the patient and family aware of the need for adequate dialysis;” 3) “It was a good 

introduction to this topic and assisted staff in presenting information;” and 4) “Quick selflearning and backed up with concept we try to sell to patients. ” 

A sampling of comments from facilities finding the brochure much less effective for 

educating patients listed several concerns: 1) “Doesn’t address 24 week therapy, diabetes, 

residual function...;” 2) “The patients who most need information are the same ones who 

struggle to understand...;” 3) “Only some patients are interested;” 4) “Language is too 

sophisticated for most of our patients; 5) “Mainly due to mismanaged distribution methods;” 

and 6) “Patients receive so much written material already, they don’t pay attention... ” 

Facilities rating the brochure as excellent for educating patients were much more likely to 

report more of their patients were interested in adequate dialysis. For example, facilities 

rating the brochure as excellent reported 75 percent of their patients were interested in 

adequate dialysis. In contrast, facilities who did not give the brochure an excellent rating 

reported only 52 percent of their patients were interested in adequate dialysis (see table 4). 

Table 4: PERCENT OF PATIENTS REPORTED INTERESTED IN ADEQUATE DIALYSIS 

by facilities rating the brochure as excellent 

Facility rated brochure as excellent Average percent of patients interested in adequate dialysis 

Yes I 75% 

No I 52% 

Additionally, facilities rating the brochure as excellent in educating patients reported almost 

1.5 times more of their patients track their URR or KT/V numbers from month to month 

(see table 5). 

8

Table 5: PERCENT OF PATIENTS IN FACILITIES REPORTED 

TRACKING THEIR URR OR KT/V NUMBER MONTH TO MONTH 

by facilities rating the brochure as excellent 

I 

Average percent of patients 

Facility rated brochure as excellent tracking number 

Yes I 40% 

IINo I 27% 

Facilities also were more likely to rate the brochure as excellent if their patients had been 

undergoing dialysis for a longer period of time (see table 6). 

Table 6: AVERAGE MONTHS PATIENTS ON DIALYSIS PER FACILITY 

by facility rating of brochure 

Facility rated brochure as excellent Average months patients on dialysis 

Yes 55 

No 41 

Facilities’ ratimm of brochure’s understandability. 

Sixty-six percent of facilities thought the brochure wa somewhat, or veq, easy for mos~ of 

their patients to understand. 

The majority (66 percent) of facilities reported the brochure was either somewhat (38 

percent), or very, easy (28 percent) for most patients to understand. Eighteen percent said it


was neither easy nor hard to understand and, 14 percent said it was somewhat hard to


understand. ~ facilities said the brochure was verv hard to understand and only one facility


reported not knowing how well patients understood the brochure’s contents.


Our patient surveys (OEI-06-95-O0320) showed an even higher number of patients (84


percent) thought the brochure was somewhat, or very, easy to understand. However, the


inability of many patients to accurately recall key brochure concepts tempers their high


ratings of ease of understanding the brochure somewhat.


Ten facilities reported most of their patients found the brochure’s content somewhat hard to


understand, citing several reasons for this difficulty in patient understanding. Six facilities


found the use of the terms URR and KT/V too confusing, and five facilities said patients


were unclear what number the brochure was talking about. Four facilities said the


brochure’s reading level was too high, and three facilities said the brochure’s content was too


advanced for their patients.


9

Facilities reporting the brochure as very easy to understand served patients with an average 

of 15 more months experience on dialysis (see table 7). Such a correlation suggests that 

patients undergoing dialysis for longer lengths of time may be more interested in or receptive 

to the brochure’s content. 

Table 7: AVERAGE MONTHS PATIENTS ON DIALYSIS PER FACILITY 

by facility rating of brochure 

Brochure rated as very easy to understand Average months patients on dialysis 

Yes 56 

No I 41 

Forty-six percent of facilities reported most or all of their patients wanted to know their own 

URR or KT/V number afier receiving the brochure, and 47 percent said hay or more of their 

patients asked questions about the brochure’s content. 

Forty-six percent of facilities reported most or all of their patients wanted to know their own 

adequacy numbers after receiving the brochure. Forty-seven percent of facilities also 

reported about half or more of their patients asked questions about the brochure’s content. 

However, 33 and 40 percent of facilities reported onlv a few patients wanted to know their 

own UR.R or KT/V numbers and/or asked questions after receiving the brochure, with six 

and three facilities, respectively, reporting none of their patients did either of these things. 

Eighteen percent of facilities reported about half or more of their patients requested more 

information about their treatment, while 55 percent of facilities said only a few patients did 

this after receiving the brochure. Additionally, 22 percent of facilities said no patients made 

such an inquiry. 

However, far fewer facilities reported any negative reaction to the brochure. Only 11 

percent of facilities reported about half or more of their patients threw the brochure away 

without reading it, and 42 percent said only a few of their patients did this. Only ten percent 

of facilities reported about half or more patients were nt interested in the brochure’s 

information. Fifty-eight percent of facilities reported only a few patients were @ interested 

in the brochure’s information, and 13 percent of facilities said that none of their patients 

were ~t interested in the brochure’s content. 

Facilities’ ratimzs of the inmortance of brochure’s content. 

Almost all facilities (98 percent) said patients need to know the information in the brochure, 

Clearly, there is almost unanimous facility support of the adequacy information discussed in 

the brochure. Further, the two facilities disagreeing with the brochure’s content said this 

was only because they had not seen a copy of the brochure or were already including this 

information on each patient’s monthly lab report. 

10

Almost all facilities had something positive to say about why the brochure’s content provided 

critical information. The majority of these explanations stressed the importance of teaching 

patients to be actively involved in their dialysis, and noted the brochure could reinforce staff 

educational efforts and help patients better understand why they might have to increase their 

treatment time on the dialysis machines. 

Specifically, the following comments represent the enthusiasm facility staff expressed about 

this information: 1) “More educated patients (are) more proactive and more responsible in 

their care...;” 2) “Encourage(s) compliance with attendance and patients to stay on prescribed 

times...;” 3) “Encourages patients to be more informed and take more responsibility, ” 4) “So 

patients will/can appreciate need for full time on dialysis;” 5) “The brochure helps reinforce 

information given by us;” 6) “The more (educational) information, the better;” and 7) “The 

more patients know about their illness, the better control they can have. ” 

Facilities’ ratinm of using a brochure as educational tool. 

Eighty-two percent offacilities reported a brochure is the method they would have used to 

communicate this information to patients, while 17 percent said they did Wt support the 

brochure as the method they would have used. 

Facility staff supporting the brochure as the method they would have used to inform patients 

said this because the brochure is compact, to the point, easy to read and distribute, and gives 

patients and families a chance to review the information at a later time. 

Others said the brochure was one of several methods they would have used, especially for 

their literate English-speaking population. A few staff also said they would supplement the 

brochure with a staff explanation of the information. Many staff members expressti the 

importance of visual aids and charts, such as the one in the brochure. 

The following comments are typical of facility staff views on the usefidness of the brochure 

as an educational tool: 1) “They (patients) needed to see printed educational material to 

believe it’s true;” 2) “Quick, self-learning and backed up concept trying to sell to patients;” 

3)	 “Easy to reach all patients and we use them in our new patient orientation packets;” 4) 

“Was easy to understand - colors were good in attracting patient attention;” 5) “Best way to 

get information to patients;” 6) Important they look at and refer back to;” and 7) “Good 

teaching tool if individually given, otherwise not sure... ” 

Facility staff less supportive of using a brochure said they would have used a videotape 

instead, especially for less literate patients. Others would have used a computer-generated 

table of this information, or relied on individual verbal, face-to-face teaching, instead. 

11

Facilities’ use of the brochure in educational outreach materials. 

i%irty percent of facilities reported they are already using the brochure or brochure’s content 

in their educational outreach materials; others have plans to do so, and gave some plausible 

explanations why they have not. 

Almost one-third of facilities used the brochure in their educational outreach materials, 

mostly by including the material in their patient newsletter or using it in an educational inservice training, or to educate new patients. Other facilities used the brochure in teaching 

families, posting it on the patient bulletin board, and in reviewing the material with patients 

when going over monthly lab report cards. 

Although 70 percent of facilities did not report including the brochure’s content in their 

educational material, 31 of 55 facilities specifically explained why they had not included the 

brochure or it’s content in their outreach efforts. 

Specifically, twelve facilities indicated they have no newsletter or educational outreach 

materials. Seven facilities were planning to include the brochure in their future outreach but 

four facilities said they had no need to do so. They feel handing the brochure out to all 

patients was enough, or that they continuously explain this information monthly. Four 

facilities said they haven’t had an opportunity due to time constraints. One facility displayed 

the brochure in their lobby area. One facility didn’t include the brochure because the 

language was too sophisticated for most of their patients. 

Facilities’ innovative methods in educating Datients. 

Facilities use a variety of innov~’ve methods to educate ESRD pti.ents about their 

treatment. Such innovative methods include using videotapes during patients’ dtiysis 

tre@nents, bulletin boards, posters, or wall chatis; along with educational cbsses, inservice trm”ning, newsletters, and monthly repoti cards. 

Videotape was the most frequently mentioned (ten facilities) method used to educate patients


about their treatment. Videos can be used during patients’ treatments and assure all patients


better understand the material, even those with reading difficulties. One facility was using


videos produced by local physicians and featuring their own patients.


Four facilities reported an innovative use of bulletin boards, wall charts, and patient incentive


programs to improve dialysis treatment, Other facilities conduct patient in-service training,


educational classes, and/or use a theme of the month to focus staff and patients on a


particular topic. Facilities also employ monthly newsletters, report cards, and one-on-one


teaching to educate patients about their treatment.


Four facilities conduct educational meetings before new patients first begin their treatment to


help them better understand their future dialysis treatment. Two facilities use current


patients to teach their new patients.


12

Facilities’ recommendations for future educational initiatives. 

Facilities recommended thti future brochures for ESRD palients should be simplified, use 

lkyman ’s terms, and include more pictures, diugrams, and bright colors. Additionally, 

facilities recommended providing a larger supply of brochures so facilities can distribute 

them to every pti”ent. 

The majority of recommendations made by facilities (13 facilities) for future brochures for 

ESRD patients involved the presentation of the brochure’s content. Facilities recommended 

brochures not be too detailed, but instead include; catchy titles, more visual explanations, 

more graphs, and larger type for visually impaired patients. Additionally, facilities 

recommended creating a separate brochure for patients with lower reading levels. One 

facility wanted the “Know Your Number” brochure to leave blanks on the recommended 

level of URR or KT/V numbers so facilities could assign higher levels for their patients, 

while one facility wanted to see the brochure split into two brochures, one discussing URR 

and one discussing KT/V. 

Seven facilities recommended printing the brochure in additional languages, with the majority 

requesting Spanish brochures. These facilities apparently were not aware HCFA has already 

produced a Spanish version of the “Know Your Number” brochure which it will distribute 

shortly to facilities. 

Six facilities recommended improvements in the distribution of future brochures, mainly by 

assuring they receive a larger supply of brochures; one for each patient, plus extras to 

display in certain areas of the facility. One facility reported confusion about how the 

brochures were distributed to patients. This facility never received the brochure and was told 

by their network that the brochures were mailed individually to patients. One facility 

recommended all staff members be informed prior to distributing the brochure to patients. 

Six facilities wanted to see additional brochures on various topics that help patients improve 

their compliance and overall treatment. Recommended topics included: fluid compliance, 

phosphate binders, and calcium intake. 

The creation of educational progmm videos for both patients and staff was recommended by 

two facilities, while one facility wanted to see follow-up material to the “Know Your 

Number” brochure, including a more in-depth explanation and a larger graph. 

Lastly, two facilities suggested continuing communication from dialysis facilities to assure 

new patients receive introductory information about dialysis and the role of networks. 

13

DIALYSIS ADEQUACY 

Facihlies smii ai least 50 percent of their pah”ents are interested in the adequacy of their 

diulysis, with 29 percent tracking their numbers month-to-month. However, only 77 

percent of facilities calculate pm-ents’ numbers d least monthly, with 21 percent doing this 

only quatierly. Further, only 53 percent of facilities ~“ve p~”ents their numbers all the 

time; many do so far less, 16 percent do this less than half the time. 

An average of 57 percent of patients from all facilities were reported to be interested in 

finding out how adequate their dialysis is. The modal percent of interested patients was 50 

percent, with a median of 60 percent of patients interested in knowing the adequacy of their 

dialysis. 

The majority of facilities (77 percent) calculate patients’ URR or KT/V numbers at least 

monthly, but 21 percent of facilities calculate such numbers only on a quarterly basis, and 3 

facilities calculate adequacy numbers only as ordered by the doctor or other staff members. 

Free-standing facilities were more likely to report more of their patients are interested in 

jinding out abou~ the adequucy of their dialysis and were also more likely to calculate 

patients’ adequacy information on a monthly basis, compared to hospital-based facilities. 

Free-standing facilities were more likely (61 vs. 42 percent) to report half or more of their


patients were interested in finding out how adequate their dialysis is, compared to hospital-


based facilities. Free-standing facilities were also three times more likely (76 vs. 24 percent)


to calculate patients’ adequacy numbers at least monthly compared to hospital-based


facilities.


Facilities who calcukzte their patients’ numbers monthly or more oj?en were much more likely 

to have distributed ~he brochure to every patient. 

Of facilities reporting they distributed the brochure to every patient, 87 percent said they also 

calculated patients’ URR or KT/V numbers at least on a monthly basis. In contrast, of 

facilities distributing the brochure to just some of their patients or to none at all only 62 and 

64 percent, respectively, calculated patients’ URR or KT/V numbers at least monthly. 

(see table 8) 

Table 8: FREQUENCY OF CALCULATING PATIENTS’ URR OR KT/V NUMBER 

Number calculated 

Monthly or more 

Less than monthly 

by distribution 

Dktributed to 

every patient 

87% 

(33) 

13% 

(5) 

of brochure 

Distributed to 

some patients 

62% 

(18) 

38% 

(11) 

Brochure not 

distributed 

64% 

(7) 

36% 

(4) 

14

Facilities with patients averaging 14 months longer on dialysis (48 months vs. 34 months) 

were significantly more likely to calculate and share patient URR or KT/V numbers on a 

monthly basis (see table 9). 

Table 9: AVERAGE MONTHS PATIENTS ON DIALYSIS PER FACILITY 

by facilities giving monthly URR or KT/V numbers to patients 

I 

Number calculated monthly I Total months patients on dialwis 

Yes I 48 

No I 34 

Although 53 percent of facilities said they give patients their URR or KT/V numbers all the 

time, muny facilin’es reported doing so far less, with 16 percent giving this information less 

than half of the time. 

The majority (53 percent) of facilities report giving patients their URR or KT/V numbers 100 

percent of the time, while 27 percent give this information only 75 percent of the time. Nine 

percent of facilities say they give this adequacy information to patients only half of the time, 

and seven percent of facilities only do so 25 percent of the time. 

Four percent of facilities never give patients information about their URR or KT/V numbers. 

Two facilities gave the following reasons for not sharing this information: 1) “Most 

outpatients are very sick. We are a hospital-based unit, ” and 2) “Most patients are not 

interested or didn ‘t understand URR or KT/V at the time the brochure came out. ” 

In our patient surveys (OEI-06-95-00320), we found only 45 percent in our first sample and 

35 percent in our second sample identified the URR test as one used in their dialysis facility 

to measure the adequacy of their dialysis, with even fewer identifying the KT/V test (37 and 

36 percent). Additionally, about one-quarter of all patients sampled said they did not know 

which test(s) were used by their dialysis facility to measure adequacy. 

Free-standing facilities were twice as likely (64 vs. 32 percent) to give patients their URR or 

KT/V numbers 100 percent of the time, compared to hospital-based facilities. 

Of facilities distributing the brochure to every patient, 73 percent also say they give patients 

their URR or KT/V number 100 percent of the time, compared to 43 and 36 percent of 

facilities distributing it to a portion of their patients or not distributing the brochure at all. 

(see table 10) 

15

Table 10: FREQUENCY PATIENTS GIVEN URR OR KT/V NUMBER 

by distribution of brochure 

Frequency number given 

100% of time 

50-75 % of time 

25% of time to never given 

Distributed to Dktributed to 

every patient some patients 

73% 43% 

(27) (12) 

19% 46% 

(7) (13) 

8% 11% 

(3) I (3) 

Brochure not 

distributed 

36% 

(4) 

27% 

(3) 

36% 

(4) 

Facilities reporting higher percentages of patients interested in adequate dialysis also were


significantly more likely to give patients their URR or KT/V number 100 percent of the


time, than facilities reporting patients with lower interest in adequate dialysis. Facilities


giving adequacy information 100 percent of the time were over 1.5 times more likely (64 vs.


41 percent) to also report patients were interested in adequate dialysis (see table 11).


Although we don’t know whether patients are more interested in adequate dialysis because


they are more frequently given this information or visa-versa, an observable correlation


exists between these variables, suggesting the importance of both of these important


elements.


Table 11: PERCENT OF PATIENTS IN FACILITIES REPORTED 

INTERESTED IN ADEQUATE DIALYSIS 

by frequency patients are given URR or KT/V number 

I 

Frequency of patients given Average percent of patients 

URR or KT/V # interested in adequate dialysis 

100 % of time	 64% 

(55) 

50-75 % of time	 54% 

(39) 

25% of time to 41% 

never given (11) 

16

Significant differences also existed in the frequency with which some facilities gave patients 

their URR or KT/V numbers based on the percentage of Hispanic patients and patients of 

other backgrounds, such as Indian, Lebanese, and/or Hawaiian/Samoan (see table 12). 

Facilities with a higher proportion of these patients were much more likely to not give their 

patients adequacy information on a regular basis. Additionally, near significant differences 

existed based on the percentage of black patients per facilities. Facilities distributing 

adequacy information only 25-50 percent of time also had a majority of black patients, 

instead of a majority of wbite patients. 

Table 12: FREQUENCY PATIENTS GIVEN URR OR KT/V NUMBER 

by distribution of patients by race 

I Dktribution of patients 

in facilities by race 

Frequency # given 

100% of time 

75% of time 

50% of time 

25% of time 

Never 

‘%White % Black % Hispanic % Asian % Other 

47% 44% 5% 2% 2% 

47% 33% 14% 5% 1% 

38% 44% 1% 3% 14% 

30% 56% 5% 7% 2% 

54% 17% 26% o% 3% 

Facilities reported an average of 29 percent of their patients track their URR or KT/V 

numbers j?om month to month; patients given ~his information all the time are signljicantly 

more likely to track their numbers. 

Vast differences existed in the percentage of patients tracking URR or KT/V information 

from month to month, as reported by facilities. Just under one-third of facilities reported ten 

percent or fewer of their patients track this information, with the median number of patients 

who track their number being 25 percent. Nevertheless, the largest number of facilities (19 

percent) reported 50 percent of their patients track adequacy information. 

Facilities reporting higher percentages of patients tracking URR or KT/V numbers on a 

monthly basis also were signitlcantly more likely to also be facilities who report they give 

patients this information all the time (see table 13). Facilities giving this information 100 

percent of the time averaged 35 percent of their patients tracking adequacy information, 

compared to only 25 and 14 percent of facilities giving this information 50-75 percent of the 

time or less. 

This correlation reinforces the importance of facilities giving this information to their patients 

every time it is calculated, so that patients can actively participate in their dialysis care. 

17

Table 13: Percent of patients in facilities reported 

tracking URR or KT/V number from month to month 

by frequency patients are given URR or KT/V number 

Frequency of patients given URR Mean of patients 

or KTIV # 

100% of time 

50-75 % of time 

25% of time to 

never given 

tracking number 

35% 

(49) 

25% 

(35) 

14% 

( 7) 

Facilities regulurly share patients’ phosphorus, potassium, albumin, and B. U.N. test results 

with them. 

In addition to facilities sharing information about patients’ URR or KT/V test results, 98 and 

97 percent of facilities reported they regularly share phosphorus and potassium test results 

with patients, while 95 and 93 percent share patients’ albumin and B. U. N results. Thirtyfive percent of facilities also share patients’ HCT/Hematocrit test results, while 29 percent 

give patients their calcium test results regularly. The protein catabolic rate is shared with 

patients by 25 percent of facilities and iron test results are shared by 15 percent of facilities. 

Additional test results regularly shared with patients include: creatinine, glucose, 

cholesterol, ferritin, and Hgb/Hemoglobin. The only facility reporting they do not share test 

results with patients regularly also said only 10 percent of their patients were interested in 

adequate dialysis. This same facility said it calculates URR and/or KT/V numbers on a 

monthly basic but never shares these test results with patients. 

Additionally, the results of our surveys (OEI-06-95-O0320) showed patients most frequently 

identified the potassium test (60 and 61 percent of patients) and the phosphorus test (55 and 

58 percent) as being used by their dialysis facility to measure adequacy, rather than the URR 

or KT/V test. 

18

RECOMMENDATIONS 

Overall, we found the brochure has the potential to serve as an effective part of a broader


strategy of improving patients’ understanding of adequate dialysis and enlisting their support


in monitoring the adequacy of their dialysis. The “Know Your Number” brochure was given


a positive assessment by facilities receiving it. However, the brochure was not received by


all facilities, nor was it fully distributed or explained to all patients by all receiving facilities.


Facilities receiving the brochure were receptive to the brochure’s content, reporting it was


essential information for patients to understand. Nevertheless, facilities varied greatly in how


they embraced the brochure’s concepts in practice, with some fully engaging patients in


understanding their own adequacy information by calculating their URR or KT/V number on


a monthly basis and regularly giving these numbers to patients, while others provide key


adequacy information to patients far less often. Yet, when facilities do provide this adequacy


information, it appears to increase patient interest and involvement in monitoring the


adequacy of their dialysis. It seems clear that the brochure’s effectiveness in educating


patients and involving them in monitoring dialysis adequacy is heavily dependent upon


facility practices and the quality of staff-patient relationships.


Based on our findings, we recommend that HCFA take the following actions to improve


kidney dialysis:


DISSEMINATION. Assure all facilities receive an ample supply of brochures and should


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


providing guidelines to facilities on effective dissemination approaches.


BROCHURE CONTENT & FORMAT. Simply the language and concepts as much as


possible in any subsequent or revised patient brochures. Consideration might be given to


developing alternate versions of the brochure for different reading levels and to add greater


use of color and graphics to gain interest and promote patient understanding.


CONTINUING PATIENT EDUCATION. Encourage continuing efforts by facilities to


educate patients and to reinforce the importance of patient understanding and monitoring of


the adequacy of their dialysis. A training video to introduce and/or reinforce the brochure


concepts might also prove effective, based on the suggestions and experiences of some


facilities.


USE OF ADEQUACY MEASURES. 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.


19

AGENCY COMMENTS 

The Health Care Financiag 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 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. 

20

EN DNOTES


1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

“lltle 42 CFR 4(H. 2 lW, Conditions tor Coverage ot”Suppliers ot”ESRD 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 permanent y 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. 

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 NIH 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 

Strong linkages exist between facilities’ ownership type and the way they are 

administered. Over three-fourths (79 percent) of the non-profit/government-owned 

facilities are also administered by a hospital, while only one for-profit facility was 

administered by a hospital. 

21

APPENDIX A 

RESPONDENT FACILITY PROFILE 

Kev facilitv characteristics 

Sixty-seven percent of our facilities were free-standing, while 30 percent were attached to a


hospital, and three percent were part of a clinic or medical complex. Sixty-five percent of


facilities were non-hospital administered and 35 percent were hospital administered. The


majority (56 percent) of responding facilities were for-profit, 39 percent were not-for-profit,


and five percent were government facilities.


Forty-three percent of dialysis facilities were located in urban areas, 29 percent in suburban


areas, and 28 percent in rural areas. Our responding dialysis facilities had an average of 16


dialysis stations, ranging between two and eighty. The median number of dialysis stations


was 13.


The average length of participation in Medicare/Medicaid for responding facilities was 11


years, with four facilities participating for only one year and eight facilities participating for


20 years. The mode for our facilities was 19 years (27 facilities) and the median was 11


years.


Patient education resDonsibifities


Sixty-four percent of responding facilities had a primary person in charge of patient


education. Eighty-nine percent of facilities listed registered nurses as the position primarily


responsible for patient education, while 66 and 59 percent of facilities, respectively, listed


the dietitian and/or social worker as having this role. Doctors provided patient education in


43 percent of facilities, dialysis facility administrators in 21 percent, technicians in 34


percent, and LVNS in 26 percent of facilities. Other staff members playing a primary role in


educating patients include the education or inservice coordinator and the director of nursing.


Three facilities specifically mentioned that everyone in the facility or a specific staff team is


in charge of patient education.


FACILITY PATIENT DEMOGRAPHICS 

Average age of patients 

The average estimated age of ESRD patients from responding facilities was 58 years old, 

with a range of patients between the ages of nine and 75. The mode and the median age 

estimated by our facilities was 60 years old, with 24 percent of facilities reporting 60 as their 

average patient age. 

A-1

Months patients on dialvsis 

Facilities reported their patients spent an average of 45 months on dialysis, with one facility 

ranging from patients only spending an average of one month on dialysis compared to 

126 months on dialysis in another facility. The mode number of months patients spent on 

dialysis was 24 months, with a median of 37 months. 

Patients’ disability level 

Facilities estimated that an average of 22 percent of their patients have a disability that limits 

their ability to read or understand information. Two facilities reported none of their patients 

had limiting disabilities, while 59 facilities said less than 24 percent of their patients have a 

disability. Five facilities reported 75 percent or more of their patients had disabilities that 

limit their ability to read or understand information. However, 21 facilities reported between 

25-49 percent of their patients had reading or comprehension disabilities and another 15 

facilities said 50 percent or more of their patients had these disabilities. 

Educational level 

Seventy-eight percent of facilities reported information about their patients educational level. 

Facilities varied greatly in the educational level of their patients (see table 1). The highest 

percent of patients (43 percent) had high school diplomas. The average percent of patients 

with less than a high school education was 42 percent. Far fewer patients had some college 

(9 percent) or college/professional degrees (5 percent). 

Table 1: PATIENT EDUCATIONAL LEVELS IN RESPONDING FACILITIES 

Average % of 

Patients’ educational level patients Minimum % Maximum % Median ‘% 

Less than high school 42% o% 100% 24% 

(3) (1) 

High school diploma 43% o% 100% 40% 

(3) (2) (6) 

Some college 9% 60% 5% 

(;: (1) (12) 

College or professional degree 5% o% 40% 4% 

(21) (1) (2) 

A-2

Racial Composition of Patients 

One hundred and five facilities reported the racial composition of their patients. White 

patients represented the largest racial group (45 percent). Black patients represented 40 

percent of patients in responding facilities (see table 2). 

Table 2: PATIENT RACIAL COMPOSITION IN RESPONDING FACILITIES 

Average % of 

Patients’ racial composition patients Minimum % Maximum % Median % 

Wl_ite 45% o% 100% 40% 

(lo) (4) (11) 

Black 40% o% 100% 40% 

(11) (2) (6) 

Hispanic 7% o% 100% o% 

(57) (1) (57) 

Asian 3% o% 57% o% 

(72) (1) (72) 

Other 3% o% 69% o% 

(83) (1) (83) 

FACILITY STAFF RESPONDENT PROFILE 

Sixty-seven percent of our facility surveys were completed by just a single respondent, while 

two staff members completed 16 percent of our surveys, and three surveys were completed 

by a team of three. Our surveys were most frequently completed by registered nurses (47 

percent), while facility administrators completed 20 percent. Dietitians completed 15 percent 

of the surveys, with social workers and director of nursing or nurse managers completing 13 

percent. Clinical coordinators completed six percent of our surveys. 

Of the 25 facilities completing the survey in teams of two or three staff members, the most 

common combination of staff was registered nurses and the director of nursing, or the 

facility administrator and registered nurses. 

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: POINT ESTIMATES AND CONFIDENCE INTERVALS FOR KEY QUESTIONS. 

95% CONFIDENCE 

QUESTION POINT ESTIMATE INTERVAL 

Proportion of facilities receiving the brochure. 

Overall 76% 68.1% - 83.9% 

Urban 64% 50.3% - 77.7% 

Suburban 81% 67.2% - 94.8% 

Rural 93% 83.9% - 100% 

Proportion of facilities handing brochure to patients. 

74% 64.7% - 83.3% 

Proportion of facilities distributing brochure to every patient. 

50% 38.5% -61.5% 

For-profit facility ownership by distribution of brochure. 

74% 60.1% - 87.9% 

Hospital administered facility by distribution of brochure. 

18% 5.8% - 30.2% 

Proportion of facilities providing an explanation of brochure to patients. 

84% 75.6% - 92.4% 

Proportion of patients in facilities appearing alert during the staff explanation. 

59% 46.3% -71.7% 

Proportion of facilities rating brochure as excellent or good. 

72% 61.9% - 82.1% 

Proportion of facilities rating the brochure as somewhat or very easy for patients to understand. 

66% 55.0% - 77.0% 

B-1

Table 1: CONT. 

95% CONFIDENCE 

QUESTION POINT ESTIM.4TE INTERVAL 

Average percent of patients interested in finding out about adequate dialysis. 

57% 51.4% - 62.6% 

Proportion of facilities calculating patients’ URR or KT/V number(s) at least monthly. 

77% 59.9% - 84.8% 

Proportion of facilities calculating URR or KT/V number(s) monthly by type of distribution of the	

brochure.	

Type of distribution:	

All patients 87% 76.3% - 97.7%	

Some patients 62% 44.3% - 79.7%	

No patients 64% 35.6% - 92.4%	

Proportion of facilities giving adequacy information to patients 100 percent of the time.


53% 43.4% - 62.0% 

Proportion of patients in facilities tracking their adequacy numbers monthly. 

29% 24.4% - 34.4% 

Proportion of facilities giving patients their potassium test results regularly. 

97% 93.8% - 100% 

B-2

TESTS FOR SIGNIFICANCE 

Differences between the way facilities responded to the survey; whether they thought the 

brochure was excellent or not, whether they thought it was very easy to understand or not, 

and whether they calculated patients’ URR or KT/V numbers at least on a monthly basis or 

not, were tested for significance for several questions. The table below shows the difference 

between groups and the resulting value when a t-test was performed. 

Table 2: TESTS FOR 

I 

in facilities 

dialysis 

in facilties 

KT/V 

SIGNIFICANCE FOR KEY QUESTIONS. 

I 

RATED BROCHURE AS EXCELLENT 

YEs NO T VALUE r 

75.1% 52.3% 2.89-

40.1% 27.1% 1.42 

55 months 41 months 2.05= 

RATED BROCHURE AS VERY EASY 

TO UNDERSTAND T VALUE 

YEs NO 

55 months 41 months 1.90-

URR OR KT/V # CALCULATED AT 

LEAST MONTHLY T VALUE 

YEs NO 

48 months 34 months 3.13-

QUESTION 

Average % of patients 

interested in adequate 

Average % of patients 

tracking their URR or 

numbers monthly 

Average months patients 

dialysis per facility 

QUESTION 

Average months patients 

dialysis per facility 

QUESTION 

Average months patients 

dialysis per facility 

on 

on 

on 

‘ 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 
� 

.. .. -et,.,4 ..” 

. Health Care Finaw!na Administra$i”n . DEPARTiMENT OF HEALTH & HUMAN SERVICES : 

5- d 

-“*,,,,mTd .p--- The Admln!strator 

Washlfigtfw. O C. Poml 

DATE: 

To 

FROM 

Administrator 

SUEU-ECT: Ofiw of hpccux @ncd (OIG) ~ Rqort%: “~OW Your Nutnhr”

Brochure - Pempcctiws of Dia.I@s Paricnts (OEI-06-9S40320) and 

“IGmw Your Numb& Brochure - E~cncu of Dinlysis Faciiiri~ 

(oEL06-95-tM321) 

We reviewed the almw-r&rcnced reports which examine the cfl%tj~m~ of the Hea?th 

Care Fmcing Administration’s End Sragv H D&ax wqzax-n . 

. 

Our detiki cwnmenti on& report rt#uuneadations arc attached fur yOur 

cousid-cration. Thank you for tix oppxtuni~ to review andmmmentm thee rupm. 

Anachmcnt 
Commenfi of the Health cue FiIIanchz Adrninistiation U-ICFA) on


Offlcc of Inspector Gened (OIG) Draft Reports:


“how Yow Number” Brochure - Perspectives of


Dialysis Patients, (OEI-06-95-00320) and “Know Your Number”’ Brochure ­


~xueriences of Dialysis Facilities. (OEI-06-95-0032 1]


“fiow YOW Number” Brochure - Perspectives of Dialvsis Patients. (OEI-06-95-0032U,) 

OIG Recommendation 1 

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

patients. 

HCFA Resuonse 

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. Impossible, future distributions will be a combination 

of direct mailing to patients and bulk mailing to facilities. 

OIG Recommendation 2 

HCFA should build on the patienth.ff relationship in order to improve patient 

understanding of urea reduction ratios md tie ufea kinetic modeI and the importanc~ of 

achieving adequate dialysis. 

~CFA Response 

We concur. The patientistaff relahonship is critical to t-he improvement of a patient’s 

understanding of end-stage rend disease (ES~). Most patients rely on their c~e 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 suggeshons on successful ways to use the brochure 

in patient education would support paticntistfiff dialogue as well as patient empow-erment. 

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

occur. 
Page 2 

<’ Know Your Number” Brochure - Exucriences 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 facdities on effective dissemination approaches. 

HCFA Responsq


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 provided long


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


on the list, To the extent possible, future mailings will be done from the most ~urrent


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


they send an ample supply to all facilities added to their Network rolls afier the mailing


list was created,


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


American Association of Kidney Patients, National Kidney Fotmdatio~ American


Nephrology Nurses Association National Renal Administrators’ Association, ESi7 ~


Network Forum and National Association of Nephrology Technicians) in the


development and distribution of the brochure, as well m alerting the renal communi~- to


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


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


brochures to their membership. The initial bulk mailing to facilities was accompanied by


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


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


facility support are 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 commwtity. We will consider developing facili~ guidelines


describing brochure disbibution 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 Recommendation203 roclmre Content and Format) 

HCFA should simpli~ the language and concepts as much’as possible in any subsequent 

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

versions of the brochure for different reading levels and to add greater use of color mi 

graphics to gain interest and promote patient understanding 

J-iCFAResuonse 

We concur. We appreciate the concern expressed regarding the language and concept ~


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


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


needs the concepts explained fi.u-ther. Consideration can also be given to developing


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


permit. Development of numerous versions of the brochure does not guarantee that all


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


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


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


that the brochure supply and the need would coincide.


In considering reaching rend patients Witi information about adequacy of dialysis. the


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


bl-ochure 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 t}w


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


distribution list


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


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


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


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


visually stimulating if at all possible.

Page 4 

91G NQQXIYIKEndation 3 (Continuirw Pah‘ent Education)

HCFA should encourage continuing cfforts by facilities to educate patients and rcinfbrce 

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

A training video to in~oduce ardor reinforce the brochure concepts might also prove 

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

We concur. If tiding 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 see the 

concepts or at least hear the concepts. SupportirIg patientistaff dialogue wotild still be 

needed, 

In additioz since facifi~ staff, in conjunction with the patient are required to 

periodically review and update the patient’s care p}a~ perhaps staff can be encouraged to 

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

address any concerns about the information in the brochure, 

OIG R ecomm endation 4 (’U e of AdequacvMea sures) 

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

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

achieve its intended impact on patients and facilities. 

HCFA / Re S?ons e 

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

dialysis at prescribed intemls, Although the re}ised ESRD Conditions for Coverage, 

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

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

facilities coWi.nuous quality improvement program. 

The Facilities of Achievement Miative will dernonstiate, 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 prulicipating facility for use in developing quality improvement interventions. The 

clinical indicators of the care received will be submitted to HCFA on a quarterly 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 ESRI) progr~ but also American Indims 

and Mican-Amcricarts are represented in the population disproportionately, 

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

publication. TM is particukidy important considering the huge Hispanic community 

affected by ESRD.