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 OIGS 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. 
OEIS Dallas Regional Oftlce prepared this report under the direction of Chester B. Slaughter, 
Regional Inspector  General. 
Project staff included: 
DALLAS  REGION  HEADQUARTERS 
Michelle Adams,  Ph. D.  Mary Beth Clarke 
Ruth Ann Dorrill  Brian Ritchie 
Karen Erickson,  Intern  Barbara Tedesco 
Sarah Taylor 
Judy Tyler 
Nancy Watts 
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  Administrations  (HCFA)  Know  Your 
Number  brochure  in educating  them  about  a way  to monitor  the  adequacy  of their 
dialysis. 
BACKGROUND  AND  METHODOLOGY 
By Medicares  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  Workgroups  report,  conducted  as 
part  of HCFAs  and  the  18 contracting  ESRD  Network  Organizations  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 
facilitys  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  pments  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  brochures  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  brochures  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,  HCFAs  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  brochures  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  brochures  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  brochures  content,  along 
with  stressing  the  importance  of the  material. 
Additional  Office  of Ins~ector  General  Work 
A companion  report  by the  Inspector  Generals  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 KT/V  numbers.  Additionally,  it 
highlights  educational  strategies  used  by facilities  to better  inform  patients,  and  provides 
recommendations  on  the  creation  and  distribution  of future  educational  brochures,  as well 
as facility  activities  to educate  and  involve  patients  in monitoring  the  adequacy  of their 
dialysis. 
... 
111  AGENCY  COMMENTS

The  Health  Care  Financing  Administration  (HCFA)  concurred  with  all the  reports

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  Foundations  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  HCFAs

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 HCFAs  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  brochures  distribution. 
BACKGROUND 
By Medicares  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.  23Over  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  patients  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  isnt  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  projects  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  projects  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).57  Only  43 
percent  of the  studys  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 projects  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  brochures  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  brochures  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  brochures  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  samples  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  HCFAS  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  brochures  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 brochures 
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  HCFAs  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  Analyms 
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  Chi-
square  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  Presidents  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 
brochures  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) 
Dont  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,  pahent 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  one
quurter 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  Seeond  Sample 
Potassium  test	 60%  61% 
(23 1)  (193) 
Phosphorous  test	 55%  58% 
(212)  (182) 
BUN	 53%  55% 
(204)  (173) 
Urea  Reduction  Ratio  (URR)	 45%  35% 
(171)  (111) 
KT/V  37%  36% 
(143)  (113) 
Clearance  32%  29% 
(122)  (90) 
Dont  Know  I  23%  I  26%
(89)  (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  dont  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  facilitys  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  occumng 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  6:  PATIENTS  KEEPING  TRACK  OF  PERSONAL  URR  OR  KT/V  NUMBER 
by	 those  knowing  URR  or KT/V  target  number 
Second  Samde 
Knew  URR  or KT/V  D]d Not  KIIOW 
Target  Number  Correct  Target  Number 
Yes  57%  43% 
(27)  (20) 
No  48%  52% 
(40)  (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 patients  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 brochures 
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  Correct  Target  Number 
Patients  finding  brochure  easy  to understand 
Yes  55%  I  45% 
I  (33)  (27) 
No  31%  69% 
(15)  (33) 
Patients  finding  brochure  very  useful 
Yes  52%  I  48% 
I  (36)  (33) 
No  28%  72% 
(9)  (23) 
Likewise,  patients  finding  the  brochure  very  helpful,  more  often  (52 percent)  correctly 
identified  the  URR  or KT/V  target  number  than  those  ~  finding  the brochure  helpful  (28 
percent,  see table  8).  Signtilcantly,  an even  higher  percent  (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,  ptients  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 brochures  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. 
II  Table  9:  PATIENTS  UNDERSTANDING  OF  BROCHURES  INFORMATION 
Second  Sample 
Very  easy  to understand  58% 
(68) 
Somewhat  easy  to understand  I  26%
(31) 
Neither  easy  nor  hard  to understand  I  12%
(14) 
I 
Somewhat  hard  to understand  3%
(4) 
II I 
Very  hard  to understand  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
 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  BROCHURES  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  IDENTIFIED  BY PATIENTS  AS THOSE  USED  BY THEIR 
DIALYSIS  FACILITY  TO  MEASURE  ADEQUATE  DIALYSIS 
Comparison  of first  and  second  sample  results 
by brochure  receipt 
First  Sample  Second  Sample 
No  No 
Brochure  Brochure  Brochure  Brochure 
Potassium  test  58%  63%  64%  54% 
(144)  (75)  (128)  (60) 
Phosphorous  test  54%  56%  62%  48% 
(134)  (67)  ( 124)  (53) 
BUN  55%  50%  57%  51% 
(135)  (60)  (114)  (56) 
Urea Reduction  Ratio  (l-RR)  39%  58%  31%  43% 
(95)  (69)  (62)  (48) 
KT/V  34%  44%  32%  43% 
(84)  (53)  (63)  (48) 
Clearance  32%  31%  29%  26% 
(79)  (10.1)  (57)  (29) 
Dont  Know  29%  13%  28%  23% 
(72)  (16)  (56)  (26) 
Other  9%  13%  8%  12% 
(23)  (16)  (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  BROCHURE 
by those  knowing  URR  or KT/V  target  number 
Second  Sample 
Knew  Target  URR  Did  Not  know 
Reeeived  Brochure  or KT/V  Number  Correct  Target  Number 
Yes
 43%  57% 
(47)  (62) 
No
 19%  81% 
(34)  (147) 
Dont  Remember
 9%  91% 
(5)  (51) 
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  Didnt 
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 Didnt  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  No 
Brochure  Brochure  Brochure  Brochure 
Yes  81%  91%  75%  95% 
(198)  (106)  (184)  (111) 
No	 19%  9%  25%  5% 
(47)  (11)  (63)  (6) 
PATIENT/STAFF  RELATIONSHIP 
E%epatient[staff  relationship  emerged  as an  impotiant  element  in patient understanding 
of adequate  dialysis  and  the  successful  use  of the  brochure. 
Staff  discussions  of adecmate  dialvsis. 
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).  Fifty-
three  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)  (6) 
I 
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 receiwngadvice 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 brochures  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  brochures  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 brochures  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  staffs  explanation.

  43 percent  reported  the  staff just  explained  the  brochure.

  6 percent  reported  they  did ~t  understand  the  staffs  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  brochures  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  pahent 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  brochures  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  brochures  content,  along 
with  stressing  the  importance  of the  material. 
22
 AGENCY  COMMENTS 
The  Health  Care  Financing  Administration  (HCFA)  concurred  with  all the  reports

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  Foundations  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  HCFAs

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

patients  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 HCFAS  comments.

23
 EN  DNOTES

1.  Title  42  CFR  405.2102,  Conditions  for  Coverage  of Suppliers  of FWH3  Services, 
October  1993;  pg.  127. 
2.  Hemodialysis  therapy  cleans  and  filters  a patients  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. 
3.  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 patients  peritoneal  membrane  of the  abdomen  to filter  their  blood, 
requiring  a catheter  to be permanently  placed  into  their  abdomen.  Wastes  are 
filtered  from  a patients  body  once  the  dialysate  is drained.  There  are  three  types 
of peritoneal  dialysis,  with  Continuous  Ambulatory  Peritoneal  Dialysis  (CAPD) 
being  the  most  common. 
4.  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. 
5.  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). 
6.  Consensus  Development  Conference  Panel.  Morbidity  and  mortality  of renal 
dialysis:  An  N_Ill consensus  conference  statement.  Ann  Intern  Meal,  1994;  121: 
62-70. 
7.  Renal  Physicians  Association.  Clinical  practice  guideline  on adequacy  of 
hemodialysis:  Clinical  practice  guideline,  number  1.  December,  1993 
8.  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  didnt  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  brochures  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  brochures  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  hadnt  gotten  around  to completing  the  mail  survey;  and 
4) four  patients  didnt  complete  our  survey  because  they  had ~t  received  the  brochure 
and  thought  they  didnt  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-
I  I 
Patients  told  test  results  by dialysis  staff 
44%  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 kuq)ccToftied  (OIG) thaft  Rqmrts: 
Of%w  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!ions  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 patients 
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 Pabent 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 patients 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 Measures) 
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.