Introductions:
Lou Diamond – Medstat
Linda Golodner - NCL
Kathryn McDonald – Stanford
William Sullivan - CMS
Larry Bostian
- NCL
Helen Wu - NQF
Mary Jo Goolsby
– AANP
Francesca Cunningham – VA
Paula Griswold –
Rebecca Burkholder – NCL
Alison Rein – NCL
Nancy Ostrove
– FDA
Jean Slutsky
– AHRQ
Jeremy Grimshaw
– OHRI
Laurie Feinberg – CMS
Susan Raetzman
– AARP
Allen Vaida
- ISMP
Objective of themeeting
LD:
What is the nature of the
group?
What is the nature of the
challenge?
Subjects for Consideration:
Inpatient
/ outpatient
OTC
/ prescription
System
/ patients
Communication
and education
LD:
What would a clearinghouse
look like?
How would we operationalize such an initiative?
What is the scale of the
initiative from a resource point of view, and how would funding be achieved?
KM:
What is going to be coming
out of the meeting?
LD:
A document describing the
various dimensions of the project, with some description of funding
requirements
Will then need to identify
sources for securing the funding
Guidance from group about
funding sources and how to proceed will be solicited
SR:
What is specific about the
gap that we are trying to fill?
LD:
No formal gap analysis to
inform the discussion, but hope to get some of that from the group
Synthesized?
SR:
LD:
Should the focus be on high-risk
scenarios?
Subset of
the population?
AV:
Are high risk situations
fully defined?
Do we know where the focus
will be?
LD:
Will have to touch on those
issues today, as we try to operationalize the
clearinghouse
AV:
Taking the 4 initiatives,
action is more for consumers, but change is more for systems
LD:
Yes, but the clearinghouse
could be for both
WS:
Good to know / keep in mind
what the problem is, so that the solution will match the problem – might not
wind up where we want to be. Also, whenever there is a process, want to outline
the process – so, where along the line is the “big payoff?” Is it at the prescription level?
Where are the payoffs that
have the largest potential benefit?
LD:
Coalition did go through the
process of defining the problem of medication use in the elderly. Did not go through medication process steps to identify where the
majority of the problems were occurring – done on an interactive basis, but not
formalized. Purpose of today’s
meeting is to define scope of the clearinghouse. It might be that, at the end of today, we
need to do some of that work to move forward.
Background – AHRQ
Experience with CPG Clearinghouse
JS:
Clinical Practice Guideline
Clearinghouse Discussion – focus of overuse versus underuse.
Process Flow
Mid 90s – feeling that there should be a clearinghouse
What would such a thing look like?
Wanted to identify why there was a clamor to
centralize standards – clinical practice guidelines
Form of the clearinghouse should be virtual (web
based):
·
Easily updated
·
Not paper based
Was developed on a platform that was web enabled
Formed
coalition to get buy-in from numerous guideline-issuing organizations (AMA and
AAHP)
Was
in place for 5 years, and guided decisions about scope and i
Wanted to insert directive guidance so that updating
of guidelines would be considered - Maximum limit of 5 years
Have seen a shift in the content of the clearinghouse
from new to updated guidelines
Scope of clearinghouse:
·
Set priority list
(similar to IOM)
·
Costly
·
Controversial
·
Large impact on
public programs
Abstracted
same fields to enable comparison across guidelines
·
In similar
disease areas
National
Quality Measures Clearinghouse
Quality
tools
·
Houses national
healthcare disparities report
·
Can search on
contents of quality tools
Mature
versus new?
·
250,000 visits
per month for a mature clearinghouse
·
NQM clearinghouse
(new) – 4 to 6 thousand visits per day
Have
created PDA downloads and real-time feeds to facilitate use
LG:
How
do individual consumers know about/access these clearinghouses?
JS:
Free
and open to the public, but no consumer-specific documents
Quality
Tools: only recently live on the web, but plan campaign
NO:
Have
had 4 “customer satisfaction” surveys
Web
based
High
level of satisfaction – 80-90%
NO:
Has
there been any thought to survey the target population?
JS:
Yes,
have i
Penetration
is still very low, but hard to capture
Weekly
email sign up that issues notices – goes to about
26,000 people, but also gets distributed beyond that.
LG:
Do
the other 2 clearinghouses have partners?
JS:
No,
just AHRQ
Each
one of the clearinghouses has a panel of experts who meet to advise
on i
Also
developed a nome
PG:
How
many staff were required to launch clearinghouse? How many to maintain?
JS:
She
was the staff for development/design
Was
conceived by one director of AHRQ and developed by another
Jean
developed scope of work and had contractors build system platform
Worked
with national library of medicine
Required
medical librarians and physicians to work on technical staff
Have
now developed links to reference other sources
Now
have “wish list” of enhancements to implement as budget permits
Defining
the scope of the clearinghouse - Discussion
LD:
One
lesson is that we need to recognize that clinical practice guideline (CPG) is
in fact a definable product – has some level of boundaries – synthesized
literature that points to what “should be.”
Can be defined along a number of dimensions.
Issues:
·
What we may be
getting into could be much less definable
·
Iterative process
that changes over time
JS:
What
is a quality tool?
Have
established criteria that likely will change over time
LD:
What
is CPG scale?
JS:
1.25
million (roughly)
WS:
Most
people don’t understand that AHRQ is an incredible organization – does all of
this work with fewer than 300 people. Do a lot with little resources
JG:
Need to define parameters
Want
to raise 2 issues: Crucial decision points
·
Evidence base or
all-i
o
Preference is to
look at more limited sphere to ensure that we “know it works”
o
Need to draw
boundaries to optimize integrity of the clearinghouse
o
How much/little
do we want to constrain?
o
Even with
rigorous i
o
Can think of
arguments for both, but want to make sure that they are considered
LD:
Going
back to AHRQ report, how many had to meet evidentiary i
JG:
How much should be explicitly evidence driven?
LD:
Do
search out guidelines in AHRQ clearinghouse
KM:
Only evaluated if there was evidence that it worked.
HW:
Also
i
There
is a lot we can do, but there is a real difference between clinical and
practice guidelines
Running
into several similar issues:
·
What is a
practice?
·
What audience is
targeted?
·
How do we capture
what’s good?
JS:
Difficult
issue of whether you want to think about “best” practices – Once you put
something is in your clearinghouse, people think that it has been endorsed by
you
It is, therefore, very important to define a priori
what is i
WS:
Cochran
collaboration in
PG:
Might
be important to have 2 categories:
·
One that is for
“good” practices
·
Another that is
for practices in the “test phase”
Would help organizations review progress and
synthesize information from others before you get to a “stamp of approval”
What
does Quality Healthcare.org do?
LD:
Don’t
want to give people the impression that there is evidence, even when there is
not?
Must find some way to convey level of evidence
Can
you declare it?
JS:
Discussed i
May
not get the people in the middle – get comments from those who either love it or
hate it.
Need
to have some parameters, but don’t want to stifle innovation in the field.
Want
to set a floor, but not set the bar too high.
AV:
Documents
say “safe” not “best”
Really have stayed away from using the “best” term. Want to ensure
use of safe practices, but that does not mean it’s the “best” practice
KM:
Evidence
about hand washing, but also evidence about getting people to wash their hands
– how do you get it to happen
Speaks
to the nebulous nature of considering a “practice” as opposed to a clinical
guideline
Struggled
with what the practice trying to achieve?
What is the target?
This
automatically creates some structure
If
you ask for that kind of pairing, you define the structure in a more meaningful
way
LD:
What
percent of guidelines is submitted versus called for?
JS:
95% submitted and 5% called for
LD:
Expects the reverse for different systems.
CPG
clearinghouse is, in large part, a passive set of activities – pulls it
together and then lets it sit.
JS:
Depends
on how you describe passive.
Have
created computerized clinical decision support list serve – work to get
information from clearinghouse into their systems in “real time” (XML, PDA, RSS)
LD:
What
are the copy write provisions?
JS:
Full
text by developers
Summaries
by AHRQ – request use of citation
JG:
Route
suggested by LD has implications.
Don’t
know yet whether many of the practices in use are best or safe.
LF:
For
the surveys of practices, can have people passively look for those. But if you have a more critical need, you can
be more active in providing that information
SR:
Struggling with idea of having two-tiered systems:
even if you have different levels of evidence, it makes sense. Need to think
hard about what we’re trying to accomplish.
AHRQ
was really trying to push the field, but that might not be the case for
development of safe practice guidelines?
Are we trying to figure out what is less versus more promising?
Individual
experience might open the door to very product oriented interventions, which
may lead down a more commercial path.
LD:
Larger
group of coalition has discussed the issue of pushing the field versus defining
what is known. The group (coalition)
really wants to facilitate change, so managing that expectation is a challenge
– very complex
PG:
What’s
hard with safe practices is not what to do, but how to get people to do it –
what are the implementation challenges?
o
Helpful tips
o
JS:
Critical point, because now there is a direct link to
implementation strategies from clearinghouse
KM:
Can
you take the techniques and get people to actualize them – moving toward higher
level of knowledge – why do you think you know what you know?
FC:
Agrees with PG. Biggest challenge for them is
implementation. The VA is still a
diverse system, so implementation in one area may not be as advantageous in
another area – speaks to need to target evaluation to relevant area or
population. Need to determine how best
to implement AND how best to measure.
LD:
Wants
to answer generic question about what the scope of the clearinghouse should
be. Please write it down and we will
capture on the screen.
JG:
Are
we talking about scope or purpose?
LD:
Start
with purpose and then get to the scope
NO:
Are
we in agreement about who this is supposed to be targeted to?
LD:
This
is a piece of the broader question of purpose.
Purpose
statements
SR:
Without
knowing size of universe, ideally would like this to identify approaches that
exist for improving safe use of medicine in outpatients
To
convey what we know about:
Practice
Adoption
of practice
And that the level of evidence is communicated
Impossible
to imagine a situation in which consumer would NOT be audience, but obviously
would involve providers and pharmacists – full team
LF:
Not a
lot to add now, but the methods will be almost as important as the target.
Might be several different ways to communicate proper
way to do something.
May be methods that can be generalized.
JG:
Information resource for stakeholders, consumers, providers, industry
Develop
educational initiatives targeted at stakeholder groups
Develop
communication/dissemination mechanisms
JS:
Accessible, centralized place to locate information on established and evolving
information in safe and effective use of pharmaceuticals in delivery of care
NO:
Easily
accessible source of health care practices that could maximize safe and
effective medication use by elderly at-risk populations
Would i
Primary
audience is health care providers, with patients as secondary target to inform
them about practices that HCP should be implementing.
AV:
Audience
has to be practitioners
Consumers
are important, but want to encourage system change
Focus
should be on change:
Should look at risk management pieces, and other types
of things that are change oriented.
Looking
at base of the system that will inform next steps (e.g., education)
PG:
Agrees
with a lot of what was said
Wants an audience of consumers as well.
Wants
to accomplish the purpose of shared learning and virtual exchange of ideas
Creating
that opportunity may accelerate improvement.
FC:
Clearinghouse
will provide guidance by serving as source of safe and appropriate use of
medications commonly prescribed to elderly population
Wants
to focus on multiple audiences: Providers, Elderly consumers
Want
to identify safe practices for high-risk populations
Look
at drug-drug interactions
Duplicate
therapies – especially where there are multiple care providers
Change
in therapy/dose adjustment – problems of how to guide practitioners/patients on
how to do this safely
MJG:
Centralized
resource with evidence based information about how to provide safe care
Multiple
audiences with varying communication tools
HW:
Why:
consumer misuse of medication
Who:
providers, at least initially
Consumers
would be targeted at some point in the future
How:
centralized resource – not guidance per se, but just another resource (passive
as opposed to motivated to achieve change)
KM:
Audience:
those who want to “fix” safety gaps – those who have seen a failure and are
empowered to make change
Distinction
of providers versus consumers is more relevant if you think in terms of groups
able to get information out there
Purpose:
Provide information to help them make changes – must have information nuggets
that are: sorted, real-time, synthesized, and structured
Would
be market driven in thinking about design and communication strategy
WS:
Agrees
with concept of marketing approach
LD:
KM
input has brought in a different perspective
JG:
Can
be a long-term process of development of processes that will help a range of
stakeholders
Role
for Federal level of policy making
May
get some key questions from consumer perspective
JS:
Let’s
say what we want to achieve, and not specify target audience at this
point. Scope can always be changed, but
purpose is more static
Comments
on scope of clearinghouse
LD:
Additional
comments about project scope/description?
SR:
Audience:
Thinks that there is a role for consumers or consumer organizations.
Not
just because they are target of behavior change, but also because they need to
know what to expect from health care providers.
Agree
that there could be a role for information in the clearinghouse that contributes
to safe and appropriate use – not necessarily a practice, but useful
information
Sense
that “broad” is ok
LF:
Has
to deal with multiple points in the system
(eg.,
Provider, manufacturer) Need to list solvable problems, and then methods for
doing so (Matrix)
JG:
Like
multi audience and matrix notion
Want
evidence based system (with synthesis), but allow for information-sharing forum
Is
synthesis a component – no, trying to i
Every
time a new study is introduced, the synthesis and guideline may need to be
updated
LD:
Not
opposed to availability of individual studies to lay public, despite potential
for over reaction
JS:
Do we
want best practices on individual pharmaceutical use, or should it cut across
diseases? How do we organize the system:
·
Where is it
implemented (where in intervention chain)
·
By disease
·
By classification
of pharmaceutical
Also agrees that principles of systematic review
should be used to aggregate what we know
JG:
How do you slice the cake?
Too narrow: no studies or single studies, which
diminishes evidence base
Too broad: not useful
NO:
Agrees with purpose statement…
Given that, 3 major issues:
·
Focus on HCP as
primary, important that it be translated in such a way that consumers can
understand what to expect
·
Must be some way
to i
·
Need to address
needs of target audience
o
Don’t really ask
target population what they want
AV:
Wants to refocus on “safe” not “best” practices
PG:
Wants to focus on previously identified stakeholders –
higher evidence standard for consumer level access of information
Should be evidence basis, but so many things are not
in the literature. May be in experiential phase, but not written up in peer
review.
Would want to see those practices i
Want implementation tips – what makes something
successful, more cost effective, etc.
Has concern that intervention evaluations don’t
disaggregate idea from management – doesn’t necessarily mean that the idea is
bad.
JS:
Often times, implementations fail because of the
system barriers. Clearinghouse role can
be to identify those barriers
WS:
Example of penicillin as “failed intervention” because
no one wanted to take the new drug – be a guinea pig
FC:
Want access to available evidence in a systematic and
appropriate way.
Many things are in progress. Could identify projects as such so that
information could be shared
MG:
Want broad scope, but think that there needs to be a
starting point – small chunk
HW:
Want to keep it fairly broad
I
JG:
May miss key pieces of
information if you start off with too narrow a focus – elderly, high-risk,
etc…Available studies may i
Inpatient versus outpatient?
Can focus on one, but can use information more broadly
where it applies. May
be both.
WS:
Interesting thing about quality...
How do you know if it’s a quality hospital?
Will the deliverable be a web-based tool – yes.
KM:
4th dimension of population in a more
general way
LG:
Thinks of food side:
where are the alerts that consumers would need? There are critical points when you need to
take a certain action – those should be identified and i
Operational model of the clearinghouse
LD:
Good discussion of purpose and scope
Doesn’t see a great deal of discrepancy
Will share comments and extract synthesis to come up
with one coherent statement of purpose and scope. Will circulate for feedback and discuss as
necessary. Will be an iterative process.
What is the operational model?
1)
Public - private
sector partnership
a.
Funding
b.
Scope
c.
Buy in
2)
Criteria for
operational confidence
KM:
Buy-in – also need to ensure that it is used. Want to test out various models to make sure
that it is known about and used. This is
enhanced by participation in design process.
Should i
NO:
Can’t rely on funding from HCP groups, but may be able
to collaborate with provider group that would be most interested in
contribution and use. Want to be
perceived as a valuable resource. Also
need pharmacy professionals.
SR:
Is there a reason why pharmacy groups or practices are
not present? Were not able to make it to
this meeting; not an intended exclusion as both groups are interested.
LD:
Should this be sitting within the public sector?
JG:
National Patient Safety Agency in the
David Cousins – follow up to learn more about the
initiative
HW:
What are the criteria for housing?
-conflicts of interest
-access
National Quality Forum as possible place to house it
PG:
Housing should be determined in part by funding source
WS:
Cochrane collaboration?
Money is the message
Who would be interested?
JG:
Can process of synthesis be outsourced?
KM:
Only if there is a fundamental understanding about why
synthesis is important and critical to partnership
LD:
Operational Competence:
· Efficiency
· Content Expertise
· Methodological Expertise
· Technical Expertise
PG:
Want organizational expertise – real world implementation
skills
SR:
Would clearinghouse rely on technical expert panel?
LD:
On one level, it is only as good as the panel you
convene and the ability of the staff to implement panel recommendations.
NO:
There are a series of academic institutions that may have
operational competencies to house the clearinghouse (CERTs)
JS:
Is the resource open and free?
JS:
Capabilities statement of
organization to do the work versus governance of who would oversee the work
process.
AHRQ came up with requirements, and then awarded
contract based on ability to perform tasks
LF:
Governance is more critical to specify a this point –
different models
JS:
Could SOS Rx serve as governing body?
AV:
Leapfrog example – wanted someone to run a site, but
didn’t have funding so it is still hanging in the balance.
LD:
SOS Rx is volunteer organization – not an entity.
NCL is spearheading activity of coalition
Need to define what the initiative could be, at some
level more specific than what we have currently.
SOS Rx could not house clearinghouse, despite
funding. Want to find “home” for the
clearinghouse and determine funding needs.
KM:
Want to compile enough detail to pull together a
funding request document
LD:
Governance piece –
Private, government, foundation, or some combination
PG:
What is the organizational/business model?
Need funding in perpetuity, not just initial seed
money.
JS:
Task in first RFP – turn fully government-funded
process into privately funded entity
Scrapped the idea, as it was impossible to see a
business plan that didn’t have access fees, which ran counter to mission
AV:
Want non-profit group to provide credibility that is
not biased toward one sector.
Governance model
LD:
Entity with all these competencies managing the CH,
and governance by expert panel
If we were to put together a steering committee that
would define and change scope of the clearinghouse, what organizations would be
on the committee? For NGC –it was health
plans and AMA.
AV:
A subgroup of SOS Rx plus representation from
pharmacy, academia, pharmacists
JG:
Important to disseminate information to stakeholders
and keep them involved.
PG:
If we want this to be used it is important to keep all
the groups engaged.
LD:
Funding, steering committee, expert panel, possibly a
sub-panel with other stakeholders - these could be all part of the
clearinghouse
Coordination and integration with other similar
efforts
LD:
This project is focused on medication use - not only
safety, elderly - not all patients, and outpatient - not inpatient.
Need to discuss other best practices related to safety
NQF has 30 safe practices covering a wide range of
safety issues, not just medication.
HW:
Summary of NQF project - Looking at
prescription medications. Wanting to design safe
practices targeting outpatient arena.
Looking at all the safe practices in existence and
sort through them to figure out scope and criteria. Commissioning two papers and will hold
workshop in the fall with all stakeholders.
Will look to see if there is enough information out
there to endorse a set of outpatient safe practices.
The project is similar to this clearinghouse
idea. Will determine
after information is gathered if there is enough to proceed forward.
Have issued a call for practices.
PG:
Timing for this project?
HW:
Within this year
If the science is there will proceed
forward. Workshop is in the fall. Looking at practices
part of general population, but will look at those practices effective with
low-lit population.
AV:
What is different from SOS Rx CH?
Would it be safe to say NQF is doing this?
LD:
As projects evolve, need to ask if scopes are
different? End goal – CH of information with multiple end users. SOS Rx project is still evolving.
Not sure how to integrate unless you have a clearly
defined project. Unable to say now that
they are two different projects, or the same project
JG:
This CH – a long-term project. The evidence
base is changing, and will continue to change.
Not a single topic area, but a long-term update required.
FC:
Mail order pharmacy – raises patient safety issues. VA
established systems approach to track errors.
75% are mail order prescriptions – need a good system for tracking. Need to look at safe practices from every
angle. VA has used
LD:
Need understanding of what organizations are
doing. A “to do” list
coming out of this meeting which will i
JG:
NQF is distinct from the SOS Rx
Budget and process
LD:
What we have done today is framed some of the issues
that need to be looked at more carefully.
Will seek input from panel. SOS
Rx will be seeking a partner to operationalize
this. A scope document is needed, an
RFP, and a review panel to select a partner.
Scale of this project is around 1 to 1.5 million
annually.
JS:
We have not decided if a virtual CH or paper
LG:
Could it be both?
Mostly virtual, but also some opportunity for paper
for certain consumers.
LD:
What form of paper?
Need to find a way to distribute.
JG:
Need to determine the model of the