Professional Documents
Culture Documents
3, 2001
The authors are affiliated with the University of Texas-Houston Medical School and
the Harris County Psychiatric Center.
Address correspondence to Patricia M. Averill, University of Texas-Houston Harris
County Psychiatric Center, 2800 South MacGregor Way, Houston, TX77021.
215
exhaust tlieir beneiits. Hou,ever. after and the Celter for Ment:rl Health Ser- ald enrployer-spolsored health insurance
vices of the Substance Abuse and Mental in 1999-2000: I. limits. Psychiatric Senices
adjustrnent fbr severlty of illness, hvo 51:1361,2000
Health Sen'ices Adniilistration. Halold
managed care variables-being sub- Alan Pincus, M.D., aud Deborah A. 6. Weissmal E, Pettigrerv K, Sotsky S, et al:
ject to a forrliulary and having ref'er- Zarin, NI.D., are co-prilcipal investigatols 'Ihe cost of irccess to mental health services
rals restricted to selected hospitals or of tlie Practice Research Network. rvltose irr uralaged care. Psychiatric Services 51:
specialist panels-rvere still assclciat- rnembers contributed their tirne to partic- 66,+-666, 2000
ipate in this study.
ed rvith an effect of'financial consid- 7. Natiorral Advisory Nlental llealth Courrcil:
erations on the provision o{'optirri:rl Parity inFinancirrg Merrtal Health Ser-
References vices: Nlarraged Care Efl'ects ol Cost, Ac-
treatment.
1. Buck JA, Uurlanci B: Ciovering rnental cess, ald Qualitv Rockville, Md, National
These results suggest that longitu- hrstitute ol NIental [{ealth, 1998
health and substalco abuse services.
dinal research is needed to more rig- Health AIIairs 16(,1):120-126, 1997
8. Stunn R, NlcCulloch J, Goldman \\I: Men-
orously chartrcterize the specific fi- tal health and substance. abuse parity: a case
nancial considerations and how they
2. Health Care l'lan Desigl alcl Cost fields:
1988-1997. Washington, DC, Hay Clrr-rup, study ol Ohio! state enployee program.
affect treatrnent, sucli as lr4iich med- i998 Joulnal r,rf Mental Health Policy and Eco-
nornics I0:129-13,{, 1998
ications or other speci{ic tretrtluents
3. Findlay S: Managed beLarioral health care
rvere substituted or changed and the in 1999: arr irrdustrl,at n crossroads. Health 9. Fralk RG, Morlock LL: \{anaging Frag-
quality and outcones o{' care ulti- Af{airs 18:116-124, 1999 rnelte<l Public Health Serwices. Nerv York.
Milbank Memorial Fuld, 1997
mately pror.ided. I 4. Jensel GA, Nlorrisey MA, Gaflney S, et al:
The leu, dominance of rnanaged carc; in- 10. Pirrcus HA, Zarin DA, Tanielian TL, et al:
Acknowledgments surarce trends in thc 1990s. Health Affairs Psvchiatric patielts and treatrnents in I997:
16( l ):1 25-i36, 1997 {indings iiorn the Arnerican Psychiatric
This study u,trs suppoftecl bt'the Jolui D. Practice Research Nehvork. Archives of
ald Catherine T. NlacArthur Forurdation 5. Sturm R, Pacula Rf,: lVleltal health paritv General Psychiatry 56:441-449, 1999
tDx BRAIN
lnpatient Patient approvals
Ambulatory Care Demographics Research
Registration
Protocol Protocol inclusion/
Specialized care Treatment Scheduling Managment exclusion criteria
settings Consent to contact
Consent to bank sample lnformed Consent
Genomics
ublications Proteomics
External Communitv activities lmaging
Collaboration Public edutational
Biomarkers
6vents
Physician groups
Specialty care providers Molecular and Human Genetics
and care givers Cancer Center
Breast Center
Tissue banks
Disease risk
identification
Centricity Health monitorino
Treatment effectiVeness lnteroperablo extraction
Prognoses I
stanaarai=J3ols HL7
Diagnostic screening Communication
and testing protocools CDISC
Con necti v ity_ tech nology
Encryptron ancl
abstraction
Study Manager
Electronic data capture
and transmission Population based risk
assessment
integrated safety Clinical outcome
Anonymized
capture and modeling
Practice guidelines
study projoct and financial Translational Science to
data interoperability clinical care
between BCM and Collaborative research
government agencies (FDA, Graduate training
NIH), clinical research program
networks and other Patient education
collaborative research programs
partners
Performance Improvement Plan
Developing a
strategy for OOR
Assurance and
Compliance
Objective
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Things to be considered first
1.
$gt"e on a practical definition of performance
improvement
"Do the right thing, the first time"
2. Aglree to goal
Goal I
"Continually and by increments, improve the way's
we assure compliance with human subject
research protections while proactively
supporting the Baylor research community"
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Things to be considered first, cont'd
Assigned lo
commiftee by
analyst
A. St otq(stions led
to devlop the actual
mea$re B. StofqusstioEused
to devolop ih aclual
measure
C. SetofqustioB used
to develop th6 aclual
masurg
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Things to be considered first, cont'd
a lnformed Consent
a
o #H
a
a o A statement that the study involves research, an explanation of the purposes ol the research and the expected duration of the subject's
participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
a o A description of any reasonably foreseeable risks or discomforts to the subject.
a o A description of any benefits to the subjects or to others that may reasonably be expected from the research.
a o A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
a o A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and notes (if
applicable) the possibility that the FDA may inspect the records.
o For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any
medical treatmenls are avarlable, if injury occurs and, if so, what they consist of, or where further information may be obtained.
o An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to
contact in the event of a research-related injury to the subject.
o A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is
otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is
otherwise entitled
o When the additional elements of information for informed consent forms are required as set forth in VA and other Federal regulations.
- o a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may
become pregnant) which are currently unforeseeable;
- o anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
- o any additional costs to the subject that may result from participation in the research;
- o the consequences of a sub.ject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- o A statement that significant new findings developed during the course of the research which may relate to the subject's willingness lo continue
participation will be provided to the subject; and
- o the approximate number of sub.jects involved in the study.
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Things to be considered first, cont'd
Goal 2
"MinLmLZe or reduce opportunities for adverse
impact"
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Things to be considered first, cont'd
Goal 3
"Improve efficiency, using both people and material
resources more effectively and productively"
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Things to be considered first, cont'd
Goal 4
"Minimrze or eliminate duplication"
Goal 5
IrtrorrndCorcertr
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Things to be considered first, cont'd
Goal 6
"Meet external pressure for accountability:
Secure Accreditation"
1122t2003
Step 2 The Organizatton
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Step 3 Develop a written Action Plan
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Step 3 Develop a written Action Plan,
cont'd
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Step 3 Develop awritten Action Plan,
cont'd
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Step 3 Develop awritten Action Plan,
cont'd
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Step 4 - Identify resource
needs
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StepSand6-Rolesand
education
o Step 5
Determine specific roles and responsibilities
o Step 6
Inform and educate
- What you are doing and *hy
- Document current process of protocol review
- Create consistency in the process review
- Monitor the stability of the research support process
- Identify areas for improvement and continuing education
- Develop a measurement program that incorporates ongoing
accreditation data collection for longitudinal tracking
1l22l2AO3
Step 6 - Education
o Inform and educate, cont'd
New techniques and tools
o BRAIN
o Reports
o Data
o Accreditation
o Benefits of effective, integrated
processes
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Step 7 - Implement
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Cu rrent Accompl ish ments :
o Where we are now.
Process map for protocol review r/
Agree on quality measures and performance measures {
Design data collection methodology {
Determine, sample size for measures and inter-rater
reliability{
Determine prior[ties for administrative review
enhancementsr/
o Document guiQance to be used to prevent "Return to PI"
process stdp{
o Re-prioritize needed enhancements to BRAIN {
o ldentify educational enhancements and overlays in BRAIN {
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Work in progress:
o What remains to be done
Add accreditation standard notations to process map
Match current checklists elements with process map
Create data collection tools
Validate data collection tools with process map and checklists
Create database
Test data collection tools
lnitiate pilot
. Prospective data collection
o Retrospective data collection
- Data and Safety Monitoring plans
- Placebo controlled trails
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