Supporting Statement A for
Office of Clinical Research Training and Medical Education/Clinical Center
The Impact of Continuing Medical Education on Physician Practice.
Date
Contact: Linda Wisniewski
Address: 10 Center Drive/1N252B
Bethesda, MD 20892-1352
Telephone: 301-402-4843
Fax: 301-435-5275
Email: wisniewskil@cc.nih.gov
Table of contents
A. JUSTIFICATION
A.1 Circumstances Making the Collection of Information Necessary
A.2. Purpose and Use of the Information COLLECTION
A.3 Use of Information Technology and Burden Reduction
A.4 Efforts to Identify Duplication and Use of Similar Information
A.5 Impact on Small Businesses or Other Small Entities
A.6 Consequences of Collecting the Information Less Frequently
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency
A.9 Explanation of Any Payment of Gift to Respondents
A.10 Assurance of Confidentiality Provided to Respondents
A.11 Justification for Sensitive Questions
A.12 Estimates of Hour Burden Including Annualized Hourly Costs
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record
keepers
A.14 Annualized Cost to the Federal Government
A.15 Explanation for Program Changes or Adjustments
A.16 Plans for Tabulation and Publication and Project Time Schedule
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions
List of Attachments:
Attachment 1: ‘Attach 1’: Survey
A.1 Circumstances Making the Collection of Information Necessary
This survey will help fulfill the requirements of:
Public Law 78-410, the Public Health Service Act (42 U.S.C. 242k), authorized establishment of the Clinical Center.
The March 3, 1998 White House Memorandum, “Conducting Conversations with America to Further Improve Customer Service,’ which directs Agencies to determine the kind and quality of service its customers want as well as their level of satisfaction with existing services.
Need:
These programs and services are aimed at educating about and improving the conduct of clinical and translational research.
The purpose of the survey is to gather information regarding the long-term outcomes of the information and medical education that the particular individual has participated in. The Clinical Center is the nation’s largest hospital dedicated to clinical research. As the Clinical Center’s central office of clinical research training and medical education, it is incumbent upon the office to re-adjust and refine the content of the Continuing Medical Education programs so that they have an appropriate impact on the physicians who attend the conferences.
There are no currently existing evaluation components.
The information collected will be to determine if the education provided affected the way patient care was delivered. The information will be used by the accrediting body to determine if a re-adjustment in the information and/or its delivery would have a more positive outcome.
There are no past data collections.
The
information collected will be used to determine the impact on patient
care. Each course will be held on a yearly basis with different
information and each course's accreditation requires the follow up
survey with each yearly application.
So although each
course ends yearly, a new application for a new course and different
attendees need to be evaluated. Basically, this will go on
indefinitely with each new course every year. At the end of the 3
year approval a new application for extension maybe applied for.
The Accreditation Council for Continuing Medical Education (ACCME) is the national accrediting body that awards accreditation to individual provider organizations. For an organization to be accredited it must follow the ACCME criteria. See page: http://www.accme.org/dir_docs/doc_upload/f4ee5075-9574-4231-8876-5e21723c0c82_uploaddocument.pdf.
The programs that will be evaluated have been accredited by a contracted accredited provider. For the activity to be accredited, the provider must adhere to the Essential Areas, in particular ‘Evaluation and Improvement’ as identified in the table on the next page:
Essential
Area and Element(s) Criteria for Compliance Essential Area 3:
Evaluation
and Improvement
The
provider must,
E 2.4
Evaluate the effectiveness of its CME activities in meeting
identified educational needs.
E
2.5 Evaluate the
effectiveness of its overall CME program and make improvements to
the program. C 11. The provider analyzes changes in learners
(competence, performance, or patient outcomes) achieved as a result
of the overall program’s activities/educational interventions. C 12. The
provider gathers data or information and conducts a program-based
analysis on the degree to which the CME mission of the provider has
been met through the conduct of CME activities/educational
interventions.
C 13. The
provider identifies, plans and implements the needed or desired
changes in the overall program (e.g., planners, teachers,
infrastructure, methods, resources, facilities, interventions) that
are required to improve on ability to meet the CME mission.
C 14. The
provider demonstrates that identified program changes or
improvements, that are required to improve on the provider’s
ability to meet the CME mission, are underway or completed.
C 15. The provider
demonstrates that the impacts of program improvements, that are
required to improve on the provider’s ability to meet the CME
mission, are measured.
Additionally, the impact on patient care is described in the journal Chest 2009;135;49S-55S, authors Paul E. Mazmanian, PhD.; David A. Davis, MD; and Robert Galbraith, MD, wrote the article ‘Continuing Medical Education Effects on Clinical Outcomes Effectiveness of Continuing Medical Education: American College of Chest Physicians Evidence-Based Educational Guidelines,
“It is said that in an ideal world, every person who is ill would receive the best care every time from every physician. However, many patients receive less than perfect care, and the continuing education of physicians is seen as fundamental to improving the care that is given. Continuing education includes instruction designed to help physicians acquire and apply scientific knowledge, demonstrate skill, and perform effectively as caregivers.”
The practical utility of the information is that it will be used to determine how medical practice has changed as a result of the information presented.
The information to be collected includes:
Whether the information delivered had an impact on the approach to research or patient care.
Whether there was an increase in the collaboration in research as a result of the conference
Whether there was an impact on the delivery of patient care.
All information will be collected electronically which will minimize time and permit electronic submission of responses. The decision to use electronic submission was based on the minimal time required by the respondent and the ease of collection of data. The survey will be anonymous will not collect personal information or Internet Provider addresses and will not allow for text input.
None of the information will be retrievable by name or other identifier because the survey will not allow the participant to input that data and the ability to collect Internet Provider addresses has been disabled so there is no ability to collect information about what computer submitted the survey.
Because there is no collection of identifiable information, a privacy impact assessment is not being conducted. The survey only allows the participant to answer an opinion with the click of a button but the participant is not able to input any text data.
There is no similar information. NIH is a unique medical environment in that the medical conferences that are held here are presenting new and innovative ways of treating patients and the information delivered is usually delivered in the NIH involves treatments and therapies in development and this kind of information is not available to the general physician practitioner in the community.
To avoid duplication of collection of the information, conference activity directors will utilize the outcomes survey in this request with the specific questions tailored to the individual conference. The results will be submitted to the Continuing Medical Education (CME) contractor, Johns Hopkins University School of Medicine Office of Continuing Medical Education.
The respondents are primarily physicians and other health care providers. The impact is expected to be minimal because the format for submission of the information will be electronic.
The collection of the information will help determine if the education provided to the participant has impacted the delivery of patient care or affected the outcomes of the care delivered. The requested frequency is once per conference to occur approximately 3-6 months after the conference ends. More frequent responses will be due to the fact that the individual physician and/or dentist may have gone to more than one conference in the time period.
To reduce the burden of the collection of data, an electronic system will be used to minimize paper and time burden on the public.
The proposed data collection is consistent with 5 CFR 1320.5
The 60-day notice was published on May 14, 2009, volume 74, page number 22749. The 60-day notice received one comment:
“these meetings should be on computer software and the general population of this nation should be able to attend. this is a very cheap way to distribute information, the general public can have some understanding of what you are telling doctors to do and the open ness of the project will help all americans. it is time to stop secret meetings. they cost more for taxpayers, they dont get the message through when videotapes can be made of the information transmitted. this l935 style of getting out information is seriously expensive and a stupid way to do business in 2009. obama said to open up the process - its time to do that.
jean public 15 elm st florham park nj07932”
This is not a research project. Therefore, no consultation with persons outside the agency has been made. However, the directors of some of the affected NIH programs have been consulted as to what metrics would be appropriate to determine the effectiveness and impact of the Continuing Medical Education Conferences involved.
There will be no payment or gifts given to respondents.
The survey tool as attached does not request, and does not allow for the input of identifying information. It is completely voluntary.
No sensitive questions will be asked.
No personally identifiable information will be collected.
The survey will be anonymous and will not collect personal information or Internet Provider addresses and will not allow for text input.
None of the information will be retrievable by name or other identifier because the survey will not allow the participant to input that data and ability to collect Internet Provider addresses has been disabled so there is no ability to collect information about what computer submitted the survey.
A.12 Estimates of Hour Burden Including Annualized Hourly Costs
Type of Respondents |
Estimated Number of Respondents |
Estimated Number of Responses per Respondent |
Average Burden Hours Per Response |
Estimated Total Annual Burden Hours Requested |
Doctoral Level |
7,500 |
2 |
0.017 |
255 |
Other Health Care Provider |
2,500 |
2 |
0.017 |
85 |
Total |
……………………… |
……………………… |
……………………… |
340 |
Type of Responders |
Number of Responders |
Frequency of Response |
Average Time for Response |
Hourly Wage |
Respondent Cost |
Physicians |
7,500 |
2 |
0.017 |
$75 |
$18,750 |
Other Health Care Providers |
2,500 |
2 |
0.017 |
$50 |
$4,167 |
Totals |
10,000 |
|
|
|
$22,917 |
A system of collection, in particular, Survey Monkey, currently in use will be used. No additional charges are expected as there is no modification to the system required.
Costs to government |
|
|
|
Item |
Cost per unit |
# of units |
Cost per item |
Salary for design time (unit=hour) |
$50 |
0.5 |
$25 |
Evaluation (unit=hour) |
$50 |
0.5 |
$50 |
Electronic Maintenance (yearly fee) |
$250 |
1 |
$250 |
Total costs |
|
|
$325 |
This is new collection of information.
There are no plans at this time for statistical analysis in publications.
A.16 - 1 Project Time Schedule
|
|
Activity |
Time Schedule |
Email sent to respondents |
3-6 months after the end of the conference. |
OMB# and expiration will be displayed.
No exceptions are requested.
| File Type | application/msword |
| File Title | Supporting Statement 'A' Preparation - 05/01/2008 |
| Subject | Supporting Statement 'A' Preparation - 05/01/2008 |
| Author | OD/USER |
| Last Modified By | curriem |
| File Modified | 2009-10-21 |
| File Created | 2009-10-21 |