Supporting Statement A 3-9

Healthcare System Surge Capacity at the Community Level

Supporting Statement A

Request for OMB Approval

March 4, 2011

Contact:

Amy McMillen

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, N.E.

Atlanta, Georgia 30333

Phone: (404) 639-1045

Fax: (404) 639-3039

Email: amcmillen@cdc.gov

Healthcare System Surge Capacity at the Community Level

This is a request for OMB approval of a new data collection. CDC is requesting a one year approval to collect data for this project.

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Healthcare Preparedness Activity (Activity), Division of Healthcare Quality Promotion (DHQP) at the Centers for Disease Control and Prevention (CDC) works with other federal agencies, state governments, medical societies and other public and private organizations to promote collaboration amongst healthcare partners, and to integrate healthcare preparedness into federal, state and local public health preparedness planning. The goal of the Activity is to help local communities’ healthcare delivery and public health sectors effectively and efficiently prepare for and respond to urgent and emergent threats.

The Activity has engaged with multiple communities to explore how they can develop plans that address healthcare system surge during an influenza pandemic. Workshops conducted in 2008 with several pilot communities have included a wide spectrum of healthcare partners (acute and outpatient settings) as well as local public health and emergency management agencies; participants have expressed that the inclusion of a broad base of partners improved their pandemic planning and response to the 2009 H1N1 influenza pandemic. Results from national assessment programs of state/local plans also suggest that strong, existing collaborations with private and public response partners are associated with more robust response plans. This leads to a hypothesis that the more ‘prepared’ communities are those that appoint multidisciplinary community partners and leaders to plan together for emergency situations or, alternatively, are those already exploring coordinated mechanisms to address everyday emergency department ‘surge’ within their community.

The information provided by pilot communities is useful but is not derived from any formal study or evaluation, and cannot be generalized to inform policy or guidance regarding surge management in a pandemic. To address that need, the Activity will examine community responses to H1N1 as a model exploring the ability of healthcare providers and public health to meet a surge in demand.

Surge is defined as a marked increase in demand for resources such as personnel, space and material (Kelen, 2006) .ⁱHealth care providers manage both routine surge (predictable fluctuations in demand associated with the weekly calendar, for example) as well as unusual surge (larger fluctuations in demand caused by rarer events such as pandemic influenza). Except in extraordinary cases, providers are expected to manage surge while adhering to their existing standards for quality and patient safety. In many communities, providers develop internal strategies for managing surge and also work with public health agencies and with other providers to form collaborations (Felland, 2008).ⁱⁱThese collaborations bring together a diverse group of stakeholders, including private and public hospitals and state and federal agencies (including CDC).

Currently, health care organizations are expected to prepare for and respond to surges in demand ranging from a severe catastrophe (for example, a nuclear detonation) to more common, less severe events (for example, a worse-than-usual influenza season). The Centers for Disease Control and Prevention and other federal agencies have dedicated considerable funding and technical assistance towards developing and coordinating community-level responses to surges in demand, but it remains a difficult task. Among the challenges:

• Surge response is coordinated by overlapping state and federal public agencies, but many resources necessary for a response are concentrated in the private sector.

• Disaster planning is generally organized along state and regional lines, but this may not reflect the structure or distribution of private sector resources within a market. For example, a community considered a single unit for the purpose of surge response may include two hospitals owned by different, competing national chains that would not collaborate under ordinary circumstances.

• If a surge does not reach the level of a major disaster where regular business is disrupted, health care providers who follow recommended response guidelines may be acting against their own business imperatives. The extent to which this represents a conflict may vary widely by the type of provider and the nature of the local market.

• Key areas of the private sector, such as independent primary care practices and skilled nursing facilities, are often left out of surge planning altogether (Hogg 2006; Cowan 2005). ^iii,iv

U.S. government grant guidance has referred to the establishment of collaborations as a strategy to improved healthcare response to disasters. A collaboration refers to a community-based effort, beginning before a disaster/surge episode and involving multiple stakeholders, through which local health care providers both receive guidance from regional/national public health authorities (including CDC) and contribute guidance about the characteristics of their own community.

While there is extensive research on managing collaborations during times of extraordinary pressure where response to surge takes precedence over other activities, less is known about developing and maintaining integrated collaborations during periods where the system must respond to unusual surge but also continue the routine provision of health care. In particular, studies have not explored how these collaborations can build on sustainable relationships between a broad range of stakeholders (including primary care providers) in communities with different market structures and different degrees of investment in public health (Health Research Institute, 2007). ^v

CDC will be working with the Center for Studying Health System Change (HSC), a nonpartisan research institution that studies local health care markets across the US to examine the broad role collaborations have played and examine what additional guidance or assistance these community healthcare providers may need to accomplish the management of surge in an event. HSC has previously conducted research in disaster preparedness and surge capacity and has extensive experience performing qualitative research involving health care providers and state and local public health leadership. It is expected that this research study will help refine current preparedness activities by identifying real-world barriers to coordination seen during the preparation for pandemic H1N1 influenza in a variety of health care markets.

This study aims to generate information about the role of community-based collaborations in disaster preparedness that the CDC can use to develop its programs guiding and supporting these collaborations. Specifically

1. How do collaborations affect preparedness and surge capacity? What types and characteristics of collaborations are most/least useful?

2. What are the barriers and facilitators to collaboration both between different types of organizations (e.g., hospitals and primary care practices) and within a single type of organization (e.g., between competing hospitals) for the purpose of surge management?

3. How is guidance from CDC received by collaborations and individual stakeholders?

Little is known about the perceptions of key stakeholders (primary care providers) regarding their role in preparedness and surge capacity; a qualitative approach will allow investigators to explore unexpected findings. Prior qualitative research done at HSC has demonstrated a gap in knowledge on the role and perceptions of stakeholders in emergent public health needs, particularly among practitioners and local health departments. By using grounded theory and qualitative methods for this exploratory study of the role of collaborations in disaster preparedness, investigators can capture and compare a variety of different participants’ perceptions, which may be nuanced and complex.

This project will explore barriers and facilitators to coordination on surge response in ten communities, eight of which have been studied longitudinally since the mid-1990s as part of HSC’s Community Tracking Study (CTS). CTS Site Visit methodology is described at http://www.hschange.org/index.cgi?data=17 (accessed 9/30/10).^vi In short, interviews of local healthcare stakeholders will be conducted at 10 sites.

The primary audiences for this project are (1) community-based stakeholders (emergency providers, primary care providers and local public health leaders) and (2) the CDC. The investigator team is led by an HSC researcher who is also a practicing emergency physician (ED), and CDC is participating in the study design. While other stakeholders are not participating directly in the study design, the open-ended and adaptive nature of qualitative research will allow participants to express their views and clarify their needs throughout the process.

Authorizing Legislation comes from Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment A).

Privacy Impact Assessment

Overview of the Data Collection System

This study will use qualitative methods, including telephone interviews guided by semi-structured protocols (see Attachments C and D) designed to elicit key themes from respondents. Interviewers will be able to probe further or deviate from protocols to the extent that respondents reveal new information. The following specific research questions will be addressed to provide an in-depth look at the role of collaborations in building community surge capacity:

1. How do collaborations affect preparedness and surge capacity? What types and characteristics of collaborations are most/least useful?

2. What are the barriers and facilitators to collaboration both between different types of organizations (e.g., hospitals and primary care practices) and within a single type of organization (e.g., between competing hospitals) for the purpose of surge management?

3. How is guidance from CDC received by collaborations and individual stakeholders?

Items of Information to be Collected

• Name

• Title

• Email address

• Telephone number

• Responses to interview questions

Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age

None

2. Purpose and Use of Information Collection

Information collected by the study will inform strategies to promote DHQP’s support of sustainable community-level collaboratives that can generate effective responses to pandemic illness and other surges in healthcare demand. Specifically, DHQP will use provider and preparedness respondents’ reports of their experiences working in collaborations to make future coalition-building efforts more sustainable for participants and responsive to community providers’ needs and concerns.

Findings will also be widely disseminated to federal, state and local policymakers, as well as private sector health care decision makers, via CDC’s website as well as HSC’s website, media outreach, email alerts, conference presentations and policymaker briefings.

Privacy Impact Assessment Information

This study will collect information from respondents about their participation in collaborations related to healthcare preparedness and surge in their communities. It will not collect any information that could be used to identify individual patients. HSC (the contractor) will collect the respondent’s name, telephone number, email address, organizational affiliation and title. This information will be used for case tracking purposes or for clarification call backs. CDC has requested that the contractor not share respondents’ identifying information with CDC staff so that respondents can be encouraged to speak freely about CDC and its role in preparedness activities. Advisement information is contained in a letter to respondents located in Attachment E.

All electronic files will be password-protected and accessible only from a secured network. When not in use by project staff, all printed information or materials that could potentially identify participants in the study will be stored in locked cabinets that are accessible only to team members. Data (interview transcripts) will be kept for one year after the completion of the study, to allow time to address any queries or concerns. Identifying information (contact information) will be filed and retrieved by the name of the individual.

The proposed data collection will likely have little or no effect on respondents’ privacy.

3. Use of Improved Information Technology and Burden Reduction

HSC and CDC will collect data through an established qualitative research methodology, which includes telephone interviews with study respondents. Because most interview questions are open-ended to allow for in-depth exploration of issues, electronic submission of responses is not a viable option.

4. Efforts to Identify Duplication and Use of Similar Information

CDC has conducted a literature review and conferred with internal staff and outside preparedness experts about ongoing research projects. From this review, CDC has not identified any in-depth interview data from practitioners and state and local preparedness experts on the collaborative efforts that are the focus of this study. Several studies have identified the difficulty of involving primary care providers in sustainable preparedness efforts, but the causes of this difficulty and the ways stakeholders have sought to build collaborations have not been explored in detail, highlighting the need for and design of this study.

5. Impact on Small Businesses or Other Small Entities

This research will involve telephone interviews with respondents at physician practices and local community preparedness associations, many of which may be small businesses. Study participation is voluntary and HSC and CDC will be respectful of study participants’ time. Interviews will be scheduled at times convenient for respondents. The interview protocols consist of the minimum questions required for study purposes. Individual interviews will last no more than an hour.

6. Consequences of Collecting the Information Less Frequently

This is a one-time collection.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request is consistent with the general information collection guidelines of 5 CFR 1320.5(d)(2). No special circumstances apply.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

1. A 60 day notice was published in the Federal Register on Monday, January 3, 2011, Volume 76, No. 2, pp. 147-148. No public comments were received.

B. Officials and researchers who have special interest and expertise in the individual activities and topics will be contacted as necessary. The following individuals were consulted for the development of this request:

Laurie Felland, MA Assistant Director of Site Visits and Senior Health Researcher 600 Maryland Avenue SW Suite 550 Washington, DC 20024

Joy Grossman, PhD Senior Health Researcher 600 Maryland Avenue SW Suite 550 Washington, DC 20024

Ms. Felland’s and Dr. Grossman’s biosketches are available at http://www.hschange.org/index.cgi?file=staff.

9. Explanations of Any Payment or Gift to Respondents

There will be no remuneration to respondents.

10. Assurance of Privacy of Data Provided to Respondents

Individuals and organizations will be assured of the privacy of their replies under Section 934(c) of the Public Health Service Act, 42 USC 299c-3(c). They will be told the purposes for which the information is collected and that, in accordance with this statute, any identifiable information about them will not be used or disclosed for any other purpose without their prior consent, unless required by law upon the demand of a court or other governmental authority.

This study will collect information from respondents about their participation in collaborations related to healthcare preparedness and surge in their communities. It will not collect any information that could be used to identify individual patients. HSC (the contractor) will collect the respondent’s name, telephone number, email address, organizational affiliation and title. This information will be used for case tracking purposes or for clarification call backs. CDC has requested that the contractor not share respondents’ identifying information with CDC staff so that respondents can be encouraged to speak freely about CDC and its role in preparedness activities. No identifying information will be transmitted to CDC. Advisement information is contained in a letter to respondents located in Attachment E.

This study has been declared exempt by the CDC IRB.

Privacy Impact Assessment Information

A. This submission has been reviewed by ICRO, who determined that the Privacy Act does not apply..

B. All electronic files will be password-protected and accessible only from a secured network. When not in use by project staff, all printed information or materials that could potentially identify participants in the study will be stored in locked cabinets that are accessible only to team members. Data (interview transcripts) will be kept for one year after the completion of the study, to allow time to address any queries or concerns. Identifying information (contact information) will be filed and retrieved by the name of the individual.

C. Verbal consent will be obtained at the beginning of each interview. See the script interviewers use to explain the study located at Appendix C and D.

D. Respondents are informed about the voluntary nature of their response.

11. Justification for Sensitive Questions

No questions of a sensitive nature will be asked. Further, during the introduction to the interview, respondents will be informed that their participation is voluntary and that they can refuse to answer any question.

12. Estimates of Annualized Burden Hours and Costs

A. Interviews will be conducted at a total of 63 organizations over the one year data collection phase of this project. Within each of the ten communities studied, two emergency practitioner respondents (one from a safety-net hospital and one from a non-safety-net hospital), two primary care providers (one from a large practice and one from a small practice) and two local preparedness experts (one from the County or local public health agency, and one coordinator or collaboration leader) will be interviewed. In three sites (Phoenix, Greenville and Seattle) an additional respondent will be identified from an outlying rural area to offer the perspective of providers in those communities.

B. Cost estimates associated with organizations’ time to participate in this research were derived from the Department of Labor Occupational Employment Statistics for regions corresponding to each community in the study. The following categories were used:

• Emergency practitioners were classified as Physicians and Surgeons, all other (291069).

• Primary care providers were classified as Family and General Practitioners (291062) and Internists, General (291063). We assumed for purposes of cost calculation that primary care respondents in the urban sites would be evenly divided between internists and family practice/general practice practitioners, and rural respondents would be family practice/general practice practitioners.

• Preparedness respondents were classified as Medical Scientists, other than Epidemiologists (191042), a category that includes public health scientists. Because hourly wages for Greenville-Maudlin-Easley, SC were not available for this category, hourly wages for Charlotte-Gastonia-Concord were used.

Exhibit 1 shows the estimated annual burden hours for each organization’s time to participate in this research. The total annual burden is estimated to be 63 hours.

Exhibit 1: Estimated Annual Burden Hours

Respondent Category	Number of Respondents	Number of Responses per Respondent	Average Burden Response (in hours)	Total Burden (in hours)
Emergency Department and Primary Care	43	1	1	43
Public Health and Preparedness/Coalition Leader	20	1	1	20
TOTAL	63			63

Exhibit 2 shows the estimated annual cost burden associated with organizations’ time to participate in this research. The average hourly wage was calculated by averaging the mean wages of professionals within the given categories across the ten study sites. Burden in hours is taken from Exhibit 1. The total annual cost burden is calculated by multiplying the mean hourly wage of each category by the burden in hours from that category, and summing these totals from both categories. The total cost burden is estimated to be $4255.32.

Exhibit 2. Estimated Annual Cost Burden to Respondents

Respondent Category	Average Hourly Wage	Burden (in hours)	Cost Burden
Emergency Department and Primary Care	$81.27	43	$3494.52
Public Health and Preparedness/Coalition Leader	$38.04	20	$760.80
TOTAL		63	$4255.32

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no direct costs to respondents other than their time to participate in this study.

14. Annualized Cost to the Government

The estimated total cost to the Federal Government for this project is $183,119.00 over the one year period of data collection. Exhibit 3 provides a breakdown of the estimated total costs..

Exhibit 3. Estimated Costs to Federal Government

Cost Component*	Total Cost (in dollars)
Project Development and Project Management (including CDC staff time)	47,370
Data Collection Activities	86,670
Data Analysis	17,555
Publication and Dissemination of Results	31,524
Total	183,119

*Costs represent fully loaded rates

15. Explanation for Program Changes or Adjustments

This is a new collection of information.

16. Plans for Tabulation and Publication and Project Time Schedule

Task	Estimated timeline following OMB clearance
Respondent selection and start of scheduling	Months 1-3
Conduct interviews	Months 4-8
Complete notes	Month 8
Data analysis and outline	Month 9
First draft	Month 10
Final product	Month 11

17. Reason(s) Display of OMB Expiration Date is Inappropriate

None

18. Exceptions for Certification for Paperwork Reduction Act Submissions

None

List of Attachments

A. Section 301 of the PHS Act (42 U.S.C. 241).  

B. 60 day Federal Register Notice

C. Interview Protocol 1

D. Interview Protocol 2

E. Invitation Letter

F. Follow-up Letter

G. Confirmation Letter

H. Thank-you Letter

I. Privacy of Data Pledge

J. Privacy of Data Agreement

K. 30 Day Federal Register Notice

iREFERENCES

Kelen G and McCarthy M, The Science of Surge. Academic Emergency Medicine 2006; 13: 1089-1093

iiFelland L, Katz A, Leibhaber A et al. Developing Health System Surge Capacity: Community Efforts in Jeopardy. Center for Studying Health System Change Issue Brief No. 5, June 2008

iiiHogg W, Huston P, Martin C et al. Enhancing Public Health Response to Respiratory Epidemics: Are Family Physicians Ready and Willing to Help? Canadian Family Physician 2006; 52: 1254-1260

ivCowan A, Ching P, Clark S. Willingness of Private Physicians to be Involved in Smallpox Preparedness and Response Activities. Biosecurity and Bioterrorism: Biodefense Strategy, Practice and Science. 2005; 3: 16-22

vClosing the Seams: Developing an Integrated Approach to Health System Disaster Preparedness. PricewaterhouseCoopers’ Health Research Institute 2007 CTS Site Visit methodology is described at http://www.hschange.org/index.cgi?data=17 (accessed 9/30/10)

vi