EHR Supporting_Statement_B_041514

Access to Electronic Health Record Data during an Outbreak

OSTLTS Generic Information Collection Request

OMB No. 0920-0879

Supporting Statement – Section B

Submitted: April 15, 2014

Program Official/Project Officer

Elizabeth Mothershed, Deputy Director for Policy (Acting)

Centers for Disease Control and Prevention

Division of Healthcare Quality and Promotion

1600 Clifton Rd, Mailstop A07, Atlanta, GA 30333

Phone: 404-639-4780

Email: [email protected]

Fax: 404-639-4043

Section B – Data Collection Procedures

1. Respondent Universe and Sampling Methods

We will be requesting participation from the following 75 key stakeholders in states in their official capacities: two healthcare associated infection (HAI) coordinators, one epidemiologist, one legal counsel, and one informatics director. Two HAI coordinators were chosen to gain multiple perspectives since there were likely multiple HAI coordinators identifying cases during the HAI fungal meningitis outbreak. Data will be collected from15 state health departments: Florida, Indiana, Kansas, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Tennessee, Texas, and Virginia. State health departments were chosen based on the five following criteria: experience with the fungal meningitis outbreak, experience with other outbreaks, leadership in electronic health record (EHR) law, leadership in EHR and Health Information Exchange (HIE), and CDC and ASTHOs relationship with the state.

2. Procedures for the Collection of Information

Data will be collected from key stakeholders in the state in their official capacities (N=75) using telephone interviews. One week following OMB approval healthcare associated infection (HAI) coordinators and epidemiologists in the 15 states will be sent an email announcing the project (see Attachment D—Project introduction email to State Health Department HAI Coordinators and Epidemiologists). During the next two to three weeks following OMB approval, an email will be sent to HAI coordinators to ask for their participation in the assessment, and help identify other key stakeholders in the state we want to include in the assessment (see Attachment E- Individual Email to HAI Coordinators/Epidemiologists) Once the HAI coordinator has identified the names and contact information for the legal counsel and informatics director in their state we want to include in the assessment, we will send an email to those key stakeholders asking for their participation in the assessment (see Attachment F- Individual Email to Legal Counsel; Attachment G- Individual Email to Informatics Directors) As participants reply to the email, phone interviews will be scheduled. Those who do not respond to the email within five days will be sent a follow-up email. Three days before the interview a reminder email will be sent to all participants (see Attachment H-Individual Email Reminder to HAI Coordinators/Epidemiologist; Attachment I-Individual Email Reminder to Legal Counsel; attachment J- Individual Email Reminder to Informatics Directors). Additionally, practice interviews with the contractor, who will be hired in March, will be conducted to help ensure quality. Phone interviews will begin three weeks after OMB approval and will continue for the next four weeks. Seven weeks after OMB approval data analysis will begin and will continue for the next three weeks. Eleven weeks after OMB approval report writing will begin and the final report will be completed seventeen weeks after OMB approval.

3. Methods to Maximize Response Rates Deal with Nonresponse

Advanced notifications (see attachment D) and email reminders (see attachments H-J) will be utilized to maximize response rates.

4. Test of Procedures or Methods to be Undertaken

The design, methodology, and sample for this project were discussed with a group of expert external stakeholders during an hour long conference call. Experts included two epidemiologists, one HAI Coordinators, one lawyer, and one Informatics Specialist. Feedback from these expert stakeholders was used to refine the sample, interview guide questions, and probes for HAI Coordinators/Epidemiologist, Legal Counsel and Informatics Directors. Each interview guide was tested by two CDC employees with state health department employees with expertise in the area of the interview guide. Feedback was used to refine questions and probes, and estimate burden hours. In the pilot test of the two HAI Coordinators/Epidemiologists the average time to complete interview, including time for reviewing instructions, was approximately 27 and 30 minutes. For the purposes of estimating burden hours, the upper limit of this range (i.e., 30 minutes) is used. In the pilot test of the Legal Counsel, the average time to complete the interview, including time for reviewing instructions, was approximately 37-40 minutes. For the purposes of estimating burden hours, the upper limit of this range (i.e. 40 minutes) is used. In the pilot test of the Informatics Directors, the average time to complete the interview, including time for reviewing instructions, was approximately 20-30 minutes. For the purposes of estimating burden hours, the upper limit of this range (i.e. 30 minutes) is used.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

The following individuals were consulted to provide advice about the design of these collection activities:

Christine Prue, PhD

Associate Director for Behavioral Science in NCEZID

Centers for Disease Control and Prevention

1600 Clifton Road NE, MS C-12

Atlanta, GA 30333

(O) 404-639-2273

The team of individuals working on this information, including instrument development, supporting data collection and analysis will consist of members from NCEZID, OSTLTS, CSELS, and ASTHO.

Name	Organization	Division	Title		Email		Phone Number
Cairns, Catherine	ASTHO	Infectious Diseases		Director, Infectious Disease		[email protected]	571-527-3150
Conn, Laura	CDC	OPHSS/Health Information Technology and Surveillance Strategy		Health Scientist		[email protected]	404-498-0971
Dolen, Virgina	ASTHO	Immunization and Infectious Disease		Senior Analyst, Immunizations and Infectious Diseases		[email protected]	571-527-3161
Joshi, Cecilia	CDC	NCEZID/Office of Infectious Diseases		Associate Director for Policy		[email protected]	404-639-7303
Mothershed, Elizabeth	CDC	NCEZID/Division of Healthcare Quality Promotion		Associate Director for Policy (Acting)		[email protected]	404-639-4780
Penn, Matthew	CDC	OSTLTS/Public Health Law Program		Director for Public Health Law		[email protected]	404-498-0452
Prue, Christine	CDC	NCEZID/Office of Infectious Diseases		Health Communication Officer		[email protected]	404-639-2273
Raber, Anjanette	CDC	NCEZID/Division of Healthcare Quality Promotion		Evaluation Fellow		[email protected]	404-639-4662
Ramanathan, Tara	CDC	OSTILTS/Public Health Law Program		Public Health Analyst		[email protected]	404-498-0455
Ruebush, Elizabeth	ASTHO	Immunization and Infectious Disease		Analyst, Infectious Disease and Immunization Policy		[email protected]	571-527-3139
Samuel, Anita	ASTHO	e-Health		Director, Informatics		[email protected]	571-527-3174
Soper, Paula	ASTHO	e-Health		Senior Director, eHealth		[email protected]	571-318-5412
Watkins, Jaqueline	CDC	NCEZID/Office of Infectious Diseases		Health Scientist		[email protected]	404-639-7404

The open-ended questions from the phone interview will be analyzed using thematic analysis.

LIST OF ATTACHMENTS – Section B

D. Introduction Email to State HAI Coordinators/ Epidemiologists

E. Individual Email to State HAI Coordinators/Epidemiologists

F. Individual Email to State Legal Counsel

G. Individual Email to State Informatics Directors

H. Individual Email Reminder to HAI Coordinators/ Epidemiologists

I. Individual Email Reminder to Legal Counsel

J. Individual Email Reminder to Informatics Directors