Cover Letter

SUBMISSION OF INFORMATION COLLECTION UNDER THE

Request for Approval under AHRQ’s Generic Clearance “Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality” (OMB Control Number: 0935-0124)

DATE OF REQUEST: April 24, 2019

SUB AGENCY (I/C): HHS/AHRQ

TITLE: Pilot Test of the Proposed Diagnostic Safety Supplemental Item Set for the Medical Office Survey on Patient Safety Culture

GENERIC CLEARANCE UNDER OMB#: 0935-0124 EXP. DATE: 11/30/2020

ABSTRACT: There has been little focus to-date on the role of patient safety culture and diagnostic error, which represents a significant gap. AHRQ has a unique opportunity to help remedy this gap by expanding its existing and highly successful Surveys on Patient Safety Culture™ (SOPS™) program to include a new supplemental item set on diagnostic error that can optionally be administered at the end of the Medical Office SOPS Survey. Similar to Westat’s work on previous SOPS survey supplemental item sets, our goal will be to develop a reliable, public-use item set to augment the Medical Office SOPS survey. The evidence shows that diagnostic errors occur more frequently in ambulatory care; therefore, developing the item set for the outpatient setting directs AHRQ’s resources to areas where the evidence indicates a gap, and the potential for improvement is significant. Therefore, we are requesting a supplemental item set so that providers of ambulatory care can efficiently assess the culture of their organization with respect to diagnostic error. Moreover, because there is overlap in the content of the SOPS Medical Office survey and the Diagnostic Safety supplemental items, we want to limit the duplication of questions on the two instruments. For this reason, Westat proposes that the limited scope of a supplemental item set (i.e., 12-15 items across 3-4 composite measures) is more appropriate than developing a separate, full-length survey.

The supplemental item set will assist medical offices in assessing factors contributing to diagnostic errors, help them identify strengths and areas for improvement to efficiently target resources to improve diagnostic processes, reduce errors and malpractice claims/costs, and improve patient safety and patient outcomes.

This research has the following objectives:

1) Conduct cognitive interviews with individual respondents to test the items in the Diagnostic Safety supplemental item set for the Medical Office Survey on Patient Safety Culture. Cognitive testing will be conducted in English.

2) Conduct pilot test data collection in 150 medical offices and based on an analysis of results, determine which survey items to retain and refine the questionnaire accordingly.

3) Engage a Technical Expert Panel (TEP) to review pilot results and finalize the supplemental item set.

4) Make the supplemental item set and related administration guidance documents publicly available.

TOTAL ANNUAL BURDEN APPROVED: 8900 Hours Per year

BURDEN USED TO DATE: 165 hours.

BURDEN THIS REQUEST: 538 hours.

FEDERAL COST: The estimated annual cost to the Federal government is $144,500_____.

IS RACE AND ETHNICITY DATA COLLECTED AS REQUIRED?

______YES ______ NO _____x_ N/A

OBLIGATION TO RESPOND:

___x__VOLUNTARY

______ REQUIRED TO OBTAIN OR RETAIN BENEFITS

______ MANDATORY

HOW WILL THIS SURVEY BE OFFERED?

__X____ WEB SITE

__ _ TELEPHONE INTERVIEW

__ ___ MAIL RESPONSE [email]

____ IN PERSON INTERVIEW

_____ OTHER: ___________________________________

CONTACT INFORMATION:

NAME: _Caren Ginsberg________________________________________

TELEPHONE NUMBER: _ (301) 427-1894_____________________

EMAIL ADDRESS: Marie. Caren.Ginsberg@ahrq.hhs.gov _________________________