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: March 25, 2019

SUB AGENCY (I/C): HHS/AHRQ

TITLE: Implementation of an Electronic Care Plan for People with Multiple Chronic Conditions

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

ABSTRACT: Coordination of care for patients with comorbidities is a known problem. This is particularly important for those with chronic kidney disease (CKD) and other conditions as they require coordination across settings and providers. Care plans can help promote coordination. A care plan is a dynamic and personalized way to document an individual’s needed healthcare activity, goals, and objectives.1, 2 An electronic care (e care) plan application (app) allows patient-centered data to be available across care and research settings. AHRQ and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) have partnered to develop and support an e care plan app for people with CKD and multiple chronic conditions (MCC). This effort is significant because CKD is common, costly, and consequential;3 people with CKD often also have MCC.4-8 Therefore, care plans are crucial tools to address and coordinate health needs of people with MCC.9

Cognitive Medical Systems is developing two key deliverables in a separate effort: (1) a Substitutable Medical Applications, Reusable Technologies (SMART®) on Fast Healthcare Interoperability Resources (FHIR®) e care plan app and (2) an FHIR Implementation Guide (IG) that documents the agreed upon technical mechanisms for data exchange between the app and other health information technology (IT) systems. To understand how the app and IG work in practice, it is necessary to understand the extent to which the app and IG enable collecting and sharing standardized data across diverse health settings and health IT systems for people with CKD and MCC. RTI (along with our subcontractors) will design and implement a pilot test to assess the e care plan app’s usefulness for patients with CKD and at least one other chronic illness by determining whether the app facilitates standardized data collection and data sharing across clinical and community settings and systems. This pilot test’s outcomes will guide further enhancement of the e care plan app and its IG to enable physicians to care for patients with MCC better and to enable patient-centered outcomes research.

TOTAL ANNUAL BURDEN APPROVED: 8900 Hours Per year

BURDEN USED TO DATE: 45 hours.

BURDEN THIS REQUEST: 34 hours.

FEDERAL COST: The estimated annual cost to the Federal government is $107,612____.

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?

______ WEB SITE

__X _ TELEPHONE INTERVIEW

_____ MAIL RESPONSE [email]

____ IN PERSON INTERVIEW

_____ OTHER: ___________________________________

CONTACT INFORMATION:

NAME: _Janey Hsiao________________________________________

TELEPHONE NUMBER: _ 301-427-1335

EMAIL ADDRESS: [email protected]>_________________________