Outcome Measure Harmonization and Data Infrastructure for Patient Centered Outcomes Research in Depression

ICR 201911-0935-002

OMB: 0935-0249

Federal Form Document

Forms and Documents
ICR Details
0935-0249 201911-0935-002
Active
HHS/AHRQ
Outcome Measure Harmonization and Data Infrastructure for Patient Centered Outcomes Research in Depression
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 01/28/2020
Retrieve Notice of Action (NOA) 11/20/2019
  Inventory as of this Action Requested Previously Approved
01/31/2023 36 Months From Approved
1,065 0 0
44 0 0
0 0 0

In support of this mission, AHRQ funded a prior project to harmonize the outcome measures collected across patient registries and routine clinical practice, with the goals of supporting the development of a robust data infrastructure that can consistently and efficiently collect high-quality data on outcome measures that are relevant to patients and clinicians and supporting patient-centered outcomes research and quality improvement. Harmonized outcome measures would also form the foundation for learning healthcare systems. Of note, AHRQ has supported the development of the Outcome Measures Framework (OMF). The OMF is a conceptual model for classifying outcomes that are relevant to patients and providers across most conditions. AHRQ, in collaboration with the U.S. Food and Drug Administration and the National Library of Medicine, recently supported an effort to use the OMF as a content model for developing harmonized outcome measures in specific disease areas, including depression. Major depressive disorder (MDD) is a common mental disorder that affects an estimated 16.2 million adults and 3.1 million adolescents in the United States. Characterized by changes in mood, cognitive function, and/or physical function that persist for two or more weeks, MDD can reduce quality of life substantially, impair function at home, work, school, and in social settings, and result in increased mortality due to suicide. MDD also is a major cause of disability, with an economic burden of approximately $210.5 billion per year in the United States. Despite the burden of MDD and the availability of treatment, the condition is often undiagnosed and untreated. In 2016, the U.S. Preventive Services Task Force recommended screening for depression in the general adult population, including pregnant and postpartum women, and in adolescents. While routine screening is intended to improve diagnosis and treatment of MDD, many questions remain, such as about the comparative effectiveness of different treatment approaches, the incidence of adverse events, when to add medications for patients who do not respond to an initial course of treatment, how and why depression recurs, and how to classify and treat treatment-resistant depression. Patient registries capture a wealth of data on depression treatment patterns and outcomes in the United States and could serve as the foundation for a national research infrastructure to address these and other research questions. Yet, a lack of harmonization in the outcome measures collected by each registry makes it challenging, if not impossible, to link and compare data across registries and related efforts. As documented in the prior project, existing registries use different outcome measures (e.g., remission as defined by the PHQ-9 vs. HAM-D) and capture data at different timepoints. Depression registries offer an excellent opportunity to demonstrate the feasibility and value of implementing the harmonized outcome measures. Existing registries already capture some of the harmonized depression measures for quality reporting, although at different timepoints; capture of these measures and the additional measures at consistent intervals will enable the registries to generate more robust data suitable for research purposes. AHRQ is now proposing to implement the harmonized depression outcome measures developed under the prior project in two patient registries (the PRIME Registry and PsychPRO) and a health system setting. The purpose of this project is to demonstrate that capturing the harmonized outcome measures in the clinical workflow and submitting these data to different registries can improve clinical care, reduce the burden of registry participation, and increase the utility of registry data for research purposes. The objectives of the project are to: - Demonstrate that collection of the harmonized outcome measures is feasible, sustainable, and useful for clinicians participating in primary care and ment

US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 1999
  
None

Not associated with rulemaking

  84 FR 43810 08/22/2019
84 FR 215 11/06/2019
Yes

3
IC Title Form No. Form Name
Attachment E: Clinician Survey 3 Attachment E: Clinician Survey
Attachment C: PHQ-9 1 Attachment C: PHQ-9
Attachment D: FIBSER 2 Attachment D: FIBSER

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 1,065 0 0 1,065 0 0
Annual Time Burden (Hours) 44 0 0 44 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new ICR.

$1,304,830
No
    No
    No
No
No
No
Uncollected
Erwin Brown 301 427-1652 erwin.brown@ahrq.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
11/20/2019


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