Safety Program in Perinatal Care (SPPC)-II Demonstration Project

Forms and Documents

Document Name	Status
Form R DUA for AIM data Form and Instruction	Unchanged
Form N Self-administered implementation surveys with clinical staff at 30 months Form and Instruction	Unchanged
Form M Self-administered implementation surveys with clinical staff at 18 months Form and Instruction	Unchanged
Form L Self-administered implementation surveys with clinical staff at 6 months Form and Instruction	Unchanged
Form J1 Qualitative, semi-structured interviews with AIM Team Leads Form and Instruction	Modified
Form G Clinical staff self-administered baseline surveys Form and Instruction	Unchanged
Form E AIM Team Lead self-administered baseline surveys Form	Unchanged
Form D c) Coaching calls Form	Unchanged
Form I Tracking attendance of facilitation sessions Form and Instruction	Unchanged
Form A Frontline staff rosters developed by AIM Team Leads Form	Unchanged
Form 1 Training of AIM Team Leads Form and Instruction	Unchanged
Attachment T List of Stakeholder Panel Members.docx Supplementary Document	2019-08-16
Attachment S -List of measures reported by hospitals for the AIM program.docx Supplementary Document	2019-08-16
SPPC-II Dem Supporting Statement Part B Revised after OMB Comments - 6.24.20- clean.docx Supporting Statement B	2020-09-23
Supporting Statement Part A.docx Supporting Statement A	2020-09-23

IC Document Collections

IC ID	Document Title	Status
237429	DUA for AIM data Form and Instruction	Unchanged
237428	Self-administered implementation surveys with clinical staff at 30 months Form and Instruction	Unchanged
237426	Self-administered implementation surveys with clinical staff at 18 months Form and Instruction	Unchanged
237418	Self-administered implementation surveys with clinical staff at 6 months Form and Instruction	Unchanged
237417	Qualitative, semi-structured interviews with AIM Team Leads Form and Instruction	Modified
237416	Clinical staff self-administered baseline surveys Form and Instruction	Unchanged
237413	AIM Team Lead self-administered baseline surveys Form	Unchanged
237411	c) Coaching calls Form	Unchanged
237409	Facilitation sessions Instruction	Unchanged
237396	Tracking attendance of facilitation sessions Form and Instruction	Unchanged
237395	Training of frontline clinical staff Instruction	Unchanged
237394	Evaluation form for training of AIM Team Leads Instruction	Unchanged
237393	Frontline staff rosters developed by AIM Team Leads Form	Unchanged
237386	Training of AIM Team Leads Form and Instruction	Unchanged

ICR Details

OMB Control No: 0935-0246	ICR Reference No: 202009-0935-005
Status: Active	Previous ICR Reference No: 201908-0935-001
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Safety Program in Perinatal Care (SPPC)-II Demonstration Project
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/10/2020
	Date Received in OIRA: 09/24/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2023	36 Months From Approved	11/30/2022
Responses	86,621	0	86,616
Time Burden (Hours)	54,659	0	54,654
Cost Burden (Dollars)	0	0	0

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Abstract: Maternal mortality and severe maternal morbidity (SMM) increased significantly and continuously in the United States (US) over the past 30 years. A considerable proportion of these adverse events are attributable to preventable harm and unintended consequences arising from clinical practice and the system of delivering perinatal care. To address these alarming trends, AHRQ has developed the Safety Program in Perinatal Care (SPPC). During its initial phase (SPPC-I), the program was comprised of three pillars: teamwork and communication, patient safety bundles, and in situ simulations. Despite several promising results, the evaluation of SPPC-I revealed considerable hospital attrition due to heavy data burden and competing safety initiatives. Also, differences in the local adaptation of the SPPC-I patient safety bundles selected by implementation sites thwarted a meaningful cross-site comparison of programmatic impact. The current, second phase of the program (SPPC-II), focuses on integrating the teamwork and communication pillar into patient safety bundles developed by key professional organizations and implemented in 20+ US states with technical assistance by the Alliance for Innovation on Maternal Health (AIM) program and funding from the Health Resources and Services Administration (HRSA). Of note, the model used by AIM to implement these bundles is through statewide perinatal quality collaboratives (PQC) aiming to enroll all birthing hospitals in the state in the PQC. During the Planning Phase of SPPC-II, the contractor, Johns Hopkins University (JHU), developed SPPC-II Training Toolkits for two AIM patient safety bundles: obstetric hemorrhage and severe hypertension in pregnancy. The aim of the SPPC-II Demonstration Project is to implement and evaluate an integrated AIM-SPPC II program that overlays the SPPC-II Training Toolkits and the AIM patient safety bundles and program infrastructure in two states -- Oklahoma (OK), currently implementing the severe hypertension bundle; and Texas (TX), currently implementing the hemorrhage bundle. Over the next five years, the AIM program is expected to cover about two thirds of US states. Therefore, there is need to determine the feasibility and impact of the proposed integrated AIM-SPPC II program, and inform future government funding decisions regarding these two programs. To this end, the SPPC-II Demonstration Project has the following goals: 1) To implement the integrated AIM-SPPC II program in birthing hospitals in OK and TX in coordination with AIM and the respective state PQC; 2) To assess the implementation of the integrated AIM-SPPC II program in these hospitals; and 3) To ascertain the short- and medium-term impact of the integrated AIM-SPPC II program on hospital (i.e. perinatal unit) teamwork and communication, patient safety, and key maternal health outcomes.

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research Act of 1999
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 43239	07/16/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 60166	09/24/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
Self-administered implementation surveys with clinical staff at 30 months	Q, N	Self-administered implementation surveys with clinical staff at 30 months ,   Consent form - Self-administered implementation surveys with clinical staff at 30 months
Qualitative, semi-structured interviews with AIM Team Leads	J1, J2	Attachment J1 Interview guide for qualitative interviews with AIM Team Leads, 3-4mo (revised) ,   Attachment J2 Interview guide for qualitative interviews with AIM Team Leads, 15-16mo (new)
Facilitation sessions
c) Coaching calls	D	Coaching calls
AIM Team Lead self-administered baseline surveys	E, F	AIM Team Leads training workshop ,   Consent form
Self-administered implementation surveys with clinical staff at 6 months	L, O	Self-administered implementation surveys with clinical staff at 6 months ,   Consent form - 6 months
DUA for AIM data	R	DUA for AIM data
Frontline staff rosters developed by AIM Team Leads	A	Frontline staff rosters developed by AIM Team Leads
Evaluation form for training of AIM Team Leads	B	Evaluation form for training of AIM Team Leads
Training of frontline clinical staff
Tracking attendance of facilitation sessions	I	Tracking attendance of facilitation sessions
Clinical staff self-administered baseline surveys	G, H	e) Clinical staff self-administered baseline surveys ,   Consent form
Training of AIM Team Leads	1	Training of AIM Team Leads
Self-administered implementation surveys with clinical staff at 18 months	M, P	Self-administered implementation surveys with clinical staff at 18 months ,   Consent form - Self-administered implementation surveys with clinical staff at 18 months

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ICR Summary of Burden

	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	86,621	86,616	0	5	0	0
Annual Time Burden (Hours)	54,659	54,654	0	5	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The increase in hours is due to the 5 additional qualitative interviews that will be conducted with AIM Team Leads.

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Annual Cost to Federal Government: $530,927

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Yes

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 09/24/2020

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