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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form J3 Interview guide for qualitative interviews with AIM Team Leads & frontline staff (summer/fall 2021)	Form and Instruction	New	Available
Form J3 Qualitative semi-structured interviews with frontline staff	Form and Instruction	New	Repair queued
Form R DUA for AIM data	Form and Instruction	Unchanged	Available
Form R DUA for AIM data	Form and Instruction	Unchanged	Repair queued
Form Q Consent form - Self-administered implementation surveys with clinical staff at 30 months	Form	Unchanged	Available
Form N Self-administered implementation surveys with clinical staff at 30 months	Form and Instruction	Unchanged	Available
Form N Self-administered implementation surveys with clinical staff at 30 months	Form and Instruction	Unchanged	Repair queued
Form P Consent form - Self-administered implementation surveys with clinical staff at 18 months	Form	Unchanged	Available
Form M Self-administered implementation surveys with clinical staff at 18 months	Form and Instruction	Unchanged	Repair queued
Form M Self-administered implementation surveys with clinical staff at 18 months	Form and Instruction	Unchanged	Repair queued
Form O Consent form - 6 months	Form	Unchanged	Available
Form L Self-administered implementation surveys with clinical staff at 6 months	Form and Instruction	Unchanged	Available
Form L Self-administered implementation surveys with clinical staff at 6 months	Form and Instruction	Unchanged	Missing upstream
Form J6 Attachment J6 Interview guide for FGDs with AIM Team Leads & frontline staff (summer/fall 2022, new)	Form and Instruction	Modified	Available
Form J5 Attachment J5 Handout 2 listing Tier 1 online modules (new)	Form and Instruction	Modified	Available
Form J3 Attachment J1 Interview guide for qualitative interviews with AIM Team Leads, 3-4mo (revised)	Form and Instruction	Modified	Available
Form J3 Qualitative, semi-structured interviews with AIM Team Leads	Form and Instruction	Modified	Repair queued
Form H Consent form	Form and Instruction	Unchanged	Available
Form G e) Clinical staff self-administered baseline surveys	Form and Instruction	Unchanged	Available
Form G Clinical staff self-administered baseline surveys	Form and Instruction	Unchanged	Available
Form F Consent form	Form and Instruction	Unchanged	Available
Form E AIM Team Leads training workshop	Form	Unchanged	Available
Form E AIM Team Lead self-administered baseline surveys	Form	Unchanged	Repair queued
Form D Coaching calls	Form	Unchanged	Available
Form D c) Coaching calls	Form	Unchanged	Repair queued
Form I Tracking attendance of facilitation sessions	Form and Instruction	Unchanged	Available
Form I Tracking attendance of facilitation sessions	Form and Instruction	Unchanged	Repair queued
Form B Evaluation form for training of AIM Team Leads	Form and Instruction	Unchanged	Available
Form A Frontline staff rosters developed by AIM Team Leads	Form	Unchanged	Available
Form A Frontline staff rosters developed by AIM Team Leads	Form	Unchanged	Repair queued
Form 1 Training of AIM Team Leads	Form and Instruction	Unchanged	Available
Form 1 Training of AIM Team Leads	Form and Instruction	Unchanged	Available
Attachment T List of Stakeholder Panel Members.docx	Supplementary Document	Uploaded 2019-08-16	Repair queued
Attachment S -List of measures reported by hospitals for the AIM program.docx	Supplementary Document	Uploaded 2019-08-16	Repair queued
SPPC-II Dem Supporting Statement Part B Revised after OMB Comments - 12.16.20 clean with highlights.docx	Supporting Statement B	Uploaded 2021-05-28	Repair queued
Supporting Statement Part A-clean with highlights eb rev +cf 12.21.docx	Supporting Statement A	Uploaded 2021-06-02	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
247674	Focus group discussions with AIM Team Leads and frontline staff	Instruction	New
247673	Qualitative semi-structured interviews with frontline staff	Form and Instruction	New	Interview guide for qualitative interviews with AIM Team Leads & frontline staff (summer/fall 2021)
247673	Qualitative semi-structured interviews with frontline staff	Form and Instruction	New
247673	Qualitative semi-structured interviews with frontline staff	Instruction	New
237429	DUA for AIM data	Form and Instruction	Unchanged	DUA for AIM data
237429	DUA for AIM data	Form and Instruction	Unchanged
237428	Self-administered implementation surveys with clinical staff at 30 months	Form	Unchanged	Consent form - Self-administered implementation surveys with clinical staff at 30 months
237428	Self-administered implementation surveys with clinical staff at 30 months	Form and Instruction	Unchanged	Self-administered implementation surveys with clinical staff at 30 months
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	Unchanged	Consent form - Self-administered implementation surveys with clinical staff at 18 months
237426	Self-administered implementation surveys with clinical staff at 18 months	Form and Instruction	Unchanged	Self-administered implementation surveys with clinical staff at 18 months
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	Unchanged	Consent form - 6 months
237418	Self-administered implementation surveys with clinical staff at 6 months	Form and Instruction	Unchanged	Self-administered implementation surveys with clinical staff at 6 months
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	Attachment J6 Interview guide for FGDs with AIM Team Leads & frontline staff (summer/fall 2022, new)
237417	Qualitative, semi-structured interviews with AIM Team Leads	Form and Instruction	Modified	Attachment J5 Handout 2 listing Tier 1 online modules (new)
237417	Qualitative, semi-structured interviews with AIM Team Leads	Form and Instruction	Modified	Attachment J1 Interview guide for qualitative interviews with AIM Team Leads, 3-4mo (revised)
237417	Qualitative, semi-structured interviews with AIM Team Leads	Form and Instruction	Modified
237416	Clinical staff self-administered baseline surveys	Form and Instruction	Unchanged	Consent form
237416	Clinical staff self-administered baseline surveys	Form and Instruction	Unchanged	e) Clinical staff self-administered baseline surveys
237416	Clinical staff self-administered baseline surveys	Form and Instruction	Unchanged
237413	AIM Team Lead self-administered baseline surveys	Form and Instruction	Unchanged	Consent form
237413	AIM Team Lead self-administered baseline surveys	Form	Unchanged	AIM Team Leads training workshop
237413	AIM Team Lead self-administered baseline surveys	Form	Unchanged
237411	c) Coaching calls	Form	Unchanged	Coaching calls
237411	c) Coaching calls	Form	Unchanged
237409	Facilitation sessions	Instruction	Unchanged
237396	Tracking attendance of facilitation sessions	Form and Instruction	Unchanged	Tracking attendance of facilitation sessions
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	Form and Instruction	Unchanged	Evaluation form for training of AIM Team Leads
237394	Evaluation form for training of AIM Team Leads	Instruction	Unchanged
237393	Frontline staff rosters developed by AIM Team Leads	Form	Unchanged	Frontline staff rosters developed by AIM Team Leads
237393	Frontline staff rosters developed by AIM Team Leads	Form	Unchanged
237386	Training of AIM Team Leads	Form and Instruction	Unchanged	Training of AIM Team Leads
237386	Training of AIM Team Leads	Form and Instruction	Unchanged

ICR Details

OMB Control No: 0935-0246	ICR Reference No: 202105-0935-001
Status: Historical Active	Previous ICR Reference No: 202009-0935-005
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: 07/06/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/02/2021
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2024	36 Months From Approved	12/31/2023
Responses	86,671	0	86,621
Time Burden (Hours)	54,693	0	54,659
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:
	86 FR 12944	03/05/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 28600	05/27/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 16

table that charts list of burden

IC Title	Form No.	Form Name
AIM Team Lead self-administered baseline surveys	E, F	AIM Team Leads training workshop ,   Consent form
Clinical staff self-administered baseline surveys	G, H	e) Clinical staff self-administered baseline surveys ,   Consent form
DUA for AIM data	R	DUA for AIM data
Evaluation form for training of AIM Team Leads	B	Evaluation form for training of AIM Team Leads
Facilitation sessions
Focus group discussions with AIM Team Leads and frontline staff
Frontline staff rosters developed by AIM Team Leads	A	Frontline staff rosters developed by AIM Team Leads
Qualitative semi-structured interviews with frontline staff	J3	Interview guide for qualitative interviews with AIM Team Leads & frontline staff (summer/fall 2021)
Qualitative, semi-structured interviews with AIM Team Leads	J6, J5, J3	Attachment J1 Interview guide for qualitative interviews with AIM Team Leads, 3-4mo (revised) ,   Attachment J5 Handout 2 listing Tier 1 online modules (new) ,   Attachment J6 Interview guide for FGDs with AIM Team Leads & frontline staff (summer/fall 2022, new)
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
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
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
Tracking attendance of facilitation sessions	I	Tracking attendance of facilitation sessions
Training of AIM Team Leads	1	Training of AIM Team Leads
Training of frontline clinical staff
c) Coaching calls	D	Coaching calls

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ICR Summary of Burden

table that charts list 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	86,671	86,621	0	50	0	0
Annual Time Burden (Hours)	54,693	54,659	0	34	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The increase of 34 hour burden is due to the additional focus group discussions that will be conducted with AIM Team Leads and frontline staff.

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Annual Cost to Federal Government: $530,928

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: 06/02/2021

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