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

ICR 202105-0935-001

OMB: 0935-0246

Federal Form Document

ICR Details
0935-0246 202105-0935-001
Received in OIRA 202009-0935-005
HHS/AHRQ
Safety Program in Perinatal Care (SPPC)-II Demonstration Project
Revision of a currently approved collection   No
Regular 06/02/2021
  Requested Previously Approved
36 Months From Approved 12/31/2023
86,671 86,621
54,693 54,659
0 0

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.

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

Not associated with rulemaking

  86 FR 12944 03/05/2021
86 FR 28600 05/27/2021
No

16
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

  Total Request 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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.

$530,928
Yes Part B of Supporting Statement
    Yes
    Yes
No
No
No
Yes
Erwin Brown 301 427-1652 [email protected]

  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.
06/02/2021


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