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[Federal Register Volume 89, Number 244 (Thursday, December 19, 2024)]
[Notices]
[Pages 103828-103830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30259]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Supplemental Evidence and Data Request on Impact of Healthcare 
Worker Safety and Wellness: A Systematic Review

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submission.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review on Impact of 
Healthcare Worker Safety and Wellness: A Systematic Review, which is 
currently being conducted by the AHRQ's Evidence-based Practice Centers 
(EPC) Program. Access to published and unpublished pertinent scientific 
information will improve the quality of this review.

DATES: Submission Deadline on or before January 21, 2025.

ADDRESSES: 
    Email submissions: [email protected].
    Print submissions:

Mailing Address: Center for Evidence and Practice Improvement, Agency 
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice 
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC 
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 
20857

FOR FURTHER INFORMATION CONTACT: Kelly Carper, eelephone: 301-427-1656 
or email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Impact of Healthcare 
Worker Safety and Wellness: A Systematic Review. AHRQ is conducting 
this review pursuant to section 902 of the Public Health Service Act, 
42 U.S.C. 299a.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the

[[Page 103829]]

literature by requesting information from the public (e.g., details of 
studies conducted). We are looking for studies that report on Impact of 
Healthcare Worker Safety and Wellness: A Systematic Review. The entire 
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/worker-safety-wellness/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Impact of Healthcare Worker Safety and 
Wellness: A Systematic Review helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this topic. In the list, please indicate whether results 
are available on ClinicalTrials.gov along with the ClinicalTrials.gov 
trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, a summary, including the following elements, if 
relevant: study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this topic. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including, if relevant, a study number, the 
study period, design, methodology, indication and diagnosis, proper use 
instructions, inclusion and exclusion criteria, and primary and 
secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this topic and an index outlining the relevant information in each 
submitted file.
    Your contribution is very beneficial to the Program. Materials 
submitted must be publicly available or able to be made public. 
Materials that are considered confidential; marketing materials; study 
types not included in the review; or information on topics not included 
in the review cannot be used by the EPC Program. This is a voluntary 
request for information, and all costs for complying with this request 
must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.
    The review will answer the following questions. This information is 
provided as background. AHRQ is not requesting that the public provide 
answers to these questions.
    Contextual Question: What are the manifestations of impaired safety 
and wellbeing of HCWs, such as burnout, moral injury, emotional 
exhaustion, staff turnover, and physical injuries?

Key Questions (KQ)

    KQ 1: What are the associations between healthcare delivery 
conditions and HCW burnout?
    KQ 2: What are the associations between HCW burnout and outcomes 
for patients, HCW families, healthcare delivery organizations, and 
society?
    KQ 3: What are the effectiveness and harms of system-level 
interventions targeting HCW burnout?

                  PECOTS (Populations, Exposures, Comparators, Outcomes, Timing and Setting) Eligibility Criteria for All Key Questions
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             Element                           Key Question 1                          Key Question 2                          Key Question 3
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Population.......................  HCWs at all organizational levels (e.g., those who provide direct patient care, support personnel, managers,
                                    executives) Examples:
                                    Physicians.
                                    Nurses: registered nurses and advanced practice nurses.
                                    Pharmacists.
                                    Allied healthcare professionals (e.g., respiratory therapists, physical therapists, social workers,
                                    emergency medical technicians).
                                    Support personnel (e.g., environmental services).
                                    Managers.
                                    Executives.
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Exposure.........................  All healthcare delivery conditions      HCW burnout, including instruments      System-level programs: interventions
                                    associated with the included studies    such as:                                that intend to reduce or prevent HCW
                                    will be recorded as exposures,          Maslach Burnout Inventory       burnout through the elimination or
                                    including                               Oldenburg Burnout Inventory     substitution of occupational
                                    Societal conditions,            Copenhagen Burnout Inventory    hazards.
                                    including federal and state laws like   Two-Item Maslach Burnout       Exclude: interventions that enable
                                    nurse staffing laws, policies like      Inventory                               the occupational hazard to remain in
                                    pandemic restrictions and               Physician Worklife Study        place (engineering, administrative
                                    credentialing, and unemployment,        Single Item Question                    controls) or increase the individual
                                    healthcare utilization, and             ProQOL Burnout scale            capacity to cope with the hazard
                                    unionization rates.                     Institute for Professional      (PPE, resilience training).
                                    Organizational factors such     Worklife Mini Z Survey
                                    as payment model, level of care,
                                    precarious and unstable scheduling,
                                    safety culture.
                                    Job and task-specific
                                    factors, such as occupational class,
                                    shift characteristics, working hours,
                                    occupational stressors, support,
                                    teamwork, and workplace hazards
                                    Individual factors, such as age and
                                    experience.
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Comparator.......................  Other healthcare delivery condition.    Other levels of HCW burnout.             Other intervention.
                                                                                                                    No intervention.
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[[Page 103830]]

 
Outcomes.........................  HCW burnout, including instruments       HCW family outcomes, such as:  HCW burnout, including instruments
                                    such as:                               [cir] Marital/relationship stress        such as:
                                    Maslach Burnout Inventory       measured by a partner                   Maslach Burnout Inventory.
                                    Oldenburg Burnout Inventory    [cir] Divorce/separation rates           Oldenburg Burnout Inventory.
                                    Copenhagen Burnout Inventory    Patient outcomes, such as:      Copenhagen Burnout
                                    Two-Item Maslach Burnout       [cir] Safety                             Inventory.
                                    Inventory                              [cir] Satisfaction                       Two-Item Maslach Burnout
                                    Physician Worklife Study       [cir] Adverse events                     Inventory.
                                    Single Item Question                   [cir] Mortality                          Physician Worklife Study
                                    Professional Quality of Life    Healthcare organization         Single Item Question.
                                    (ProQOL) Burnout scale                  outcomes, such as:                      ProQOL Burnout scale.
                                    Institute for Professional     [cir] Productivity (including            Institute for Professional
                                    Worklife Mini Z Survey                  presenteeism, absenteeism, work-        Worklife Mini Z Survey.
                                                                            related injuries and illnesses)
                                                                           [cir] Staff turnover (including due to
                                                                            retirement, leaving the profession,
                                                                            mortality, or suicide)
                                                                            Societal outcomes, such as:
                                                                           [cir] Workforce shortages
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Mediating Factors................   Individual factors such as stress, satisfaction, wellbeing, engagement, sleep quality, suicidal ideation,
                                    depression, anxiety, meaningful work, mattering, moral distress or injury, workplace injury or illness.
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Modifying Factors................  [cir] Demographic characteristics: (e.g., age, sex, race, ethnicity).
                                   [cir] Occupational title (e.g., physician, nurse, allied health professional, other).
                                   [cir] Educational attainment (e.g., high school, some college, college degree, graduate degree).
                                   [cir] Experience (e.g., number of years employed).
                                   [cir] Income (e.g., household income, socioeconomic status).
                                   [cir] Time (e.g., year of outcome ascertainment, or binned by pre-, concurrent and post-pandemic).
                                   [cir] Shift characteristics: (e.g., timing, duration, knowledge of shift, mandatory overtime).
                                   [cir] Job tasks (e.g., patient-facing vs. non-patient-facing, physical demands as high, moderate, low).
                                   [cir] Geographic location (e.g., U.S. census region, urban vs. suburban vs. rural).
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Study Designs....................   Cross-sectional studies.                                                Randomized controlled
                                    Cohort studies.                                                         trials.
                                                                                                                    Non-randomized controlled
                                                                                                                    trials.
                                                                                                                    Observational cohort studies
                                                                                                                    with a comparison group.
                                                                                                                    Pre-post studies (with
                                                                                                                    adjustment for confounders).
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Timing...........................  Published since 2014.
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Settings.........................  All U.S. healthcare delivery settings where HCWs work (e.g., ambulatory, prehospital, emergency, various inpatient
                                    services, post-acute or skilled nursing/long-term care, including medical, surgical, and mental health care
                                    settings).
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Abbreviations: HCW = healthcare worker; PPE = personal protective equipment, ProQOL = Professional Quality of Life.

    Dated: December 12, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-30259 Filed 12-18-24; 8:45 am]
BILLING CODE 4160-90-P
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