<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02260245</url>
  </required_header>
  <id_info>
    <org_study_id>2014P000045</org_study_id>
    <nct_id>NCT02260245</nct_id>
  </id_info>
  <brief_title>Stepping Up for Safety: Improving Teamwork at the Planned Parenthood Affiliates Through the TeamSTEPPS Model</brief_title>
  <official_title>Stepping Up for Safety: Improving Teamwork at the Planned Parenthood Affiliates Through the TeamSTEPPS Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Affiliates Risk Management Services, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) is an&#xD;
      evidence-based teamwork system designed to improve communication and teamwork skills among&#xD;
      health professionals. The program was developed by the Agency for Healthcare Research and&#xD;
      Quality (AHRQ) and the Department of Defense's Patient Safety Program as the national&#xD;
      standard for team training in health care.&#xD;
&#xD;
      The purpose of this study is to evaluate the effect of the TeamSTEPPS program on the team&#xD;
      knowledge, skills and attitudes and patient safety at Planned Parenthood affiliates&#xD;
      nationwide.&#xD;
&#xD;
      The investigators hypothesize that implementation of the TeamSTEPPS program will be&#xD;
      associated with improved team knowledge, skills, and attitudes; clinical outcomes; and&#xD;
      process outcomes.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
        1. To assess the effect of the TeamSTEPPS training program on team communication and&#xD;
           effective team work&#xD;
&#xD;
        2. To assess the effect of the TeamSTEPPS training program on process outcomes&#xD;
&#xD;
        3. To assess the effect of the TeamSTEPPS training program on clinical outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 1999, the healthcare community received a wake-up call when the Institute of Medicine's&#xD;
      landmark report, To Err Is Human, [IOM, 1999] revealed that up to 98,000 Americans die each&#xD;
      year from medical errors, with several more thousand injured. Most medical errors result from&#xD;
      systems deficiencies, and they include such events as missed or delayed diagnoses and&#xD;
      medication errors. The morbidity, mortality, and associated costs that result from medical&#xD;
      errors can have far-reaching consequences, not only for patients and their families, but also&#xD;
      for caregivers, health care organizations, and the community at large.&#xD;
&#xD;
      Publication of the IOM report heralded a seismic shift in the culture and delivery of health&#xD;
      care as medical facilities sought to identify and redesign vulnerable systems to make them&#xD;
      safer. Most efforts to date have concentrated on hospital-based systems, however, and a&#xD;
      tremendous need exists to adapt &quot;lessons learned&quot; and patient safety strategies and tools to&#xD;
      ambulatory-care facilities [Sclafani 2012]. Toward that end, Affiliates Risk Management&#xD;
      Services, Inc. (ARMS), the risk management foundation for Planned Parenthood of America&#xD;
      (PPFA), is partnering with Beth Israel Deaconess Medical Center/Harvard Medical School&#xD;
      (BIDMC/HMS) and the Agency for Healthcare Research and Quality (AHRQ) to bring team training&#xD;
      to PPFA's large clinical network. This network is comprised of 74 affiliates operating&#xD;
      ambulatory health centers throughout the United States that provide reproductive health&#xD;
      services to approximately 3 million women and men annually.&#xD;
&#xD;
      Implementation of a medical teamwork system has been associated with reduced medical errors,&#xD;
      improved clinical and process outcomes, and medical and liability cost savings [Colla 2005;&#xD;
      Mann 2006; Pratt 2007; Neilsen 2007, Neily 2010; Gillespie 2010; Weaver 2010; Moffatt 2012;&#xD;
      Gluck 2012; Sawyer 2013]. For example, in a recent large study involving more than 100,000&#xD;
      surgical procedures in 100 Veterans Administration hospitals, patients whose surgical staff&#xD;
      had undergone team training experienced a 50% greater decline in surgical mortality than&#xD;
      those whose staff had not been team-trained [Neily 2010]. In a seminal study at BIDMC/HMS,&#xD;
      implementation of a team training initiative among labor and delivery staff resulted in a 50%&#xD;
      decrease both in the incidence of adverse obstetrical outcomes and the number of high&#xD;
      severity malpractice claims, representing a savings of several million dollars [Mann 2006,&#xD;
      Pratt 2007]. Team training results in higher quality, safer care by producing high performing&#xD;
      teams, clarifying roles and responsibilities, improving information sharing, and eliminating&#xD;
      barriers to quality and safety. Moreover, team training has the potential to help shift the&#xD;
      organizational culture of health care institutions from hierarchical models to ones that&#xD;
      foster team learning, collaboration, transparency, and open communication.&#xD;
&#xD;
      The move toward greater safety in health care is not only the &quot;right thing to do&quot; for&#xD;
      patients, but it has become a national imperative. Nearly half of The Joint Commission's&#xD;
      standards for accreditation of health care facilities directly relate to patient safety [The&#xD;
      Joint Commission, online 2013], and effective communication and team work are key components&#xD;
      of the American Congress of Obstetricians and Gynecologists' [ACOG] recently-launched&#xD;
      voluntary accreditation program for medical office settings [Sclafani et al. 2012]. Indeed,&#xD;
      the ability to thrive in the new environment of health care reform demands delivery of care&#xD;
      that is safe, high-quality, efficient, and cost-effective, all characteristics affected by&#xD;
      team training. The time has come to bring the benefits of team training to the Planned&#xD;
      Parenthood network and the myriad patients who turn to Planned Parenthood as their trusted&#xD;
      health care provider.&#xD;
&#xD;
      This is a prospective cohort study to evaluate the effect of the TeamSTEPPS program on team&#xD;
      knowledge, skills and attitudes, process outcomes, and clinical outcomes in Planned&#xD;
      Parenthood affiliates in the United States.&#xD;
&#xD;
      Study Population: Planned Parenthood affiliate employees and clients will serve as the study&#xD;
      population for this study. Some endpoints, such as attitudes about team work, will rely on&#xD;
      client and employee surveys pre- and post-intervention. Process outcomes such as frequency of&#xD;
      team briefs will rely on affiliate documentation of the frequency of these events pre- and&#xD;
      post-intervention. Clinical outcomes, such as adverse events, will utilize the secure online&#xD;
      de-identified reporting system, ARMS Risk Management Information System (AIMS).&#xD;
&#xD;
      Intervention: During a two-year period, ARMS/BIDMC plans to offer TeamSTEPPS master training&#xD;
      for key staff from 16 Planned Parenthood affiliates and to assist these master trainers as&#xD;
      they implement targeted improvements through team training at the affiliate level.&#xD;
      TeamSTEPPS, an evidence-based teamwork system designed to improve communication and teamwork&#xD;
      skills among health professionals, was developed by AHRQ and the Department of Defense's&#xD;
      Patient Safety Program as the national standard for team training in health care [AHRQ on&#xD;
      line; Sheppard et al. 2013]. Faculty members from AHRQ's TeamSTEPPS national training center&#xD;
      at the University of Washington have agreed to provide a dedicated master training course for&#xD;
      Planned Parenthood affiliates. ARMS will work with the faculty to adapt the TeamSTEPPS&#xD;
      curriculum to the Planned Parenthood clinical context.&#xD;
&#xD;
      Procedures:&#xD;
&#xD;
      The training and implementation cycle includes the following main components that are&#xD;
      occurring independent of the evaluation:&#xD;
&#xD;
        1. Developing a Teamwork Improvement Action Plan Using a guide developed by AHRQ, ARMS&#xD;
           staff and BIDMC/HMS faculty will work with each participating affiliate to develop a&#xD;
           Teamwork Improvement Action Plan prior to the master training program. The purpose is to&#xD;
           help each affiliate prepare for team training by identifying an appropriate training&#xD;
           team and determining two to three key targets for improvement through team training, how&#xD;
           the intervention will be implemented, and how to measure success.&#xD;
&#xD;
        2. TeamSTEPPS Master Training Each of the selected affiliates will send a 2-4 person team&#xD;
           to a 2-day TeamSTEPPS &quot;train the trainer&quot; program in June 2014. The teams will be&#xD;
           multidisciplinary (for example, quality leader, physician, nurse manager) and consist of&#xD;
           leaders who are well-positioned by their roles to offer team training to frontline&#xD;
           surgical abortion staff at their affiliates.&#xD;
&#xD;
           The training curriculum teaches practical tools and strategies, such as briefs, huddles,&#xD;
           debriefs, time outs, and SBAR (situation - background - assessment - recommendation)&#xD;
           communication skills that when practiced regularly, cultivate the core team skills&#xD;
           necessary for effective team work.&#xD;
&#xD;
        3. TeamSTEPPS Implementation at the Clinic Level Following the master training, the&#xD;
           TeamSTEPPS master trainers will implement their Action Plans at their affiliates.&#xD;
&#xD;
        4. Continued Training and Sustainability ARMS staff will advise and support the new master&#xD;
           trainers as they reinforce the principles and skills of TeamSTEPPS on an ongoing basis.&#xD;
           In addition, the trainers will be encouraged to participate in AHRQ's TeamSTEPPS user&#xD;
           support network, which includes web conferences and an online discussion forum, as well&#xD;
           as AHRQ's annual TeamSTEPPS national conference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">November 2020</completion_date>
  <primary_completion_date type="Actual">November 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in team attitudes and perceptions</measure>
    <time_frame>Pre-intervention, six months post-intervention, and every 12 months thereafter</time_frame>
    <description>Surveys will be completed by staff at each affiliate; additional surveys will be completed anonymously by patients regarding their perceptions of teamwork among the affiliate staff members involved in their care. These measures will be used to create a composite measure, and change from baseline to each of the study time-points will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in process outcomes and behavioral change</measure>
    <time_frame>Pre-intervention, six months post-intervention, and every 12 months thereafter</time_frame>
    <description>A designated staff member at each affiliate will complete a questionnaire regarding site practices such as the use of time-outs and the occurrence of briefs and debriefs. These outcomes will be combined as a composite measure, and change from baseline to each of the study time-points will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in clinical outcomes</measure>
    <time_frame>Pre-intervention, six months post-intervention, and every 12 months thereafter</time_frame>
    <description>Adverse outcomes are collected by AIMS and will be reported in a de-identified report to the research team. All adverse outcomes will be combined to create a composite measure, and change from baseline to each of the study time-points will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient cycle times</measure>
    <time_frame>Six-month period before intervention and for six months after a six-month washout period after intervention</time_frame>
    <description>Organizations track the time that patients spend in the clinic such that changes in patient cycle time (intake to exit) can be measured</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Improving Team Work at the Planned Parenthood Affiliates</condition>
  <arm_group>
    <arm_group_label>Team training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participating affiliates will undergo team training using the TeamSTEPPS model</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Team training using the TeamSTEPPS model</intervention_name>
    <description>Two or three master trainers from each affiliate will be undergo train-the-trainer training to bring back to their affiliate.</description>
    <arm_group_label>Team training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planned Parenthood employee&#xD;
&#xD;
          -  Planned Parenthood client&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen E Paul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <reference>
    <citation>Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/</citation>
    <PMID>25077248</PMID>
  </reference>
  <reference>
    <citation>Sclafani J, Levy B, Lawrence H, Saraco M, Cain JM. Building a better safety net: taking the safety agenda to office-based women's health. Obstet Gynecol. 2012 Aug;120(2 Pt 1):355-9. doi: 10.1097/AOG.0b013e318260957c. Erratum In: Obstet Gynecol. 2012 Oct;120(4):957.</citation>
    <PMID>22668586</PMID>
  </reference>
  <reference>
    <citation>Colla JB, Bracken AC, Kinney LM, Weeks WB. Measuring patient safety climate: a review of surveys. Qual Saf Health Care. 2005 Oct;14(5):364-6. doi: 10.1136/qshc.2005.014217.</citation>
    <PMID>16195571</PMID>
  </reference>
  <reference>
    <citation>Pratt SD, Mann S, Salisbury M, Greenberg P, Marcus R, Stabile B, McNamee P, Nielsen P, Sachs BP. John M. Eisenberg Patient Safety and Quality Awards. Impact of CRM-based training on obstetric outcomes and clinicians' patient safety attitudes. Jt Comm J Qual Patient Saf. 2007 Dec;33(12):720-5. doi: 10.1016/s1553-7250(07)33086-9. No abstract available.</citation>
    <PMID>18200896</PMID>
  </reference>
  <reference>
    <citation>Nielsen PE, Goldman MB, Mann S, Shapiro DE, Marcus RG, Pratt SD, Greenberg P, McNamee P, Salisbury M, Birnbach DJ, Gluck PA, Pearlman MD, King H, Tornberg DN, Sachs BP. Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):48-55. doi: 10.1097/01.AOG.0000250900.53126.c2.</citation>
    <PMID>17197587</PMID>
  </reference>
  <reference>
    <citation>Neily J, Mills PD, Young-Xu Y, Carney BT, West P, Berger DH, Mazzia LM, Paull DE, Bagian JP. Association between implementation of a medical team training program and surgical mortality. JAMA. 2010 Oct 20;304(15):1693-700. doi: 10.1001/jama.2010.1506.</citation>
    <PMID>20959579</PMID>
  </reference>
  <reference>
    <citation>Gillespie BM, Chaboyer W, Murray P. Enhancing communication in surgery through team training interventions: a systematic literature review. AORN J. 2010 Dec;92(6):642-57. doi: 10.1016/j.aorn.2010.02.015.</citation>
    <PMID>21130202</PMID>
  </reference>
  <reference>
    <citation>Moffatt-Bruce SD, Funai EF, Nash M, Gabbe SG. Patient safety strategies: are we on the same team? Obstet Gynecol. 2012 Oct;120(4):743-5. doi: 10.1097/AOG.0b013e31826af730. No abstract available.</citation>
    <PMID>22996089</PMID>
  </reference>
  <reference>
    <citation>Gluck PA. Patient safety: some progress and many challenges. Obstet Gynecol. 2012 Nov;120(5):1149-59. doi: 10.1097/aog.0b013e31826feaa0.</citation>
    <PMID>23090534</PMID>
  </reference>
  <reference>
    <citation>Sawyer T, Laubach VA, Hudak J, Yamamura K, Pocrnich A. Improvements in teamwork during neonatal resuscitation after interprofessional TeamSTEPPS training. Neonatal Netw. 2013 Jan-Feb;32(1):26-33. doi: 10.1891/0730-0832.32.1.26.</citation>
    <PMID>23318204</PMID>
  </reference>
  <reference>
    <citation>Weaver SJ, Rosen MA, DiazGranados D, Lazzara EH, Lyons R, Salas E, Knych SA, McKeever M, Adler L, Barker M, King HB. Does teamwork improve performance in the operating room? A multilevel evaluation. Jt Comm J Qual Patient Saf. 2010 Mar;36(3):133-42. doi: 10.1016/s1553-7250(10)36022-3.</citation>
    <PMID>20235415</PMID>
  </reference>
  <reference>
    <citation>Sheppard F, Williams M, Klein VR. TeamSTEPPS and patient safety in healthcare. J Healthc Risk Manag. 2013;32(3):5-10. doi: 10.1002/jhrm.21099.</citation>
    <PMID>23335296</PMID>
  </reference>
  <reference>
    <citation>Baker DP, Amodeo AM, Krokos KJ, Slonim A, Herrera H. Assessing teamwork attitudes in healthcare: development of the TeamSTEPPS teamwork attitudes questionnaire. Qual Saf Health Care. 2010 Dec;19(6):e49. doi: 10.1136/qshc.2009.036129. Epub 2010 Aug 10.</citation>
    <PMID>20702444</PMID>
  </reference>
  <reference>
    <citation>Castner J. Validity and reliability of the Brief TeamSTEPPS Teamwork Perceptions Questionnaire. J Nurs Meas. 2012;20(3):186-98. doi: 10.1891/1061-3749.20.3.186.</citation>
    <PMID>23362556</PMID>
  </reference>
  <reference>
    <citation>Mann S, Marcus R, Sachs B. Lessons from the cockpit: How team training can reduce errors on L&amp;D. Contemp OB/GYN, January 2006, p. 1-7.</citation>
  </reference>
  <reference>
    <citation>Agency for Healthcare Research and Quality (AHRQ). TeamSTEPPS: National Implementation. Rockville MD: AHRQ. Available at teamstepps.ahrq.gov. Accessed February 1, 2013.</citation>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>November 21, 2020</last_update_submitted>
  <last_update_submitted_qc>November 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Maureen Paul</investigator_full_name>
    <investigator_title>Division Director of Family Planning</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02260245
org study id: 2014P000045
nct id: NCT02260245
lead sponsor: 
collaborator: 
has dmc: No
TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) is an
      evidence-based teamwork system designed to improve communication and teamwork skills among
      health professionals. The program was developed by the Agency for Healthcare Research and
      Quality (AHRQ) and the Department of Defense's Patient Safety Program as the national
      standard for team training in health care.

      The purpose of this study is to evaluate the effect of the TeamSTEPPS program on the team
      knowledge, skills and attitudes and patient safety at Planned Parenthood affiliates
      nationwide.

      The investigators hypothesize that implementation of the TeamSTEPPS program will be
      associated with improved team knowledge, skills, and attitudes; clinical outcomes; and
      process outcomes.

      Aims:

        1. To assess the effect of the TeamSTEPPS training program on team communication and
           effective team work

        2. To assess the effect of the TeamSTEPPS training program on process outcomes

        3. To assess the effect of the TeamSTEPPS training program on clinical outcomes
In 1999, the healthcare community received a wake-up call when the Institute of Medicine's
      landmark report, To Err Is Human, [IOM, 1999] revealed that up to 98,000 Americans die each
      year from medical errors, with several more thousand injured. Most medical errors result from
      systems deficiencies, and they include such events as missed or delayed diagnoses and
      medication errors. The morbidity, mortality, and associated costs that result from medical
      errors can have far-reaching consequences, not only for patients and their families, but also
      for caregivers, health care organizations, and the community at large.

      Publication of the IOM report heralded a seismic shift in the culture and delivery of health
      care as medical facilities sought to identify and redesign vulnerable systems to make them
      safer. Most efforts to date have concentrated on hospital-based systems, however, and a
      tremendous need exists to adapt "lessons learned" and patient safety strategies and tools to
      ambulatory-care facilities [Sclafani 2012]. Toward that end, Affiliates Risk Management
      Services, Inc. (ARMS), the risk management foundation for Planned Parenthood of America
      (PPFA), is partnering with Beth Israel Deaconess Medical Center/Harvard Medical School
      (BIDMC/HMS) and the Agency for Healthcare Research and Quality (AHRQ) to bring team training
      to PPFA's large clinical network. This network is comprised of 74 affiliates operating
      ambulatory health centers throughout the United States that provide reproductive health
      services to approximately 3 million women and men annually.

      Implementation of a medical teamwork system has been associated with reduced medical errors,
      improved clinical and process outcomes, and medical and liability cost savings [Colla 2005;
      Mann 2006; Pratt 2007; Neilsen 2007, Neily 2010; Gillespie 2010; Weaver 2010; Moffatt 2012;
      Gluck 2012; Sawyer 2013]. For example, in a recent large study involving more than 100,000
      surgical procedures in 100 Veterans Administration hospitals, patients whose surgical staff
      had undergone team training experienced a 50% greater decline in surgical mortality than
      those whose staff had not been team-trained [Neily 2010]. In a seminal study at BIDMC/HMS,
      implementation of a team training initiative among labor and delivery staff resulted in a 50%
      decrease both in the incidence of adverse obstetrical outcomes and the number of high
      severity malpractice claims, representing a savings of several million dollars [Mann 2006,
      Pratt 2007]. Team training results in higher quality, safer care by producing high performing
      teams, clarifying roles and responsibilities, improving information sharing, and eliminating
      barriers to quality and safety. Moreover, team training has the potential to help shift the
      organizational culture of health care institutions from hierarchical models to ones that
      foster team learning, collaboration, transparency, and open communication.

      The move toward greater safety in health care is not only the "right thing to do" for
      patients, but it has become a national imperative. Nearly half of The Joint Commission's
      standards for accreditation of health care facilities directly relate to patient safety [The
      Joint Commission, online 2013], and effective communication and team work are key components
      of the American Congress of Obstetricians and Gynecologists' [ACOG] recently-launched
      voluntary accreditation program for medical office settings [Sclafani et al. 2012]. Indeed,
      the ability to thrive in the new environment of health care reform demands delivery of care
      that is safe, high-quality, efficient, and cost-effective, all characteristics affected by
      team training. The time has come to bring the benefits of team training to the Planned
      Parenthood network and the myriad patients who turn to Planned Parenthood as their trusted
      health care provider.

      This is a prospective cohort study to evaluate the effect of the TeamSTEPPS program on team
      knowledge, skills and attitudes, process outcomes, and clinical outcomes in Planned
      Parenthood affiliates in the United States.

      Study Population: Planned Parenthood affiliate employees and clients will serve as the study
      population for this study. Some endpoints, such as attitudes about team work, will rely on
      client and employee surveys pre- and post-intervention. Process outcomes such as frequency of
      team briefs will rely on affiliate documentation of the frequency of these events pre- and
      post-intervention. Clinical outcomes, such as adverse events, will utilize the secure online
      de-identified reporting system, ARMS Risk Management Information System (AIMS).

      Intervention: During a two-year period, ARMS/BIDMC plans to offer TeamSTEPPS master training
      for key staff from 16 Planned Parenthood affiliates and to assist these master trainers as
      they implement targeted improvements through team training at the affiliate level.
      TeamSTEPPS, an evidence-based teamwork system designed to improve communication and teamwork
      skills among health professionals, was developed by AHRQ and the Department of Defense's
      Patient Safety Program as the national standard for team training in health care [AHRQ on
      line; Sheppard et al. 2013]. Faculty members from AHRQ's TeamSTEPPS national training center
      at the University of Washington have agreed to provide a dedicated master training course for
      Planned Parenthood affiliates. ARMS will work with the faculty to adapt the TeamSTEPPS
      curriculum to the Planned Parenthood clinical context.

      Procedures:

      The training and implementation cycle includes the following main components that are
      occurring independent of the evaluation:

        1. Developing a Teamwork Improvement Action Plan Using a guide developed by AHRQ, ARMS
           staff and BIDMC/HMS faculty will work with each participating affiliate to develop a
           Teamwork Improvement Action Plan prior to the master training program. The purpose is to
           help each affiliate prepare for team training by identifying an appropriate training
           team and determining two to three key targets for improvement through team training, how
           the intervention will be implemented, and how to measure success.

        2. TeamSTEPPS Master Training Each of the selected affiliates will send a 2-4 person team
           to a 2-day TeamSTEPPS "train the trainer" program in June 2014. The teams will be
           multidisciplinary (for example, quality leader, physician, nurse manager) and consist of
           leaders who are well-positioned by their roles to offer team training to frontline
           surgical abortion staff at their affiliates.

           The training curriculum teaches practical tools and strategies, such as briefs, huddles,
           debriefs, time outs, and SBAR (situation - background - assessment - recommendation)
           communication skills that when practiced regularly, cultivate the core team skills
           necessary for effective team work.

        3. TeamSTEPPS Implementation at the Clinic Level Following the master training, the
           TeamSTEPPS master trainers will implement their Action Plans at their affiliates.

        4. Continued Training and Sustainability ARMS staff will advise and support the new master
           trainers as they reinforce the principles and skills of TeamSTEPPS on an ongoing basis.
           In addition, the trainers will be encouraged to participate in AHRQ's TeamSTEPPS user
           support network, which includes web conferences and an online discussion forum, as well
           as AHRQ's annual TeamSTEPPS national conference.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in team attitudes and perceptions
time frame: Pre-intervention, six months post-intervention, and every 12 months thereafter
description: Surveys will be completed by staff at each affiliate; additional surveys will be completed anonymously by patients regarding their perceptions of teamwork among the affiliate staff members involved in their care. These measures will be used to create a composite measure, and change from baseline to each of the study time-points will be assessed.
measure: Change in process outcomes and behavioral change
time frame: Pre-intervention, six months post-intervention, and every 12 months thereafter
description: A designated staff member at each affiliate will complete a questionnaire regarding site practices such as the use of time-outs and the occurrence of briefs and debriefs. These outcomes will be combined as a composite measure, and change from baseline to each of the study time-points will be assessed.
measure: Change in clinical outcomes
time frame: Pre-intervention, six months post-intervention, and every 12 months thereafter
description: Adverse outcomes are collected by AIMS and will be reported in a de-identified report to the research team. All adverse outcomes will be combined to create a composite measure, and change from baseline to each of the study time-points will be assessed.
measure: Change in patient cycle times
time frame: Six-month period before intervention and for six months after a six-month washout period after intervention
description: Organizations track the time that patients spend in the clinic such that changes in patient cycle time (intake to exit) can be measured
arm group label: Team training
arm group type: Other
description: All participating affiliates will undergo team training using the TeamSTEPPS model
intervention type: Behavioral
intervention name: Team training using the TeamSTEPPS model
description: Two or three master trainers from each affiliate will be undergo train-the-trainer training to bring back to their affiliate.
arm group label: Team training
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maureen E Paul, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
citation: Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/
PMID: 25077248
citation: Sclafani J, Levy B, Lawrence H, Saraco M, Cain JM. Building a better safety net: taking the safety agenda to office-based women's health. Obstet Gynecol. 2012 Aug;120(2 Pt 1):355-9. doi: 10.1097/AOG.0b013e318260957c. Erratum In: Obstet Gynecol. 2012 Oct;120(4):957.
PMID: 22668586
citation: Colla JB, Bracken AC, Kinney LM, Weeks WB. Measuring patient safety climate: a review of surveys. Qual Saf Health Care. 2005 Oct;14(5):364-6. doi: 10.1136/qshc.2005.014217.
PMID: 16195571
citation: Pratt SD, Mann S, Salisbury M, Greenberg P, Marcus R, Stabile B, McNamee P, Nielsen P, Sachs BP. John M. Eisenberg Patient Safety and Quality Awards. Impact of CRM-based training on obstetric outcomes and clinicians' patient safety attitudes. Jt Comm J Qual Patient Saf. 2007 Dec;33(12):720-5. doi: 10.1016/s1553-7250(07)33086-9. No abstract available.
PMID: 18200896
citation: Nielsen PE, Goldman MB, Mann S, Shapiro DE, Marcus RG, Pratt SD, Greenberg P, McNamee P, Salisbury M, Birnbach DJ, Gluck PA, Pearlman MD, King H, Tornberg DN, Sachs BP. Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):48-55. doi: 10.1097/01.AOG.0000250900.53126.c2.
PMID: 17197587
citation: Neily J, Mills PD, Young-Xu Y, Carney BT, West P, Berger DH, Mazzia LM, Paull DE, Bagian JP. Association between implementation of a medical team training program and surgical mortality. JAMA. 2010 Oct 20;304(15):1693-700. doi: 10.1001/jama.2010.1506.
PMID: 20959579
citation: Gillespie BM, Chaboyer W, Murray P. Enhancing communication in surgery through team training interventions: a systematic literature review. AORN J. 2010 Dec;92(6):642-57. doi: 10.1016/j.aorn.2010.02.015.
PMID: 21130202
citation: Moffatt-Bruce SD, Funai EF, Nash M, Gabbe SG. Patient safety strategies: are we on the same team? Obstet Gynecol. 2012 Oct;120(4):743-5. doi: 10.1097/AOG.0b013e31826af730. No abstract available.
PMID: 22996089
citation: Gluck PA. Patient safety: some progress and many challenges. Obstet Gynecol. 2012 Nov;120(5):1149-59. doi: 10.1097/aog.0b013e31826feaa0.
PMID: 23090534
citation: Sawyer T, Laubach VA, Hudak J, Yamamura K, Pocrnich A. Improvements in teamwork during neonatal resuscitation after interprofessional TeamSTEPPS training. Neonatal Netw. 2013 Jan-Feb;32(1):26-33. doi: 10.1891/0730-0832.32.1.26.
PMID: 23318204
citation: Weaver SJ, Rosen MA, DiazGranados D, Lazzara EH, Lyons R, Salas E, Knych SA, McKeever M, Adler L, Barker M, King HB. Does teamwork improve performance in the operating room? A multilevel evaluation. Jt Comm J Qual Patient Saf. 2010 Mar;36(3):133-42. doi: 10.1016/s1553-7250(10)36022-3.
PMID: 20235415
citation: Sheppard F, Williams M, Klein VR. TeamSTEPPS and patient safety in healthcare. J Healthc Risk Manag. 2013;32(3):5-10. doi: 10.1002/jhrm.21099.
PMID: 23335296
citation: Baker DP, Amodeo AM, Krokos KJ, Slonim A, Herrera H. Assessing teamwork attitudes in healthcare: development of the TeamSTEPPS teamwork attitudes questionnaire. Qual Saf Health Care. 2010 Dec;19(6):e49. doi: 10.1136/qshc.2009.036129. Epub 2010 Aug 10.
PMID: 20702444
citation: Castner J. Validity and reliability of the Brief TeamSTEPPS Teamwork Perceptions Questionnaire. J Nurs Meas. 2012;20(3):186-98. doi: 10.1891/1061-3749.20.3.186.
PMID: 23362556
citation: Mann S, Marcus R, Sachs B. Lessons from the cockpit: How team training can reduce errors on L&D. Contemp OB/GYN, January 2006, p. 1-7.
citation: Agency for Healthcare Research and Quality (AHRQ). TeamSTEPPS: National Implementation. Rockville MD: AHRQ. Available at teamstepps.ahrq.gov. Accessed February 1, 2013.
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Maureen Paul
investigator title: Division Director of Family Planning