NCT05187598

Brief Summary

Patient safety, which is an important concept in terms of providing effective and high-quality health care, is defined as "preventing health care errors and eliminating or reducing patient damage caused by health care errors". Worldwide, adverse events from unsafe care are estimated to be one of the 10 leading causes of death and disability. Ineffective communication between healthcare professionals, which is among the factors that cause errors related to patient safety, is reported as one of the factors that have the most impact on medical errors and unintentional patient harm. Studies show that ineffective communication between healthcare professionals may be responsible for up to 80% of all preventable adverse events rather than the patient's medical condition. Considering the number of lawsuits and cost increase due to errors that violate patient safety, it is stated that medical errors are higher especially in the field of perinatology. In studies conducted, errors in the communication process were identified as the main cause in 72% of all perinatal deaths. The perinatal period is a physiological process. However, undesirable events can develop suddenly and rapidly, and this situation threatens both pregnant/mother and fetus/newborn health. Therefore, it is necessary to maintain uninterrupted communication in this area. It is very important for students to acquire these communication skills effectively before they graduate. Therefore, this research; In order to determine the effect of professional communication training among health professionals to be given to nursing students on the professional communication skills of students, a parallel-group was planned as a randomized controlled trial. The study is planned to be conducted in Hacettepe University Nursing Faculty. Research data will be collected using the Student Introductory Information Form, Effective Communication Skills Among Healthcare Professionals Evaluation Form, Self-Assessment Form for Effective Communication among Healthcare Professionals, and Semi-Structured Focus Group Interview Form. Nursing students who meet the inclusion criteria will be included in the research. Students will be divided into 2 groups as the experimental and the control group. Students in the experimental group will be given training on effective communication among health professionals. No training will be given to the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

8 days

First QC Date

December 20, 2021

Last Update Submit

September 10, 2022

Conditions

Keywords

nursing studentscommunicationpatient safetystandard participant

Outcome Measures

Primary Outcomes (2)

  • Effective communication form among perinatal healthcare professionals

    It is the evaluation of the professional communication of nursing students with a nurse and a physician working in the perinatal area through an effective communication form.

    1 week before the intervention to 1 week after the intervention.

  • Self-assessments of effective communication skills form among perinatal healthcare professionals

    It is the self-evaluation of nursing students for their professional communication with a nurse and a physician working in the perinatal area through an effective communication self-assessment form.

    1 week before the intervention to 1 week after the intervention.

Study Arms (2)

Effective communication training in perinatal patient safety

EXPERIMENTAL

Nursing department students will be given training on effective communication training in perinatal patient safety.

Other: Effective communication training in perinatal patient safety

Control group

NO INTERVENTION

There is no intervention for this group

Interventions

Students will be given theoretical training, group discussion will be made over sample videos, and students will participate in the standard participant practice and a post-analysis session will be held.

Effective communication training in perinatal patient safety

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • To have taken the course of Obstetrics-Gynecology Nursing,
  • To be able to understand, and speak Turkish at a good level,
  • Being able to use a computer,
  • Having personal internet access.
  • To be a volunteer.

You may not qualify if:

  • Not participating in any stage of the research,
  • Having a disability (physical/visual/auditory) that may prevent computer and internet use,
  • Wanting to leave the at any stage of the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (18)

  • Janakiraman V, Ecker J. Quality in obstetric care: measuring what matters. Obstet Gynecol. 2010 Sep;116(3):728-732. doi: 10.1097/AOG.0b013e3181ea4d4f.

    PMID: 20733459BACKGROUND
  • Deering S, Johnston LC, Colacchio K. Multidisciplinary teamwork and communication training. Semin Perinatol. 2011 Apr;35(2):89-96. doi: 10.1053/j.semperi.2011.01.009.

    PMID: 21440817BACKGROUND
  • Hailu FB, Kassahun CW, Kerie MW. Perceived Nurse-Physician Communication in Patient Care and Associated Factors in Public Hospitals of Jimma Zone, South West Ethiopia: Cross Sectional Study. PLoS One. 2016 Sep 15;11(9):e0162264. doi: 10.1371/journal.pone.0162264. eCollection 2016.

    PMID: 27632162BACKGROUND
  • Hogan H, Zipfel R, Neuburger J, Hutchings A, Darzi A, Black N. Avoidability of hospital deaths and association with hospital-wide mortality ratios: retrospective case record review and regression analysis. BMJ. 2015 Jul 14;351:h3239. doi: 10.1136/bmj.h3239.

    PMID: 26174149BACKGROUND
  • James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013 Sep;9(3):122-8. doi: 10.1097/PTS.0b013e3182948a69.

    PMID: 23860193BACKGROUND
  • Jha AK, Prasopa-Plaizier N, Larizgoitia I, Bates DW; Research Priority Setting Working Group of the WHO World Alliance for Patient Safety. Patient safety research: an overview of the global evidence. Qual Saf Health Care. 2010 Feb;19(1):42-7. doi: 10.1136/qshc.2008.029165.

    PMID: 20172882BACKGROUND
  • Karkowsky CE, Chazotte C. Simulation: improving communication with patients. Semin Perinatol. 2013 Jun;37(3):157-60. doi: 10.1053/j.semperi.2013.02.006.

    PMID: 23721771BACKGROUND
  • Leonard M, Graham S, Bonacum D. The human factor: the critical importance of effective teamwork and communication in providing safe care. Qual Saf Health Care. 2004 Oct;13 Suppl 1(Suppl 1):i85-90. doi: 10.1136/qhc.13.suppl_1.i85.

    PMID: 15465961BACKGROUND
  • Lippke S, Derksen C, Keller FM, Kotting L, Schmiedhofer M, Welp A. Effectiveness of Communication Interventions in Obstetrics-A Systematic Review. Int J Environ Res Public Health. 2021 Mar 5;18(5):2616. doi: 10.3390/ijerph18052616.

    PMID: 33807819BACKGROUND
  • Lyndon A. Communication and teamwork in patient care: how much can we learn from aviation? J Obstet Gynecol Neonatal Nurs. 2006 Jul-Aug;35(4):538-46. doi: 10.1111/j.1552-6909.2006.00074.x.

    PMID: 16882000BACKGROUND
  • Makary MA, Daniel M. Medical error-the third leading cause of death in the US. BMJ. 2016 May 3;353:i2139. doi: 10.1136/bmj.i2139. No abstract available.

    PMID: 27143499BACKGROUND
  • Martinez-Galiano JM, Martinez-Vazquez S, Rodriguez-Almagro J, Hernandez-Martinez A. The magnitude of the problem of obstetric violence and its associated factors: A cross-sectional study. Women Birth. 2021 Sep;34(5):e526-e536. doi: 10.1016/j.wombi.2020.10.002. Epub 2020 Oct 17.

    PMID: 33082123BACKGROUND
  • Muller M, Jurgens J, Redaelli M, Klingberg K, Hautz WE, Stock S. Impact of the communication and patient hand-off tool SBAR on patient safety: a systematic review. BMJ Open. 2018 Aug 23;8(8):e022202. doi: 10.1136/bmjopen-2018-022202.

    PMID: 30139905BACKGROUND
  • Pettker CM, Thung SF, Lipkind HS, Illuzzi JL, Buhimschi CS, Raab CA, Copel JA, Lockwood CJ, Funai EF. A comprehensive obstetric patient safety program reduces liability claims and payments. Am J Obstet Gynecol. 2014 Oct;211(4):319-25. doi: 10.1016/j.ajog.2014.04.038. Epub 2014 Jun 9.

    PMID: 24925798BACKGROUND
  • Reising DL, Carr DE, Gindling S, Barnes R, Garletts D, Ozdogan Z. Team Communication Influence on Procedure Performance: Findings From Interprofessional Simulations with Nursing and Medical Students. Nurs Educ Perspect. 2017 Sep/Oct;38(5):275-276. doi: 10.1097/01.NEP.0000000000000168.

    PMID: 28562460BACKGROUND
  • Vincent C, Amalberti R. Safety in healthcare is a moving target. BMJ Qual Saf. 2015 Sep;24(9):539-40. doi: 10.1136/bmjqs-2015-004403. Epub 2015 Jul 6. No abstract available.

    PMID: 26150547BACKGROUND
  • Woloshynowych M, Rogers S, Taylor-Adams S, Vincent C. The investigation and analysis of critical incidents and adverse events in healthcare. Health Technol Assess. 2005 May;9(19):1-143, iii. doi: 10.3310/hta9190.

    PMID: 15890139BACKGROUND
  • Zavertnik JE, Huff TA, Munro CL. Innovative approach to teaching communication skills to nursing students. J Nurs Educ. 2010 Feb;49(2):65-71. doi: 10.3928/01484834-20090918-06. Epub 2010 Feb 4.

    PMID: 19810670BACKGROUND

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sergul Duygulu, PhD

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor does not know who is in the control group and who is in the intervention group.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: parallel group randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 12, 2022

Study Start

November 27, 2021

Primary Completion

December 5, 2021

Study Completion

September 1, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

There is a plan to make IPD

Shared Documents
STUDY PROTOCOL
Time Frame
December 2022
Access Criteria
Statistical analyzes of the study will be made by an expert. The data will be shared with the expert by providing statistical blinding. The results of the study will be published in an international journal.

Locations