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Communication and Patient Safety in Gynecology and Obstetrics - Study Protocol of an Intervention Study (TeamBaby)

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ClinicalTrials.gov Identifier: NCT03855735
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
Aktionsbündnis Patientensicherheit
Techniker Krankenkasse
University Hospital Ulm
The Innovation Fund
University Hospital, Frankfurt
Information provided by (Responsible Party):
Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE February 27, 2019
Last Update Posted Date August 28, 2020
Actual Study Start Date  ICMJE September 2, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Core competencies and preventable adverse events - specialists [ Time Frame: 16 Months ]
    The core competencies of all specialists will improve measurably. Furthermore, the number of preventable adverse events (pAEs) and their associated costs should be significantly changed over time.
  • Core competencies surrounding communication - patients and relatives [ Time Frame: 16 Months ]
    It is expected that patients/accompanying persons in the intervention group will (1) measurably improve their communication competencies with skilled employees after the intervention compared to those giving birth/accompanying persons in the control group, and (2) a higher expectation of self-efficacy in communication with skilled employees will arise. In addition, it is expected that (3) the number and severity of preventable adverse events (pAEs) in the intervention group will be measurably reduced compared to the number and severity of preventable adverse events in the control group.
  • Usability and effectiveness of the digital communication app [ Time Frame: 16 Months ]
    The use of a digital communication app will lead to a significantly changed number, severity and cost of preventable adverse events (pAEs) in the intervention group compared to the intervention group without an app.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • SACCIA core competencies and preventable adverse events - specialists [ Time Frame: 16 Months ]
    The SACCIA core competencies of all specialists will improve measurably. Furthermore, the number of severities of avoidable adverse events and their associated costs should be significantly reduced longnitudinally.
  • SACCIA core competencies and communication - patients and relatives [ Time Frame: 16 Months ]
    It is expected that patients/accompanying persons in the intervention group will develop significantly higher SACCIA competencies in communication with skilled workers after the intervention compared to those giving birth/accompanying persons in the control group (1), and (2) a higher expectation of self-efficacy in communication with skilled workers will arise. In addition, it is expected that (3) the number and severity of avoidable adverse events in the intervention group will be significantly reduced compared to the number and severity of avoidable adverse events in the control group.
  • Use of the digital SACCIA app [ Time Frame: 16 Months ]
    The use of a digital SACCIA app will lead to a significantly higher reduction in the number, severity and cost of avoidable adverse events in the intervention group compared to the intervention group without an app.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • Proximal outcomes to the online training [ Time Frame: 16 months ]
    outcome expectancy, intentions, action and coping plans, behavior, self-efficacy, patient satisfaction, employee satisfaction
  • Covariables of the training and preventable adverse events (pAEs) [ Time Frame: 16 months ]
    barriers and resources
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Communication and Patient Safety in Gynecology and Obstetrics - Study Protocol of an Intervention Study
Official Title  ICMJE "Sufficiency, Accuracy, Clarity, Contextualization, and Interpersonal Adaptation - Safe, Digitally Supported Communication in Gynecology and Obstetrics: TeamBaby"
Brief Summary The purpose of this project with pregnant women and their relatives is to improve communication between all parties involved in order to increase sustainable patient's safety. To this end, clinical staff, expectant mothers and their partners as well as relatives will be trained in personal sessions. The aim is to improve their ability to communicate more confidently with each other. In addition, an app will be developed to support all participants in their communication with each other and in overcoming difficulties in everyday hospital life. The project contributes to reduce the frequency of preventable adverse events (pAEs) in gynecology and obstetrics and to increase patients' satisfaction with their treatment. Data will be collected in three study phases: 1. implementation phase - online training (observations, interviews, focus groups) incl. retrospective cohort study and pre-experimental study pre/post-test (interviews, analysis of hospital data); 2. effectiveness study with randomized controlled study design (interviews); 3. implementation of the app (observations, interviews, focus groups) as well as case-control study (interviews, analysis of hospital data).
Detailed Description

Phase 1: Needs assessment, retrospective cohort study and pre-experimental study

The concept of needs assessment is based on a previous approach, which aims to implement the safety of patient transfers in intensive care units. This should lead to a comprehensive understanding of the beneficial and inhibitory conditions as well as potentials for the implementation of the intervention in the field (e.g., how different communication models competencies can be integrated beyond training into clinical practice; possible options): diaries, regular e-mails with tips on practical application, etc.). Observations for the ethnographic analyses are recorded in a standardized observation protocol, focus groups and interviews are conducted with partially standardized guidelines with at least one person from each occupational group in order to gain as comprehensive an impression as possible of possible resources and barriers for the implementation of the intervention. The data will then be analyzed in terms of content using an inductive approach and used to develop the training. Migration background will be considered exploratively in the data collection and testing as well as participatory in the app development (i.e. it will be ensured that patients and accompanying persons with migration background will also be included in the development). Different communication models competencies and tailoring based on the Health Action Process Approach (HAPA) will also be integrated into the training. A short manual for practical support and written documentation of the training process will be prepared, also to avoid failure of implementation. The online training will be offered in the pre-experimental study to all professionals at both intervention sites. The aim is to investigate the connection between training participation and preventable Adverse Events (pAEs), to observe mechanisms of action and to create a basis for the implementation of phase 2. The study has a one-group, pre-/post-design. The study includes all specialists (e.g. doctors, nurses, midwives, obstetricians) at both locations (full utilization) with a total of N = 140 participants. Specialists are trained in interdisciplinary groups of 10 to 12 participants. All target criteria are shown in Table 4.

Implementation phase: Research questions, methods, study population and target criteria Stage Research question Method Target group/Data source Outcome A What is the prevalence of pAEs? Monitoring protocols and routine data Anonymous routine data of the hospital from 2018, Mixed Methods study Quality indicators: Reporting according to safe communication, pAEs, retrospective cost analyses of pAEs B What are effective interventions to optimize communication in everyday hospital life? Updating the status of applications Pubmed, PsychInfo, Cochrane Database Overview of effective interventions and effect strengths C What is the adherence for equivalent patient safety measures (e.g. hand hygiene)? Questionnaire All employees at both intervention sites Adherence to patient safety measures; relationships between adherence and quality indicators D What are possible resources and barriers for the implementation of an intervention in order to optimize communication in everyday hospital life? Ethnographic observation; guideline-based individual and focus group interviews Physicians, nursing staff, training assistants, psychologists, midwives Classify resources and barriers E What is an appropriate strategy to implement effective interventions to optimize communication? Triangulation of results from previous phases Matching of data from interviews, focus groups and questionnaires with evidence from the literature Implementation strategy, regarding resources and barriers in implementing the intervention to patient safety Note: pAEs = preventable adverse events

Since the aim is to achieve full utilization, no inclusion and exclusion criteria are defined. Differences between the measurement times are checked using linear and general mixed models, initial values of the first measurement time are taken into account as covariates. Clinics are modeled as a fixed effect. For the entire analysis, corresponding confidence intervals of 95 % are determined. To calculate the standardized mean difference (SMD) between the two measurement points, the non-standardized regression coefficients are standardized to the pooled standard deviation of the observed measured values. According to Cohen's recommendations, SMDs are interpreted as follows: small effect by SMD = 0.2; medium effect by SMD = 0.5; large effect by SMD = 0.8. The odds ratio of binary outcomes is subjected to a logit transformation to calculate effect strengths. To check whether the intervention effect on the primary target criterion is moderated by external variables, reciprocal interaction terms are considered in the model estimation. Continuous moderators are standardized by z-transformation. The estimated parameter of the interaction between the z-transformed continuous variable and the effect estimator of the group difference thus represents the additional intervention effect if the potential moderator increases by a standard deviation. Participants are only included in the analysis if they participate in the corresponding follow-up online survey and are analyzed according to intention to treat. Differences are interpreted as significant when the p-value of a two-sided test is <0.05.

Phase 2: Quasi-experimental efficacy study

In Phase 2, the effectiveness of the communication intervention for the target group of women giving birth/family members is assessed using the gold standard, i.e. randomized control trial (RCT). In each institution, four employees are enabled to train patients and their relatives on the short manual developed to teach different communication models competencies. When a woman gives birth and her relatives are admitted, they are randomly assigned to a training group (IG) or a control group (CG). The pAEs are collected on a person-specific basis (anonymized) and coded in parallel. With an alpha error of 0.05 and a power of 80%, a sample of N = 352 is necessary (to be analyzed IG: N = 176; CG: N = 176) in order to be able to prove an effect of d = 0.3. With an assumed drop-out of 20%, N = 424 participants (to be recruited IG: N = 212; CG: N = 212) would have to be recruited (recruitment sample). The target criteria are evaluated statistically and clinically as in phase 1. Group differences are checked by means of linear and general mixed models, initial values of the first measurement point are considered as covariates. Clinics are modelled as fixed effects. For the entire analysis, corresponding confidence intervals of 95 % are determined. To calculate the standardized mean difference (SMD) between the two measurement points, the non-standardized regression coefficients are standardized to the pooled standard deviation of the observed measured values. According to Cohen's recommendations, SMDs are interpreted as follows: small effect by SMD = 0.2; medium effect by SMD = 0.5; large effect by SMD = 0.8. The odds ratio of binary outcomes is subjected to a logit transformation to calculate effect strengths. To check whether the primary target criterion is moderated by external variables, reciprocal interaction terms are considered in the model estimation. Continuous moderators are standardized by z-transformation. The estimated parameter of the interaction between the z-transformed continuous variable and the effect estimator of the group difference thus represents the additional intervention effect if the potential moderator increases by one standard deviation. Participants are only included in the analysis if they participate in the corresponding follow-up online survey and are analyzed according to intention to treat. Differences are interpreted as significant when the p-value of a two-sided test is <0.05.

Phase 3: Implementation of the app and case-control study

From all findings in phases 1 and 2, the digital app will be developed in a participatory and theory-driven way. The aim is to determine the extent to which the app supports secure communication processes among specialists and patients/relatives in their daily work and thus leads to a reduction in pAEs. The app helps users (skilled workers, mothers and relatives) to prepare for the interview and to cope with possible problems during the interview. Subsequently, a monitoring takes place in which communication with focus on (1) the own role, (2) the role of the communication partner as well as (3) the resonance (feeling of the uniform understanding) is evaluated. In this way, dyadic self-reported and externally reported data are collected and learning from the communication of all participants is ensured. Controls form the data of the participants of both intervention arms of the preceding RCT study from phase 2 (historical control groups; No-Treatment CG analysis: N = 176; No-Treatment CG recruited: N = 212; Treatment CG analysis: N = 176; Treatment CG recruited: N = 212). This allows a first limited statement about the possible effect of a process supporting digital app. With an alpha error of 0.05 and a power of 80%, a sample of N = 352 (analysis sample) is required to be able to prove an effect of d = 0.3. Due to the historical control group, only N = 176 participants need to be analyzed for the intervention group (IG analysis). Assuming a drop-out of 20%, N = 424 participants would have to be recruited (recruitment sample). Due to the historical control group only N = 212 participants have to be recruited for the intervention group (IGrecruited). The target criteria (primary: pAEs; Secondary: pAE costs, different communication models competencies, training-proximal outcomes such as outcome expectations, behavioral intention, action and coping planning, behavior, self-efficacy expectation, adherence safety culture, perceived safety culture, treatment satisfaction; covariates: sociodemographic characteristics incl. migration status) are evaluated statistically and clinically as in Phase 1 and 2. Group differences are checked by means of linear and general mixed models, initial values of the first measurement point are considered as covariates. Clinics are modeled as fixed effects. For the entire analysis, corresponding confidence intervals of 95 % are determined. To calculate the standardized mean difference (SMD) between the two measurement points, the non-standardized regression coefficients are standardized to the pooled standard deviation of the observed measured values. According to Cohen's recommendations, SMDs are interpreted as follows: small effect by SMD = 0.2; medium effect by SMD = 0.5; large effect by SMD = 0.8. The odds ratio of binary outcomes is subjected to a logit transformation to calculate effect strengths. To check whether the primary target criterion is moderated by external variables, reciprocal interaction terms are considered in the model estimation. Continuous moderators are standardized by z-transformation. The estimated parameter of the interaction between the z-transformed continuous variable and the effect estimator of the group difference thus represents the additional intervention effect if the potential moderator increases by one standard deviation. Participants are only included in the analysis if they participate in the corresponding follow-up survey and are analyzed according to intention to treat. Differences are interpreted as significant when the p-value of a two-sided test is <0.05.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pregnancy Related
Intervention  ICMJE Behavioral: Intervention Group (IG)
The developed short manual for the teaching of different communication models competences will enable those who have been arbitrarily assigned to the intervention group and their relatives to develop secure communication competences. The intervention group will also have access to the digital app.
Study Arms  ICMJE
  • Experimental: Intervention Group (IG)
    Those who give birth and relatives who have been arbitrarily assigned to the control group receive online training on different communication models competencies and will gain access to the digital app.
    Intervention: Behavioral: Intervention Group (IG)
  • No Intervention: No Intervention
    Those who give birth and relatives who have been arbitrarily assigned to the control group do not receive any training on different communication models competencies and will not gain access to the digital app. The control group will receive a paper-pencil version.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2019)		 140
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2019)		 952
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Expectant mother or patient in gynecology and obstetrics or social support providers (spouse/partner, relative, close friend) to be recipient of the training
  • Professional in a gynecology and obstetrics hospital to be trainer of the patients and the social support providers
  • Aged 18 years and above
  • Healthy volunteers
  • Declaration of consent for participation in the study

Exclusion Criteria:

  • Not proficient in the German language and/ or does not have the capability of writing
  • Severe cognitive deficits (unable to read/write/answer questions) and impairments due to diagnosed brain injuries, neurological disorders, etc.
  • Insufficient corrected eyesight (patients must be able to read on the cell phone)
  • Participation in another research study or intervention trial conducted in the clinic
  • Younger than 18 years
  • High risk, emergency case
  • Withdraw of consent for participation in the study at any point in time
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sonia Lippke, Prof. Dr. +49 421 200-4730 s.lippke@jacobs-university.de
Contact: Franziska M. Keller +49 421 200-4721 f.keller@jacobs-university.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03855735
Other Study ID Numbers  ICMJE 01VSF18023 ( Other Grant/Funding Number: The Federal Joint Committee (G-BA) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH
Study Sponsor  ICMJE Jacobs University Bremen gGmbH
Collaborators  ICMJE
  • Aktionsbündnis Patientensicherheit
  • Techniker Krankenkasse
  • University Hospital Ulm
  • The Innovation Fund
  • University Hospital, Frankfurt
Investigators  ICMJE
Principal Investigator: Sonia Lippke, Prof. Dr. Jacobs University Bremen, Germany
PRS Account Jacobs University Bremen gGmbH
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP