Communication and patient safety in gynecology and obstetrics - study protocol of an intervention study

Abstract

Background: Patient safety is a key target in public health, health services and medicine. Communication between all parties involved in gynecology and obstetrics (clinical staff/professionals, expectant mothers/patients and their partners, close relatives or friends providing social support) should be improved to ensure patient safety, including the avoidance of preventable adverse events (pAEs). Therefore, interventions including an app will be developed in this project through a participatory approach integrating two theoretical models. The interventions will be designed to support participants in their communication with each other and to overcome difficulties in everyday hospital life. The aim is to foster effective communication in order to reduce the frequency of pAEs. If communication is improved, clinical staff should show an increase in work satisfaction and patients should show an increase in patient satisfaction.

Methods: The study will take place in two maternity clinics in Germany. In line with previous studies of complex interventions, it is divided into three interdependent phases. Each phase provides its own methods and data. Phase 1: Needs assessment and a training for staff (n = 140) tested in a pre-experimental study with a pre/post-design. Phase 2: Assessment of communication training for patients and their social support providers (n = 423) in a randomized controlled study. Phase 3: Assessment of an app supporting the communication between staff, patients, and their social support providers (n = 423) in a case-control study. The primary outcome is improvement of communication competencies. A range of other implementation outcomes will also be assessed (i.e. pAEs, patient/treatment satisfaction, work satisfaction, safety culture, training-related outcomes).

Discussion: This is the first large intervention study on communication and patient safety in gynecology and obstetrics integrating two theoretical models that have not been applied to this setting. It is expected that the interventions, including the app, will improve communication practice which is linked to a lower probability of pAEs. The app will offer an effective and inexpensive way to promote effective communication independent of users' motivation. Insights gained from this study can inform other patient safety interventions and health policy developments.

Trial registration: ClinicalTrials.gov Identifier: NCT03855735; date of registration: February 27, 2019.

Keywords: App; Communication competences; Digitization; HAPA; Health services research; Midwifery models of care; Participatory intervention development; Patient safety; Preventable adverse events; eHealth.

Fig. 1

Components of the HAPA model and planned training modules for improving communication competences and adopting the behavior “effective communication”

Fig. 2

Study flow with project phases and stages, study participants and outcome (Study Flowcharts for all three Phases are in the Appendix). Note. The phases consist of different stages (see Table 3). Stages A to C (see Table 3) will be addressed in Phase 1. Stages D and E will be addressed in Phase 1 and 3

Fig. 3

Example of the monitoring and guidance functions of the app

Fig. 4

Trial design for Phase 1. Step 1: Participants (clinical staff members) are initially identified, informed and invited to take part in the training. Step 2: Participants give informed consent while baseline variables that can be measured independently are assessed. All participants in this phase receive the training so that there is no allocation to either treatment or control group but only to similar treatment groups. Step 3: Pre-tests². Step 4: Participants complete the communication training. Step 5: Post-tests³. Step 6: Follow-up after 3 months. Note: ¹ Baseline data includes baseline assessments of pAE prevalence and costs, adherence safety culture and job description. ² Pre-test assessment includes demographic data, competences, training-related outcomes and work satisfaction. ³ Post-test assessments include competences and training-related outcomes. ⁴ At three months post-intervention, job stress and satisfaction, competences, behavior change as training-related outcomes and adherence safety culture will be assessed.

Fig. 5

Trial design for Phase 2. Step 1: Participants (mothers-to-be/patients and their social support providers) are initially identified and screened for eligibility. Step 2: If eligible, participants are invited to take part in the study, give informed consent and are allocated to either the intervention group (IG, Communication training) or the control group (CG). Step 3: Pre-tests. Step 4: Participants in the intervention group complete the communication training. Step 5: Post-tests. Step 6: pAEs are assessed after the patient gave birth. Note: ¹ For inclusion and exclusion criteria, see Table 6. ² Baseline data includes baseline assessments of pAE prevalence and costs. ³ Pre-test assessment includes demographic data, perceived social support, competences, training-related outcomes, subjective safety culture and treatment satisfaction.⁴ Post-test assessments include perceived social support, competences and training-related outcomes. ⁵ At three months post-intervention, perceived social support, competences, behavior change as training-related outcome, subjective safety culture and treatment satisfaction will be assessed

Fig. 6

Trial design for Phase 3. Step 1: Participants (mothers-to-be/patients and their social support providers) are initially identified and screened for eligibility. All staff members are eligible for phase 3. Step 2: If eligible, participants give informed consent. Step 3: Pre-tests⁴. Step 4: Participants are provided with the Effective Communication App. Step 5: Post-tests⁵. Step 6: 3-months follow-up; person-specific pAEs are assessed after the patient gave birth. Possible reasons for participant drop-out have already been presented in Fig. 4/5. Note: ¹ The comparator groups do not complete any tests again. Data acquisition in this group will be finished during Phase 2. ² For inclusion/exclusion criteria, see Table 6. ³ Baseline data includes baseline assessments of pAE prevalence and costs. ⁴ Pre-test assessment includes demographic data, perceived social support, competences, training-related outcomes, subjective safety culture and treatment satisfaction. ⁵ Post-test assessments include perceived social support, competences and training-related outcomes. ⁶ At three months post-intervention, perceived social support, competences, behavior change as training-related outcome, subjective safety culture and treatment satisfaction will be assessed.