TeamBaby - Safe, Digitally Supported Communication in Obstetrics and Gynecology (TeamBaby)

• ClinicalTrials.gov Identifier: NCT03855735
• Recruitment Status: Recruiting
• First Posted: February 27, 2019
• Last Update Posted: March 14, 2023
• Sponsor: Jacobs University Bremen gGmbH
• Collaborators: German Coalition for Patient Safety (Aktionsbündnis Patientensicherheit); Techniker Krankenkasse; University Hospital Ulm; The German Innovation Fund (Innovationsfonds); Goethe University
• Information provided by (Responsible Party): Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH

Study Description

Brief Summary:

The purpose of this project with obstetric healthcare workers, pregnant women and their relatives is to improve communication between all parties involved in order to increase sustainable patient safety. To this end, clinical staff, expectant mothers and their partners as well as relatives will be trained in personal sessions and through digital interventions. 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 - Training for obstetric healthcare workers at two German university hospitals which will be developed and implemented based on observations, interviews, and focus groups and pre-experimental study with pre/post-test (questionnaires for participants, interviews). To evaluate patient safety, an analysis of hospital data will be conducted incl. retrospective cohort study;
2. Effectiveness study with randomized controlled study design (questionnaires and interviews). In the intervention group, pregnant women and their relatives will be trained in safe communication;
3. Implementation of an app (evaluated via questionnaires, observations, interviews, focus groups). Women who receive the training via the app will be compared to the historical control group as case-control study (questionnaires, interviews, analysis of hospital data).

Condition or disease	Intervention/treatment	Phase
Pregnancy Related	Behavioral: TeamBaby Online Communication Training (IG1) and TeamBaby Web-App Communication Training (IG2)	Not Applicable

Detailed Description:

Phase 1:

The concept of the needs assessment is based on a previous approach, which aimed to implement an intervention to increase 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 techniques can be integrated beyond training into clinical practice). 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 and app intervention. 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 the staff trainings and preventable Adverse Events (pAEs) that are compared between the year 2018 (before the staff trainings) and 2020 (after the staff trainings), to observe mechanisms of action and to create a basis for the implementation of phase 2.

Additional remark 23/06/22: The paper comparing pAEs between 2018 and 2020 is currently under review.

The study regarding the questionnaire evaluation has a one-group, pre-/post-design. The study includes all specialists (e.g. doctors, nurses, midwives, obstetricians) at both locations with a total of N = 140 participants. Specialists are trained in interdisciplinary groups of 10 to 12 participants.

Additional remark 23/06/22: The paper concerning the evaluation of communication behavior and behavioral factors associated with this behavior has been published.

Summary of the implementation phase: Research questions, methods, study population and target criteria

A: What is the prevalence of pAEs? This question will be answered using monitoring protocols and anonymous routine data of the hospital from 2018 in a Mixed Methods study: Quality indicators include the reporting according to safe communication, pAEs, and a retrospective cost analysis of pAEs.

Additional remark 23/06/22: The paper for the evaluation of pAEs has been published.

B: What are effective interventions to optimize communication in everyday hospital life? This question will be answered by updating the status of the literature search in Pubmed, PsychInfo, Cochrane Database to provide an overview of effective interventions and effect strengths.

Additional remark 23/06/22: The systematic review has been published.

C: What is the adherence for equivalent patient safety measures (e.g. hand hygiene)? Using questionnaire data of all employees at both intervention sites to measure adherence to patient safety measures and identify relationships between adherence and quality indicators Additional remark 23/06/22: The paper including questionnaire and observational data has been published.

D: What are possible resources and barriers for the implementation of an intervention in order to optimize communication in everyday hospital life? The question will be answered in Ethnographic observation and guideline-based individual and focus group interviews with physicians, nursing staff, training assistants, psychologists, and midwives to classify resources and barriers.

Additional remark 23/06/22: The according publication has been finalized.

E: What is an appropriate strategy to implement effective interventions to optimize communication? For this question, there will be a triangulation of results from previous steps including the matching of data from interviews, focus groups and questionnaires with evidence from the literature to determine the implementation strategy regarding resources and barriers in implementing the intervention to patient safety.

Additional remark 23/06/22: The triangulation was published.

Since the aim is to achieve full inclusion of all healthcare workers in Phase 1, 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 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.

Additional remark 22/06/22: The evaluation of questionnaire data has been published.

Due to the COVID-19 pandemic, the trainings for staff members had to be paused. Although all staff members (N=141) were trained, only N=67 provided questionnaire data at both time points (before and after the training). Hence, the analysis was performed as a MANOVA to evaluate the questionnaire data.

The manuscript evaluating clinical data (preventable adverse events) is currently under review.

Phase 2:

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.

Additional remark 28/06/22: The manuscript regarding the questionnaire data is currently under review. Due to a higher drop-out than originally calculated, the analysis was changed from an ANCOVA to a multilevel linear model to evaluate training effects.

Phase 3:

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 to be and relatives) to refine and improve their communication skills and, hence, to prepare for a safe birth. 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). The RCT in Phase 3 includes an intervention group who will have immediate access to the web-app after a baseline questionnaire and a waiting-list control group who will receive access to the web-app after a waiting period of 4 weeks. Recruiting is not only limited to the 2 clinics to reach a sample size with enough power to detect significant effects, but also includes a Germany-wide implementation and recruitment. 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 (IG recruited). 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) 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 424 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel design for Phase 2 and sequential design in Phase 3
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: "Sufficiency, Accuracy, Clarity, Contextualization, and Interpersonal Adaptation - Safe, Digitally Supported Communication in Gynecology and Obstetrics: TeamBaby"
• Actual Study Start Date: September 2, 2019
• Estimated Primary Completion Date: March 30, 2023
• Estimated Study Completion Date: September 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: TeamBaby Online Training Intervention Group Phase 2 (IG1); Those who give birth and relatives who have been arbitrarily assigned to the intervention group receive an interactive online training on different communication models and competencies (Phase 2).	Behavioral: TeamBaby Online Communication Training (IG1) and TeamBaby Web-App Communication Training (IG2); 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 (Phase 2). In Phase 3, the intervention group will have access to the digital app.
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 prior to giving birth.
Experimental: TeamBaby App Training Intervention Group Phase 3 (IG2); Those who give birth and relatives who have been arbitrarily assigned to the intervention group will gain access to the digital app and receive a communication training via the app (Phase 3).	Behavioral: TeamBaby Online Communication Training (IG1) and TeamBaby Web-App Communication Training (IG2); 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 (Phase 2). In Phase 3, the intervention group will have access to the digital app.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. Proximal outcomes to the online training [ Time Frame: 16 months ]
   outcome expectancy, intentions, action and coping plans, behavior, self-efficacy, patient satisfaction, employee satisfaction
2. Covariables of the training and preventable adverse events (pAEs) [ Time Frame: 16 months ]
   barriers and resources

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Sonia Lippke, Prof. Dr.; +49 421 200-4730; s.lippke@jacobs-university.de

Contact: Christina Derksen; +49 421 200-4732; teambaby@jacobs-university.de

Locations

Germany

Universitaetsklinikum Ulm; Klinik fuer Frauenheilkunde und Geburtshilfe; Recruiting

Ulm, Baden-Württemberg, Germany, 89075

Contact: Frank Reister, MD Frank.Reister@uniklinik-ulm.de

Universitätsklinikum Frankfurt; Klinik für Frauenheilkunde und Geburtshilfe; Recruiting

Frankfurt, Germany

Contact: Frank Louwen, MD louwen@em.uni-frankfurt.de

Sponsors and Collaborators

Jacobs University Bremen gGmbH

German Coalition for Patient Safety (Aktionsbündnis Patientensicherheit)

Techniker Krankenkasse

University Hospital Ulm

The German Innovation Fund (Innovationsfonds)

Goethe University

Investigators

• Principal Investigator: Sonia Lippke, Prof. Dr.; Jacobs University Bremen, Germany

  Study Documents (Full-Text)

Documents provided by Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH:

Study Protocol  [PDF] November 28, 2019

More Information

Additional Information:

Project description and outline of partners 

Publications of Results:

Derksen C, Keller FM, Lippke S. Obstetric Healthcare Workers' Adherence to Hand Hygiene Recommendations during the COVID-19 Pandemic: Observations and Social-Cognitive Determinants. Appl Psychol Health Well Being. 2020 Dec;12(4):1286-1305. doi: 10.1111/aphw.12240. Epub 2020 Oct 5.

Schmiedhofer M, Derksen C, Keller FM, Dietl JE, Haussler F, Strametz R, Koester-Steinebach I, Lippke S. Barriers and Facilitators of Safe Communication in Obstetrics: Results from Qualitative Interviews with Physicians, Midwives and Nurses. Int J Environ Res Public Health. 2021 Jan 21;18(3):915. doi: 10.3390/ijerph18030915.

Keller, F., Derksen, C., Schmiedhofer, M., Welp, A., Kötting, L. and Lippke, S., 2020. Patientensicherheit und wahrgenommene Risiken für Vermeidbare Unerwünschte Ereignisse aus Sicht von Patienten und Beschäftigten im Gesundheitswesen. Monitor Versorgungsforschung, 13(05/2020), pp.83-89. doi:http://doi.org/10.24945/MVF.05.20.1866-0533.2251

Derksen C, Kotting L, Keller FM, Schmiedhofer M, Lippke S. Psychological Intervention to Improve Communication and Patient Safety in Obstetrics: Examination of the Health Action Process Approach. Front Psychol. 2022 Feb 18;13:771626. doi: 10.3389/fpsyg.2022.771626. eCollection 2022.

Huner B, Derksen C, Schmiedhofer M, Lippke S, Janni W, Scholz C. Preventable Adverse Events in Obstetrics-Systemic Assessment of Their Incidence and Linked Risk Factors. Healthcare (Basel). 2022 Jan 4;10(1):97. doi: 10.3390/healthcare10010097.

Keller FM, Derksen C, Kotting L, Schmiedhofer M, Lippke S. Development of the perceptions of preventable adverse events assessment tool (PPAEAT): measurement properties and patients' mental health status. Int J Qual Health Care. 2021 Apr 16;33(2):mzab063. doi: 10.1093/intqhc/mzab063.

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.

Schmiedhofer M, Derksen C, Dietl JE, Haussler F, Louwen F, Huner B, Reister F, Strametz R, Lippke S. Birthing under the Condition of the COVID-19 Pandemic in Germany: Interviews with Mothers, Partners, and Obstetric Health Care Workers. Int J Environ Res Public Health. 2022 Jan 28;19(3):1486. doi: 10.3390/ijerph19031486.

Other Publications:

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Bartlett G, Blais R, Tamblyn R, Clermont RJ, MacGibbon B. Impact of patient communication problems on the risk of preventable adverse events in acute care settings. CMAJ. 2008 Jun 3;178(12):1555-62. doi: 10.1503/cmaj.070690.

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.

Hickson GB, Clayton EW, Githens PB, Sloan FA. Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA. 1992 Mar 11;267(10):1359-63.

Olde Bekkink M, Farrell SE, Takayesu JK. Interprofessional communication in the emergency department: residents' perceptions and implications for medical education. Int J Med Educ. 2018 Oct 25;9:262-270. doi: 10.5116/ijme.5bb5.c111.

Lyndon A, Zlatnik MG, Wachter RM. Effective physician-nurse communication: a patient safety essential for labor and delivery. Am J Obstet Gynecol. 2011 Aug;205(2):91-6. doi: 10.1016/j.ajog.2011.04.021. Epub 2011 Apr 16.

Antony J, Zarin W, Pham B, Nincic V, Cardoso R, Ivory JD, Ghassemi M, Barber SL, Straus SE, Tricco AC. Patient safety initiatives in obstetrics: a rapid review. BMJ Open. 2018 Jul 6;8(7):e020170. doi: 10.1136/bmjopen-2017-020170.

Chang YS, Coxon K, Portela AG, Furuta M, Bick D. Interventions to support effective communication between maternity care staff and women in labour: A mixed-methods systematic review. Midwifery. 2018 Apr;59:4-16. doi: 10.1016/j.midw.2017.12.014. Epub 2017 Dec 27.

Hannawa AF. Disclosing medical errors to patients: effects of nonverbal involvement. Patient Educ Couns. 2014 Mar;94(3):310-3. doi: 10.1016/j.pec.2013.11.007. Epub 2013 Nov 28.

Zech A, Gross B, Jasper-Birzele C, Jeschke K, Kieber T, Lauterberg J, Lazarovici M, Pruckner S, Rall M, Reddersen S, Sandmeyer B, Scholz C, Stricker E, Urban B, Zobel A, Singer I. Evaluation of simparteam - a needs-orientated team training format for obstetrics and neonatology. J Perinat Med. 2017 Apr 1;45(3):333-341. doi: 10.1515/jpm-2016-0091.

Berg CJ, Harper MA, Atkinson SM, Bell EA, Brown HL, Hage ML, Mitra AG, Moise KJ Jr, Callaghan WM. Preventability of pregnancy-related deaths: results of a state-wide review. Obstet Gynecol. 2005 Dec;106(6):1228-34. doi: 10.1097/01.AOG.0000187894.71913.e8.

Tanaka K, Eriksson L, Asher R, Obermair A. Incidence of adverse events, preventability and mortality in gynaecological hospital admissions: A systematic review and meta-analysis. Aust N Z J Obstet Gynaecol. 2019 Apr;59(2):195-200. doi: 10.1111/ajo.12937. Epub 2019 Jan 20.

Panagioti M, Geraghty K, Johnson J, Zhou A, Panagopoulou E, Chew-Graham C, Peters D, Hodkinson A, Riley R, Esmail A. Association Between Physician Burnout and Patient Safety, Professionalism, and Patient Satisfaction: A Systematic Review and Meta-analysis. JAMA Intern Med. 2018 Oct 1;178(10):1317-1331. doi: 10.1001/jamainternmed.2018.3713. Erratum In: JAMA Intern Med. 2019 Apr 1;179(4):596.

Retraction in: JAMA Intern Med. 2020 Jul 1;180(7):931

Welp A, Meier LL, Manser T. Emotional exhaustion and workload predict clinician-rated and objective patient safety. Front Psychol. 2015 Jan 22;5:1573. doi: 10.3389/fpsyg.2014.01573. eCollection 2014.

Welp A, Meier LL, Manser T. The interplay between teamwork, clinicians' emotional exhaustion, and clinician-rated patient safety: a longitudinal study. Crit Care. 2016 Apr 19;20(1):110. doi: 10.1186/s13054-016-1282-9.

Morony S, Weir K, Duncan G, Biggs J, Nutbeam D, Mccaffery KJ. Enhancing communication skills for telehealth: development and implementation of a Teach-Back intervention for a national maternal and child health helpline in Australia. BMC Health Serv Res. 2018 Mar 7;18(1):162. doi: 10.1186/s12913-018-2956-6.

Avula R, Menon P, Saha KK, Bhuiyan MI, Chowdhury AS, Siraj S, Haque R, Jalal CS, Afsana K, Frongillo EA. A program impact pathway analysis identifies critical steps in the implementation and utilization of a behavior change communication intervention promoting infant and child feeding practices in Bangladesh. J Nutr. 2013 Dec;143(12):2029-37. doi: 10.3945/jn.113.179085. Epub 2013 Sep 25.

Tan DJA, Sultana R, Han NLR, Sia ATH, Sng BL. Investigating determinants for patient satisfaction in women receiving epidural analgesia for labour pain: a retrospective cohort study. BMC Anesthesiol. 2018 May 9;18(1):50. doi: 10.1186/s12871-018-0514-8.

Weis J, Zoffmann V, Egerod I. Improved nurse-parent communication in neonatal intensive care unit: evaluation and adjustment of an implementation strategy. J Clin Nurs. 2014 Dec;23(23-24):3478-89. doi: 10.1111/jocn.12599. Epub 2014 Apr 3.

Bolognesi M, Nigg CR, Massarini M, Lippke S. Reducing obesity indicators through brief physical activity counseling (PACE) in Italian primary care settings. Ann Behav Med. 2006 Apr;31(2):179-85. doi: 10.1207/s15324796abm3102_10.

Omura M, Maguire J, Levett-Jones T, Stone TE. The effectiveness of assertiveness communication training programs for healthcare professionals and students: A systematic review. Int J Nurs Stud. 2017 Nov;76:120-128. doi: 10.1016/j.ijnurstu.2017.09.001. Epub 2017 Sep 5.

Haug S, Meyer C, Dymalski A, Lippke S, John U. Efficacy of a text messaging (SMS) based smoking cessation intervention for adolescents and young adults: study protocol of a cluster randomised controlled trial. BMC Public Health. 2012 Jan 19;12:51. doi: 10.1186/1471-2458-12-51.

Lippke S, Fleig L, Wiedemann AU, Schwarzer R. A Computerized Lifestyle Application to Promote Multiple Health Behaviors at the Workplace: Testing Its Behavioral and Psychological Effects. J Med Internet Res. 2015 Oct 1;17(10):e225. doi: 10.2196/jmir.4486.

Duan YP, Liang W, Guo L, Wienert J, Si GY, Lippke S. Evaluation of a Web-Based Intervention for Multiple Health Behavior Changes in Patients With Coronary Heart Disease in Home-Based Rehabilitation: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Nov 19;20(11):e12052. doi: 10.2196/12052.

Storm V, Dorenkamper J, Reinwand DA, Wienert J, De Vries H, Lippke S. Effectiveness of a Web-Based Computer-Tailored Multiple-Lifestyle Intervention for People Interested in Reducing their Cardiovascular Risk: A Randomized Controlled Trial. J Med Internet Res. 2016 Apr 11;18(4):e78. doi: 10.2196/jmir.5147.

Lippke S, Schwarzer R, Ziegelmann JP, Scholz U, Schuz B. Testing stage-specific effects of a stage-matched intervention: a randomized controlled trial targeting physical exercise and its predictors. Health Educ Behav. 2010 Aug;37(4):533-46. doi: 10.1177/1090198109359386. Epub 2010 Jun 14.

Lippke S, Plotnikoff RC. Testing two principles of the Health Action Process Approach in individuals with type 2 diabetes. Health Psychol. 2014 Jan;33(1):77-84. doi: 10.1037/a0030182. Epub 2012 Oct 22.

Lippke S, Corbet JM, Lange D, Parschau L, Schwarzer R. Intervention Engagement Moderates the Dose-Response Relationships in a Dietary Intervention. Dose Response. 2016 Mar 16;14(1):1559325816637515. doi: 10.1177/1559325816637515. eCollection 2016 Jan-Mar.

Sprangers S, Dijkstra K, Romijn-Luijten A. Communication skills training in a nursing home: effects of a brief intervention on residents and nursing aides. Clin Interv Aging. 2015 Jan 20;10:311-9. doi: 10.2147/CIA.S73053. eCollection 2015.

Zhang CQ, Zhang R, Schwarzer R, Hagger MS. A meta-analysis of the health action process approach. Health Psychol. 2019 Jul;38(7):623-637. doi: 10.1037/hea0000728. Epub 2019 Apr 11.

Reyes Fernandez B, Lippke S, Knoll N, Blanca Moya E, Schwarzer R. Promoting action control and coping planning to improve hand hygiene. BMC Public Health. 2015 Sep 25;15:964. doi: 10.1186/s12889-015-2295-z.

Lhakhang P, Lippke S, Knoll N, Schwarzer R. Evaluating brief motivational and self-regulatory hand hygiene interventions: a cross-over longitudinal design. BMC Public Health. 2015 Feb 4;15:79. doi: 10.1186/s12889-015-1453-7.

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Lippke S, Wienert J, Keller FM, Derksen C, Welp A, Kotting L, Hofreuter-Gatgens K, Muller H, Louwen F, Weigand M, Ernst K, Kraft K, Reister F, Polasik A, Huener Nee Seemann B, Jennewein L, Scholz C, Hannawa A. Communication and patient safety in gynecology and obstetrics - study protocol of an intervention study. BMC Health Serv Res. 2019 Nov 28;19(1):908. doi: 10.1186/s12913-019-4579-y.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Keller FM, Dahmen A, Derksen C, Kotting L, Lippke S. Psychosomatic Rehabilitation Patients and the General Population During COVID-19: Online Cross-sectional and Longitudinal Study of Digital Trainings and Rehabilitation Effects. JMIR Ment Health. 2021 Aug 26;8(8):e30610. doi: 10.2196/30610.

• Responsible Party: Prof. Dr. Sonia Lippke, Principal Investigator and Professor of Health Psychology & Behavioral Medicine, Jacobs University Bremen gGmbH
• ClinicalTrials.gov Identifier: NCT03855735
• Other Study ID Numbers: 01VSF18023 ( Other Grant/Funding Number: The Federal Joint Committee (G-BA) )
• First Posted: February 27, 2019
• Last Update Posted: March 14, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH:

Preventable adverse events; Patient safety; Core communication competences; Different communication models; HAPA; Participatory intervention development; Digitization; App; eHealth; Health services research