Assessment of relevance and actual implementation of person-centeredness in healthcare and social support services for women with unintended pregnancy in Germany (CarePreg): results of expert workshops.

INTRODUCTION: Person-centeredness is a key principle in the German healthcare system. However, access to high-quality care for women with unintended pregnancy is limited due to social stigma and legal restrictions. There is little research on the adoption of person-centeredness in care for women with unintended pregnancy. The aim of this study was to analyze relevance and actual implementation of dimensions of person-centeredness in psycho-social and medical abortion care from the view of abortion care providers. METHODS: Counselors and gynecologist working in psycho-social or medical abortion care participated in one of two digital workshops. Discussions were semi-structured based on the 16 dimensions of an integrative model of person-centeredness, audio-recorded and transcribed verbatim. During qualitative content analysis, deductive categories based on the integrative model of person-centeredness were applied and inductive categories were developed. Additionally, participants rated relevance and actual implementation of the dimensions in an online survey. RESULTS: The 18 workshop participants most intensively discussed the dimensions "access to care", "person-centered characteristics of healthcare providers" and "personally tailored information". Four additional categories on a macro level ("stigmatization of women with unintended pregnancy", "stigmatization of healthcare providers", "political and legal aspects" and "corona pandemic") were identified. Most dimensions were rated as highly relevant but implementation status was described as rather low. CONCLUSIONS: In Germany, high quality person-centered care for women with unintended pregnancy is insufficiently implemented through limited access to information, a lack of abortion care providers, and stigmatization. There is a need for changes in health care structures to enable nationwide person-centered care for women with unintended pregnancy. Those changes include a more easy access to evidence-based information and person-centered abortion care, more education on abortion care for healthcare providers, integration of topics of abortion care in medical schools and promotion of de-stigmatizing actions to enable abortions as part of the general healthcare.

Effects of a shared decision-making implementation programme on patient-centred communication in oncology-Secondary analysis of a randomised controlled trial.

BACKGROUND: There is a need for better implementation of patient-centred (PC) communication and shared decision-making (SDM) in routine cancer care. OBJECTIVE: The aim of this study was to assess whether a programme to implement SDM in oncology had effects on PC communication in clinical encounters. DESIGN: This study constitutes a secondary analysis of data derived from an implementation trial applying a stepped wedge design that, among other strategies, incorporated training and coaching to enhance the PC communication skills of physicians. SETTING AND PARTICIPANTS: We analysed audio recordings of clinical encounters collected in three departments of a comprehensive cancer centre in Germany before and after rolling out the implementation programme. MAIN VARIABLES STUDIED: We assessed the PC communication skills of physicians. MAIN OUTCOME MEASURES: Each recording was rated by two researchers using the German version of the Four Habits Coding Scheme (4HCS), an observer-based measure of PC communication. Interrater reliability of the outcome measure was acceptable but moderate. Demographic data of patients participating in audio recordings were analysed. METHODS: Data were analysed using descriptive statistics and linear mixed-effects models. RESULTS: In total, 146 encounters, 74 before and 72 after implementation, were evaluated. The mean age of patients was 57.1 years (SD = 13.8), 70.3% were female, the largest portion of patients had medium formal education (32.4%) and were (self-) employed (37.8%). No statistically significant effect of the implementation programme on the physicians' PC communication skills was found. DISCUSSION: The results indicate that the investigated programme to implement SDM in oncology, including training and coaching, had no effects on PC communication in clinical encounters. These results are in contrast to other studies that report the effects of specific training or coaching on PC communication. Reasons for the lack of effect include the short duration of our training compared to other studies, limited reliability and moderate interrater reliability of the 4HCS scale, limited reach of the intervention programme as well as the inclusion of physicians regardless of their exposure to the interventions. CONCLUSION: Further research is needed to develop implementation strategies that improve physicians' PC communication skills. PATIENT CONTRIBUTION: Data on patients and clinical encounters with patients and physicians were analysed. There was no other patient or public involvement.

Evaluation of a patient-centered communication skills training for nurses (KOMPAT): study protocol of a randomized controlled trial.

BACKGROUND: To ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only. METHODS: This study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training. DISCUSSION: To our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes. TRIAL REGISTRATION: Clinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022).

Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is highly relevant in oncology but rarely implemented in routine care. In a stepped-wedge cluster randomized implementation trial, the outcome evaluation of a theoretically and empirically based multi-component SDM implementation program did not show a statistically significant effect on patient-reported SDM uptake. Within this SDM implementation trial, a thorough a priori planned process evaluation was conducted. Thus, the aim of this study was to investigate factors influencing SDM implementation in the context of a multi-component SDM implementation program. METHODS: We conducted qualitative process evaluation of a stepped-wedge SDM implementation trial. Qualitative data included interviews with nurses and physicians of participating departments, field notes by the study team, and meeting minutes. Data were analyzed via deductive and inductive qualitative content analysis on basis of the Consolidated Framework for Implementation Research (CFIR). RESULTS: Transcripts of 107 interviews with 126 nurses and physicians, 304 pages of field note documentation, and 125 pages of meeting minutes were analyzed. Major factors influencing SDM implementation were found for all domains of the CFIR: a) four regarding characteristics of the individuals involved (e.g., perceived personal relevance, individual motivation to change), b) eleven regarding the inner setting (e.g., leadership engagement, networks and communication, available resources, compatibility with clinical practice), c) two regarding the outer setting (e.g., culture of health care delivery), d) eight regarding characteristics of the intervention (e.g., relative advantage, adaptability), and e) three regarding the implementation process (e.g., integration into existing structures). Furthermore, we found strong interrelations between several of the influencing factors within and between domains. CONCLUSIONS: This comprehensive process evaluation complements the outcome evaluation of the SDM implementation trial and adds to its interpretation. The identified influencing factors can be used for planning, conducting, and evaluating SDM implementation in the future. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351, registered 8 January 2018, https://clinicaltrials.gov/ct2/show/NCT03393351.

Translation and psychometric evaluation of the German version of the IcanSDM measure - a cross-sectional study among healthcare professionals.

BACKGROUND: Shared decision-making (SDM) between patients and healthcare professionals (HCPs) is a key component of patient-centred care. To implement SDM in clinical practice and to evaluate its effects, it is helpful to know about HCPs' perception of SDM barriers. The measure IcanSDM was developed in Canada and assesses the perception of SDM barriers. To our knowledge, no equivalent measure exists in German. Therefore, the aim of this study was to translate and adapt the IcanSDM measure to be used by a German speaking population and evaluate its psychometric properties. METHODS: This is a cross-sectional psychometric study based on a secondary analysis of baseline data from a SDM implementation study. The original 8-item IcanSDM was translated into German using a team translation protocol. We assessed comprehensibility via cognitive interviews with n = 11 HCPs. Based on results of cognitive interviews, the translated IcanSDM version was revised. Two hundred forty-two HCPs filled out the measure. Psychometric analysis included acceptance (completion rate), item characteristics (response distribution, skewness, item difficulties, corrected item-total correlations, inter-item correlations), factorial structure (confirmatory factor analysis (CFA), model fit), and internal consistency (Cronbach's α). RESULTS: We translated and adapted the German IcanSDM successfully except for item 8, which had to be revised after the cognitive interviews. Completion rate was 98%. Skewness of the items ranged between -.797 and 1.25, item difficulties ranged between 21.63 and 70.85, corrected item-total-correlations ranged between .200 and .475, inter-item correlations ranged between .005 and .412. Different models based on CFA results did not provide a valid factorial structure. Cronbach's α ranged between .563 and .651 for different factor models. CONCLUSION: We provide the first German measure for assessing perception of SDM barriers by HCPs. The German IcanSDM is a brief measure with good acceptance. However, we found unsatisfying psychometric properties, which were comparable to results of the original scale. In a next step, the IcanSDM should be further developed and modified and predictive validity should be evaluated.

Adaptation and qualitative evaluation of Ask 3 Questions - a simple and generic intervention to foster patient empowerment.

BACKGROUND: Patients are often not actively engaged in medical encounters. Short interventions like Ask 3 Questions (Ask3Q) can increase patient participation in decision-making. Up to now, Ask3Q was not available in German. OBJECTIVE: To translate Ask3Q and evaluate its acceptability and feasibility. METHODS: We translated and adapted several English versions of Ask3Q using a team translation protocol and cognitive interviews. Acceptability and feasibility of the final German Ask3Q version were assessed via focus groups and interviews with patients and healthcare professionals (HCPs). Data were analysed via qualitative content analysis. RESULTS: Translation and adaptation were successful. Participants of focus groups and interviews perceived Ask3Q as a tool to empower patients to ask more questions. Moreover, it was seen as a guideline for physicians not to forget conveying important information. Several characteristics of patients, HCPs, the clinical setting and the intervention were identified as facilitators and barriers for an effective implementation of Ask3Q. CONCLUSION: We provide the German version of Ask3Q. According to participants, implementation of Ask3Q in the German healthcare system is feasible. Future studies should evaluate if positive effects of Ask3Q can be replicated for patient participation and communication behaviour of HCPs in Germany.

Assessment of person-centeredness in healthcare and social support services for women with unintended pregnancy (CarePreg): protocol for a mixed-method study.

INTRODUCTION: For women with unintended pregnancy, access to high-quality care has been found limited due to social stigma and legal restrictions, especially when seeking abortion. To foster person-centeredness (PC), recognising the experiences and needs of women is the first premise. This study aims to (1) identify relevant dimensions of PC (2) evaluate PC in healthcare and social support services, (3) develop recommendations for further actions in healthcare and social support services for women with unintended pregnancy. METHODS AND ANALYSIS: We will use a mixed-methods approach. Phase 1: expert workshops with 10-15 healthcare professionals and counsellors and semistructured interviews with 15-20 women with unintended pregnancy will be conducted to assess the relevance of PC dimensions. Phase 2: quantitative assessment of PC dimensions within healthcare and support services will be conducted. We aim to include 600 women with an unintended pregnancy (1) until 24 weeks of pregnancy or (2) who sought abortion within the past 8 weeks, over three measurement points within 12 months. To deepen the results, semistructured interviews will be conducted. Phase 3: a workshop with 10-15 experts and an online survey with 100-150 experts will be used to indicate recommendations. Participants will be gained through relevant care facilities. An ethical advisory board and an advisory board of affected women will be involved throughout the study. ETHICS AND DISSEMINATION: The study will be carried out in accordance to the latest version of the Helsinki Declaration of the World Medical Association and principles of good scientific practice. The study was approved by the Local Psychological Ethics Committee of the University Medical Center Hamburg-Eppendorf, Germany (LPEK-0260). Written informed consent will be sought prior to study participation. The study results will be disseminated in scientific journals, through collaboration partners and plain language press releases.

Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care. METHODS: In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics. RESULTS: A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = - 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching). CONCLUSIONS: The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 , registered 8 January 2018.

Translation and psychometric evaluation of the German version of the Organisational Readiness for Implementing Change measure (ORIC): a cross-sectional study.

OBJECTIVES: To translate the Organisational Readiness for Implementing Change measure into German and assess its psychometric properties. DESIGN: Cross-sectional psychometric study based on secondary analysis of baseline data from a shared decision-making implementation study. SETTING: Three departments within one academic cancer centre in Hamburg, Germany. PARTICIPANTS: For comprehensibility assessment of the translated ORIC version, we conducted cognitive interviews with healthcare professionals (HCPs, n=11). Afterwards, HCPs (n=230) filled out the measure. PRIMARY AND SECONDARY OUTCOME MEASURES: The original English version of the ORIC was translated into German using a team translation protocol. Based on comprehensibility assessment via cognitive interviews with HCPs, the translated version was revised. We analysed acceptance (completion rate), factorial structure (exploratory factor analysis (EFA), confirmatory factor analysis (CFA), model fit), item characteristics (item difficulties, corrected item-total correlations, inter-item correlations) and internal consistency (Cronbach's α). RESULTS: Translation and cognitive testing of the German ORIC was successful except for item 10, which showed low comprehensibility as part of content validity in cognitive interviews. Completion rate was >97%. EFA and CFA provided a one-factorial structure. Item difficulties ranged between 55.98 and 65.32, corrected item-total-correlation ranged between 0.665 and 0.774, inter-item correlations ranged between 0.434 and 0.723 and Cronbach's α was 0.93. CONCLUSIONS: The German ORIC is a reliable measure with high completion rates and satisfying psychometric properties. A one-factorial structure of the German ORIC was confirmed. Item 10 showed limited comprehensibility and therefore reduces content validity of the measure. The German ORIC can be used to analyse organisational readiness for change as a precursor for implementation success of various interventions.

Vision- and health-related quality of life before and after vision restoration training in cerebrally damaged patients.

PURPOSE: The aim of the study was to examine if improvements of stimulus detection performance in visual field tests after intensive visual training of the visual field border zone in patients with visual field defects are associated with changes in self-reported vision- and health-related quality of life (QoL). METHODS: We studied a clinical sample of 85 patients suffering from visual field loss after brain damage that underwent repetitive, daily light stimulation (vision restoration training, VRT) of the visual field border and the blind visual field for up to 75 hrs (N=16) or 150 hrs (N=69). Stimulus detection was quantified in the central visual field with a campimetric method before and after intervention. Health-related QoL was assessed by the Health-Survey SF-36 and vision-related QoL by the 39-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). RESULTS: Both vision- and health-related QoL measures improved after VRT. Significant increases were found in 8 out of 12 NEI-VFQ and 3 out of 8 SF-36 subscales. Of the 85 participants 6% showed a decrease in stimulus detection performance, 42% showed an increase of less than 5% detected stimuli, 24% showed an increase of 5-10% detected stimuli and 28% of more than 10% detected stimuli. Changes in campimetric stimulus detection rates were related to NEI-VFQ subscales point differences general vision (3 points), difficulty with near vision activities (4 points), limitations in social functioning due to vision (4 points) and driving problems (12 points). There was no relation of visual field changes to changes in SF-36 component and subscale scores. CONCLUSIONS: The NEI-VFQ is a valuable measure of self-reported visual impairment in patients with visual field defects. Stimulation of the visual field by training may lead to improvements of vision-related QoL which were correlated with the extent of visual field enlargements.

Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care. METHODS: We use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics' quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary. DISCUSSION: This study is the first large study on routine implementation of SDM conducted in German cancer care. We expect to foster implementation of SDM at the enrolled clinics. Insights gained from this study, using a theoretically and empirically grounded approach, can inform other SDM implementation studies and health policy developments, both nationally and internationally. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 . Registered 8 January 2018.

Sex hormones modulate neurophysiological correlates of visual temporal attention.

The functional cerebral asymmetry (FCA) in processing targets within rapid serial visual presentation (RSVP) streams has been reported to fluctuate across the menstrual cycle, with identification of the second of two closely spaced targets being impaired when both targets occur in the left or the right hemifield stream during the luteal phase, while during the menstrual phase identification of the second target is only impaired for target pairs presented in the right hemifield stream. This fluctuation has been proposed to result from variations in estradiol levels. The current study used EEG to investigated whether the cycle-related fluctuation in RSVP target identification FCA relates to changes in early, stimulus-driven, bottom-up or in later, top down-driven aspects of FCA. While the former would be expected to become evident in the early visual evoked potentials (VEPs) P1 or N1, the latter would be evident in later event-related potentials (ERPs) such as N2pc or P3. Women performed a dual-stream RSVP task once during the menstrual phase and once during the follicular phase. Estradiol levels were determined from saliva samples. In contrast to previous findings, FCA in RSVP target identification was not affected by cycle phase. However, the impairment in second-target identification when targets where closely spaced was generally smaller during the menstrual phase than during the follicular phase. This effect was matched by shorter peak latencies of P1 VEPs for the menstrual phase, and by a reduction in the latency of the second-target P3 ERP for closely spaced relative to widely spaced target pairs, again for the menstrual phase. Results suggest that in a dual-stream RSVP setup, target identification, early stage stimulus processing, and target consolidation are affected by cycle phase, but that the asymmetry of these effects does not differ between menstrual and follicular phase. The observed cycle-related modulations in neurophysiology and behavior could relate to the effects of estradiol on the locus ceruleus norepinephrine (LC-NE) system, which is known to play a major role in arousal, attention and stress response.