This document is based on the SPIRIT guidelines.1 The numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. A completed SPIRIT checklist is included as additional file.
Participants
Eligibility criteria {10}
Inclusion criteria
- Parents or guardians of infants born preterm after December 31st, 2009, with a VLBW <1500g, and postnatal treatment at the UMC Mainz
- Informed (electronic) consent
- Self-reported sufficient proficiency of German language
Exclusion criteria
- Self-reported acute, severe psychiatric condition
Consent provisions {26a, 26b}
Please see the “Ethics and dissemination” section.
Interventions
Description of study intervention(s) {11a}
Embedded in an online-survey, participants will be exposed to two video-vignettes produced specifically for the COPE-trial. The scripted video-vignettes (video A and B) depict a fictional medical consultation between a physician and the parents of a preterm infant. Purpose of the consultation is the disclosure of an unfavorable prognosis on the occasion of a severe intraventricular hemorrhage with parenchymal involvement. Prognostic information in both scenarios is based on data regarding the estimation of outcome from scientific publications.25, 26 Video A and B differ solely in prognostic framing. Video A exemplifies a more optimistic framing, whereas Video B illustrates a more pessimistic framing. The differing degree of optimism is achieved by varying selected text passages. The number of empathic statements is equal and both vignettes conclude with an identical reassurance of non-abandonment by the physician. Other aspects of the physician-parent communication, e.g., the setting/environment, the consulting physician, the parents, and the content of the consultation, are standardized. The length of both videos is about 3 minutes each. A female physician was chosen to communicate the prognosis. This reflects the clinical reality of the NICU at the UMC Mainz. The parents are a heterosexual Caucasian couple around 25-30 years old.
Prior to exposure to the intervention, participants are provided with a short (approximately 1.5 minutes) explanatory film contextualizing the medical consultation. A fictional premature infant named Luisa is born with a gestational age of 23 weeks + 5 days due to an amniotic infection syndrome. Luisa experiences an intraventricular hemorrhage on her third day of life. On this occasion, the parents are contacted by telephone by the attending neonatologist. They are asked to come to the unit in person for the purpose of a physician-parent conversation in a timely manner.
Explanation for the choice of comparators {6b}
Since the optimum framing of prognostic disclosure to parents in the context of complications with an associated unfavorable prognosis in the NICU setting is unknown, we decided to depict two opposing levels of optimism (more optimistic vs. more pessimistic) out of a spectrum of gradations of optimism. As the introduction indicates, these two selected opposing gradations are found in clinical practice as well as in research. Accordingly, this selection is suitable for the purpose of the present project. Stimulus for the choice of comparators as well as for the use of scripted video-vignettes as study material originated from a study in adult oncology investigating the influence of more or less optimistic communication on the perception of physician compassion.22 The selection of the questionnaires chosen to assess physician professionalism and physician compassion was inspired by the aforementioned and one related study.22, 27
The conception, cinematic realization and application of the video-vignettes comply with recommendations by Hillen and van Vliet.28, 29 Case vignette and scripts were designed with an interdisciplinary team and implemented with professional actors and filmmakers.
Criteria for discontinuing or modifying allocated interventions {11b}
Individual preterm end of study
The individual participant can discontinue the study at any time. The study-related and intervention-related risks for participants are assumed to be minimal. Due to the fact that the study will be conducted as an online-survey, among other things, there is no risk of commuting accidents. In addition, the interventions are videos which represent a fictional scenario and do not involve any intervention in the current clinical reality, and the actors as well as the setting (i.e., the filming location) are unknown to the parents. Deliberate care was taken to minimize the relatability to the parents’ own story.
Preterm end of entire study
Please see the “Interim analyses {21b}” section.
Strategies to improve adherence to interventions {11c}
Data collection is performed on one day within approximately 30 min (time for procession of the online-survey) and thus participant adherence can be expected. However, detailed education and transparency regarding the study procedure prior to the online-survey are intended to prepare participants as best as possible for study participation and to minimize the risk of non-adherence or drop-out. Education includes the duration of the online-survey (Baseline-Questionnaire, single videos, Post-Intervention-Questionnaire) and the request to complete the study to the last page in case of participation. The communication of availability for questions or in case of concerns at any time serves the same purpose.
Relevant concomitant care permitted or prohibited during the trial {11d}
Not applicable, as there is no interference with concomitant care. The video-vignettes depict a fictitious scenario and participants’ infants have already been discharged from the NICU.
Harms {22}, and provisions for ancillary and post-trial care {30}
Watching the videos and the subsequent answering of questions may cause an emotional reaction in parents. However, the risk of experiencing significant distress is considered to be minor. Parents that feel too distressed can discontinue the questionnaire at any time. Additionally, distressed participants are encouraged to contact the research team in case consultative psychological care is required.
Outcomes {12}
Primary outcome:
- Parents’ preference with regard to prognostic framing, i.e. the parents’ preference for video A or B after watching both videos
Secondary outcomes:
- Parents’ state-anxiety due to/after watching each video
- Parents’ satisfaction with prognostic framing in the first video
- Realism of the evaluation of the conveyed prognosis following the first video:
- Subjective evaluation of the severity of the prognosis
- Objective ability to recall conveyed prognostic information
- Degree of optimism with regard to the infant's future (future optimism) following the first video
- Degree of hope with regard to the infant's future (future hope) following the first video
- Degree of preparedness by the medical consultation (first video) to make a shared therapeutic decision
- General impression of the consulting physician (first video) on parents
- Professionalism of the consulting physician (first video)
- Compassion of the consulting physician (first video)
Further outcomes are:
10. Perception of prognostic framing following each video
11. Parents’ personal preference of gradation of prognostic framing (level of optimism) after watching both videos
12. Importance of physician-parent communication in general and of prognostic information in particular (on completion of the survey)
13. Burden due to study participation in general and to interventions in particular (on completion of the survey)
A tabular overview of all relevant outcome measures and the time points of assessment thereof (data acquisition) complemented by a detailed description of all collected baseline data, of all outcome measures and of the respective data collection instruments can be found in the “Data collection: outcome measures and assessments” section.
Participant timeline {13}
Study procedures, examination methods, and outcome assessment
Figure 1 provides an overview of the study sequence and corresponds to the participant timeline. Following the recruitment of participants, the online-survey based on a two-part questionnaire with embedded scripted video-vignettes (interventions) is applied.
Sample size rationale {14}
At first, we conservatively assumed that only one parent of each child participates. The data can be arranged in a 2 x 2 table, with columns defining the sequence order ‘AB’ vs. ‘BA’ and rows defining whether the first video was preferred over the second one. Then, the square root of the odds ratio is a period-adjusted estimate of the preference ratio, i.e., a general tendency towards or against preferring the latter video is corrected for. Assuming that in fact there is no such period effect, the discriminatory power for detecting a preference ratio of 3:2, based on a two-sided chi-square test with level a = 0.05, is 0.80, if 194 individual/single parent decisions are evaluable (using SAS software’s proc power). Assuming a substantial period effect, such that the first video is preferred with odds 1:1 in sequence group ‘AB’ and with odds 9:4 in group ‘BA’, the period adjusted preference ratio results, but then the required case number is 204. Assuming further that 95% percent of participating parents actually decide and share their preference, 215 families are to be recruited. If we now assume that always both parents participate and that the concordance of the evaluation corresponds to a kappa of 0.5, then at least 153 families would have to be recruited (using the standard formula for cluster randomized trials and multiplying 204 with the variance inflation factor 1.5 results in 306 parents, i.e. in 153 families). A blinded sample size reassessment is planned after 50 to 70 parents. For details please see the “Interim analyses {21b}” section.
Participant recruitment {15}
Contact with potential participants is established via personal and electronic means. Participants receive a letter with information material (written information) two weeks ahead of a phone call by a research team member (oral information). The material comprises a synopsis of the research project, information concerning data protection regulations, the declaration of consent and contact details of the research team. The telephone contact is intended to provide a more detailed, in-depth explanation of study-related content and space for queries. The concomitant identification of parents not eligible for participation is a further purpose of the conversation. In addition, potential participants will be contacted personally at neurodevelopmental follow-up appointments, and through a local parents’ mutual support group.
Persons interested in participation contact the research team electronically (e-mail). Parents and guardians are asked to simultaneously include in the electronic feedback to the research team whether one or both parents of the same child will participate. In response, the participants are provided with their personal access data (link and password) for the password-protected online-survey. The personal link containing the information which study group the respective participant is assigned to is part of the first e-mail. For data security reasons, the password (a multi-digit access code) is communicated in the second e-mail. Although the recruitment procedure implies contacting and educating parents of the same preterm infant together, concerning participation they are not treated as entity. Individual parents are considered equally as related parents of the same child. A special provision in the case of participation of both parents is that they are assigned to the same study group. This is to ensure that the assumed common response tendency (covariance) based on a couple’s shared experience of prematurity is taken into consideration. However, in order to be able to simultaneously investigate sex-specific or parent-specific differences in processing the same lived experience, related parents are marked as such in the data set. This is ensured by the multi-digit access code containing a matching prefix for parents of the same child.