Better preparing parents for difficult treatment decisions
| ISRCTN | ISRCTN16123073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16123073 |
- Submission date
- 06/12/2023
- Registration date
- 17/01/2024
- Last edited
- 24/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Decisions about treatment options for critically ill infants in neonatal intensive care units present emotional and ethical difficulties for parents and healthcare professionals. “What would you do if it were your child?” is a question parents often ask physicians when they are unsure about which treatment to choose for their child. This study aims to gain a better understanding of the needs of parents during the decision-making process regarding two treatment options to improve medical counseling and to support parents in making decisions about the treatment of critically ill infants. The focus is on disclosure versus non-disclosure of the physician's personal perspectives in a counseling session.
Who can participate?
Adult parents (or other legal representatives) of a preterm infant born at less than 32 weeks gestation who are 18 years of age or older. They will either be recruited at the Division of Neonatology at the Inselspital Bern or via parent support groups e.g. “Frühchen Schweiz” (https://www.fruehchenschweiz.ch).
What does the study involve?
Data will be collected via a web-based questionnaire using the SoSci Survey computer software. The study is a two-arm simulation-based, randomized controlled trial using audio-visual animations to explore attitudes and views towards disclosure of a physicians' personal perspective in a counseling session with parents of critically ill infants.
What are the possible benefits and risks of participating?
Participating parents are unlikely to receive any direct individual benefit from the study. A possible group benefit may come from improved counseling practices for future parents in a similar situation. Watching the scenarios in video format and then answering related questions may elicit an emotional response from parents. However, the risk for relevant stress is estimated to be minor. The risk to participants is minimal.
Where is the study run from?
Division of Neonatology, Inselspital Bern, University Hospital, Switzerland
When is the study starting and how long is it expected to run for?
January 2023 until April 2024
Who is funding the study?
Insel Gruppe AG, Direktion Lehre und Forschung and Division of Neonatology, Inselspital Bern, University Hospital are funding the study.
Who is the main contact?
Dr. sc. hum. Christine Arnold, christine.arnold@insel.ch
Contact information
Public, Scientific, Principal Investigator
Inselspital, Universitätsspital Bern
Friedbühlstrasse 19
Bern
3010
Switzerland
 ORCID ID |
0000-0003-4201-1800 |
|---|---|
| Phone | +41316321453 |
| christine.arnold@insel.ch |
Study information
| Study design | Simulation-based randomized controlled trial with two arms |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Internet/virtual |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Disclosure versus non-disclosure of physicians' personal perspective during decision-making with parents of critically ill infants |
| Study acronym | PHILIPA |
| Study objectives | It is hypothesized that disclosure of the physician's personal perspective will result in better parental preparation for decision-making. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The study protocol was submitted to the Berne Cantonal Ethics Committee for clarification of competence (BASEC-No.: Req-2023-00884). Opinion: 17/07/2023: the ethics committee was not responsible; that is, the project does not require approval, because the project does not fall under the Human Research Act, Article 2, Paragraph 1. |
| Health condition(s) or problem(s) studied | Parents of preterm infants |
| Intervention | The study is a simulation-based, randomized controlled trial (RCT) with two arms, which, through the presentation of audio-visual animations, explores attitudes and views on the disclosure of physicians' perspectives in a counseling session with parents of critically ill infants. Parents will be individually randomized 1:1 via SoSci Survey to either control or intervention group. To collect data on a secondary outcome (preference), the groups will each receive the intervention of the group to which they are not assigned. The intervention group (disclosure group) will receive an animated scenario in which a physician discloses her personal perspective in a consultation about a therapeutic decision regarding the placement of a tracheostoma in a critically ill infant in response to the question "What would you do if it were your child?” In contrast, in the control group (non-disclosure group), the physician will not disclose her personal perspective, but will answer the question "What would you do if it were your child?" with general facts. |
| Intervention type | Other |
| Primary outcome measure | Degree of parental preparation for a medical decision is measured using the 10-item German version of the Preparation for Decision-Making Scale (PDMS-G) after animation 1. |
| Secondary outcome measures | Current secondary outcome measures as of 24/05/2024: 1. Parental preference concerning disclosure versus non-disclosure of physicians' personal perspectives during the shared decision-making process will be asked with a dichotomous question (t2, after animation 2). 2. Preference for or against tracheostomy will be asked with a dichotomous question (t1). 3. The physician compassion as assessed by the parents using the German translation of the Physician Compassion Questionnaire (range 5–50), t1. Previous secondary outcome measures: 1. Parental preference concerning disclosure versus non-disclosure of physicians' personal perspectives during the shared decision-making process will be asked with a dichotomous question (t2, after animation 2). 2. Preference for or against tracheostomy will be asked with a dichotomous question (t1). 3. The physician compassion as assessed by the parents using the German translation of the Physician Compassion Questionnaire (range 5–50), t1. 4. Parental anxiety after control/intervention will be assessed using the German short version (5 items) of the state scale of the State-Trait-Anxiety-Inventory (STAI-SKD), t1. |
| Overall study start date | 01/01/2023 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 232 |
| Total final enrolment | 218 |
| Key inclusion criteria | Current participant inclusion criteria as of 24/05/2024: 1. Parent (or other legal representative) of a preterm infant born at less than 37 weeks gestation 2. Parents (other legal representative) ≥ 18 years Previous participant inclusion criteria: 1. Parent (or other legal representative) of a preterm infant born at less than 32 weeks gestation 2. Parents (other legal representative) ≥ 18 years |
| Key exclusion criteria | Insufficient knowledge of project language (German or English). |
| Date of first enrolment | 01/02/2024 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Bern
3010
Switzerland
Sponsor information
Hospital/treatment centre
Friedbühlstrasse 19
Bern
3010
Switzerland
| Phone | +41 31 632 14 01 |
|---|---|
| andre.kidszun@insel.ch |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- Inselspital, Bern University Hospital, Inselspital, Bern University Hospital, University Hospital of Bern, Universitätsspital Bern, Inselspital, Hôpital universitaire de Berne
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Furthermore, the results will be presented at international congresses. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. sc. hum. Christine Arnold, christine.arnold@insel.ch. Data will be available after the study ends (01/01/2025). No consent was required due to the anonymous nature of the survey. The data is collected anonymously. Anonymized data will be made available for secondary analysis, as well as to other researchers, upon reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 14/07/2023 | 24/05/2024 | No | No |
| Protocol file | version 2 | 18/01/2024 | 24/05/2024 | No | No |
Additional files
Editorial Notes
24/05/2024: The following changes were made:
1. Protocols (not peer-reviewed) versions 1 and 2 added.
2. Secondary outcome measures were updated.
3. The participant inclusion criteria were updated.
4. Total final enrolment added.
07/02/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 15/01/2024 to 01/02/2024.
2. The recruitment end date was changed from 15/04/2024 to 30/04/2024.
08/12/2023: Study's existence confirmed by the Health, Social and Integration Directorate, Cantonal Ethics Committee for Research, Berne, Switzerland.
