Better preparing parents for difficult treatment decisions

Disclosure versus non-disclosure of physicians' personal perspective during decision-making with parents of critically ill infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16123073

Enrollment

232

Registered

2024-01-17

Start date

2024-02-01

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parents of preterm infants Other

Interventions

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 physicia

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Insufficient knowledge of project language (German or English).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Switzerland

Contacts

Public ContactChristine Arnold

christine.arnold@insel.ch+41316321453

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 29, 2026