Transplant Trial Watch

Graphic narrative based informed consent for bronchoscopy improves satisfaction in patients after lung-transplantation: A randomized controlled trial.

Seeliger, B., et al.

Patient Education & Counseling 2021 [record in progress].


Aims
This study aimed to evaluate if supplementing standard informed consent (IC) with a graphic narrative illustrating bronchoscopy for post-lung transplantation (LTx) surveillance led to improvements on patient satisfaction, periprocedural anxiety and experience.

Interventions
Patients were randomised to receive either a standard IC form with a graphic narrative illustrating the procedure (intervention group) or a standard IC form alone (control group).

Participants
60 primary lung transplant recipients.

Outcomes
The primary outcome was the overall patient satisfaction with the IC process. The secondary outcomes were change in state anxiety level, satisfaction with IC and adverse experience during bronchoscopy.

Follow-up
Immediately after informed consent.

CET Conclusions
The randomised controlled trial tested the hypothesis that a graphic narrative illustrating bronchoscopy for post-LTx surveillance will improve the overall patient satisfaction regarding the quality of patient informed consent and may decrease pre-procedural anxiety and periprocedural discomfort. Adult recipients and paediatric recipients who were in transition to adult care, were scheduled for the first non-sedated surveillance bronchoscopy after their primary lung transplant (median days after transplant ranged from 2-5 days). Based on a table of random numbers and using numbered, sealed envelopes participants were randomised to the standardised informed consent form plus the graphic narrative or the standardised consent form only. The power calculation was based on the primary outcome patient satisfaction and indicated that 60 patients needed to be included in the study. Overall satisfaction with informed consent was significantly higher in the graphic narrative group. Patient anxiety measured before and after informed consent (but before the bronchoscopy) was similar between groups. The patient reported bronchoscopy experience of anxiety, dyspnoea, cough, gagging, pain or discomfort was similar between groups. The graphic narrative may be a simple tool to improve overall patient reported satisfaction with the informed consent form.

Jadad score
3

Data analysis
Per protocol analysis

Allocation concealment
Yes

Trial registration
DRKS00018088

Funding source
No funding received