Decision-support interventions for patients considering clinical trial participation may
promote informed decisions. However, decision interventions for people considering clinical
trial participation are still limited.
This study aims to develop and test the acceptability and feasibility of a decision-support
intervention to enhance informed decision-making regarding clinical trial participation.
A decision-support intervention has been developed for a Danish nationwide randomised
controlled trial (RCT) among patients with laryngeal and pharyngeal cancer referred to
curative intended radiotherapy. The primary endpoints in this RCT are levels of dysphagia and
xerostomia.
The decision-support intervention consists of three components, including (1) a patient
decision aid tailored to clinical trial participation and (2) decision coaching consultations
carried out by trained healthcare professionals. Finally, (3) a training program in decision
coaching will be an integrated part of the intervention.
To feasibility test (beta test) the intervention, 60 patient participants will be included,
separated into pre- (n=30) and post- (n=30) intervention groups. Pre-intervention to complete
the survey based on current clinical practice. Post-intervention to complete the survey
following engagement in the decision support intervention.
A total of 12 physicians will be recruited and trained in decision coaching. To assess the
acceptability of the intervention, the physicians will be interviewed. Additionally, they
will be asked to audio-record two decision coaching sessions to test the fidelity of the
intervention.
Methods:
Patient participants outcome ( questionnaire survey)
The stages of decision making measure (self translated forward/backward)
Decisional conflict scale
The decision preparation scale (post intervention measure)
Items on health literacy related to the specific context (understanding the trial, the
treatment modalities, practical issues, etc.)
Decision preference
The interviews with the clinicians (decision coaches) will follow the interpretive
description methodology and be conducted as qualitative, semi-structured audio-recorded
interviews. The interviews will be carried out on the telephone.
The quantitative data will be hosted, organised, and analysed in STATA. The qualitative data
will be hosted, organised, and analysed in a software system called NVivo.
To evaluate the impact of the decision-support intervention, it is necessary to assess the
extent to which it is used as intended in clinical practice. This is referred to as a
fidelity test. Hence, the decision coaches will be provided with dictaphones and asked to
audio-record the consultations. The audio records will be evaluated using the Decision
Support Analysis Tool (DSAT-10), which is a tool to assess practitioners' use of decision
support and communication skills during a clinical encounter.
Further studies
Building upon the current study, the potential for further development, implementation and
evaluation across proton therapy clinical trials will be determined.
Assessing a decision support intervention for trial participation in a single host trial is
challenging due to the limited period of the host trial and insufficient statistical power
for comparative tests.
Additional intervention development could involve establishing an online decision support
intervention platform for Danish proton therapy clinical trials and a training platform in
decision coaching for healthcare professionals. Moreover, integrating measurements
(decisional conflict, etc.) as active pro measures to identify decisional needs during
decisional coaching could be explored.
A cluster randomised trial is the most suitable approach for full-scale implementation and
evaluation.
