Thyroid cancer
Conditions
Interventions
The intervention consists of a decision aid, a values clarification exercise
(the booster), and the values communication training for physicians.
The decision aid is randomised. We choose for this de
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients with primary and advanced thyroid cancer
Exclusion criteria
Exclusion criteria: Exclusion criteria are clinical exclusion criteria, lack of Dutch language proficiency, and mental incompetence hampering the process of shared decision making as judged by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome, SDM measure from the consultation Our primary outcome measure is the quality of SDM, assessed from the audio-recording of the consultation. These recordings are transcribed and scored on the 5-item Observer OPTION scale assessing to what extent physicians involves patients in decision making. Atlas.ti is used to code the transcripts. Coders will be trained by an experienced coder using the training module from the OPTION instrument. Each consultation is assessed by two coders to enhance accuracy and test reliability. Coders are blinded to the randomisation arm. Prior to coding, in the intervention group only, utterances identifying the intervention group will be removed by an independent third coder. Discrepant ratings are iteratively discussed and resolved by consensus. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures The outcomes below are measured to monitor the effectiveness of the decision aid/SDM-booster. a) choice and decision making role b) knowledge c) evaluation of the decision d) worries and trust e) patient evaluation of SDM process f) audio-recording Additional outcomes scored from the audio-recording are: -duration of the consultation -has a treatment choice been made -is an additional consultation necessary Physicians* understanding of patients* values In the SDM-booster, three common values are incorporated that can be valued by patients as well as physicians. Physicians* understanding of patient values is assessed by the agreement between patient values and physicians* substitute values in relation to these three common values. For this purpose, importance weights are obtained for these three values, using a 4-points importance scale ranging from *hardly important * to *very important * Patient values are measured pre-consultation at T1 and post consultation at T2. In the COMBO group, patient values will be measured at T1 after reading the decision aid. Physicians* substitute values are asked at the end of the decision making consultation using a short questionnaire. The physician is invited to assume the patient perspective and asked: *How important does this patient find each of these three values?" Responses are on the 4-point importance Likert scale. In addition, physician's own values are asked as follows: *And for yourself, which of these values do you find most important considering this patient", again using the importance Likert scale. | — |
Countries
Netherlands
Outcome results
None listed