No registrations found.
ID
Source
Health condition
Decision Aids, Shared Decision Making, Gallstones, Inguinal Hernia, Surgery, treatment preferences, PROMS
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint will be the change in patients treatment preference before and after the decision aid.
Secondary outcome
- The difference between treatment preference of physician and patient after the decision aid.
- The difference between physicians and patients treatment preferences and final shared decision.
- Patient satisfaction after 6 months.
- Patient Reported Outcomes after 6 months.
- Operation rate
Background summary
This study is a single centre, prospective cohort study. In this single centre decision aids, tools with balanced, patient adjusted information about the harms and benefits of treatments (surgery or no surgery), are standardized care for patients with gallstones and inguinal hernia. Patients will all be recruited in the Netherlands.
We aim to determine the change in patient treatment preference before and after the decision aid. Secondarily, we research patient reported outcomes with questionnaires after 3 and 6 months.
After inclusion of 350 patients and 6 months follow-up, statistical analysis will be carried out using IBM SPSS.
Study design
t = 0 months
Decision Aid
Questionnaires:
Patient demographics
EQ5D
GSL / EuraHS
SDM-9
Treatment Preference
t = 3 months
Questionnaires:
EQ5D
GSL / EuraHS
SDM-9
Satisfaction and Painscore
t = 6 months
Questionnaires:
EQ5D
GSL / EuraHS
SDM-9
Satisfaction and Painscore
Intervention
Decision Aids:
Tools with balanced, patient adjusted information about the harms and benefits of treatments. Decision aids facilitate SDM.
Questionnaires:
EQ5D
Gallstone Symptom List (GSL) Or EuraHS
Shared Decision Making Questionnaire - 9 (SDM-9)
Satisfaction, Pain, Treatment preference
Carmen Latenstein
Nijmegen 6500 HB
The Netherlands
06-19402554
carmen.latenstein@radboudumc.nl
Carmen Latenstein
Nijmegen 6500 HB
The Netherlands
06-19402554
carmen.latenstein@radboudumc.nl
Inclusion criteria
- 18 years of age or older
- refered for surgical consultation with gallstones or inguinal hernia
Exclusion criteria
- Complicated gallstone disease
- Mentally incompetent
- Insufficient knowledge of Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7292 |
| NTR-old | NTR7501 |
| Other | Commissie Mensgebonden Onderzoek : 2017-3972 |