No registrations found.
ID
Source
Health condition
Shared decision making, Hernia inguinal, knee osteoarthritis, hip osteoarthritis, gallstones, treatment, surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint will be patient reported outcomes of patients with and without decision aid after 0, 3, 6 and 12 months
Secondary outcome
- Operation rate in patients with and without decision aid.
- Patient satisfaction of patients with and without decision aid after 0, 3, 6 and 12 months
- Healthcare costs of patients with and without decision aid.
Background summary
This is a multi center, prospective cohort study. In this study we would like to determine the impact of decision aids, tools with balanced and patient adjusted information about the harms and benefits of treatments (surgery or no surgery), in standardized care in patients with gallstones, inguinal hernia, hip- and knee osteoarthritis. Patients will all be recruited in the Netherlands.
We aim to evaluate the patient reported outcomes in patients with and without a decision aid. Secondarily, we aim to determine the effect on of decision aids on operation rate, satisfaction and health care costs.
After inclusion of the patients and 12 months follow-up, statistical analysis will be carried out using IBM SPSS
Study objective
Primary hypothesis
Our primary hypothesis is that the implementation of decision aids for patients who suffer from symptomatic cholecystolithiasis, inguinal hernia, knee or hip osteoarthritis will result in better patient reported outcomes.
Secondary hypothesis
Secondarily we hypothesized that there is a significant reduction in operation rate. Patients will be more satisfied and implementation of decision aids is cost-effective.
Study design
t = 0 months
Decision Aid
Questionnaires:
Patient demographics
EQ5D
GSL / EuraHS / HOOS / KOOS
SDM-9
Treatment Preference
t = 3 months
Questionnaires:
EQ5D
GSL / EuraHS / HOOS / KOOS
SDM-9
Satisfaction and Painscore
t = 6 months
Questionnaires:
EQ5D
GSL / EuraHS / HOOS / KOOS
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)
- EuraHS
- Shared Decision Making Questionnaire - 9 (SDM-9)
- Collaborate
- SFHLQ
- HOOS
- KOOS
- Treatment preference, satisfaction and painscore
Inclusion criteria
- 18 years of age or older
- referred for surgical consultation with symptomatic cholecystolithiasis, inguinal hernia, knee osteoarthritis or hip osteoarthritis
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 | NL7400 |
| NTR-old | NTR7616 |
| Other | Commissie Mensgebonden Onderzoek : 2018-4815 |