The use of an interactive web-based Decision Aid reduces decisional conflict and increases patient satisfaction with information and care.
ID
Bron
Verkorte titel
Aandoening
- Baarmoeder-, bekken- en ligamentum-latumafwijkingen
Aandoening
Pelvic organ prolapse, cystocele, rectocele, enterocele, uterine descent, surgery, pessary, treatment
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Overige
Uitkomstmaten
Primaire uitkomstmaten
The main study endpoints are: satisfaction with treatment decision (making), and satisfaction with information.
Achtergrond van het onderzoek
Female pelvic organ prolapse (POP) is a common problem among women worldwide. The prevalence in The Netherlands ranges from 8.4 to 11% in women aged 45-85 years. Pessary or surgical treatment are the two commonly applied treatments. The lack of randomized controlled treatment studies in this field makes recommendations on the best treatment option for individual patients speculative. Choice of treatment depends on both patient and doctor preference. Information on POP provided to patients is not always accurate. This can result in incorrect or incomplete ideas and expectations about the disease and its treatment. Shared decision making (SDM) and the use of a decision aid (DA) are ways to provide patients with sufficient information and improve their knowledge. Furthermore it helps clarify their preferences regarding treatment and improves comfort and participation in the process of decision making, it reduces decisional conflict and makes patients feel more comfortable with their choices. To this end a web-based DA for the treatment of POP was developed. The aim of this study is to investigate the effects of the DA on SDM regarding treatment choice and patient-reported outcomes.
Doel van het onderzoek
The use of an interactive web-based Decision Aid reduces decisional conflict and increases patient satisfaction with information and care.
Onderzoeksopzet
T1: max. 2 weeks after treatment decision, before start treatment
T2: 6 months after T1
T3: 12 months after T1
T4: 24 months after T1
Onderzoeksproduct en/of interventie
In the intervention group, patients will be presented with the decision aid after diagnosis. After completing the web-based decision aid program, patients’ preferences will be discussed with the clinician during the next consultation. In the control group patients will receive information regarding treatment options as usual.
Algemeen / deelnemers
Hilvarenbeekseweg 60
L.E. Drost
Hilvarenbeekseweg 60
Tilburg 5000 LC
The Netherlands
l.drost@erasmusmc.nl
Wetenschappers
Hilvarenbeekseweg 60
L.E. Drost
Hilvarenbeekseweg 60
Tilburg 5000 LC
The Netherlands
l.drost@erasmusmc.nl
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Woman with a symptomatic prolapse
2. Woman for whom a (new) treatment must be chosen. Patients are eligible for at least two treatment options
3. Patients have to be able to make use of a computer with internet access in order to make use of the web-based decision aid and to complete the online questionnaires
4. Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients with a history of gynaecological cancer
2. Patients and clinicians who do not have any access to the internet
3. Patients and clinicians who do not have sufficient knowledge of the Dutch language
4. More than 1 POP-surgery in the past or POP-surgery < 2 years. Anti-incontinence surgery is not considered POP surgery here.
5. In case of a second opinion, the patient will not be included if the first opinion was obtained in one the hospitals involved in the study
6. Patients participating in the PEOPLE study
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5795 |
| NTR-old | NTR6070 |
| CCMO | NL55737.028.15 |