Evaluation of a Decision Analysis Model in a Decision Aid for Fracture Prevention in Postmenopausal Women: Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Decisional conflict
Study Overview
Brief Summary
Fragility fractures, often caused by low bone mineral density, are a major health concern for postmenopausal women. One way to prevent these fractures is by taking medication, but deciding whether to start treatment can be difficult due to potential risks and side effects.
This study will test a web-based tool designed to help women make informed decisions about fracture prevention treatment. The tool provides information about the benefits and risks of treatment. Some women in the study will also receive additional support through a decision analysis report, which helps weigh different factors when making a choice.
The study will examine whether using this tool improves decision-making, increases confidence in making a choice, and enhances satisfaction with the decision. It will also explore what factors influence women's decisions and at what level of risk they choose to start treatment.
By understanding how decision aids impact choices, researchers aim to improve the way healthcare providers support patients in making informed decisions about their health.
Detailed Description
Open-label, randomized, open-label, multicenter, three parallel arms, controlled clinical trial. It will be carried out in primary care centers belonging to the Autonomous Communities of Madrid and Catalonia.
The participants will be recruited in the medical consultation, by their family doctor, who will assess the fulfillment of the inclusion criteria a priori and according to eligibility, will offer the woman to participate in the study, informing her about the nature of the research. The informed consent form will be signed online, and the inclusion criteria will be verified by the participant herself when accessing the tool. Participation will be voluntary and does not entail economic incentives for the participants.
Random assignment will be simple following a 1:1:1 ratio to each group. To avoid possible contamination bias, randomization will be performed at the physician level, so that each professional will be randomized to one of the intervention groups so that he/she will apply exclusively one of the study's interventions to all the participants he/she recruits. Due to the characteristics of the interventions it will not be possible to blind the interveners and participants. After randomization, only the data analysts will be blinded to the randomization sequence. The central research team will primarily contact participants via email to send the decision aid tool link and questionnaire links. They will also follow up to ensure the completion of all data provided by the participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Postmenopausal women older than 50 years
- •No medical history of fragility fractures
- •With or without a BMD measurement performed
- •Having been considered candidates to pharmacological treatment prevention for fragility fractures.
- •A 10 year fracture risk assessment according to FRAX for Major fracture >5%.
Exclusion Criteria
- •women with a history of fragility fracture
- •being treated with bisphosphonates or other osteoporosis drugs (except for vitamin D and calcium supplements
- •suffer from serious concomitant pathologies (cancer, chronic renal insufficiency, etc.)
- •women under permanent treatment with glucocorticoids.
Arms & Interventions
Decision aid plus decision analysis model
Participants in this group will use DASH-Osteo decision aid plus the information in plain language, provided by a decision analysis model which will include the utilities provided by the same participants in the web- based tool, and will make a shared decision with their healthcare professional.
Intervention: Decision aid with decision analysis model (Other)
Decision aid only
Participants in this group will use DASH-osteo decision and will make a shared decision with their healthcare professional.
Intervention: Decision aid alone (Other)
Control
Participants in this group will make a decision according to centre's usual practice
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Decisional conflict
Time Frame: Decisional conflict will be measured one time up to 26 weeks, after participant use of the web-based tool.
We will use the Decisional conflict scale (O'Connor 1998, updated 2010), to evaluate the uncertainty and the decision-making conflict across participants. It is a 16-item scale. IItems are summed, then multiplied by 25. Scoring goes from 0 (low decisional conflict) to 100 (high decisional conflict). Patients with a total score \>38 tend to delay decisions, whereas those with ≤ 25 tend to make decisions(1, 2) 1. O'Connor AM. Validation of a Decisional Conflict Scale. Med Decis Making \[Internet\]. 1995 Feb;15(1):25-30. Available from: http://dx.doi.org/10.1177/0272989X9501500105 2. Bunn H, O'Connor A. Validation of Client Decision-Making Instruments in the Context of Psychiatry. Can J Nurs Res \[Internet\]. 1996;28(3):13-27. Available from: https://pubmed.ncbi.nlm.nih.gov/8997937/
Secondary Outcomes
- Decision self-efficacy(Decision-Self-efficacy scale will be applied, up to 26 weeks, after using the decision aid tool.)
- Participant satisfaction with the decision process(Satsfaction will be assessed up to 26 weeks, after participant's second visit with their physician.)