Evaluation of a Decision Analysis Model in the DASH-Osteo Decision Aid.

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Invitation-only

Conditions

Fracture Risk Assessment

Osteoporotic Fractures

Diphosphonates

Osteoporosis, Postmenopausal

Treatments

Other: Decision aid with decision analysis model

Other: Usual Care

Other: Decision aid alone

Study type

Interventional

Funder types

Other

Identifiers

NCT07120854

24/202-P

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 estimated patients

Sex

Female

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

114 participants in 3 patient groups

Decision aid plus decision analysis model

Experimental group

Description:

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.

Treatment:

Other: Decision aid with decision analysis model

Decision aid only

Experimental group

Description:

Participants in this group will use DASH-osteo decision and will make a shared decision with their healthcare professional.

Treatment:

Other: Decision aid alone

Control

Active Comparator group

Description:

Participants in this group will make a decision according to centre's usual practice