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Feasibility and Preliminary Effectiveness of a Shared Decision-making Process

NCT05424809 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-08-03

No results posted yet for this study

Summary

Background: Shared decision-making is a process where health professionals and patients work together through conversation and using tools to make the best possible decision for the person. Patient decision aids provide information based on the best available evidence, support the deliberative process, and further help clarifies individual patient values and preferences. Incorporating shared decision-making in clinical practice is challenging.

Hypothesis: A proposed shared decision-making implementation model is feasible and improves patients' knowledge of possible treatment options, as well as patients' perception and degree of satisfaction with the decision-making process.

Objective: To evaluate the feasibility and preliminary effectiveness of implementing a shared decision-making model in a tertiary university hospital.

Methods: It is proposed to carry out a pilot randomized clinical study (ratio 1:1), with two arms, in parallel, open, single center. Adult patients from two clinical processes will be included: a) Obesity (treatment options: bariatric surgery or medical management (healthy habits +/- pharmacological treatment), and b) Advanced Chronic Kidney Disease (ACKD) (treatment options: hemodialysis, peritoneal dialysis, or conservative treatment).

Since it is a pilot study, the investigators estimated a random sample of between 20 to 40 participants per intervention group and control group (total sample 40 to 80 per pathology) would be needed. The intervention group will carry out the shared decision-making model, and the control group will receive the usual clinical practice with detailed information from a health professional.

The primary outcomes of interest to be evaluated are a) feasibility; b) quality of the decision and the decision-making process.

Conditions

  • Clinical Decision Making
  • Patient-Centered Care
  • Obesity
  • Chronic Kidney Diseases

Interventions

BEHAVIORAL

Shared decision-making model

The model is based on a person-centred care process, where an exchange of information is carried out between the health professional and the patient to make the best decision that is consistent with the person's values and preferences. A six-stage process constitutes the model: 1) Identificacion of the decision point, 2) design of a specific patient decision aid, 3) identification of possible barriers and ways to overcome them, 4) training for professionals, 5) 3-steps implementation of shared decision-making in clinical practice, 6) evaluation

Sponsors & Collaborators

  • Hospital Vall d'Hebron

    lead OTHER

Principal Investigators

  • Karla Salas Gama, MD · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2022-11-23
Completion
2022-12-23

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05424809 on ClinicalTrials.gov