Feasibility and Preliminary Effectiveness of a Shared Decision-making Process

Obesity Clinical Trial

Official title: Feasibility and Preliminary Effectiveness of a Shared Decision-making Process in a Tertiary University Hospital: Protocol of a Pilot Randomized Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. Some studies have analyzed the implementation of shared decision-making in specific clinical processes. However, the investigators have only been able to identify one study, still in progress, that plans to implement and evaluate the integration of a shared decision-making program in a university hospital.

Hypothesis: The 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. The guidelines of the 2010 CONSORT statement for reporting randomized trials will be followed. 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 to decide: 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 outcomes of interest to be evaluated are a) feasibility (defined by the number of patients in the intervention group who agree to participate in a shared decision-making process and who complete the entire study process); b) quality of the decision and the decision-making process (defined by the degree of knowledge, scale of satisfaction with the decision, quality of the process, decisional conflict and perception of information and inclusion in the process).

The recruitment of patients will begin in May 2022. The assignment of patients in Obesity will be carried out from the Agenda Service, where a person outside the research team will randomly assign each patient to the first visit of the intervention group or control group. In ACKD, the assignment will be randomly through the REDCap computer program. The coded collection of variables will also be carried out through the REDCap program. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05424809
• Study type: Interventional
• Source: Hospital Vall d'Hebron
• Contact: Karla Salas-Gama, MD
• Phone: +34667117798
• Email: karla.salas@vallhebron.cat
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Completion date: December 23, 2022