Clinical trial NCT05424809: Feasibility and Preliminary Effectiveness of a Shared Decision-making Process
Official title: Feasibility and Preliminary Effectiveness of a Shared Decision-making Process in a Tertiary University Hospital: Protocol of a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Decision Making
Patient-Centered Care
Obesity
Chronic Kidney Diseases
Lead sponsor: Hospital Vall d'Hebron
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria Obesity:

* Adult patients, between 18 and 60 years old, Spanish or Catalan speakers, who have scheduled a visit to the obesity clinic.
* BMI≥40Kg/m2 or ≥35kg/m2 with major associated comorbidities, likely to improve after weight loss
* Presence of morbid obesity established for at least five years
* Absence of endocrine disorders that cause obesity
* Favorable psychiatric-psychological evaluation
* Informed consent to participate in the study after having received all the necessary information (oral and written)

Exclusion Criteria Obesity:

* Patient with cognitive impairment that does not allow for a shared decision-making process.
* Unstable organic disease limiting the probability of success and benefit of participation in the obesity unit program.
* Patients previously operated on bariatric surgery
* Clinical contraindications included in the general criteria of the Bariatric Surgery Protocol of the Hospital Universitari Vall d'Hebron
* Clinical contraindications for pharmacological treatment according to technical date of GLP-1 analogues (Trulicity, Ozempic, Victoza, Saxenda)

Inclusion Criteria ACKD:

* Adult patients aged 18 or over who speak Spanish or Catalan who have a scheduled visit to the ACKD clinic.
* Advanced chronic kidney disease (GFR ≤20ml/min) that requires assessment of the start of renal replacement therapy through any dialysis, transplant or conservative treatment.
* Informed consent to participate in the study after having received all the necessary information (oral and written)

Exclusion Criteria ACKD:

* Having previously performed any modality of renal replacement therapy.
* Patient with cognitive impairment that does not allow for a shared decision-making process.

Primary outcomes:
measure: Feasibility of the decision-making model
timeFrame: 4-6 weeks
measure: Preliminary effectiveness - Knowledge
timeFrame: 4-6 weeks
measure: Preliminary effectiveness - Satisfaction with decision
timeFrame: 4-6 weeks
measure: Preliminary effectiveness - Perception of shared decision-making process
timeFrame: 4-6 weeks
measure: Preliminary effectiveness - Decisional conflict
timeFrame: 4-6 weeks
measure: Preliminary effectiveness - Perception of participation in the decision-making process
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Decision made
timeFrame: 4-6 weeks
measure: Duration of each medical visit
timeFrame: 4-6 weeks
measure: Number of visits necessary until the final decision is made
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Karla Salas Gama, MD
role: PRINCIPAL_INVESTIGATOR
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