An interventional study of Shared decision-making model in Clinical Decision Making, Patient-Centered Care and Obesity, sponsored by Hospital Vall d'Hebron. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by Hospital Vall d'Hebron · Not applicable, Interventional, and Other
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Hospital Vall d'Hebron is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Obesity:
Exclusion Criteria Obesity:
Inclusion Criteria ACKD:
Exclusion Criteria ACKD:
In the intervention group, the shared decision-making model will be carried out. This model was proposed and designed through a participatory and deliberative process.
Behavioral: Shared decision-making model
Information without an estructured 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
Feasibility of the decision-making model
The number of patients in the intervention group agreed to participate in a shared decision-making process and complete the entire process until answering the questionnaires. A value of ≥80% of the intervention group will be considered viable
Time frame: 4-6 weeks
Preliminary effectiveness - Knowledge
Measured through multiple-choice questions proposed by the study researchers. We will measure the number of correct answers in both groups
Time frame: 4-6 weeks
Preliminary effectiveness - Satisfaction with decision
Measured with the self-reported Satisfaction With Decision scale (SWDs) (6 items with 5-item Likert scales)
Time frame: 4-6 weeks
Preliminary effectiveness - Perception of shared decision-making process
Measures patients' perceptions of how clinicians' performance fits the shared decision-making process. We will use the self-reported 9-item Shared Decision-Making Questionnaire (9 items with 6-item Likert scale)
Time frame: 4-6 weeks
Preliminary effectiveness - Decisional conflict
Measured with the self-reported Decisional Conflict Scale (16 items with 5-item Likert scale)
Time frame: 4-6 weeks
Preliminary effectiveness - Perception of participation in the decision-making process
Measured with the CollaboRATE scale (3 item self-report questions, range from 0 to 7
Time frame: 4-6 weeks
Decision made
Number of participants that choose one option: * Obesity group: surgical intervention vs medical treatment * ACKD group: hemodialysis vs peritoneal dialysis vs conservative care
Time frame: 4-6 weeks
Duration of each medical visit
We will measure, in minutes, the total time of clinical encounters for both groups
Time frame: 4-6 weeks
Number of visits necessary until the final decision is made
number of visits
Time frame: 4-6 weeks
Plan to share: No
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Hospital Vall d'Hebron