Feasibility and Preliminary Effectiveness of a Shared Decision-making Process in a Tertiary University Hospital: Protocol of a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Preliminary effectiveness - Perception of shared decision-making process
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Preliminary effectiveness - Perception of shared decision-making process
时间窗: 4-6 weeks
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)
Feasibility of the decision-making model
时间窗: 4-6 weeks
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
Preliminary effectiveness - Knowledge
时间窗: 4-6 weeks
Measured through multiple-choice questions proposed by the study researchers. We will measure the number of correct answers in both groups
Preliminary effectiveness - Decisional conflict
时间窗: 4-6 weeks
Measured with the self-reported Decisional Conflict Scale (16 items with 5-item Likert scale)
Preliminary effectiveness - Perception of participation in the decision-making process
时间窗: 4-6 weeks
Measured with the CollaboRATE scale (3 item self-report questions, range from 0 to 7
Preliminary effectiveness - Satisfaction with decision
时间窗: 4-6 weeks
Measured with the self-reported Satisfaction With Decision scale (SWDs) (6 items with 5-item Likert scales)
次要结局
- Number of visits necessary until the final decision is made(4-6 weeks)
- Decision made(4-6 weeks)
- Duration of each medical visit(4-6 weeks)
研究者
Karla Salas Gama
Dr Karla Salas-Gama - Quality Department, Hospital Vall d'Hebron
Hospital Vall d'Hebron