Feasibility and Preliminary Effectiveness of a Shared Decision-making Process

NCT05424809 | Unknown

• 1 other identifier: PR(AG)148/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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)

  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)

  4-6 weeks

• Preliminary effectiveness - Decisional conflict

  Measured with the self-reported Decisional Conflict Scale (16 items with 5-item Likert scale)

  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

  4-6 weeks

Secondary Outcomes (3)

• Decision made

  4-6 weeks

• Duration of each medical visit

  4-6 weeks

• Number of visits necessary until the final decision is made

  4-6 weeks

Study Arms (2)

Shared decision-making model

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Information without an estructured shared decision-making model

Interventions

Shared decision-making model BEHAVIORAL

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

Shared decision-making model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Vall d'Hebron: lead

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08023, Spain

RECRUITING

Related Publications (11)

• Fearns N, Kelly J, Callaghan M, Graham K, Loudon K, Harbour R, Santesso N, McFarlane E, Thornton J, Treweek S. What do patients and the public know about clinical practice guidelines and what do they want from them? A qualitative study. BMC Health Serv Res. 2016 Feb 24;16:74. doi: 10.1186/s12913-016-1319-4.

  PMID: 27121606 BACKGROUND

• Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.

  PMID: 28402085 BACKGROUND

• Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.

  PMID: 22618581 BACKGROUND

• Legare F, Adekpedjou R, Stacey D, Turcotte S, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for increasing the use of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2018 Jul 19;7(7):CD006732. doi: 10.1002/14651858.CD006732.pub4.

  PMID: 30025154 BACKGROUND

• Sondergaard SR, Madsen PH, Hilberg O, Jensen KM, Olling K, Steffensen KD. A prospective cohort study of shared decision making in lung cancer diagnostics: Impact of using a patient decision aid. Patient Educ Couns. 2019 Nov;102(11):1961-1968. doi: 10.1016/j.pec.2019.05.018. Epub 2019 May 16.

  PMID: 31129012 BACKGROUND

• Steffensen KD, Vinter M, Cruger D, Dankl K, Coulter A, Stuart B, Berry LL. Lessons in Integrating Shared Decision-Making Into Cancer Care. J Oncol Pract. 2018 Apr;14(4):229-235. doi: 10.1200/JOP.18.00019.

  PMID: 29641952 BACKGROUND

• Danner M, Geiger F, Wehkamp K, Rueffer JU, Kuch C, Sundmacher L, Skjelbakken T, Rummer A, Novelli A, Debrouwere M, Scheibler F; SHARE TO CARE (S2C) Project Team. Making shared decision-making (SDM) a reality: protocol of a large-scale long-term SDM implementation programme at a Northern German University Hospital. BMJ Open. 2020 Oct 10;10(10):e037575. doi: 10.1136/bmjopen-2020-037575.

  PMID: 33039998 BACKGROUND

• Chabrera C, Areal J, Font A, Caro M, Bonet M, Zabalegui A. [Spanish version of the Satisfaction With Decision scale: cross-cultural adaptation, validity and reliability]. Enferm Clin. 2015 May-Jun;25(3):117-23. doi: 10.1016/j.enfcli.2015.02.005. Epub 2015 Apr 25. Spanish.

  PMID: 25921323 BACKGROUND

• De las Cuevas C, Perestelo-Perez L, Rivero-Santana A, Cebolla-Marti A, Scholl I, Harter M. Validation of the Spanish version of the 9-item Shared Decision-Making Questionnaire. Health Expect. 2015 Dec;18(6):2143-53. doi: 10.1111/hex.12183. Epub 2014 Mar 5.

  PMID: 24593044 BACKGROUND

• Urrutia M, Campos S, O'Connor A. [Validation of a Spanish version of the Decisional Conflict scale]. Rev Med Chil. 2008 Nov;136(11):1439-47. doi: 10.4067/s0034-98872008001100010. Spanish.

  PMID: 19301775 BACKGROUND

• Bravo P, Contreras A, Dois A, Villarroel L. [Adapting and validating the generic instrument CollaboRATE to measure women's participation in health related decision-making during the reproductive process]. Aten Primaria. 2018 May;50(5):274-281. doi: 10.1016/j.aprim.2017.04.003. Epub 2017 Jul 29. Spanish.

  PMID: 28760344 BACKGROUND

MeSH Terms

Conditions

Obesity; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Karla Salas Gama, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karla Salas-Gama, MD

CONTACT

+34667117798; karla.salas@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Karla Salas-Gama - Quality Department, Hospital Vall d'Hebron

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: May 20, 2022
• Primary Completion: November 23, 2022
• Study Completion: December 23, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)