Clinical Decision MakingNCT05424809
Feasibility and Preliminary Effectiveness of a Shared Decision-making Process
A study testing Shared decision-making model in people with Clinical Decision Making and Patient-Centered Care, run by Hospital Vall d'Hebron at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Decision Making, Patient-Centered Care, Obesity
- What is being tested?
- Shared decision-making model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2022to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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)
- Having previously performed any modality of renal replacement therapy.
- Patient with cognitive impairment that does not allow for a shared decision-making process.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08023
Karla Salas-Gama, MD, +34667117798, karla.salas@vallhebron.cat
About this study
Official title: Feasibility and Preliminary Effectiveness of a Shared Decision-making Process in a Tertiary University Hospital: Protocol of a Pilot Randomized Clinical Trial
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.
Read more
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.
Read the 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.
- Being tested
- Shared decision-making model
- Medical subject headings
- Obesity, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision-making modelBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Shared decision-making model |
| Usual care | No intervention | Information without an estructured shared decision-making model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 4-6 weeks
Preliminary effectiveness - Decisional conflict
Measured with the self-reported Decisional Conflict Scale (16 items with 5-item Likert scale)
Measured: 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
Measured: 4-6 weeks
Secondary outcomes (3)
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
Measured: 4-6 weeks
Duration of each medical visit
We will measure, in minutes, the total time of clinical encounters for both groups
Measured: 4-6 weeks
Number of visits necessary until the final decision is made
number of visits
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start20 May 2022
- Primary completion23 Nov 2022 (estimated)
- Study completion23 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Clinical Decision MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla Salas Gama, Hospital Vall d'Hebron
- Investigators
- Karla Salas Gama, MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424809
- Sponsor's protocol ID
- PR(AG)148/2022
- Status last verified
- Aug 2022
- First submitted
- 15 Jun 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27121606Stacey 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.
PubMed 28402085Elwyn 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.
PubMed 22618581Legare 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.
PubMed 30025154Sondergaard 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.
PubMed 31129012Steffensen 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.
PubMed 29641952Danner 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.
PubMed 33039998Chabrera 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.
PubMed 25921323De 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.
PubMed 24593044Urrutia 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.
PubMed 19301775Bravo 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.
PubMed 28760344
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of a Shared Decision-making Process in a Tertiary University Hospital: Protocol of a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05424809
- Acronym / sponsor ID
- PR(AG)148/2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 23 Nov 2022 (estimated)
- Study completion
- 23 Dec 2022 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared decision-making model | Experimental | Behavioral: Shared decision-making modelIn the intervention group, the shared decision-making model will be carried out. This model was proposed and designed through a participatory and deliberative process. |
| Usual care | No intervention | –Information without an estructured shared decision-making model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision-making modelThe 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 | Behavioural | Shared decision-making model |
Primary outcome
Feasibility of the decision-making model
Time frame: 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
Time frame: 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 - Satisfaction with decision
Time frame: 4-6 weeks
Measured with the self-reported Satisfaction With Decision scale (SWDs) (6 items with 5-item Likert scales)
Preliminary effectiveness - Perception of shared decision-making process
Time frame: 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)
Preliminary effectiveness - Decisional conflict
Time frame: 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
Time frame: 4-6 weeks
Measured with the CollaboRATE scale (3 item self-report questions, range from 0 to 7
3 secondary outcomes
Decision made
Time frame: 4-6 weeks
Duration of each medical visit
Time frame: 4-6 weeks
Number of visits necessary until the final decision is made
Time frame: 4-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 27121606Fearns 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.
- Background: PubMed 28402085Stacey 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.
- Background: PubMed 22618581Elwyn 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.
- Background: PubMed 30025154Legare 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.
- Background: PubMed 31129012Sondergaard 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.
- Background: PubMed 29641952Steffensen 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.
- Background: PubMed 33039998Danner 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.
- Background: PubMed 25921323Chabrera 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.
- Background: PubMed 24593044De 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.
- Background: PubMed 19301775Urrutia 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.
- Background: PubMed 28760344Bravo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla Salas Gama, MD principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision-making model in people with Clinical Decision Making and Patient-Centered Care, run by Hospital Vall d'Hebron at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karla Salas-Gama, MD (+34667117798, karla.salas@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the decision-making model (time frame: 4-6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05424809, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.