Surgical Procedure, UnspecifiedNCT03537352
Shared Decision Making in a General Hospital
An observational study of Surgical Procedure, Unspecified and General Medical Condition, run by Psychiatric Hospital of Attica at 1 site in Greece.
Trial summary
A pilot cross-sectional study will investigate the differential effect of the type of disorder (surgical versus non-surgical) on the scores of the 9-item shared decision making questionnaire. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Procedure, Unspecified, General Medical Condition
- What is being tested?
- Any appropriate surgical treatment and Any appropriate drug or non-drug treatment excluding surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 14 May 2018to 21 Nov 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in 4 acute wards (2 for surgical and 2 for non-surgical disorders) or the relevant outpatient departments
Who may be able to join
- Hospitalization in the Thriassion General Hospital of Elefsina
- Ability to give informed consent
Who cannot join
- Inability to complete the neuropsychological assessment
- Mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shared Decision Making in Patients With Surgical or Non-Surgical Diseases in a General Hospital: A Pilot Study
A pilot cross-sectional study will investigate the differential effect of the type of disorder (surgical versus non-surgical) on the scores of the 9-item shared decision making questionnaire.
Read the detailed description
During a pilot cross-sectional study, the 9- Item Shared Decision Making Questionnaire (9SDMQ) will be administered in two groups of participants, one (N=60) suffering from surgical diseases and one (N=60) from non-surgical medical diseases. Patients hospitalized in four acute wards (2 surgical and 2 non-surgical wards) or visiting the relevant outpatient departments of the Triassion General Hospital of Elefsina, Greece will be recruited. The primary outcome will be the difference on the 9SDMQ scores (transformed in a 1-100% scale) in patients suffering from surgical versus non-surgical disorders. Secondary outcome measures will include the effect of patients' demographic and clinical variables, of physicians' demographic variables and of the score on the Montreal Cognitive Assessment on the 9SDMQ scores. Additionally the relationship of patients' satisfaction on the 9SDMQ scores will also be investigated.
- Being tested
- Any appropriate surgical treatment, Any appropriate drug or non-drug treatment excluding surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any appropriate surgical treatmentProcedure or surgery
Any appropriate surgical treatment for the management of patient's current disorder
Any appropriate drug or non-drug treatment excluding surgeryDrug
Any appropriate drug or non-drug treatment excluding surgery for the management of patient's current disorder
| Study group | Role | What they receive |
|---|---|---|
| Surgical Disorders | A. Surgical Disorders:
1. Current Hospitalization at the Surgical Inpatient Department or at the Inpatient Department of Otorhinolaryngology or at the Inpatient Department of Cardiology OR
2. Current Follow-up at the Surgical Outpatient Department or at the Outpatient Department of Otorhinolaryngology or at the Outpatient Department of Cardiology due to a disorder for which any appropriate surgical treatment (surgery) is a treatment option. Receives: Procedure: Any appropriate surgical treatment | |
| Non-Surgical General Medical Disorders | 1. Current Hospitalization at the Internal Medicine Inpatient Department or at the Inpatient Department of Cardiology OR
2. Current Follow-up at the Internal Medicine Outpatient Department or at the Outpatient Department of Cardiology due to a disorder for which surgery is not a treatment option and any appropriate drug or non-drug treatment excluding surgery is a treatment option. Receives: Drug: Any appropriate drug or non-drug treatment excluding surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders
Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders
Measured: one year
Secondary outcomes (4)
Effect of patients' age, education, gender, maternal education, nationality on 9-item SDM Questionnaire scores
Effect of patients' age, education, gender, maternal education, nationality on 9-item SDM Questionnaire scores
Measured: one year
Effect of treating physicians' age, specialty, years of experience on 9-item SDM Questionnaire scores
Effect of treating physicians' age, specialty, years of experience on 9-item SDM Questionnaire scores
Measured: one year
Effect of patients' Montreal Cognitive Assessment scores on 9-item SDM Questionnaire scores
Effect of patients' Montreal Cognitive Assessment scores on 9-item SDM Questionnaire scores
Measured: one year
Correlation of the 9-item SDM Questionnaire scores with the Client Satisfaction Questionnaire scores
Correlation of the 9-item SDM Questionnaire scores with the Client Satisfaction Questionnaire scores
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start14 May 2018
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Hospital of Attica
- Sponsor type
- University, hospital or other
- Collaborators
- Thriasio General Hospital of Elefsina
- Responsible party
- Principal investigator, Dimitrios Kontis, Psychiatric Hospital of Attica
- Investigators
- Dimitrios Kontis, MD, PHD, Study director, Psychiatric Hospital of Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537352
- Sponsor's protocol ID
- PsychiatricHA
- Status last verified
- Nov 2018
- First submitted
- 15 May 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taking shared decision making more seriously. Lancet. 2011 Mar 5;377(9768):784. doi: 10.1016/S0140-6736(11)60290-0. No abstract available.
PubMed 21377556Chewning B, Bylund CL, Shah B, Arora NK, Gueguen JA, Makoul G. Patient preferences for shared decisions: a systematic review. Patient Educ Couns. 2012 Jan;86(1):9-18. doi: 10.1016/j.pec.2011.02.004. Epub 2011 Apr 6.
PubMed 21474265De Las Cuevas C, Penate W, Perestelo-Perez L, Serrano-Aguilar P. Shared decision making in psychiatric practice and the primary care setting is unique, as measured using a 9-item Shared Decision Making Questionnaire (SDM-Q-9). Neuropsychiatr Dis Treat. 2013;9:1045-52. doi: 10.2147/NDT.S49021. Epub 2013 Jul 30.
PubMed 23950646Flynn KE, Smith MA, Vanness D. A typology of preferences for participation in healthcare decision making. Soc Sci Med. 2006 Sep;63(5):1158-69. doi: 10.1016/j.socscimed.2006.03.030. Epub 2006 May 11.
PubMed 16697096Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
PubMed 19879711Mah HC, Muthupalaniappen L, Chong WW. Perceived involvement and preferences in shared decision-making among patients with hypertension. Fam Pract. 2016 Jun;33(3):296-301. doi: 10.1093/fampra/cmw012. Epub 2016 Mar 18.
PubMed 26993483Pollard S, Bansback N, Bryan S. Physician attitudes toward shared decision making: A systematic review. Patient Educ Couns. 2015 Sep;98(9):1046-57. doi: 10.1016/j.pec.2015.05.004. Epub 2015 May 23.
PubMed 26138158Schneider A, Korner T, Mehring M, Wensing M, Elwyn G, Szecsenyi J. Impact of age, health locus of control and psychological co-morbidity on patients' preferences for shared decision making in general practice. Patient Educ Couns. 2006 May;61(2):292-8. doi: 10.1016/j.pec.2005.04.008.
PubMed 15896943Smith GL, Volk RJ. Nonclinical Factors Affecting Shared Decision Making. JAMA. 2017 Jul 25;318(4):391. doi: 10.1001/jama.2017.7841. No abstract available.
PubMed 28742899Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
PubMed 24470076
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Patients With Surgical or Non-Surgical Diseases in a General Hospital: A Pilot Study
- ClinicalTrials.gov ID
- NCT03537352
- Acronym / sponsor ID
- PsychiatricHA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Psychiatric Hospital of AtticaUniversity, hospital or other
- Collaborators
- Thriasio General Hospital of Elefsina
- Study start
- 14 May 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 25 May 2018 (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.
A pilot cross-sectional study will investigate the differential effect of the type of disorder (surgical versus non-surgical) on the scores of the 9-item shared decision making questionnaire.
Detailed description
During a pilot cross-sectional study, the 9- Item Shared Decision Making Questionnaire (9SDMQ) will be administered in two groups of participants, one (N=60) suffering from surgical diseases and one (N=60) from non-surgical medical diseases. Patients hospitalized in four acute wards (2 surgical and 2 non-surgical wards) or visiting the relevant outpatient departments of the Triassion General Hospital of Elefsina, Greece will be recruited. The primary outcome will be the difference on the 9SDMQ scores (transformed in a 1-100% scale) in patients suffering from surgical versus non-surgical disorders. Secondary outcome measures will include the effect of patients' demographic and clinical variables, of physicians' demographic variables and of the score on the Montreal Cognitive Assessment on the 9SDMQ scores. Additionally the relationship of patients' satisfaction on the 9SDMQ scores will also be investigated.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Disorders | – | Procedure: Any appropriate surgical treatmentA. Surgical Disorders: 1. Current Hospitalization at the Surgical Inpatient Department or at the Inpatient Department of Otorhinolaryngology or at the Inpatient Department of Cardiology OR 2. Current Follow-up at the Surgical Outpatient Department or at the Outpatient Department of Otorhinolaryngology or at the Outpatient Department of Cardiology due to a disorder for which any appropriate surgical treatment (surgery) is a treatment option. |
| Non-Surgical General Medical Disorders | – | Drug: Any appropriate drug or non-drug treatment excluding surgery1. Current Hospitalization at the Internal Medicine Inpatient Department or at the Inpatient Department of Cardiology OR 2. Current Follow-up at the Internal Medicine Outpatient Department or at the Outpatient Department of Cardiology due to a disorder for which surgery is not a treatment option and any appropriate drug or non-drug treatment excluding surgery is a treatment option. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in 4 acute wards (2 for surgical and 2 for non-surgical disorders) or the relevant outpatient departments
Key inclusion criteria (2 listed)
- Hospitalization in the Thriassion General Hospital of Elefsina
- Ability to give informed consent
Key exclusion criteria (2 listed)
- Inability to complete the neuropsychological assessment
- Mental retardation
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 |
|---|---|---|
| Any appropriate surgical treatmentAny appropriate surgical treatment for the management of patient's current disorder | Procedure or surgery | Surgical Disorders |
| Any appropriate drug or non-drug treatment excluding surgeryAny appropriate drug or non-drug treatment excluding surgery for the management of patient's current disorder | Drug | Non-Surgical General Medical Disorders |
Primary outcome
Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders
Time frame: one year
Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders
4 secondary outcomes
Effect of patients' age, education, gender, maternal education, nationality on 9-item SDM Questionnaire scores
Time frame: one year
Effect of treating physicians' age, specialty, years of experience on 9-item SDM Questionnaire scores
Time frame: one year
Effect of patients' Montreal Cognitive Assessment scores on 9-item SDM Questionnaire scores
Time frame: one year
Correlation of the 9-item SDM Questionnaire scores with the Client Satisfaction Questionnaire scores
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Background: PubMed 21377556Taking shared decision making more seriously. Lancet. 2011 Mar 5;377(9768):784. doi: 10.1016/S0140-6736(11)60290-0. No abstract available.
- Background: PubMed 21474265Chewning B, Bylund CL, Shah B, Arora NK, Gueguen JA, Makoul G. Patient preferences for shared decisions: a systematic review. Patient Educ Couns. 2012 Jan;86(1):9-18. doi: 10.1016/j.pec.2011.02.004. Epub 2011 Apr 6.
- Background: PubMed 23950646De Las Cuevas C, Penate W, Perestelo-Perez L, Serrano-Aguilar P. Shared decision making in psychiatric practice and the primary care setting is unique, as measured using a 9-item Shared Decision Making Questionnaire (SDM-Q-9). Neuropsychiatr Dis Treat. 2013;9:1045-52. doi: 10.2147/NDT.S49021. Epub 2013 Jul 30.
- Background: PubMed 16697096Flynn KE, Smith MA, Vanness D. A typology of preferences for participation in healthcare decision making. Soc Sci Med. 2006 Sep;63(5):1158-69. doi: 10.1016/j.socscimed.2006.03.030. Epub 2006 May 11.
- Background: PubMed 19879711Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
- Background: PubMed 26993483Mah HC, Muthupalaniappen L, Chong WW. Perceived involvement and preferences in shared decision-making among patients with hypertension. Fam Pract. 2016 Jun;33(3):296-301. doi: 10.1093/fampra/cmw012. Epub 2016 Mar 18.
- Background: PubMed 26138158Pollard S, Bansback N, Bryan S. Physician attitudes toward shared decision making: A systematic review. Patient Educ Couns. 2015 Sep;98(9):1046-57. doi: 10.1016/j.pec.2015.05.004. Epub 2015 May 23.
- Background: PubMed 15896943Schneider A, Korner T, Mehring M, Wensing M, Elwyn G, Szecsenyi J. Impact of age, health locus of control and psychological co-morbidity on patients' preferences for shared decision making in general practice. Patient Educ Couns. 2006 May;61(2):292-8. doi: 10.1016/j.pec.2005.04.008.
- Background: PubMed 28742899Smith GL, Volk RJ. Nonclinical Factors Affecting Shared Decision Making. JAMA. 2017 Jul 25;318(4):391. doi: 10.1001/jama.2017.7841. No abstract available.
- Background: PubMed 24470076Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
- 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.
Dimitrios Kontis, MD, PHD study director
Psychiatric Hospital of Attica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Unspecified and General Medical Condition, run by Psychiatric Hospital of Attica at 1 site in Greece.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 27 Nov 2018. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in scores of the 9-Item Shared Decision Making Questionnaire between surgical and non-surgical disorders (time frame: one year). 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 NCT03537352, which also lists 10 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 27 Nov 2018.