Shared Decision MakingNCT03266796
Shared Decision Making in Physical Therapy: a Cross-sectional Observational Study
An observational study of Shared Decision Making, run by Klinik Valens at 1 site in Switzerland.
Trial summary
Shared decision making (SDM) is increasingly recommended in health care and reduces the unbalanced power between physical therapists and patients. There is an increased focus on communication between physical therapists and their patients during the goal setting process in current research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shared Decision Making
- What is being tested?
- goal setting process
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to 5 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thirty patients will be recruited. The planned sample may seem heterogenic because patients with all musculoskeletal conditions are included. However, the goal setting process is expected to be independent of diagnosis and the sample is therefore considered sufficiently homogeneous.
Who may be able to join
- musculoskeletal disorders First treatment German speaking
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Shared decision making (SDM) is increasingly recommended in health care and reduces the unbalanced power between physical therapists and patients. There is an increased focus on communication between physical therapists and their patients during the goal setting process in current research. This study will focus on SDM in physical therapy goal setting.
The SDM Process includes a problem definition and different goal options. Good communication between physical therapists and patients during the goal setting process with an explicit agreeing on both sides regarding treatment goals and options improves patient satisfaction, treatment adherence and health outcomes.
Patients generally prefer to be actively involved in the shared decision making process. However, the preferred level of involvement of patients regarding decisions differs. Therefore, physical therapist should consider about patients' preferred level of involvement in shared decision making. Previous research observed SDM behaviours of physical therapists only in private practice settings. Research in other settings like the rehabilitation setting are recommended. It is unknown whether there are differences between settings in the SDM behaviours of physical therapists during first consultation.
Read the detailed description
Background
Shared decision making (SDM) is increasingly recommended in health care and reduces the unbalanced power between physical therapists and patients. There is an increased focus on communication between physical therapists and their patients during the goal setting process in current research. This study will focus on SDM in physical therapy goal setting.
The SDM Process includes a problem definition and different goal options. Therefore, SDM may be especially important during the goal setting process in the first consultation, where a problem definition and several goal options are of interest.
An increased involvement of patients in SDM is based on clear information, empathy, two-way communication and respect for patients' beliefs and concerns. Therefore, patients are more willing to reveal information. Good communication between physical therapists and patients during the goal setting process with an explicit agreeing on both sides regarding treatment goals and options improves patient satisfaction, treatment adherence and health outcomes.
During the shared goal setting several topics should be discussed including patient's expectations and concerns, different possible goals and their pros and cons. The quality of this communication during the goal setting process can be evaluated by the OPTION Scale.
Patients generally prefer to be actively involved in the shared decision making process.
Previous research observed SDM behaviours of physical therapists, the patient's preferred level of involvement and the agreement between the patient's preferred level of involvement and the physical therapists' perception of the patient's preference during different therapy consultations in private practice settings.
Communication between physical therapists and patients may be affected by patient's self-efficacy and educational background and physical therapist's education and working experiences. These factors will therefore be evaluated in the planned study. In addition, therapists should consider patients individual preferences regarding their preferred level of involvement in the goal setting process. The control preference scale measures patients' preferred level of involvement and physical therapists' perception of this level.
It is unknown whether there are differences between settings in the SDM behaviours of physical therapists. SDM may be different in rehabilitation and private practice settings. As in private practice one physical therapist is treating the patient, there are several physical therapists treating the patient in rehabilitation setting.
- Conditions
- Shared Decision Making
- Being tested
- goal setting process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
goal setting processBehavioural
goal setting process during the first consultation
| Study group | Role | What they receive |
|---|---|---|
| Patients & Physical therapists | First consultations of peoples with musculoskeletal disorders and their physical therapists will be audiotaped. Audiotapes will be used to analyse the communication between the patients and their physicaltherapists to explore how much physical therapists involve their patients in the goal setting process, to see if there is a shared decision making existing. Receives: Behavioral: goal setting process |
What is being measured
The primary outcome is the main question the study is designed to answer.
OPTION scale
The OPTION scale measures physical therapists behaviour in shared decision making. It is a measurement that evaluates the involvement of patients in shared decision making and was shown to be reliable (Elwyn et al., 2003). The OPTION scale includes items looking at communication between physical therapist and patient, especially an identified problem, patient's beliefs and concerns, different goal and treatment option and their pros and cons, patient's preferred level of involvement, possibilities for patient's to ask questions and a review of the physical therapist at the end.
Measured: day 1 (e.g. "through study completion, an average of 1 year")
Secondary outcomes (1)
Control Preference Scale (CPS)
The Control Preference Scale (CPS) measures physical therapists perception about their patient's preferences and patient's preference in SDM. The CPS is valid and reliable in healthcare decision making, easy to conduct and clinically relevant (Degner et al., 1997).
Measured: day 1 (e.g. "through study completion, an average of 1 year")
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Sep 2017
- Primary completion31 Jan 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Shared 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Hausheer, cand. MScPT, Klinik Valens
- Investigators
- Andrea C. Hausheer, cand. MScPT, Principal investigator, Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266796
- Sponsor's protocol ID
- Projekt ID: 2017-00848
- Status last verified
- Mar 2018
- First submitted
- 5 Aug 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beers E, Lee Nilsen M, Johnson JT. The Role of Patients: Shared Decision-Making. Otolaryngol Clin North Am. 2017 Aug;50(4):689-708. doi: 10.1016/j.otc.2017.03.006. Epub 2017 May 30.
PubMed 28571664Durand MA, Yen R, Barr PJ, Cochran N, Aarts J, Legare F, Reed M, James O'Malley A, Scalia P, Painchaud Guerard G, Elwyn G. Assessing medical student knowledge and attitudes about shared decision making across the curriculum: protocol for an international online survey and stakeholder analysis. BMJ Open. 2017 Jun 23;7(6):e015945. doi: 10.1136/bmjopen-2017-015945.
PubMed 28645974Dierckx K, Deveugele M, Roosen P, Devisch I. Implementation of shared decision making in physical therapy: observed level of involvement and patient preference. Phys Ther. 2013 Oct;93(10):1321-30. doi: 10.2522/ptj.20120286. Epub 2013 May 2.
PubMed 23641024Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R. Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care. 2003 Apr;12(2):93-9. doi: 10.1136/qhc.12.2.93.
PubMed 12679504Loh A, Simon D, Wills CE, Kriston L, Niebling W, Harter M. The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial. Patient Educ Couns. 2007 Aug;67(3):324-32. doi: 10.1016/j.pec.2007.03.023. Epub 2007 May 16.
PubMed 17509808Bertakis KD. The communication of information from physician to patient: a method for increasing patient retention and satisfaction. J Fam Pract. 1977 Aug;5(2):217-22.
PubMed 894226Brady TJ. The patient's role in rheumatology care. Curr Opin Rheumatol. 1998 Mar;10(2):146-51. doi: 10.1097/00002281-199803000-00011.
PubMed 9567211Roter DL, Hall JA, Merisca R, Nordstrom B, Cretin D, Svarstad B. Effectiveness of interventions to improve patient compliance: a meta-analysis. Med Care. 1998 Aug;36(8):1138-61. doi: 10.1097/00005650-199808000-00004.
PubMed 9708588Kaplan SH, Greenfield S, Ware JE Jr. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Med Care. 1989 Mar;27(3 Suppl):S110-27. doi: 10.1097/00005650-198903001-00010.
PubMed 2646486Duncan E, Best C, Hagen S. Shared decision making interventions for people with mental health conditions. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD007297. doi: 10.1002/14651858.CD007297.pub2.
PubMed 20091628Chewning 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 21474265Burton D, Blundell N, Jones M, Fraser A, Elwyn G. Shared decision-making in cardiology: do patients want it and do doctors provide it? Patient Educ Couns. 2010 Aug;80(2):173-9. doi: 10.1016/j.pec.2009.10.013. Epub 2009 Nov 30.
PubMed 19945818Weiss MC, Peters TJ. Measuring shared decision making in the consultation: a comparison of the OPTION and Informed Decision Making instruments. Patient Educ Couns. 2008 Jan;70(1):79-86. doi: 10.1016/j.pec.2007.09.001. Epub 2007 Oct 17.
PubMed 17942270Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
PubMed 9505581Doyle C, Lennox L, Bell D. A systematic review of evidence on the links between patient experience and clinical safety and effectiveness. BMJ Open. 2013 Jan 3;3(1):e001570. doi: 10.1136/bmjopen-2012-001570.
PubMed 23293244
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Physical Therapy: a Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT03266796
- Acronym / sponsor ID
- Projekt ID: 2017-00848
- Conditions
- Shared Decision Making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 30 Aug 2017 (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.
Shared decision making (SDM) is increasingly recommended in health care and reduces the unbalanced power between physical therapists and patients. There is an increased focus on communication between physical therapists and their patients during the goal setting process in current research. This study will focus on SDM in physical therapy goal setting.
The SDM Process includes a problem definition and different goal options. Good communication between physical therapists and patients during the goal setting process with an explicit agreeing on both sides regarding treatment goals and options improves patient satisfaction, treatment adherence and health outcomes.
Patients generally prefer to be actively involved in the shared decision making process. However, the preferred level of involvement of patients regarding decisions differs. Therefore, physical therapist should consider about patients' preferred level of involvement in shared decision making. Previous research observed SDM behaviours of physical therapists only in private practice settings. Research in other settings like the rehabilitation setting are recommended. It is unknown whether there are differences between settings in the SDM behaviours of physical therapists during first consultation.
Detailed description
Background
Shared decision making (SDM) is increasingly recommended in health care and reduces the unbalanced power between physical therapists and patients. There is an increased focus on communication between physical therapists and their patients during the goal setting process in current research. This study will focus on SDM in physical therapy goal setting.
The SDM Process includes a problem definition and different goal options. Therefore, SDM may be especially important during the goal setting process in the first consultation, where a problem definition and several goal options are of interest.
An increased involvement of patients in SDM is based on clear information, empathy, two-way communication and respect for patients' beliefs and concerns. Therefore, patients are more willing to reveal information. Good communication between physical therapists and patients during the goal setting process with an explicit agreeing on both sides regarding treatment goals and options improves patient satisfaction, treatment adherence and health outcomes.
During the shared goal setting several topics should be discussed including patient's expectations and concerns, different possible goals and their pros and cons. The quality of this communication during the goal setting process can be evaluated by the OPTION Scale.
Patients generally prefer to be actively involved in the shared decision making process.
Previous research observed SDM behaviours of physical therapists, the patient's preferred level of involvement and the agreement between the patient's preferred level of involvement and the physical therapists' perception of the patient's preference during different therapy consultations in private practice settings.
Communication between physical therapists and patients may be affected by patient's self-efficacy and educational background and physical therapist's education and working experiences. These factors will therefore be evaluated in the planned study. In addition, therapists should consider patients individual preferences regarding their preferred level of involvement in the goal setting process. The control preference scale measures patients' preferred level of involvement and physical therapists' perception of this level.
It is unknown whether there are differences between settings in the SDM behaviours of physical therapists. SDM may be different in rehabilitation and private practice settings. As in private practice one physical therapist is treating the patient, there are several physical therapists treating the patient in rehabilitation setting.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients & Physical therapists | – | Behavioral: goal setting processFirst consultations of peoples with musculoskeletal disorders and their physical therapists will be audiotaped. Audiotapes will be used to analyse the communication between the patients and their physicaltherapists to explore how much physical therapists involve their patients in the goal setting process, to see if there is a shared decision making existing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients will be recruited. The planned sample may seem heterogenic because patients with all musculoskeletal conditions are included. However, the goal setting process is expected to be independent of diagnosis and the sample is therefore considered sufficiently homogeneous.
Key inclusion criteria (1 listed)
- musculoskeletal disorders First treatment German speaking
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| goal setting processgoal setting process during the first consultation | Behavioural | Patients & Physical therapists |
Primary outcome
OPTION scale
Time frame: day 1 (e.g. "through study completion, an average of 1 year")
The OPTION scale measures physical therapists behaviour in shared decision making. It is a measurement that evaluates the involvement of patients in shared decision making and was shown to be reliable (Elwyn et al., 2003). The OPTION scale includes items looking at communication between physical therapist and patient, especially an identified problem, patient's beliefs and concerns, different goal and treatment option and their pros and cons, patient's preferred level of involvement, possibilities for patient's to ask questions and a review of the physical therapist at the end.
1 secondary outcome
Control Preference Scale (CPS)
Time frame: day 1 (e.g. "through study completion, an average of 1 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 6 Mar 2018.
- Results publication: PubMed 28571664Beers E, Lee Nilsen M, Johnson JT. The Role of Patients: Shared Decision-Making. Otolaryngol Clin North Am. 2017 Aug;50(4):689-708. doi: 10.1016/j.otc.2017.03.006. Epub 2017 May 30.
- Results publication: PubMed 28645974Durand MA, Yen R, Barr PJ, Cochran N, Aarts J, Legare F, Reed M, James O'Malley A, Scalia P, Painchaud Guerard G, Elwyn G. Assessing medical student knowledge and attitudes about shared decision making across the curriculum: protocol for an international online survey and stakeholder analysis. BMJ Open. 2017 Jun 23;7(6):e015945. doi: 10.1136/bmjopen-2017-015945.
- Results publication: PubMed 23641024Dierckx K, Deveugele M, Roosen P, Devisch I. Implementation of shared decision making in physical therapy: observed level of involvement and patient preference. Phys Ther. 2013 Oct;93(10):1321-30. doi: 10.2522/ptj.20120286. Epub 2013 May 2.
- Results publication: PubMed 12679504Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R. Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care. 2003 Apr;12(2):93-9. doi: 10.1136/qhc.12.2.93.
- Results publication: PubMed 17509808Loh A, Simon D, Wills CE, Kriston L, Niebling W, Harter M. The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial. Patient Educ Couns. 2007 Aug;67(3):324-32. doi: 10.1016/j.pec.2007.03.023. Epub 2007 May 16.
- Results publication: PubMed 894226Bertakis KD. The communication of information from physician to patient: a method for increasing patient retention and satisfaction. J Fam Pract. 1977 Aug;5(2):217-22.
- Results publication: PubMed 9567211Brady TJ. The patient's role in rheumatology care. Curr Opin Rheumatol. 1998 Mar;10(2):146-51. doi: 10.1097/00002281-199803000-00011.
- Results publication: PubMed 9708588Roter DL, Hall JA, Merisca R, Nordstrom B, Cretin D, Svarstad B. Effectiveness of interventions to improve patient compliance: a meta-analysis. Med Care. 1998 Aug;36(8):1138-61. doi: 10.1097/00005650-199808000-00004.
- Results publication: PubMed 2646486Kaplan SH, Greenfield S, Ware JE Jr. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Med Care. 1989 Mar;27(3 Suppl):S110-27. doi: 10.1097/00005650-198903001-00010.
- Results publication: PubMed 20091628Duncan E, Best C, Hagen S. Shared decision making interventions for people with mental health conditions. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD007297. doi: 10.1002/14651858.CD007297.pub2.
- Results publication: 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.
- Results publication: PubMed 19945818Burton D, Blundell N, Jones M, Fraser A, Elwyn G. Shared decision-making in cardiology: do patients want it and do doctors provide it? Patient Educ Couns. 2010 Aug;80(2):173-9. doi: 10.1016/j.pec.2009.10.013. Epub 2009 Nov 30.
- Individual participant dataSharing planned: Undecided
Related trials for Shared Decision Making
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Recruiting
BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma
Asthma
Active, not recruiting
Engaging Adolescents in Decisions About Return of Genomic Research Results
Genetic Screening, Adolescent
RecruitingObservational study
A Prospective Registry of Patients With Endoscopically Resected Malignant Colorectal Polyps (pT1 Colorectal Cancer)
Malignant Colorectal Polyp, Colorectal Cancer
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.
Andrea C. Hausheer, cand. MScPT principal investigator
Klinik Valens
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 Shared Decision Making, run by Klinik Valens at 1 site in Switzerland.
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 1 inclusion and 1 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 6 Mar 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 Switzerland. 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?
OPTION scale (time frame: day 1 (e.g. "through study completion, an average of 1 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 NCT03266796, which also lists 17 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 6 Mar 2018.