NCT03266796

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

August 5, 2017

Last Update Submit

March 5, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    day 1 (e.g. "through study completion, an average of 1 year")

Secondary Outcomes (1)

  • Control Preference Scale (CPS)

    day 1 (e.g. "through study completion, an average of 1 year")

Other Outcomes (2)

  • General Self-Efficacy Scale (GSE)

    day 1 (e.g. "through study completion, an average of 1 year")

  • Characteristics of patients and physical therapists

    day 1 (e.g. "through study completion, an average of 1 year")

Study Arms (1)

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.

Behavioral: goal setting process

Interventions

goal setting process during the first consultation

Patients & Physical therapists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • musculoskeletal disorders First treatment German speaking

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kliniken Valens

Valens, 7317, Switzerland

Location

Related Publications (17)

  • 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.

  • Durand 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.

  • Dierckx 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.

  • Elwyn 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.

  • Loh 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.

  • Bertakis 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.

  • Brady TJ. The patient's role in rheumatology care. Curr Opin Rheumatol. 1998 Mar;10(2):146-51. doi: 10.1097/00002281-199803000-00011.

  • Roter 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.

  • Kaplan 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.

  • Duncan 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.

  • Chewning 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.

  • Burton 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.

  • Weiss 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.

  • Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.

  • Doyle 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.

  • Elwyn G, Edwards A, Mowle S, Wensing M, Wilkinson C, Kinnersley P, Grol R. Measuring the involvement of patients in shared decision-making: a systematic review of instruments. Patient Educ Couns. 2001 Apr;43(1):5-22. doi: 10.1016/s0738-3991(00)00149-x.

  • Luszczynska A, Scholz U, Schwarzer R. The general self-efficacy scale: multicultural validation studies. J Psychol. 2005 Sep;139(5):439-57. doi: 10.3200/JRLP.139.5.439-457.

Study Officials

  • Andrea C. Hausheer, cand. MScPT

    Klinik Valens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc

Study Record Dates

First Submitted

August 5, 2017

First Posted

August 30, 2017

Study Start

September 1, 2017

Primary Completion

January 31, 2018

Study Completion

March 5, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations