A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations
NCT ID: NCT04452903
Last Updated: 2021-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
558 participants
INTERVENTIONAL
2020-07-01
2020-12-20
Brief Summary
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Detailed Description
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Intervention: A single session of training in consultation-based communication skills Detail: a 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.
Comparison: No training Detail: The control group receives no extra training. Outcome: New patients' perception of consultations Detail: The Primary Outcome Measure is the Consultation-Based Reassurance Questionnaire (CRQ) The CRQ measures patients' perceptions of consultation. It consists of four subscales, each with three items: data-gathering, relationship-building, generic reassurance, and cognitive reassurance. The investigators are assessing change between two-time points (before and after the intervention). And also, the difference between study groups. This is collected twice: at baseline, and at follow up, from the intervention and control groups.
Type of Question: therapy Detail: The study tests whether a single training sessions can improve communication in consultations with physiotherapists.
Type of Study: RCT
Detail: Stage 1: Pre-randomization:
The physiotherapists (n=30) will hand out a Consultation-Based Reassurance Questionnaire (CRQ) in a sealed envelope to each eligible patient (age 18+) they receive for the first consultation in two weeks period. The patient will complete the questionnaire in private, post consultation, and place it in a closed box. The physiotherapist will recruit a minimum of five patients each (n\>150).
Baseline measures are: age, gender, pain area, chronicity, pain severity, disability, satisfaction from the consultation and the Consultation-Based Reassurance Questionnaire.
Stage 2: Randomization:
The process for randomization:
First, participating physiotherapists will be matched for gender, seniority, and quality of reassurance in every clinic. They will then be allocated into one of the two arms at random (1:1), according to a computer random number list.
Stage 3: Follow up:
After the intervention, both the intervention and control groups will again hand out the questionnaires (age, gender, pain area, chronicity, pain severity, disability, satisfaction from the consultation and the CRQ) to new eligible patients that arrive for the first consultation. The physiotherapist will recruit a minimum of ten patients each (total sample therefore n\> 300, minimum number per arm=150).
sample size The sample size was calculated with G\*Power 3.1.9.4 using the t-test family to detect the difference between two independent means (two groups). The input parameters were as follows: for a two-tailed test, assuming a medium effect size of 0.5, α=0.05, and β=0.95, the total sample size recommended was 210 participants. One hundred five participants in each study group (intervention and control).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
The outcome assessor will not know who was in the intervention group and who was in the control
Study Groups
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Reassurance intervention
The physiotherapist in the intervention group (n=15) will participate in a 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.
communication skills
3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.
Control
The physiotherapist in the control group (n=15) receives no training.
No interventions assigned to this group
Interventions
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communication skills
3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.
Eligibility Criteria
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Inclusion Criteria
* Working for Clalit Health Services. Dan-Petach Tikva region
* Willing to participate in a 3-hour communication skills workshop
* Patients:
* over the age of 18
* literate in Hebrew
* Willing to participate in the study
Exclusion Criteria
* Illiterate in Hebrew
18 Years
ALL
Yes
Sponsors
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Ariel University
OTHER
Responsible Party
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Principal Investigators
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Noa Ben Ami, PhD
Role: PRINCIPAL_INVESTIGATOR
Ariel University
Locations
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Distric DAN - PETACH TIKVA
Petah Tikva, , Israel
Countries
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References
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Holt N, Pincus T. Developing and testing a measure of consultation-based reassurance for people with low back pain in primary care: a cross-sectional study. BMC Musculoskelet Disord. 2016 Jul 12;17:277. doi: 10.1186/s12891-016-1144-2.
Pincus T, Holt N, Vogel S, Underwood M, Savage R, Walsh DA, Taylor SJC. Cognitive and affective reassurance and patient outcomes in primary care: a systematic review. Pain. 2013 Nov;154(11):2407-2416. doi: 10.1016/j.pain.2013.07.019. Epub 2013 Jul 18.
Holt N, Mansell G, Hill JC, Pincus T. Testing a Model of Consultation-based Reassurance and Back Pain Outcomes With Psychological Risk as Moderator: A Prospective Cohort Study. Clin J Pain. 2018 Apr;34(4):339-348. doi: 10.1097/AJP.0000000000000541.
Other Identifiers
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0127-19-com2
Identifier Type: -
Identifier Source: org_study_id
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