A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations

NCT ID: NCT04452903

Last Updated: 2021-01-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-12-20

Brief Summary

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The aim of this study is to test the effectiveness of a single training session in communication skills at improving patients' perceptions of physiotherapy consultations.

Detailed Description

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Population: Physiotherapists Detail: Physiotherapists (n=30) who work at 'Clalit' institute's (public health management organization in Israel) at four physiotherapy clinics.

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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Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participant (patients of the physiotherapists) are unaware of the intervention.

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.

Group Type EXPERIMENTAL

communication skills

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Physiotherapists:

* 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

* Unwilling to participate in the trial
* Illiterate in Hebrew
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ariel University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Israel

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.

Reference Type RESULT
PMID: 27405870 (View on PubMed)

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.

Reference Type RESULT
PMID: 23872104 (View on PubMed)

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.

Reference Type RESULT
PMID: 29509169 (View on PubMed)

Other Identifiers

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0127-19-com2

Identifier Type: -

Identifier Source: org_study_id

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