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

A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Communication
• Intervention / Treatment: Behavioral: communication skills

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel
    • Distric DAN - PETACH TIKVA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Control; The physiotherapist in the control group (n=15) receives no training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consultation reassurance questionnaire (0-72). Change is being assess before and after the intervention.	A questionnaire that measures patients' perceptions of consultation- higher values represent a better communication skills	measure assessing change between two time points: base line and at two month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The numeric pain rating scale (0-10)	For the most severe and average pain intensity ( 0= no pain and 10 =the worst pain)	2 month
Disability (0-10)	For disability (0= no disability and 10 =the worst disability)	2 month
Satisfaction (0-10)	For satisfaction from the first consultation with the physiotherapist (0= no satisfied at all and 10 =very satisfied)	2 month

Collaborators and Investigators

• Sponsor: Ariel University
• Investigators: Principal Investigator: Noa Ben Ami, PhD, Ariel University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 29, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: communication skills; Consultation reassurance questionnaire
• Other Study ID Numbers: 0127-19-com2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No