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

Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452903
• Other study ID #: 0127-19-com2
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: June 2020
• Source: Ariel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: December 20, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communication

Intervention

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.

Locations

Country	Name	City	State
Israel	Distric DAN - PETACH TIKVA	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Ariel University

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

Pincus T, Holt N, Vogel S, Underwood M, Savage R, Walsh DA, Taylor SJ. Cognitive and affective reassurance and patient outcomes in primary care: a systematic review. Pain. 2013 Nov;154(11):2407-16. doi: 10.1016/j.pain.2013.07.019. Epub 2013 Jul 18. Review — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Disability (0-10)	For disability (0= no disability and 10 =the worst disability)	2 month
Secondary	Satisfaction (0-10)	For satisfaction from the first consultation with the physiotherapist (0= no satisfied at all and 10 =very satisfied)	2 month