A Study of the Effect of Patient Education (Talking Health Together) in Improving Doctor-patient Communication

A Multi-centre, Randomised Trial in Ontario to Evaluate the Efficacy of Talking Health Together T.M. (T.H.T. in Practice), a Communication Education Intervention for Primary Care Patients With Chronic Disease.

This study is being carried out to see if patients make the lifestyle changes or take their medication as instructed by their doctor during their visit as a result of the T.H.T. patient-education training. Proper information exchange between doctors and patients is an important part of quality health care. Although many patients would like more information, they often do not ask for it directly during doctor-patient visits. The patient-training in this study specifically aims at improving patient participation during medical appointments by building communication skills such as requests for information and sharing health concerns with the doctor.

Study Overview

• Status: Completed
• Conditions: Doctor-patient Communication Improvement
• Intervention / Treatment: Other: placebo; Behavioral: THT PACE Training

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Burlington, Ontario, Canada
      • Research Site
    • Hamilton, Ontario, Canada
      • Research Site
    • Kitchener-Waterloo, Ontario, Canada
      • Research Site
    • Mississauga, Ontario, Canada
      • Research Site
    • Oakville, Ontario, Canada
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, aged 40 years of age or greater
• Clinical documentation of diagnosis not to target of at least one of the following: Type II Diabetes Mellitus, Hypertension or Hypercholesterolemia
• Receive a prescribed medication for the chronic disease for which they were included in the study

Exclusion Criteria:

• Patients in active phase of cancer treatment (i.e. chemotherapy or radiotherapy at time of study).
• Inability to carry out the encounter with their physician in English without need of assistance
• Uncomfortable using a computer for routine activities such as regular access to the web and e-mail.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: THT PACE eLearning module; The PACE (prepare, ask, check, express) training methodology will be available to patients before their 2nd doctor visit	Behavioral: THT PACE Training; Patient training
Active Comparator: THT PACE eLearning module & nurse-led workshop training; THT PACE eLearning and then nurse-led workshop for training on PACE methodology	Behavioral: THT PACE Training; Patient training
Placebo Comparator: Usual care; Patients just go to their doctor as they normally would but get some disease specific information in the form of brochures as do intervention arms	Other: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the impact, compared to Usual Care, of training interventions on patients with chronic disease on patient participation in primary care encounters assessed after intervention.	once

Secondary Outcome Measures

Outcome Measure	Time Frame
physician satisfaction and sense of partnership with the doctor-patient encounter;
patient perception of quality of doctor-patient communication and relationship and patient confidence in own ability to communicate effectively with their doctor;	Twice
patient perception of the management of their chronic disease(s); and patient recall of discussions of lifestyle recommendations and chronic disease medications discussed during the encounter.	Twice

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Dr. Marie-Therese Lussier; Dr. Claude Richard
• Investigators: Principal Investigator: Dr. Marie-Thérèse Lussier, MD, BSc., MSc., FCMFC, Université de Montréal

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: April 8, 2009
• First Submitted That Met QC Criteria: April 9, 2009
• First Posted (Estimate): April 10, 2009

Study Record Updates

• Last Update Posted (Estimate): August 22, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Doctor-patient communication; Encounters; Patient education training
• Other Study ID Numbers: THT in practice