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

This study has been completed.
Sponsor:
Collaborators:
Dr. Marie-Therese Lussier
Dr. Claude Richard
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00879736
First received: April 8, 2009
Last updated: August 19, 2011
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Doctor-patient Communication Improvement
 Behavioral: THT PACE Training
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. [ Time Frame: once ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • physician satisfaction and sense of partnership with the doctor-patient encounter; [ Designated as safety issue: No ]
  • patient perception of quality of doctor-patient communication and relationship and patient confidence in own ability to communicate effectively with their doctor; [ Time Frame: Twice ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Twice ] [ Designated as safety issue: No ]

Enrollment: 322
Study Start Date: March 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879736

Locations
Canada, Ontario
Research Site
Burlington, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kitchener-Waterloo, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Oakville, Ontario, Canada
Sponsors and Collaborators
AstraZeneca
Dr. Marie-Therese Lussier
Dr. Claude Richard
Investigators
Principal Investigator: Dr. Marie-Thérèse Lussier, MD, BSc., MSc., FCMFC Université de Montréal
  More Information

No publications provided

Responsible Party: AstraZeneca, Astrazeneca
ClinicalTrials.gov Identifier: NCT00879736     History of Changes
Other Study ID Numbers: THT in practice
Study First Received: April 8, 2009
Last Updated: August 19, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by AstraZeneca:
Doctor-patient communication
Encounters
Patient education training

ClinicalTrials.gov processed this record on May 16, 2013