Objectives

To evaluate the effectiveness of the PERSISTANCE Disease Management program on:

  • Treatment persistence
  • Clinical symptoms
  • Quality of life
  • Productivity and disability metrics
  • Return on investment for employer

 

Design

PERSISTANCE, a pragmatic randomized controlled trial, will be conducted among workers aged 18 to 64 years and who have begun an antidepressant treatment for depression or generalized anxiety. Employees will be recruited in pharmacy or in companies that participate in the research project. Like most evaluation studies, participants will be randomized (by chance) to one of the following groups :

 

Pragmatic randomized controlled trial

Patients randomized to the PERSISTANCE group will receive the complete program (telephone follow-up, information modules, feed-back letters to the physician) whereas patients randomized to the usual care group, will have a telephone interview at registration, will be contacted at six months and receive the information modules then as well. It should be noted that even though patients in the usual care group do not have the same intensity of follow-up, they will recieve more information than what is available right now through the health care system. Patients will be informed of this randomization process in the consent form which they will need to sign prior to enrollment.

 

Inclusion/Exclusion criteria

  • Aged between 18 and 64 years old
  • Able to read and understand French or English
  • Have access to a telephone (day or evening)
  • Have understood, signed and faxed the informed consent
  • Must register in the study as soon as possible following treatment initiation (before 6 months)
  • Must have a diagnosis of depression or generalized anxiety
  • Not having taken antidepressants in the 3 months prior to current treatment initiation (new treatment);
  • Not taking antidepressants for conditions other than depression or anxiety: Obsessive-compulsive disorders, attention-deficit disorders, pain contol, bipolar disorder ARE NOT eligible
  • Willing to provide his/her Quebec health insurance number and private medical policy number so that researchers at the Centre de Recherches du CHUM can track in a confidential manner the prescriptions and medical services received throughout the duration of the research project

 

Recruitment

The study is conducted in collaboration with Quebec enterprises and pharmacist. Employees will be informed of the PERSISTANCE research study by their pharmacist, posters placed in strategic locations within the company, or through internal communications (intranet). Employees must register to become part of the program and send us via fax their signed consent form. The consent form explains the study and what their participation entails. Employees are guaranteed confidentiality and that no information will be given to a third party, not their employer, nor their insurance company. Their participation involves telephone interviews at home or during work breaks. Each interview will last approximately 30 to 60 minutes.

 

Scientific Committee

Principal investigator

  • Yola Moride PhD, FISPE, Researcher, Centre de Recherche, CHUM (CRCHUM); Associate Professor, Faculty of Pharmacy, Université de Montréal

Co-investigators

  • Guillaume Galbaud du Fort, Centre for Clinical Epidemiology, Jewish General Hospital
  • Michel Rossignol, Direction de santé publique de Montréal
  • Jacques Lelorier, CHUM - Hôtel Dieu de Montréal, Université de Montréal
  • Jean Lachaine, Faculty of Pharmacy, Université de Montréal
  • Jean-Paul Collet, Child and Family Research, University of British Columbia
  • Michel Perreault, Douglas Mental Health University Institute
  • Jean-Pierre Bonin, Faculty of Nursing, University of Montreal

Collaborators

  • Marie Tournier (Dept. Psychiatry, Bordeaux University)
  • Greg Simon (Group Health Cooperative, USA)
  • Jean-Remi Provost (Association Revivre)
  • Thierry Ducruet (Statistician)
  • Michelle Savoie, Researcher, Centre de Recherche, CHUM

 

Sponsor

This study is funded by:

Canadian Institutes of Health Research (CIHR)
Eli Lilly, Lundbeck, Sanofi-aventis
Merck, Pfizer, AstraZeneca

 

 

 

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