Evaluation of a Decision Aid for Adult Cystic Fibrosis Patients Considering Bilateral Lung Transplantation

This study has been completed.
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00345449
First received: June 27, 2006
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

In 2006, the International Patient Decision Aids Collaboration (IPDAS) reached agreement on criteria for evaluation. Accordingly, the primary outcome is 'decision quality' 3 weeks after using the decision aid. Decision quality is defined as the extent to which a patient decision aid improves the match between the chosen option and the features that matter most to the informed patient. Measures include: a) patients' knowledge of essential facts [options, benefits, harms, and outcome probabilities]; and b. the congruence between the option chosen and patients' informed values regarding benefits and risks.

In the past twenty years lung transplantation has become the most widely accepted option of treating cystic fibrosis patients with severe lung disease. Lung transplantation can be a good experience for many patients, improving their quality of life and their survival. However there are potential risks of lung transplantation including infection, organ rejection and early death. Cystic fibrosis patients are often faced with making a choice of whether to be referred for lung transplantation when they are very sick and there is the immediate need to survive. Our group has developed a tool called a decision aid which we hope will assist the patient and family in making this choice. The decision aid guides the patient through a series of steps where they weigh the benefits and risks of being referred for lung transplantation and the benefits and risks of receiving 'usual care' without the option of referral.


Condition Intervention
Cystic Fibrosis
Behavioral: Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Evaluation of a Decision Aid for Adult Cystic Fibrosis Patients Considering Bilateral Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Knowledge, realistic expectations and decisional conflict 3 weeks after using the decision aid.

Secondary Outcome Measures:
  • Durability of the decision one year after the patient decision aid.

Estimated Enrollment: 200
Study Start Date: September 2006
Study Completion Date: September 2008
Detailed Description:

Patients randomized to either arm of the study will be required to undergo a lung transplantation education and counselling session with their CF physician prior to randomization. Subsequent to this session patients will be randomly allocated to receive: 1) usual care plus the patient decision aid or 2) usual care. For purposes of this study, usual care will include a booklet entitled, "Cystic fibrosis and lung transplantation" written by the Canadian Cystic Fibrosis Foundation plus any other written or educational material that the local CF centre normally provides.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FEV less than or equal to 40% predicted

Exclusion Criteria:

  • Patients unable to provide informed consent
  • Patients on a lung transplant waiting list
  • Patients who are lung transplant recipients
  • Patients deemed too sick for transplant
  • Only one sibling per family to minimize contamination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345449

Locations
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Shawn Aaron, MD FRCPC Ottawa Hospital Research Institute
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00345449     History of Changes
Other Study ID Numbers: 2004776-01
Study First Received: June 27, 2006
Last Updated: July 8, 2009
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
cystic fibrosis,
lung disease,
lung transplantation,
decision aid

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014