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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

June 27, 2006
July 8, 2009
September 2006
Not Provided
Knowledge, realistic expectations and decisional conflict 3 weeks after using the decision aid.
Minimally clinically important differences between groups of knowledge, decisional conflict and expectations in relation to referral for lung transplantation.
Complete list of historical versions of study NCT00345449 on ClinicalTrials.gov Archive Site
Durability of the decision one year after the patient decision aid.
Durability of the decision will be measured yearly for 3 years.
Not Provided
Not Provided
 
Evaluation of a Decision Aid for Adult Cystic Fibrosis Patients Considering Bilateral Lung Transplantation
Evaluation of a Decision Aid for Adult Cystic Fibrosis Patients Considering Bilateral Lung Transplantation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Cystic Fibrosis
Behavioral: Decision Aid
Not Provided
Vandemheen KL, O'Connor A, Bell SC, Freitag A, Bye P, Jeanneret A, Berthiaume Y, Brown N, Wilcox P, Ryan G, Brager N, Rabin H, Morrison N, Gibson P, Jackson M, Paterson N, Middleton P, Aaron SD. Randomized trial of a decision aid for patients with cystic fibrosis considering lung transplantation. Am J Respir Crit Care Med. 2009 Oct 15;180(8):761-8. Epub 2009 Jul 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2008
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00345449
2004776-01
Not Provided
Not Provided
Ottawa Hospital Research Institute
Not Provided
Principal Investigator: Shawn Aaron, MD FRCPC Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP