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

NCT00345449 | Completed

• 1 other identifier: 2004776-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis,; lung disease,; lung transplantation,; decision aid

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Durability of the decision one year after the patient decision aid.

Interventions

Decision Aid BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FEV less than or equal to 40% predicted

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• 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. doi: 10.1164/rccm.200903-0421OC. Epub 2009 Jul 9.

  PMID: 19590021 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Lung Diseases

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Shawn Aaron, MD FRCPC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2006
• First Posted: June 28, 2006
• Study Start: September 1, 2006
• Study Completion: September 1, 2008
• Last Updated: July 9, 2009

Record last verified: 2009-07

Locations

CA (1)