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Evaluation of the Acceptability, Feasibility and Effectiveness of Two Methods of Involvement of Patients With Cognitive Disability in Clinical Guidelines Development: a Randomized Crossover Pilot Trial

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ClinicalTrials.gov Identifier: NCT02023138
Recruitment Status : Unknown
Verified December 2013 by Marie-Eve Lamontagne, Laval University.
Recruitment status was:  Not yet recruiting
First Posted : December 30, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Marie-Eve Lamontagne, Laval University

Brief Summary:
There is a lack of evidence about the best method to involve the patient and population (IPP) into clinical practice guidelines (CPG) development. The goal of this pilot study is to document the acceptability, feasibility and effectiveness of two methods for the implication of patients with a traumatic brain injury (TBI) in CPG development. Method: A single blind, randomized crossover trial will be performed with patients having a TBI. Participants: A convenience sample of 20 patients a) with a moderate-to-severe TBI (Glascow Coma Scale <13), b) living with a TBI for two to four years, c) French-speaking, d) able to use a computer and e) able to participate in a two-hour group meeting will be recruited among the members of the Associations TCC Des Deux Rives. Procedures: The patients will first receive a in-person training on guidelines and IPP. They will be randomized into Group 1 or Group 2 by a researcher blinded to experimentation. They will experiment either group discussion (control intervention) or a Wiki (experimental intervention). Phase 1: A week after the training, Group 1 participants will be invited to a discussion group animated by an experimented moderator, where they will be asked to discuss a CPG recommendation chosen by the research team in an existing CPG. The participants will be asked : 1) about their opinion of the recommendation; 2) if they have a preference in regard to the recommendation ; 3) if they have some modification, correction or addition to bring to this recommendation. In the mean time, Group 2 participants will receive an email presenting a link to a Wiki. They will be invited to answer the same three questions as Group 1, but using a Wiki platform. The patients will have a week to interact and answer the questions; recalls could be sent by email if required. At the end of Phase 1, participants of both groups will fill a questionnaire documenting the acceptability of the method experimented. Phase 2: As per the crossover design, the Group 1 participants will then be assigned to the Wiki intervention and the Group 2 participants will be assigned to the discussion group intervention. The procedure will be repeated with a second recommendation. At the end of Phase 2, the patients will be asked to answer a short survey to validate their preferences about the two methods. Tools: The acceptability of the methods will be evaluated with a questionnaire adapted from Sidani and al. and validated with three TBI individuals. The feasibility of the intervention will be evaluated using a) the number of participants who reached the group or the Wiki, b) the number of participants who completed the intervention c) the number of support interventions required in the group and in the Wiki. The effectiveness of the two methods will be evaluated by submitting the adapted recommendations to a panel of expert clinicians evaluators blinded to the methodologies of recommendations adaptation. They will be invited to rate the clarity, accuracy, appropriateness and usefulness of the recommendations. Analysis: Feasibility indicators will be reported using descriptive statistics. Within-subject analysis using non-parametric statistics will be performed to assess the acceptability of the two methods. AC1 coefficient of raters' agreement will be calculated on the expert evaluation scores, and the effectiveness of the methods will be compared using appropriate non parametric statistics to. Impact: This pilot trial will be the first one to evaluate methodologies for involving disabled individuals into CPG development.

Condition or disease Intervention/treatment Phase
Brain Injury Other: Focus group Other: Wiki Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Acceptability, Feasibility and Effectiveness of Two Methods of Involvement of Patients With Cognitive Disability in Clinical Guidelines Development: a Randomized Crossover Pilot Trial
Study Start Date : January 2014
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Arm Intervention/treatment
Active Comparator: Focus group Other: Focus group
Two hours focus group to allow the participants to modify a clinical practice guideline recommendation

Other: Wiki
A specially tailored interactive communication website (Wiki) to allow the participants to modify a clinical practice guideline recommendation

Experimental: Wiki Other: Focus group
Two hours focus group to allow the participants to modify a clinical practice guideline recommendation

Other: Wiki
A specially tailored interactive communication website (Wiki) to allow the participants to modify a clinical practice guideline recommendation




Primary Outcome Measures :
  1. Acceptability [ Time Frame: Immediatly (less than 12 hours) after the intervention, at the end of week 2 and week 3. ]
    The acceptability of the method will be evaluated through individual questionnaire administred seven days after having make the wiki available, or immediatly after the focus group.

  2. Feasibility [ Time Frame: At the end of the experimentation of the two methods (end of week 3) ]
    The feasability will be assed by considering the number of participants reaching and using each method, and by recording the number of support intervention required for the use of each method.

  3. Effectiveness [ Time Frame: Within one month after the experimentation of the two methods. ]
    After the adaptation of the two recommendations using the two methods, twenty experts, blind to the method used to formulate the recommendations, will rate each recommendation for its clarity, accuracy, appropriateness and usefulness of the recommendations using 10 points likert scales. An electronic questionnaire will be send to the experts and they will have one week to rate the recommendations.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • having suffered a moderate-to-severe TBI (Glascow Coma Scale <13)
  • living with a TBI for two to four years
  • French-speaking
  • able to use a computer
  • able to participate in a two-hour group meeting

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023138


Contacts
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Contact: Marie-Eve Lamontagne, Ph.D. 418-529-9141 ext 2423 marie-eve.lamontagne@cirris.ulaval.ca
Contact: Véronique Gauthier, M.Sc. 418-529-9141 veronique.gauthier@cirris.ulaval.ca

Locations
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Canada, Quebec
Association de personnes TCC du Québec Not yet recruiting
Québec, Quebec, Canada
Sub-Investigator: Valérie Plamondon, B.Sc.         
Sponsors and Collaborators
Laval University

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Responsible Party: Marie-Eve Lamontagne, Assistant professor, Laval University
ClinicalTrials.gov Identifier: NCT02023138     History of Changes
Other Study ID Numbers: KT Canada 87776
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

Keywords provided by Marie-Eve Lamontagne, Laval University:
Clinical practice guideline
Brain injury
Acceptability
Feasibility
Effectiveness

Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries