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

NCT ID: NCT02023138

Last Updated: 2013-12-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-03-31

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.

Conditions

Brain Injury

Keywords

Clinical practice guideline; Brain injury; Acceptability; Feasibility; Effectiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Focus group

Group Type: ACTIVE_COMPARATOR

Focus group

Intervention Type: OTHER

Two hours focus group to allow the participants to modify a clinical practice guideline recommendation

Wiki

Intervention Type: OTHER

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

Wiki

Group Type: EXPERIMENTAL

Focus group

Intervention Type: OTHER

Two hours focus group to allow the participants to modify a clinical practice guideline recommendation

Wiki

Intervention Type: OTHER

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

Interventions

Focus group

Two hours focus group to allow the participants to modify a clinical practice guideline recommendation

Intervention Type: OTHER

Wiki

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Marie-Eve Lamontagne

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Association de personnes TCC du Québec

Québec, Quebec, Canada

Countries

Canada

Central Contacts

Marie-Eve Lamontagne, Ph.D.

Role: CONTACT

Phone: 418-529-9141

Email: marie-eve.lamontagne@cirris.ulaval.ca

Véronique Gauthier, M.Sc.

Role: CONTACT

Phone: 418-529-9141

Email: veronique.gauthier@cirris.ulaval.ca

References

Lamontagne ME, Gagnon MP, Perreault K, Gauthier V. Evaluating the Acceptability, Feasibility, and Outcomes of Two Methods Involving Patients With Disability in Developing Clinical Guidelines: Crossover Pilot Study. J Particip Med. 2021 Nov 23;13(3):e24319. doi: 10.2196/24319.

Reference Type: DERIVED

PMID: 34812733 (View on PubMed)

Other Identifiers

KT Canada 87776

Identifier Type: -

Identifier Source: org_study_id