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

December 23, 2013 updated by: Marie-Eve Lamontagne, Laval University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada
        • Association de personnes TCC du Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediatly (less than 12 hours) after the intervention, at the end of week 2 and week 3.
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.
At the end of the experimentation of the two methods (end of week 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.
Within one month after the experimentation of the two methods.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KT Canada 87776

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