A Randomized Trial Comparing "Push" Versus "Pull" Technology for Mobilizing Pain Evidence Into Practice Across Different Health Professions

September 22, 2015 updated by: Joy MacDermid, McMaster University
Pain is a problem for many Canadians. Unfortunately, many doctors, nurses, therapists, and psychologists have trouble keeping up to date and applying the latest research that might help patients suffering with pain. This study will determine whether sending alerts about new pain research directly to these health professionals, and providing them with access to accumulated alerts, will help. The study will compare knowledge and decisions made by health professionals about managing pain problems. The investigators will compare physicians, nurses, rehab therapists and psychologists at the beginning of the study and after having access to different ways to find out about new pain research. One group will receive alerts about new pain studies that have been found to be high quality and relevant to patient care, and will be able to search the alerts database. The other group will be able to find the same studies,but must go to the database of research studies to locate them. The investigators will include 670 doctors, nurses, rehab therapists, and psychologists in this study. A process like tossing a coin will determine which way they are able to get pain research information. The investigators will monitor how much information they access and how they apply it to managing pain problems. The investigators expect that reminding health care providers about new research findings directly will help them, since difficulty finding studies and lack of time prevent them from using the latest research. The investigators expect that reminders about the latest research will help them make better decisions about caring for patients' pain.

Study Overview

Status

Status

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

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.

Detailed Description

The Problem: Pain affects all Canadians during acute injury or disease. Chronic noncancer pain affects 29% of Canadians, half of whom are unable to participate in their usual work/social roles. Pain is the primary reason that patients consult health practitioners. Research has shown the benefits, harms, and costs of numerous interventions for pain, but uptake of this knowledge is far from satisfactory. Optimizing pain care requires ready access and use of best evidence within and across different disciplines and settings.

The Research Question: The purpose of this randomized trial is to determine whether a technology-based "push" of new, high-quality pain research to physicians, nurses, rehabilitation and psychology professionals results in better knowledge and clinical decision-making around pain, when offered in addition to traditional "pull" evidence technology. A secondary objective is to identify disciplinary variations in response to evidence and differences in the patterns of accessing research evidence.

The Study Sample: 670 Physicians, nurses, occupational/physical therapists and psychologists ((80/group X 2 comparison groups X 4 disciplines) + 30 for dropouts)will be recruited through professional associations, websites/conferences and social media. This provides > 90% power to detect main effects; 80% power for subgroup effects.

Outcome Measures: The primary outcomes are uptake and application of evidence. Uptake will be determined by embedded tracking of what research is accessed during use of the intervention. A random subset of 30 participants/discipline will undergo chart-stimulated recall (CSR) to assess the nature and depth of evidence utilization in actual case management (0, 9 months). A different random subset of 30 participants/discipline will be tested for their skills in accessing evidence using a standardized simulation test (final 3 months). Secondary outcomes include usage and self-reported evidence-based practice attitudes and behaviours (0, 3, 9, 15, 18 months).

Intervention/Methods: Participants who agree to this study of a free literature service will be randomly allocated to Push + Pull versus Pull evidence support. Push + Pull is evidence on pain that is extracted from medical, nursing and rehabilitation journals and appraised for quality and relevance and sent out to clinicians (derived from the successful MacPLUS/Evidence Updates), delivered by e-mail alerts or available for searches of the accumulated database). Pull will be an intervention with a similar front-face but requires clinicians to go to the site and extract evidence from an electronic database. The trial will begin with a 3-month (repeated) baseline, during which average participant use of the standard PULL resource will be monitored. Participants will then be randomly allocated to receive PUSH + PULL or continue to use the PULL resource. After six months, participants will cross over to the alternate intervention for an additional six months. To complete the trial, both groups will finish with three months of PUSH + PULL access.

Analyses: The investigators will use an analysis of covariance (ANCOVA), where discipline and setting are covariates to assess differential responses across main effects of Push + Pull vs. Pull. Content analysis of the CSR interview will be use to describe the application of evidence within actual cases.

Impact/Timeliness: The trial will inform our understanding on information preferences and behaviours across disciplines/practice settings. If this intervention is effective, sustained support will come through professional/health system initiatives emerging to optimize pain management in Canada.

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 (Actual)

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.
675

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 Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1C7
        • McMaster University

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • licensed physicians, nurses, occupational therapists (OT), physical therapists (PT), or psychologists who see patients at least 1 day/week;
  • fluent in English;
  • have access to a computer at home or at work which has unrestricted access to the World Wide Web,
  • have an active email account

Exclusion Criteria:

  • currently participating in other knowledge translation interventions

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: Double

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.
Experimental: Push + Pull
Push + Pull is evidence on pain that is extracted from medical, nursing, psychology and rehabilitation journals, appraised for quality and relevance, and delivered to clinicians by e-mail alerts or available for searches of the accumulated database.
Behavioral: Push + Pull
Push + Pull is evidence on pain that is extracted from medical, nursing, psychology and rehabilitation journals, appraised for quality and relevance, and delivered to clinicians by e-mail alerts or available for searches of the accumulated database.
Placebo Comparator: Pull
Pull will be an intervention with a similar front-face but requires clinicians to go to the site and extract evidence from an electronic database.
Behavioral: Pull
Pull will be an intervention with a similar front-face but requires clinicians to go to the site and extract evidence from an electronic database.

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
Application of evidence (chart-stimulated recall)
Time Frame: 0, 9 months
A random subset of 30 participants/discipline will undergo chart-stimulated recall to assess the nature and depth of evidence utilization in actual case management.
0, 9 months
Skill at accessing research evidence
Time Frame: 15 months
A different random subset of 30 participants/discipline will be tested for their skills in accessing evidence using a standardized simulation test.
15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usage of PainPLUS
Time Frame: Every month
Embedded tracking of number/frequency of article access and type of evidence. Level of satisfaction with PainPLUS
Every month
Attitudes about Evidence-Based Practice Questionnaire
Time Frame: 0, 3, 9, 15, and 18 months
Knowledge/Attitude/Behaviour Questionnaire
0, 3, 9, 15, and 18 months
Familiarity/Access to Technology
Time Frame: 0 months
0 months

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.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joy MacDermid, PhD, McMaster 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

Helpful Links

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.
August 1, 2011

Primary Completion (Actual)

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.
December 1, 2014

Study Completion (Actual)

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, 2015

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).
May 4, 2011

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.
May 4, 2011

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.
May 5, 2011

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.
September 23, 2015

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.
September 22, 2015

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.
September 1, 2015

More Information

Terms related to this study

Keywords

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.
  • CIHR-228972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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