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. 2021 Dec 24;25(2):697–711. doi: 10.1111/hex.13417

Table 1.

Detailed patient engagement plan, innovative clinical trial low‐back pain study, Year 1

Meetings required Patient time Researcher time Training required Responsible team member
Barriers assessment—knowledge translation and dissemination
September–October 2020
This project activity includes helping to translate important messages about why we are trying to change practice and the key barriers to following low‐back pain guidelines that were found in our assessment. We want to translate the results from the barriers assessment into understandable focused messages that are relevant for the different knowledge users. The knowledge users for the study will be researchers, clinicians, patients and policymakers. Levels of patient engagement for this activity are outlined below.
Inform
Meetings required Patient time Researcher time Training required Responsible team member
0 Patient‐determined None required PE coordinator
Meetings required Patient time Researcher time Training required Responsible team member
Patient responsibilities
  • Review the dissemination plan and related materials provided
Researcher commitment
We will keep you informed by regularly communicating with you and providing you with copies of materials within 1–2 weeks of producing them.
  • The patient engagement coordinator will email you copies of materials we produce
Consult
Meetings required Patient time Researcher time Training required Responsible team member
0 30 min–1 h A. P.—2 h None required Research Manager NL
E. G.—1 h PE coordinator
Meetings required Patient time Researcher time Training required Responsible team member
Patient responsibilities
  • Review drafts of the key messages and dissemination materials crafted for each user group.
  • Provide written feedback (emailed to Research Manager NL) on the accessibility/usability of the material from your perspective within 1–2 weeks of receiving these documents.
Researcher commitment
We will consider your feedback as we prepare the final versions of key messages and dissemination materials and let you know how your feedback influenced the process.
  • Research Manager NL will email you draft copies of the materials we have produced (cc PE coordinator).
  • PE coordinator will communicate to you how your input has influenced our work.
Involve
Meetings required Patient time Researcher time Training required Responsible team member
1 1.5–2 h
  • A. P.—3 h
  • A. M. P.—1.5 h 
  • E. G.—1.5 h
None required

Research Manager NL

Senior Research Manager, national site

PE coordinator

Meetings required Patient time Researcher time Training required Responsible team member
Patient responsibilities
  • Review drafts of the key messages and dissemination materials crafted for each user group.
  • Provide written feedback on the accessibility/usability of the material from your perspective and help to generate a list of potential frequently asked questions within 1–2 weeks of receiving these documents.
Researcher commitment
We will work with you to ensure your feedback is incorporated and directly reflected in the finished product to the maximum extent possible (while maintaining the integrity of the research).
  • Research Manager NL will email you draft copies of the materials we have produced (cc PE coordinator).
  • Selected members of the NL team will meet with you to review your feedback and discuss how we plan to incorporate it into the final product.
Collaborate
Meetings required Patient time Researcher time Training required Responsible team member
2–3 Up to 7 h (includes meeting hours and independent work)
  • A. P.
  • A. M. P.
  • 7—NL SUPPORT
  • Patient training (TDF)

Research Manager NL

Senior Research Manager, National site

PE Scientific Lead

Meetings required Patient time Researcher time Training required Responsible team member
Patient responsibilities
  • Attend a lecture on the TDF.
  • Partner with researchers on the team to translate the key messages and identify the most appropriate communication/dissemination methods. This includes:
  • o
    participating in training on the theoretical domains framework,
  • o
    attending meetings with selected team members to review the results, cocreate key messages based on those results and write the text for a 1‐page infographic report,
  • o
    reviewing and commenting on subsequent drafts.
  • Become a local champion of the key message by spreading the key message at different functions and through relevant personal networks if possible.
Researcher commitment
We will work with you to cocreate dissemination materials and select communication strategies, relying on your advice and innovation in this area. We will incorporate your advice and recommendations to the maximum extent possible.
  • Research Managers and a local facilitator with meet with you to review the results of the barriers assessment and begin work on breaking the results down into key messages.
  • Subsequent meetings will focus on developing the text for a 1‐page infographic report, selecting communication channels, and reviewing edits and feedback on various drafts of the report.
Trial—intervention development
September–December 2020
Includes reviewing the problems identified in the barriers assessment, determining which problems were most important and able to be targeted and matching them with appropriate behaviour change techniques.
Inform
Meetings required Patient time Researcher time Training required Responsible team member
0 Patient‐determined None required PE coordinator
Meetings required Patient time Researcher time Training required Responsible team members
Patient responsibilities
  • Review the behaviour change techniques that are selected to form the intervention.
Researcher commitment
We will keep you informed by telling you when the behaviour change techniques (BCTs) have been selected by the stakeholder committee.
  • PE coordinator will email you correspondence within 1–2 weeks of making these decisions, indicating which behaviour change techniques have been selected to form our intervention and what barriers they address
Consult
1 1.5 h

A. M. P.—3 h

A. P.—2 h

E. G.—1.5 h

Brief BCT foundational lecture for patients

Senior Research Manager, National site

Research Manager, NL site

PE coordinator

Patient responsibilities
  • Attend a brief foundational lecture on BCTs.
  • Review a summary of BCTs selected to target the problems identified in the barriers assessment and the process for delivering the intervention.
  • Provide written feedback (emailed to Research Manager NL) highlighting your concerns or questions you have with the approach we have selected within 1–2 weeks of receiving the summary.
Researcher commitment
We will consider your feedback and let you know how it influenced the intervention development.
  • Senior Research Manager, National site will deliver a short foundational lecture for patients.
  • Research Manager NL will email you a summary of the BCTs selected to target relevant barriers identified in the barriers assessment and the process for delivering the intervention (cc PE coordinator).
  • After we have reviewed your feedback, the PE coordinator will communicate to you how your participation influenced intervention development.
Involve
2 3 h
  • A. M. P.—3 h
  • A. P.—5 h
  • A. H.—5 h
  • E. G.—3 h
Brief BCT foundational lecture for patients

Senior Research Manager, national site

NL site lead

Research Manager, NL

PE coordinator

Patient responsibilities
  • Review a summary of BCTs selected to target the problems identified in the barriers assessment and the process for delivering the intervention.
  • Provide written feedback (emailed to Research Manager) highlighting your concerns or questions you have with the approach we have selected within 1–2 weeks of receiving the summary.
  • Attend a round‐table meeting to review your critique and determine how the team can incorporate your feedback.
Researcher commitment
We will work with you to ensure your feedback is incorporated and directly reflected in the intervention that is developed to the maximum extent possible.
  • Senior Research Manager, National site will deliver a short foundational lecture for patients.
  • Research Manager, NL will email you draft copies of the materials we have produced (cc PE coordinator).
  • Selected members of the NL team will meet with you to review your feedback and discuss how it can be incorporated.
Collaborate
3–4

4–5 Days (32–40 h)

This includes time for training, meetings and independent work

  • A. M. P.—6 h
  • A. H.—2 days
  • A. P.—2 days
  • N. L. support 2 days
  • E. G.—4 h

Formal BCT training (available online)

*Note: This is much more extensive training than the training required for the consult and collaborate levels

Senior Research Manager, National site

NL site lead

Research manager, NL

PE Scientific lead

PE coordinator

Patient responsibilities
  • Participate in focused conversations, team meetings, and larger stakeholder group meetings to review results of barriers assessment and potential BCTs for this intervention
  • o
    help to select appropriate BCTs to target the problems identified in the barriers assessment and
  • o
    plan the process for delivering the intervention.
  • Help to find participants (e.g., patients or others depending on your individual networks) for a larger, key stakeholder group who will be advising on the intervention development and materials moving forward.
Researcher commitment
We will work with you to codevelop the intervention for the LBP project, relying on your advice and unique perspective. We will incorporate your advice and recommendations to the maximum extent possible.
  • PE coordinator will advise you on where to find the online BCT training.
  • The Senior Research Manager, national site and the PE coordinator with meet with you to review the training and answer any questions you may have.
  • Subsequent meetings with the NL team and the larger group of key stakeholders will focus on selecting the BCTs and determining how the intervention will be delivered.
  • The Scientific PE Lead will facilitate these meetings.
Trial—intervention materials
October–December 2020
Includes developing physician and patient education materials that will be used in intervention delivery (e.g., anything developed for physicians or patients (videos, pamphlets, etc.)
Inform
0 Patient‐determined None required PE coordinator
Patient responsibilities
  • Review the intervention materials that are selected for the intervention within 1–2 weeks of receiving this documentation.
Researcher commitment
We will keep you informed by sharing the intervention materials we have selected with you.
  • PE coordinator will email you the intervention materials that have been developed/selected for this intervention.
Consult
0 1.5 h

A. H.—3 h

B. F.—2 h

A. P.—2 h

E. G.—2 h

None required

NL site lead

Research Manager, NL

PE coordinator

Students affiliated with this phase of the project

Patient responsibilities
  • Review the intervention materials produced and/or selected for the intervention (may include videos or scripts for family doctors, education or treatment planning materials for patients).
  • Provide written feedback (emailed to Research Manager, NL) highlighting the concerns or questions you have about the materials within 1–2 weeks of receiving the materials.
Researcher commitment
We will consider your feedback and let you know how it influenced the intervention development.
  • Research Manager, NL will email you the intervention materials (cc PE coordinator).
  • After we have reviewed your feedback the PE coordinator will communicate to you how your participation influenced our intervention materials.
Involve
1 2.5 h

A. H.—5 h

B. F.—3. 5 h

A. P.—4 h

E. G.—2 h

None required

NL site lead

Students affiliated with this phase of the project

Research Manager NL

PE coordinator

Patient responsibilities
  • Review the intervention materials produced and/or selected for the intervention (may include videos or scripts for family doctors, education or treatment planning materials for patients).
  • Provide written feedback (emailed to Research Manager NL) highlighting the concerns or questions you have about the materials within 1–2 weeks of receiving the materials.
  • Attend a round‐table meeting to review your critique and determine how the team can incorporate your feedback.
Researcher commitment
We will work with you to ensure your feedback is incorporated and directly reflected in the intervention that is developed to the maximum extent possible.
  • Research Manager NL will email you draft copies of the materials we have produced (cc PE coordinator)
  • Selected members of the NL team will meet with you to review your feedback and discuss how it can be incorporated.
Collaborate
2–3 Up to 7 h (includes meeting hours and independent work)

A. H.—2 days

A. P.—2 days

B. F.—2 days

NL SUPPORT—2 days

E. G.—4 h

  • Patient training (TDF)

NL site lead

Research Manager NL

Students affiliated with this phase of the project

Scientific PE Lead

PE coordinator

Patient responsibilities
  • Attend a lecture on the TDF. Note: This is the same training required at the collaboration level for the barriers assessment. If you have completed the lecture for the barriers assessment, you are not required to repeat it.
  • Partner with researchers and other stakeholders to select and potentially modify or develop intervention materials. This includes:
  • o
    attending meetings with selected team members to review intervention materials relevant to the BCTs selected during intervention development,
  • o
    Cocreate new materials and/or modify existing materials (as required),
  • o
    review and comment on materials selected.
  • Help to find participants (e.g., patients or others depending on your individual networks) for a larger, key stakeholder group who will be advising on the intervention development and materials moving forward.
Researcher commitment
We will work with you to select, modify, and/or create intervention materials to support the implementation of the selected BCTs, relying on your advice and unique perspective. We will incorporate your advice and recommendations to the maximum extent possible.
  • The PE coordinator will send you copies of any relevant materials that the team is already aware of for your review before meeting.
  • Subsequent meetings with the NL team and a larger group of key stakeholders will focus on selecting the intervention materials, identifying how they should be modified, and creating new materials as needed.
  • The Scientific PE Lead will facilitate these meetings.