Patient Centered Outcomes Research

Toolkit to Promote Patient and Family Engagement during Critical Illness in Patient Centered Outcomes Research

nurse speaks with patient and family member
Section Contents

Methods

  • We implemented the mixed-methods approach Group Concept Mapping (GCM) with recently discharged ICU patients, their family members/caregivers, & ICU clinicians and researchers
  • Stakeholders identified barriers to research participation in 7 domains
  • Stakeholders rated the barriers for feasibility to addressing the barrier, and the impact of doing so

Based on the results of the project and pertinent literature on recruiting research participants, a number of strategies were identified to overcome barriers to engaging ICU patients and family members in PCOR/CER.

The strategies reviewed by the advisory board members and sorted into applicable categories.

Strategies

  • Strategies for Engaging Patients/Family Members during the ICU Stay
    • Involve a trusted ICU provider
    • Utilize trained research staff for recruitment
    • Ensure that patients/families have sufficient information to make informed decisions about research participation
    • Clarify that participation in research will not impact ICU care
    • Consider use of a patient and family advisory group
  • Strategies for Engaging Patients/Family Members after ICU Hospitalization
    • Enlist interest in potential studies prior to discharge if possible
    • Obtain accurate follow up contact information
    • Consider patient and family member’s ability to participate in research post discharge
    • Use public facing platforms, such as social media, posters, information leaflets, animations, videos to publicize research opportunities
  • Strategies for Addressing ICU Setting Limitations
    • Promote a research culture in the ICU
    • Address barriers to informed consent
  • Strategies for Addressing Research Logistics
    • Provide clinical staff with access to research training and information about ICU research and consent processes.
    • Assess capacity of patient/family to participate – have clear eligibility criteria
    • Avoid a narrow recruitment window
    • Consider timing of recruitment in context of patient/family readiness to participate
    • Evaluate use of electronic patient recruitment tools
    • Consider use of decision aids
  • Addressing Research Fears
    • Build trust between patients/family members, ICU clinicians, and research team
    • Use a structured approach when discussing research with patients/family members
    • Reduce decision-maker burden on family members with staged consent with information provided initially and  recruitment completed at later time
    • Offer patients/family members the opportunity to access summaries of study findings
    • Provide information on where patients/family members can access further information about the study
    • If patient/family decline study participation, explore additional information needs or potential misunderstandings
  • Considerations for ICU Clinicians
    • Keep up-to-date with research opportunities that exist for patients/family members
    • Embed research in routine clinical practice
    • Address patient/family misperceptions or fears related to research participation
  • Considerations for ICU Researchers
    • Ensure recruitment materials and consent forms are appropriate for patient/family members with varied educational levels
    • Utilize experienced persons for recruitment
    • Actively involve patients/family members in the design of  study and information materials, if possible
    • Explore clinician reluctance to enroll patients/family members for research studies
    • Provide incentives/compensation based on research involvement
  • Patient/Family Logistics
    • Ensure patient/family privacy and time for decision making
    • Written study information should be easy to understand and include information relevant to patients/families
    • Use patient/family member facing information such as posters, information leaflets, animations and videos to publicize research opportunities
  • Experiences Related to ICU Stay
    • Consider best timing to approach patient/family for research participation
    • Evaluate implications of research participation within content of treatment plan

References

Turnbull AE, Hashem MD, Rabiee A, et al. Evaluation of a strategy for enrolling the families of critically ill patients in research using limited human resources. PLoS ONE 2017; 12(5): e0177741.

Burns KEA, Rizvi L, Smith OM, et al. Is there a role for physician involvement in introducing research to surrogate decision makers in the intensive care unit? (The Approach trial: a pilot mixed methods study). Intensive Care Med 2015; 41(1): 58–67.

Young B, Woolfall, K, Frith, L. et al. The Perspectives Study: From Evidence to Guidance on Patient Recruitment to Clinical Research in Intensive Care Units, 2016-2019. Colchester, Essex: UK Data Service: 2021. https://reshare.ukdataservice.ac.uk/854286/

Dotolo D, Nielsen EL, Curtis JR, & Engelberg RA. Strategies for Enhancing Family Participation in Research in the ICU: Findings From a Qualitative Study. Journal of Pain and Symptom Management, 2017;54(2):226-230.e1

Paddock K, Woolfall K, Frith L, et al. Strategies to enhance recruitment and consent to intensive care studies: A qualitative study with researchers and patient–public involvement contributors. BMJ Open, 2021;11(9):e048193

Raven-Gregg T, Wood F, Shepherd V. Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis. Clinical Trials 2021;4:436-448. 

Sole ML, Middleton A, Deaton L, et al. Enrollment challenges in critical care nursing research. American Journal of Critical Care 2017;26:395–400. 

Chlan L, Guttormson J, Tracy MF, et al. Strategies for overcoming site and recruitment challenges in research studies based in intensive care units. Am J Crit Care 2009;18(5):410–417.

Acknowledgement: Work reported in this toolkit was partially funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (EACB-26623). The statements in this toolkit are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.