Strategies for overcoming site and recruitment challenges in research studies based in intensive care units.

Full Abstract

Although enrolling a sufficient number of participants is a challenge for any multisite clinical trial, recruiting patients who are critically ill and receiving mechanical ventilatory support presents additional challenges because of the severity of the patients' illness and the impediments to their communication. Recruitment challenges related to the research sites, nursing staff, and research participants faced in the first 2 years of a 4-year multisite clinical trial of a patient-directed music intervention for managing anxiety in the intensive care unit were determined. Strategies to overcome these challenges, and thereby increase enrollment, were devised. Individual strategies, such as timing of screening on a unit, were tailored to each participating site to enhance recruitment for this trial. Other strategies, such as obtaining a waiver for a participant's signature, were instituted across all participating sites. Through implementation of these various strategies, the mean monthly enrollment of participants increased by 50%. Investigators are advised to plan well in advance of starting recruitment for a clinical trial based in an intensive care unit, anticipate peaks and valleys in recruitment, and be proactive in addressing issues creatively as the issues arise.

Author information

Author/s: Chlan, Linda (L); Guttormson, Jill (J); Tracy, Mary Fran (MF); Bremer, Karin Lindstrom (KL);

Affiliation: School of Nursing at the University of Minnesota, Minneapolis, MN 55455, USA. chlan001(-atsign-)umn.edu

Grants: R01 NR009295-01A1 (Agency:NINR NIH HHS) ; R01NR009295 (Agency:NINR NIH HHS)

Journal and publication information

Publication Type: Journal Article; Research Support, N.I.H., Extramural

Journal: American journal of critical care : an official publication, American Association of Critical-Care Nurses (Am J Crit Care), published in United States. (Language: eng)

Reference: 2009-Sep; vol 18 (issue 5) : pp 410-7

Dates: Created 2009/09/02; Completed 2009/10/13; Revised 2009/10/14;

PMID: 19723861, status: MEDLINE (last retrieval date: 10/15/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

External Links for this article
(including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.

MeSH headings (categories)

This article was linked to the MESH Headings shown below.

This article has not been indexed for related articles as yet, however you can still use the live related article search links below.

See 100+ related articles.

See a large map of 100+ related articles.