CHALLENGES OF RECRUITMENT TO A RANDOMIZED CLINICAL TRIAL FOR OSTEOPOROSIS PREVENTION

2.50
Hdl Handle:
http://hdl.handle.net/10755/165296
Category:
Abstract
Type:
Presentation
Title:
CHALLENGES OF RECRUITMENT TO A RANDOMIZED CLINICAL TRIAL FOR OSTEOPOROSIS PREVENTION
Author(s):
Ott, Carol; Twiss, Janice J.; Waltman, Nancy L.; Gross, Gloria J.; Lindsey, Ada M.
Author Details:
Carol Ott, RN, OCN, PhD, University of Nebraska Medical Center, College of Nursing, Kearney, Nebraska, USA; Janice J. Twiss, APRN, PhD; Nancy L. Waltman, APRN, PhD; Gloria J. Gross, RN, PhD; Ada M. Lindsey, RN, PhD, FAAN
Abstract:
The purpose of this presentation is to describe recruitment planning and monitoring for a federally funded home-based clinical trial with a longitudinal design with four recruitment catchment areas that include 100 mile radius around each site across a 500 mile wide state. Recruitment is a challenging issue for a statewide randomized intervention trial for osteoporosis prevention with an accrual goal of 240 healthy postmenopausal women with a history of breast cancer. This recruitment goal was distributed to target 60% from two metropolitan sites and 40% from two rural sites with monthly monitoring of contacts and enrollment from each site for each recruitment method At the 66% time point into the 18 month recruitment phase, only 39% of the overall accrual goal had been attained. Re-evaluation of effective strategies and exploration of new ones were necessary. Recruitment strategies were intensified using the more successful methods and abandoning those less successful based on the following distribution: newspaper ads 43%, word of mouth 17%, TV interviews 10%, presentations to support and women’s groups 8%, fliers 7%, radio PSA’s and ads 4%, physician clinics 2%. Additional strategies were developed to address motivators for participation in clinical trials (e.g. staying healthy and trying a novel experience) and deterrents (e.g. fear of the unknown and unclear expectations). Because 86% of women were demonstrating bone loss via free DEXA screening, recruitment information also began emphasizing the prevalence of the problem in this population. As a result of these modifications and with 3 months remaining in the modified recruitment time line, 90% of the recruitment goal of 240 women are enrolled. Of 669 women screened to date via telephone and lab/DEXA testing, 215 (32%) have met eligibility criteria - 66% metropolitan and 34% rural. Recruitment costs per enrolled participant is $30. Tracking of recruitment efforts in large clinical trials should be ongoing, site specific, and cost effective. Monthly monitoring of accrual as a result of each recruitment strategy allowed for early identification of areas for change. Changes incorporated early in the recruitment phase addressed unique aspects of rural vs metropolitan areas and is resulting in achievement of accrual goals.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2005
Conference Name:
30th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Orlando, Florida, USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleCHALLENGES OF RECRUITMENT TO A RANDOMIZED CLINICAL TRIAL FOR OSTEOPOROSIS PREVENTIONen_GB
dc.contributor.authorOtt, Carolen_US
dc.contributor.authorTwiss, Janice J.en_US
dc.contributor.authorWaltman, Nancy L.en_US
dc.contributor.authorGross, Gloria J.en_US
dc.contributor.authorLindsey, Ada M.en_US
dc.author.detailsCarol Ott, RN, OCN, PhD, University of Nebraska Medical Center, College of Nursing, Kearney, Nebraska, USA; Janice J. Twiss, APRN, PhD; Nancy L. Waltman, APRN, PhD; Gloria J. Gross, RN, PhD; Ada M. Lindsey, RN, PhD, FAANen_US
dc.identifier.urihttp://hdl.handle.net/10755/165296-
dc.description.abstractThe purpose of this presentation is to describe recruitment planning and monitoring for a federally funded home-based clinical trial with a longitudinal design with four recruitment catchment areas that include 100 mile radius around each site across a 500 mile wide state. Recruitment is a challenging issue for a statewide randomized intervention trial for osteoporosis prevention with an accrual goal of 240 healthy postmenopausal women with a history of breast cancer. This recruitment goal was distributed to target 60% from two metropolitan sites and 40% from two rural sites with monthly monitoring of contacts and enrollment from each site for each recruitment method At the 66% time point into the 18 month recruitment phase, only 39% of the overall accrual goal had been attained. Re-evaluation of effective strategies and exploration of new ones were necessary. Recruitment strategies were intensified using the more successful methods and abandoning those less successful based on the following distribution: newspaper ads 43%, word of mouth 17%, TV interviews 10%, presentations to support and women’s groups 8%, fliers 7%, radio PSA’s and ads 4%, physician clinics 2%. Additional strategies were developed to address motivators for participation in clinical trials (e.g. staying healthy and trying a novel experience) and deterrents (e.g. fear of the unknown and unclear expectations). Because 86% of women were demonstrating bone loss via free DEXA screening, recruitment information also began emphasizing the prevalence of the problem in this population. As a result of these modifications and with 3 months remaining in the modified recruitment time line, 90% of the recruitment goal of 240 women are enrolled. Of 669 women screened to date via telephone and lab/DEXA testing, 215 (32%) have met eligibility criteria - 66% metropolitan and 34% rural. Recruitment costs per enrolled participant is $30. Tracking of recruitment efforts in large clinical trials should be ongoing, site specific, and cost effective. Monthly monitoring of accrual as a result of each recruitment strategy allowed for early identification of areas for change. Changes incorporated early in the recruitment phase addressed unique aspects of rural vs metropolitan areas and is resulting in achievement of accrual goals.en_GB
dc.date.available2011-10-27T12:16:00Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:16:00Z-
dc.conference.date2005en_US
dc.conference.name30th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationOrlando, Florida, USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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