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Patient-centered recruitment and retention for a randomized controlled study.

ABSTRACT: BACKGROUND:Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial. METHODS:This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients. RESULTS:We recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians' offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders' advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge. CONCLUSIONS:We have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies. TRIAL REGISTRATION:Clinicaltrials.gov , ID: NCT02032550 . Registered on 22 November 2013.

SUBMITTER: Chhatre S

PROVIDER: S-EPMC5870194 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Patient-centered recruitment and retention for a randomized controlled study.

Chhatre Sumedha S Jefferson Ashlie A Cook Ratna R Meeker Caitlin R CR Kim Ji Hyun JH Hartz Kayla Marie KM Wong Yu-Ning YN Caruso Adele A Newman Diane K DK Morales Knashawn H KH Jayadevappa Ravishankar R

Trials 20180327 1

<h4>Background</h4>Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial.<h4>Methods</h4>This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients.<h4>Results< ...[more]

PMID: 29587805

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Project description:BACKGROUND/AIMS:In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS:Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5?years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p?<?0.05. RESULTS:Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p?=?0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p?=?0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p?=?0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p?=?0.06), understanding the study purpose (83.6% vs 71.0%, p?=?0.02), nature and extent (82.8% vs 70.2%, p?=?0.02), and potential societal benefits (82.8% vs 67.9%, p?=?0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p?=?0.03) were better in the video compared to the no video consent group. CONCLUSION:The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Project description:OBJECTIVES:Our primary aim of this pilot study was to test feasibility of the planned design, the interventions (education plus telephone coaching), and the outcome measures, and to facilitate a power calculation for a future randomized controlled trial to improve adherence to recovery goals following hip fracture. DESIGN:This is a parallel 1:1 randomized controlled feasibility study. SETTING:The study was conducted in a teaching hospital in Vancouver, BC, Canada. PARTICIPANTS:Participants were community-dwelling adults over 60 years of age with a recent hip fracture. They were recruited and assessed in hospital, and then randomized after hospital discharge to the intervention or control group by a web-based randomization service. Treatment allocation was concealed to the investigators, measurement team, and data entry assistants and analysts. Participants and the research physiotherapist were aware of treatment allocation. INTERVENTION:Intervention included usual care for hip fracture plus a 1-hour in-hospital educational session using a patient-centered educational manual and four videos, and up to five postdischarge telephone calls from a physiotherapist to provide recovery coaching. The control group received usual care plus a 1-hour in-hospital educational session using the educational manual and videos. MEASUREMENT:Our primary outcome was feasibility, specifically recruitment and retention of participants. We also collected selected health outcomes, including health-related quality of life (EQ5D-5L), gait speed, and psychosocial factors (ICEpop CAPability measure for Older people and the Hospital Anxiety and Depression Scale). RESULTS:Our pilot study results indicate that it is feasible to recruit, retain, and provide follow-up telephone coaching to older adults after hip fracture. We enrolled 30 older adults (mean age 81.5 years; range 61-97 years), representing a 42% recruitment rate. Participants excluded were those who were not community dwelling on admission, were discharged to a residential care facility, had physician-diagnosed dementia, and/or had medical contraindications to participation. There were 27 participants who completed the study: eleven in the intervention group, 15 in the control group, and one participant completed a qualitative interview only. There were no differences between groups for health measures. CONCLUSION:We highlight the feasibility of telephone coaching for older adults after hip fracture to improve adherence to mobility recovery goals.

Project description:BackgroundAlthough the majority of American Indians/Alaska Natives reside in urban areas, there are very few randomized controlled trials analyzing culturally centered substance use prevention interventions for this population.MethodsWe describe methods employed to recruit and retain urban American Indian/Alaska Native adolescents into a randomized controlled trial, which was focused on testing the potential benefits of a substance use prevention intervention for this population. We also report challenges encountered in recruitment and retention of participants and strategies employed addressing these challenges. Data collection occurred from August 2014 to October 2017.ResultsWe partnered with two community-based organizations in different cities in California. We utilized American Indian/Alaska Native recruiters from communities, placed flyers in community-based organizations, and asked organizations to post flyers on their web and social media sites. We also offered gift cards for participants. Our initial recruitment and retention model was moderately successful; however, we encountered five main challenges: (1) transportation, (2) increasing trust and interest, (3) adding research sites, (4) getting the word out about the project, and (5) getting youth to complete follow-up surveys. Strategies employed to overcome transportation challenges included shortening the number of sessions, offering sessions on both weekends and weekdays, and increasing bus tokens and transportation options. We hired more staff from American Indian/Alaska Native communities, added more research sites from our previously established relationships, and were more proactive in getting the word out on the project in American Indian/Alaska Native communities. We also utilized more field tracking and emailed and mailed survey invitations to reach more participants for their follow-up surveys. Because of our efforts, we were nearly able to reach our initial recruitment and retention goals.ConclusionAlthough our research team had previously established relationships with various urban American Indian/Alaska Native communities, we encountered various recruitment and retention challenges in our study. However, by identifying challenges and employing culturally appropriate strategies, we were able to collect valuable data on the potential effectiveness of a substance use prevention intervention for urban American Indian/Alaska Native adolescents. Findings from this study assist toward the development of potentially successful strategies to successfully recruit and retain urban American Indian/Alaska Native adolescents in randomized controlled trials.

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Patient-centered recruitment and retention for a randomized controlled study.

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Patient-centered recruitment and retention for a randomized controlled study.

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