Overcoming recruitment barriers revealed high readiness to participate and low dropout rate among people with schizophrenia in a randomized controlled trial testing the effect of a Guided Self-Determination intervention

BMC Psychiatry

Vibeke Zoffmann⁶  Lars Hansson⁵  Kelly D Buck³  Paul H Lysaker⁴  Povl Munk-Jørgensen¹  Rikke Jørgensen² 

[1] Department M, Aarhus University Hospital, Aarhus, Denmark;Unit for Psychiatric Research, Aalborg Psychiatric Hospital, Aalborg University Hospital, Mølleparkvej 10, 9000 Aalborg, Denmark;Roudebush Veteran Affairs Medical Center, Indianapolis, IN, USA;Indiana University School of Medicine, Indianapolis, USA;Lund University, Lund, Sweden;NKLMS Oslo University Hospital, Oslo, Norway

关键词: Readiness;    Strategies;    Recruitment challenges;    Organization;    Randomized controlled trial;    Outpatients;    Schizophrenia;   

Others  :  1123803
DOI  :  10.1186/1471-244X-14-28

 received in 2013-03-06, accepted in 2014-01-29,  发布年份 2014

【 摘 要 】

Background

Recruitment is one of the most serious challenges in performing randomized controlled trials. Often clinical trials with participants diagnosed with schizophrenia are terminated prematurely because of recruitment challenges resulting in a considerable waste of resources in the form of time, funding, and the participants’ efforts. Dropout rates in schizophrenia trials are also high.

Recruitment challenges are often due to patients not wanting to participate in research but can also be due to clinicians’ concerns regarding individuals diagnosed with schizophrenia as participants in research. This paper reports how overcoming recruitment challenges not related to patients revealed high readiness to take part and low dropout rates in a one year long randomized controlled trial testing Guided Self-Determination (GSD) among outpatients with schizophrenia receiving treatment in Assertive Outreach Teams in the northern part of Denmark.

Methods

GSD is a shared decision-making and mutual problem-solving method using reflection sheets, which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia. Descriptive data on strategies to overcome recruitment challenges were derived from notes and observations made during the randomized controlled trial testing of GSD in six outpatient teams.

Results

Three types of recruitment challenges not related to patients were identified and met during the trial: 1) organizational challenges, 2) challenges with finding eligible participants and 3) challenges with having professionals invite patients to participate. These challenges were overcome through: 1) extension of time, 2) expansion of the clinical recruitment area and 3) encouragement of professionals to invite patients to the study. Through overcoming these challenges, we identified a remarkably high patient-readiness to take part (101 of 120 asked accepted) and a low dropout rate (8%).

Conclusion

Distinction between recruitment challenges was important in discovering the readiness among patients with schizophrenia to take part in and complete a trial with the GSD-intervention.

【 授权许可】

   
2014 Jørgensen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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