title: Cost-effectiveness of a nurse-led intervention to optimise implementation of guideline-concordant continence care: Study protocol of the COCON study.
abstract: BACKGROUND
  Guidelines on urinary incontinence recommend that absorbent products are only used as a coping strategy pending definitive treatment, as an adjunct to ongoing therapy, or for long-term management after all treatment options have been explored. However, these criteria are rarely met and a significant share of long-term product users could still benefit from therapeutic interventions recommended in guidelines for urinary incontinence. Better implementation of these guidelines can potentially result in both health benefits for women and long-term cost savings for society. The aim of the COCON study is to evaluate the (cost-)effectiveness of a nurse-led intervention to optimise implementation of guideline-concordant continence care in comparison with usual care for urinary incontinent women aged 55 years and over who use absorbent products.
  
  
  METHODS
  This randomised clinical trial compares usual care with a nurse-led intervention to optimise implementation of guideline-concordant continence care. Women (anticipatedN= 160) are recruited in 12 community pharmacies in three Dutch regions, and are eligible for trial entry when they are 55 years and over, community-dwelling and long-term users of absorbent products (≥4 months) reimbursed by health insurance. Measurements are administered at baseline, 3, 6 and 12 months. Primary outcome is severity of urinary incontinence (ICIQ-UI SF); other outcomes include health related quality of life (EQ-5D-5 L), use of absorbent products (in accordance with the recommended criteria in guidelines) (yes/no), and societal costs. Mixed model analysis will be performed to compare (the course) of outcomes between groups. The economic evaluation will be performed from a societal perspective. The implementation process is investigated using the Tailored Implementation for Chronic Diseases (TICD) framework.
  
  
  CONCLUSIONS
  Results will add to current knowledge of the (cost-)effectiveness of nurse-led primary healthcare to improve guideline-concordant care for older women with urinary incontinence. In addition, the results will provide more insight into care needs and health service utilization of this group of women, as well as into use of absorbent products in accordance with the recommended criteria in guidelines. Finally, results will increase our understanding of the intervention's uptake and could provide useful insights for future dissemination and sustenance.
  
  
  BACKGROUND
  Dutch Trial Register NTR4396, registered 13-January-2014.
authors.affiliation: Amsterdam Public Health research institute, VU University Medical Center, Amsterdam, The Netherlands.|Department of General Practice and Elderly Care Medicine, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Aaltje P D
authors.initials: APD
authors.lastname: Jansen
authors.affiliation: Amsterdam Public Health research institute, VU University Medical Center, Amsterdam, The Netherlands.|Department of General Practice and Elderly Care Medicine, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Maaike E
authors.initials: ME
authors.lastname: Muntinga
authors.affiliation: Department of Health Sciences and Amsterdam Public Health research institute, Faculty of Earth and Life Sciences, Vrije Universiteit, Amsterdam, The Netherlands.
authors.forename: Judith E
authors.initials: JE
authors.lastname: Bosmans
authors.affiliation: Maastricht University, Maastricht, The Netherlands; Pelvic care Center Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: Bary
authors.initials: B
authors.lastname: Berghmans
authors.affiliation: Department of General Practice, University of Groningen; University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Janny
authors.initials: J
authors.lastname: Dekker
authors.affiliation: Amsterdam Public Health research institute, VU University Medical Center, Amsterdam, The Netherlands.|Department of Clinical Pharmacology and Pharmacy, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Hugtenburgh
authors.affiliation: Amsterdam Public Health research institute, VU University Medical Center, Amsterdam, The Netherlands.|Department of General Practice and Elderly Care Medicine, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Giel
authors.initials: G
authors.lastname: Nijpels
authors.affiliation: Zonnehuisgroep Amstelland, Amstelveen, The Netherlands.
authors.forename: Paul
authors.initials: P
authors.lastname: van Houten
authors.affiliation: Faculty of Health and Social Studies, HAN University of Applied Sciences, Nijmegen, The Netherlands.|Radboud University Medical Center, Radboud Institute for Health Science, IQ healthcare, Nijmegen, The Netherlands.
authors.forename: Miranda G H
authors.initials: MGH
authors.lastname: Laurant
authors.affiliation: Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Huub C H
authors.initials: HCH
authors.lastname: van der Vaart
keywords: Absorbent products; Community continence care; Cost-effectiveness; Implementation; Nursing; Primary care; Randomised controlled trial; Supplementation; Urinary incontinence