Cost-effectiveness of a nurse-led intervention to optimise implementation of guideline-concordant continence care: Study protocol of the COCON study

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 (anticipated N = 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. Discussion 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. Trial registration Dutch Trial Register NTR4396, registered 13-January-2014 Electronic supplementary material The online version of this article (doi:10.1186/s12912-017-0204-8) contains supplementary material, which is available to authorized users.


Information, education and advice (tailored to woman's situation/type of UI)
-Etiology of UI (anatomy, pelvic floor muscles), influence of lifestyle on UI, e.g. fluid intake, coffee and alcoholic beverage, weight, constipation, and role of mobility, comorbidity, ageing, and medications. -Recommendations on lifestyle and healthy toilet behaviour -BMI > 30: Lose weight (GP request for dietician referral) UUI SUI MUI FUI OB UTI

Shared decision making (tailored to woman's situation/type of UI)
-Advise on appropriate treatment/care options, as well as GP diagnostics.
-Counsel about prognosis, adverse effects, and (long-term) implications of appropriate treatment/care options.
-Support in deciding on an action plan, register wished care -If treatment is not possible or rejected, or if absorbent use is indicated, facilitate that woman receive pads that are adapted to her personal needs and leakage.
-letter to woman's GP with the findings, action plan, and advice for GP diagnostics and referrals -inform pharmacist about decisions on absorbent products use • EHR reminds nurse of consultations and provides the summary of the woman's situation and the action plan agreed on • Monitor: assess UI status, impact of UI, satisfaction with care, GP/professional's response to advices on referrals and diagnostics, evaluate and readjust action plan, build woman's self-confidence • Information, education and advice (tailored to woman's situation) Frequency and moments of consultations depend on care agreed on (in any case follow-up consultations take place at 3 and 6 months after shared decision on an action plan ánd at the end of the project) -letter to woman's GP 3 with the findings, action plan, and advice for GP diagnostics and referrals -inform pharmacist about decisions on absorbent products use 1) no Pelvic Floor Muscle Training (PFMT) in the past, no contra-indications for PFMT and Sandvik index score: mild or moderate (score < 4)  PFMT 2) no Pelvic Floor Muscle Training (PFMT) in the past, no contra-indications for PFMT and a Sandvik index score: severe (score > 6)  GP request for surgery 3) PFMT in the past without persistent improvement of complaints  GP request for surgery 4) PFMT contra-indicated due to comorbidities/limitations  GP request for surgery 5) Recent surgery without persistent improvement of complaints or surgery contra-indicated due to comorbidities/limitations  absorbent products and skin products adapted to woman's personal needs and leakage Agreed on PFMT  -after 6 weeks a consult by telephone to evaluate effects and to stimulate adherence -after 3 months: face-to-face consult to evaluate effect of PFMT in case of insufficient improvement after 3 months: GP request for surgery Agreed on surgery  after 6 weeks a consult by telephone to evaluate situation (GP's response, planned surgery) as well as 6 weeks after surgery

Information, education and advice (tailored to woman's situation/type of UI)
-GP patient leaflet on urge urinary incontinence -In case of obstipation (which might influence UUI): lifestyle advice, consider GP request for additional diagnostics and drugs to regulate obstipation. After 2 weeks: evaluation of the effect on defecation pattern. 2) BT without persistent improvement of complaints, no contra-indications for anticholinergics use  GP request for additional overactive bladder drugs (anticholinergics) + BT continuation 3) Overactive bladder drugs use without persistent improvement of complaints  GP request for a higher dose of anticholinergics or other type of anticholinergic drug 4) Overactive bladder drugs use (higher dose/other drugs) without persistent improvement of complaints or adverse effects  GP request for Multidisciplinary medical specialist team/surgery, PSNS or botox 5) BT without persistent improvement of complaints and Anticholinergics/overactive bladder drugs contra-indicated  GP request for Multidisciplinary medical specialist team/surgery, PSNS or botox 6) recent surgery without persistent improvement of complaints or surgery contra-indicated due to comorbidities/limitations  absorbent products and skin products adapted to woman's personal needs and leakage

UUI
Agreed on BT  -after 2 weeks a consult by telephone to evaluate effects and to stimulate adherence -after 6 weeks: face-to-face consult to evaluate effect of BT (Bladder diaries are used as an aid in the the evaluation of the therapy).
-in case of insufficient improvement after 3 months: GP request for overactive bladder drugs (if indicated) or surgery, PSNS or botox.
Agreed on overactive bladder drugs or BT and additional overactive bladder drugs  -after 6 weeks: a consult to evaluate effects and adverse effects of drugs Agreed on surgery, botox or PSNS  -after 6 weeks a consult by telephone to evaluate situation (GP's response, planned surgery) as well as 6 weeks after surgery