scholarly journals Cost-effectiveness of a stepwise cardiometabolic disease prevention program: results of a randomized controlled trial in primary care

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Daphne M. Stol ◽  
Eelco A. B. Over ◽  
Ilse F. Badenbroek ◽  
Monika Hollander ◽  
Mark M. J. Nielen ◽  
...  

Abstract Background Cardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care. Methods A randomized controlled trial in a primary care setting in which 1934 participants aged 45–70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (− 2.26 mmHg; 95% CI − 4.01: − 0.51) and total cholesterol (− 0.15 mmol/l; 95% CI − 0.23: − 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective. Results After 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (− 0.0154; 95% CI − 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention. Conclusions Implementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended. Trial registration Dutch Trial Register NTR4277, registered on 26 November 2013

2009 ◽  
Vol 195 (4) ◽  
pp. 308-317 ◽  
Author(s):  
Hans-Helmut König ◽  
Anja Born ◽  
Dirk Heider ◽  
Herbert Matschinger ◽  
Sven Heinrich ◽  
...  

BackgroundIndividuals with anxiety disorders often do not receive an accurate diagnosis or adequate treatment in primary care.AimsTo analyse the cost-effectiveness of an optimised care model for people with anxiety disorders in primary care.MethodIn a cluster randomised controlled trial, 46 primary care practices with 389 individuals positively screened with anxiety were randomised to intervention (23 practices, 201 participants) or usual care (23 practices, 188 participants). Physicians in the intervention group received training on diagnosis and treatment of anxiety disorders combined with the offer of a psychiatric consultation–liaison service for 6 months. Anxiety, depression, quality of life, service utilisation and costs were assessed at baseline, 6-month and 9-month follow-up.ResultsResultsNo significant differences were observed between intervention and control group on the Beck Anxiety Inventory, Beck Depression Inventory and EQ–5D during follow-up. Total costs were higher in the intervention group (€4911 v. €3453, P = 0.09). The probability of an incremental cost-effectiveness ratio <€50 000 per quality-adjusted life year was below 10%.ConclusionsThe optimised care model did not prove to be cost-effective.


2014 ◽  
Vol 45 (7) ◽  
pp. 1401-1412 ◽  
Author(s):  
P. Otero ◽  
F. Smit ◽  
P. Cuijpers ◽  
A. Torres ◽  
V. Blanco ◽  
...  

BackgroundAlthough depression is a common problem among non-professional caregivers, only one trial has evaluated the efficacy of indicated prevention targeting this population and the long-term efficacy is unknown. The aim of this study was to evaluate the long-term efficacy of a brief intervention for the indicated prevention of depression in a sample of female caregivers.MethodA randomized controlled trial was conducted involving 173 participants (mean age 53.9 years) who were allocated to the intervention (n = 89) or the usual-care control group (n = 84). Blinded interviewers conducted assessments at 1, 3, 6 and 12 months of follow-up. The main outcome measure was the incidence of major depression and the secondary outcomes were compliance with treatment, depressive symptoms, emotional distress and caregiver burden.ResultsAt the 12-month follow-up, a lower incidence of depression as evaluated using the Structured Clinical Interview for Axis I Disorders of the DSM-IV was found in the intervention group compared with the control group (10.1%v.25.0%). The relative risk was 0.40 and statistically significant [χ2 = 6.68, degrees of freedom = 1,p = 0.010, 95% confidence interval (CI) 0.20–0.81], and the number needed to treat was 7 (95% CI 4–27). There was a significant delay in the onset of depression in the intervention group (p = 0.008). The good complier caregivers had a lower incidence of depression. The intervention effect on depressive symptoms, emotional distress and caregiver burden were maintained for 12 months.ConclusionsThis is the first study to demonstrate that a brief problem-solving intervention can prevent the onset of depression among non-professional caregivers over the longer term.


2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513


Author(s):  
Anne Loohuis ◽  
Henk van der Worp ◽  
Nienke Wessels ◽  
Janny Dekker ◽  
Marijke Slieker-ten Hove ◽  
...  

Objective: Long-term cost-effectiveness of app-based treatment for female stress, urgency, or mixed urinary incontinence (UI) compared to care-as-usual in primary care. Design: A pragmatic, randomised controlled, superiority trial. Setting: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. Population: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. 262 women randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up. Methods: The standalone app included conservative management for UI with motivation aids (e.g., reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. Main outcome measures: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTS-QoL, EQ-5D-5L) on superiority with linear regression on an intention-to-treat basis. Cost-effectiveness and -utility from a societal perspective, based on Incontinence Impact Adjusted Life Years (IIALYs) and Quality Adjusted Life years (QALYs). Results: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6), with a non-significant mean difference of 0.903 (-0.66 to 1.871). Costs were lower for app-based treatment with \euro-161 (95%CI: -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger ICER (-3,696) and ICUR (\euro6,379). Conclusion: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of long-term cost-effectiveness. Funding: Dutch Organisation for Health Research and Development (ZonMw: 837001508), sub-funding P.W. Boer Foundation Dutch Trial Register identifier: Trial NL4948 (www.trialregister.nl/trial/4948).


2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Torunn Askim ◽  
Birgitta Langhammer ◽  
Hege Ihle-Hansen ◽  
Jon Magnussen ◽  
Torgeir Engstad ◽  
...  

Background. There are no evidence-based strategies that have been shown to be superior in maintaining motor function for months to years after the stroke. The LAST study therefore intends to assess the effect of a long-term follow-up program for stroke patients compared to standard care on function, disability and health.Design. This is a prospective, multi-site randomised controlled trial, with blinded assessment 18 months after inclusion. A total of 390 patients will be recruited and randomised to a control group, receiving usual care, or to an intervention group 10 to 16 weeks after onset of stroke. Patients will be stratified according to stroke severity, age above 80, and recruitment site. The intervention group will receive monthly coaching on physical activity by a physiotherapist for 18 consecutive months after inclusion.Outcomes. The primary outcome is motor function (Motor Assessment Scale) 18 months after inclusion. Secondary outcomes are: dependency, balance, endurance, health-related quality of life, fatigue, anxiety and depression, cognitive function, burden on caregivers, and health costs. Adverse events and compliance to the intervention will be registered consecutively during follow-up.


2019 ◽  
Author(s):  
Lynne Taylor ◽  
John Parsons ◽  
Denise Taylor ◽  
Elizabeth Binns ◽  
Sue Lord ◽  
...  

Abstract Background Falls are two to four times more frequent amongst long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesized that a progressive exercise program targeting balance and strength will reduce falls rates when compared to a seated exercise program and do so cost effectively. Methods/Design This is a single blind, parallel-group, randomized controlled trial with blinded assessment of outcome and intention-to-treat analysis. LTC residents (age ≥65 years) will be recruited from LTC facilities in New Zealand. Participants (n= 528 total; with a 1:1 allocation ratio) will be randomly assigned to either a novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia, (intervention group) or a seated exercise program (control group). The intervention and control group classes will be delivered for 1 hour twice weekly over 1 year. The primary outcome is rate of falls (per 1000 person years) within the intervention period. Secondary outcomes will be risk of falling (the proportion of fallers per group), falls rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance assessed at baseline, 6 and 12 months. Cost effectiveness will be examined using intervention and health service costs. The trial commenced recruitment on 31 November 2018. Discussion This study evaluates the efficacy and cost effectiveness of a progressive strength and balance exercise program for aged-care residents to reduce falls. The outcomes will aid development of evidenced-based exercise programs for this vulnerable population.


Psychologica ◽  
2020 ◽  
Vol 63 (2) ◽  
pp. 53-68
Author(s):  
Sharon Allan ◽  
Bilge Uzun ◽  
Cecilia A. Essau

The present study examined the benefit of a transdiagnostic prevention program, Super Skills for Life (SSL), among adolescents with internalizing and/or externalizing problems in two types of school settings (mainstream school and pupil referral unit) using a randomized waitlist-controlled trial (RCT). The main aims were to examine the effects of the SSL-A in reducing internalizing and externalizing problems in adolescents, and to identify the moderating role of gender, age, and school type on the intervention outcome. The RCT involved 112 adolescents aged 11 to 14 years old, randomly allocated to either an SSL intervention group or a waitlist-control group (WLC). Adolescents in the intervention group participated immediately in the SSL-A, whereas adolescents in the WLC group received the intervention after the intervention group completed the 6 months follow-up assessment. Results showed that internalizing and externalizing problems were significantly reduced from pre-test to follow-up assessments. Gender, age and school setting moderated the intervention outcome. Specifically, males, younger adolescents and adolescents from mainstream schools showed a significant reduction over time on both internalizing and externalizing problems. This study provides evidence for the benefits of a transdiagnostic prevention program for internalizing and externalizing problems in two types of school settings.


2017 ◽  
Vol 21 (3) ◽  
pp. 1-206 ◽  
Author(s):  
Hazel Gilbert ◽  
Stephen Sutton ◽  
Richard Morris ◽  
Irene Petersen ◽  
Qi Wu ◽  
...  

BackgroundThe NHS Stop Smoking Services (SSSs) offer help to smokers who want to quit. However, the proportion of smokers attending the SSSs is low and current figures show a continuing downward trend. This research addressed the problem of how to motivate more smokers to accept help to quit.ObjectivesTo assess the relative effectiveness, and cost-effectiveness, of an intervention consisting of proactive recruitment by a brief computer-tailored personal risk letter and an invitation to a ‘Come and Try it’ taster session to provide information about the SSSs, compared with a standard generic letter advertising the service, in terms of attendance at the SSSs of at least one session and validated 7-day point prevalent abstinence at the 6-month follow-up.DesignRandomised controlled trial of a complex intervention with follow-up 6 months after the date of randomisation.SettingSSSs and general practices in England.ParticipantsAll smokers aged ≥ 16 years identified from medical records in participating practices who were motivated to quit and who had not attended the SSS in the previous 12 months. Participants were randomised in the ratio 3 : 2 (intervention to control) by a computer program.InterventionsIntervention – brief personalised and tailored letter sent from the general practitioner using information obtained from the screening questionnaire and from medical records, and an invitation to attend a taster session, run by the local SSS. Control – standard generic letter from the general practice advertising the local SSS and the therapies available, and asking the smoker to contact the service to make an appointment.Main outcome measures(1) Proportion of people attending the first session of a 6-week course over a period of 6 months from the receipt of the invitation letter, measured by records of attendance at the SSSs; (2) 7-day point prevalent abstinence at the 6-month follow-up, validated by salivary cotinine analysis; and (3) cost-effectiveness of the intervention.ResultsEighteen SSSs and 99 practices within the SSS areas participated; 4384 participants were randomised to the intervention (n = 2636) or control (n = 1748). One participant withdrew and 4383 were analysed. The proportion of people attending the first session of a SSS course was significantly higher in the intervention group than in the control group [17.4% vs. 9.0%; unadjusted odds ratio (OR) 2.12, 95% confidence interval (CI) 1.75 to 2.57;p < 0.001]. The validated 7-day point prevalent abstinence at the 6-month follow-up was significantly higher in the intervention group than in the control group (9.0% vs. 5.6%; unadjusted OR 1.68, 95% CI 1.32 to 2.15;p < 0.001), as was the validated 3-month prolonged abstinence and all other periods of abstinence measured by self-report. Using the National Institute for Health and Care Excellence decision-making threshold range of £20,000–30,000 per quality-adjusted life-year gained, the probability that the intervention was more cost-effective than the control was up to 27% at 6 months and > 86% over a lifetime horizon.LimitationsParticipating SSSs may not be representative of all SSSs in England. Recruitment was low, at 4%.ConclusionsThe Start2quit trial added to evidence that a proactive approach with an intensive intervention to deliver personalised risk information and offer a no-commitment introductory session can be successful in reaching more smokers and increasing the uptake of the SSS and quit rates. The intervention appears less likely to be cost-effective in the short term, but is highly likely to be cost-effective over a lifetime horizon.Future workFurther research could assess the separate effects of these components.Trial registrationCurrent Controlled Trials ISRCTN76561916.Funding detailsThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 3. See the NIHR Journals Library website for further project information.


2020 ◽  
Vol 3 ◽  
pp. 33
Author(s):  
Dominic Trépel ◽  
Shehzad Ali ◽  
Simon Gilbody ◽  
Alfonso Leiva ◽  
Dean Mcmillan ◽  
...  

Background: In Spain, long-term use of benzodiazepine is prevalent in 7% of the population; however, this longer-term use lacks clinical benefits, costs €90million per year and side-effects further add extra cost through adverse health outcomes. This study aims to estimate the cost-effectiveness of primary care services stepped dose reduction of long-term benzodiazepines using either Structured Interview with Follow-up (SIF) or Without Follow-up (SIW), compared to Treatment as Usual (TAU). Design: Cost-effectiveness analysis was conducted alongside randomised control utilizing data from three arm cluster randomized trial. Setting: Primary care. Participants: 75 general practitioners were randomised to one of the three arms (TAU, SIW, SIF). Measurements: Cost and Cost per Quality-Adjusted Life Year (QALY) Results: Compared to usual care, providing SIW per participant costs an additional €117.94 and adding patient follow-up, €218.4. As a result of intervention, participants showed a gain of, on average, for SIW 0.0144 QALY (95% CI -0.0137 to 0.0425) and for SIF 0.0340 QALYs (0.0069 to 0.0612). The Incremental Cost Effectiveness Ratio was €8190.28/QALY (SIW) and €6423.53/QALY (SIF). At the Spanish reimbursement threshold (€45,000 per QALY) the chance interventions are cost effective is 79.8% for SIW and 97.7% for SIF. Conclusions: Brief structured interventions to discontinue long-term benzodiazepine use represent value for money, particularly with scheduled follow-up appointments, and would represent a cost-effective investment by the Spanish healthcare to reduce prevalence of long-term use.


BJGP Open ◽  
2017 ◽  
Vol 1 (4) ◽  
pp. bjgpopen17X101265 ◽  
Author(s):  
Rhona Eveleigh ◽  
Esther Muskens ◽  
Peter Lucassen ◽  
Peter Verhaak ◽  
Jan Spijker ◽  
...  

BackgroundAntidepressant use has increased exponentially in recent decades, mostly due to long continuation.AimTo assess the effectiveness of a tailored recommendation to withdraw antidepressant treatment.Design & settingRandomised controlled trial in primary care (PANDA study) in the Netherlands.MethodLong-term antidepressant users (≥9 months) were selected from GPs prescription databases. Patients were diagnosed with the Composite International Diagnostic Interview (CIDI). Long-term users without indication for maintenance treatment (overtreatment) were selected. The intervention consisted of disclosure of the current psychiatric diagnosis combined with a tailored treatment recommendation. Patients were followed for 12 months.ResultsThe study included 146 participants from 45 family practices. Of the 70 patients in the intervention group, 34 (49%) did not comply with the advice to stop their antidepressant medication. Of the 36 (51%) patients who agreed to try, only 4 (6%) succeeded. These figures were consistent with the control group, where 6 (8%) of the 76 patients discontinued antidepressant use successfully. Patients who were recommended to discontinue their antidepressant medication reported a higher relapse rate than the control group (26% versus 13%, P = 0.05).ConclusionChanging inappropriate long-term antidepressant use is difficult.


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