Booklet for Childhood Fever in Out-of-Hours Primary Care: A Cluster-Randomized Controlled Trial

INTRODUCTION

Fever is the most common reason for a child to be taken to a physician, and most fever consultations take place in general practice.¹ As many parents work during the day and fever typically rises in the early evening, these rates are even higher during out-of-hours care.^1,2 In most cases, fever is caused by benign viral infections, and general recommendations given by a family physician are sufficient for management.³ One in every 3 to 4 children who visit family physician out-of-hours care with a fever receives an antibiotic prescription, however.^4,5 These prescription rates are nearly twice as high as those during routine office hours.⁶

Consultations are generally driven by parental concerns about harmful consequences of fever. These concerns can be more prominent when needing to consult a family physician on call who is not their personal family physician.⁷

Previous studies have shown that antibiotic prescribing is strongly influenced by patients’ expectations and that family physicians experience pressure from patients to prescribe antibiotics.⁸ Most parents of a febrile child in fact do not expect antibiotics, but seek reassurance and consistent, reliable information about fever, specific symptoms, and self-management strategies.^7,9,10 Nevertheless, conveying evidence-based information to parents is challenging for family physicians, even more so in time-pressured consultations in the evening and at night.¹¹ A systematic review showed that information leaflets offered during family physician consultations for common infections are promising tools to provide parents with a safety net and to reduce antibiotic prescribing.¹² No studies of leaflets have been performed during out-of-hours care or in childhood fever consultations, however.

The CHILdhood Infections (CHILI) study therefore aimed to develop and assess the effectiveness of an illness-focused interactive fever booklet for parents on the management of children presenting with fever at family physician out-of-hours care.

METHODS

RESULTS

A total of 106,014 telephone contacts for children took place at the 20 participating out-of-hours centers during the trial period (Figure 1). Of these contacts, 36.1% were fever related, and 77.3% of these fever-related contacts resulted in a face-to-face consultation with a family physician. A total of 3,518 family physicians (range per center, 73 to 273) recruited to the trial 25,355 children (11,945 in the intervention group and 13,410 in the control group, with number varying from 366 to 2,756 per center, equally divided across groups).

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Figure 1

Trial participant recruitment and inclusion.

FP = family physician.

Baseline characteristics of the enrolled children are shown in Table 1. The distribution of age, sex, socioeconomic status, and ICPC diagnosis were similar between the intervention and control groups and between centers.

In the intervention group, the booklet was used in only 3,407 (28.5%) of the encounters (range across centers, 23.1% to 38.5%). Antibiotic prescribing did not differ significantly between centers in which family physicians had access to the booklet and control centers (OR = 0.90; 95% CI, 0.79-1.02; ICC = 0.005) (Table 2). There were no significant differences in rates of repeated consultations at the out-of-hours centers within 2 weeks of the index consultation for the same illness episode, or in out-of-hours repeated consultation rates within 6 months after randomization or referral rates to secondary care at the index consultation.

Children in the group with booklet access were less likely than usual care counterparts to receive a prescription for any medication including nonantibiotic medications (OR = 0.87; 95% CI, 0.77-0.97; ICC = 0.004). The most commonly prescribed nonantibiotic medications were xylomethazoline, salbutamol, and ibuprofen (Supplemental Table 1, available at http://www.annfammed.org/content/16/4/314/suppl/DC1/). Adjusting for sex, age, and socioeconomic status had no effect on any of these outcomes. Mean antibiotic prescription rates varied between the 3 most common ICPC codes, as shown in Table 3. Amoxicillin was the most commonly prescribed antibiotic, accounting for 76.1% of all antibiotic prescriptions in the trial.

When analyses took compliance with the intervention into consideration, there was a significant reduction in antibiotic prescribing among the 3,407 children seen by family physicians who used the booklet during the consultation compared with children seen by family physicians in the control group (OR = 0.83; 95% CI, 0.74-0.94; ICC = 0.002) (Table 2). This significant benefit was sustained during the 2-week follow-up (including the index consultation) (OR = 0.84; 95% CI, 0.75-0.95; ICC = 0.002). After correcting for compliance, we also found no significant differences in out-of-hours reconsultation rates within 6 months after randomization, or in referral rates to secondary care at the index consultation. But children for whom the booklet was actually used were less likely to receive a prescription for any medication including a nonantibiotic medication (OR = 0.77; 95% CI, 0.70-0.86; ICC = 0.001).

In the CACE analysis, booklet use was associated with reduced odds of antibiotic prescriptions during index consultations (OR =0.71; 95% CI, 0.63-0.79) and of any prescription during index consultations (OR = 0.62; 95% CI, 0.57-0.69). The ICC for compliance was 0.09.

Supplemental Table 2 (available at http://www.annfammed.org/content/16/4/314/suppl/DC1/) shows patient characteristics for the subgroups having access to booklet vs using the booklet vs not using the booklet in the intervention group; Supplemental Table 3 (available at http://www.annfammed.org/content/16/4/314/suppl/DC1/) shows the same data for parents participating in the telephone survey. Parents in the subsample interviewed by telephone were comparable to those in the main study (Supplemental Table 3, available at http://www.annfammed.org/content/16/4/314/suppl/DC1/). Of the 553 parents surveyed, 36.0% indicated they received the booklet. In the control group, 2.8% of parents reported receiving written patient information or referral to a website with patient information. A minority, 23.5% of the 553 parents, reported having visited their own family physician before consulting out-of-hours care, with no significant difference between intervention and control groups. We observed a significant reduction in intention to reconsult for similar illnesses among parents in the group in which family physicians had access to booklet (OR = 0.55; 95% CI, 0.35-0.85; 75.6% vs 84.4%, ICC <.001) (Table 4).

DISCUSSION

Family physicians having easy access to an illness-focused interactive booklet on childhood fever and common infections used the booklet in fewer than 1 in 3 fever-related consultations in out-of-hours general practice. Access to the booklet did not significantly reduce antibiotic prescriptions at index consultations; however, our prespecified analysis suggested that actual use of the booklet reduced antibiotic prescriptions at the index consultation, overall medication prescriptions, and parents’ intention to reconsult for future similar illnesses.

This is one of the largest cluster-randomized controlled trials ever performed in general practice and the first to assess the effectiveness of a booklet for one of the most common reasons for childhood consultations and antibiotic prescriptions. We chose a cluster-randomized design because individual randomization would have led to a high risk of contamination. Specific considerations for choosing this design are described elsewhere.¹³

Family physicians believe that interventions for use during out-of-hours care need to be readily available in every consultation room.¹⁵ Widespread availability acts as a reminder to use them. This was also the reason we chose a paper booklet in an era of Internet and smartphone applications. The cluster design enabled us to provide every consultation room at intervention centers with the necessary material, making the study more pragmatic. A cluster-randomized controlled trial, however, has important limitations.

With our trial’s cluster-randomization and pragmatic nature, we aimed to get as close as possible to actual practice and to the considerations of family physicians’ prescribing decisions in childhood fever consultations. As in everyday practice, we anticipated that not every child in the intervention group would receive a booklet. Moreover, family physicians were provided with only brief e-mail instructions about use of the intervention. We specifically decided not to provide a special, more intensive training or meeting as doing so would have made the intervention more costly and unlikely to be undertaken in actual daily practice. A recent Cochrane review on this subject backed up our approach.²⁰ We chose to perform a pragmatic study, allowing for variation and facilitating possible implementation into daily practice.

We expected compliance (use of the booklet) to be lower than 100%, but had no comparable data informing us what actual compliance would likely be, so we had to consider and prespecify additional analyses correcting for compliance during the design of this study.¹³ The chosen complier analysis, CACE, enabled us to evaluate the effect of actually receiving the booklet on antibiotic prescriptions in a more robust way than simply undertaking a per-protocol analysis alongside the intention-to-treat analysis. Estimation of CACE is, however, dependent on potentially challengeable assumptions that cannot be tested, which means that a risk of postrandomization recruitment bias cannot be completely excluded.^18,21 As is shown in Supplemental Table 2, however, characteristics of those children for whom the booklet was used were comparable to those for whom the booklet was not used. The only noticeable differences were in the percentage of children with ICPC code A03.00 for fever and R74.00 for acute upper respiratory tract infection between groups using and not using the booklet. These differences could suggest that family physicians were more likely to use the booklet in cases of fever without a specific diagnosis. Furthermore, best available statistical models and software do not allow for correction of the cluster effect in a CACE analysis with a dichotomous outcome. Nevertheless, an increasing number of studies have shown that a CACE analysis is much closer to the real-world intention-to-treat estimates of treatment effects.^8,21,22

Our trial shows that handing out patient information leaflets about childhood fever during routine out-of-hours care is very uncommon, as only 2.8% of parents consulting at control centers reported receiving such information. This result indicates that even in the bread-and-butter condition of childhood fever, uptake and handout of available patient information materials (either written or online) is very low in routine care, even though they are crucial for parents to learn about self-management strategies and alarm symptoms. Provision of patient information materials is largely a clinician behavior, however, and could be influenced by relatively light-touch interventions such as desk or computer prompts, or even dissemination of the results of this and similar studies.

Blinding of the participating family physicians regarding the intervention was not possible, but to minimize the risk of bias we blinded them to the outcome in both groups and blinded outcome assessors. In terms of generalizability, more than 1 in 3 active family physicians in the Netherlands took part in the study, and we believe that this population is representative of the wider family physician population in the country. In addition, the Netherlands has one of the lowest antibiotic prescribing rates in the world. One could expect the effect of the booklet to be larger in countries with higher antibiotic prescribing rates.

We found a significantly lower antibiotic prescription rate of 25.2% in the usual care group vs 21.9% in the group in which the booklet was actually used. The difference was less than the absolute 6% difference (25% vs 19%) that we chose for our sample size calculation. Our findings are in keeping with a previous UK study that found a significant reduction in antibiotic prescribing with use of an interactive booklet about childhood respiratory tract infections during in-hours general practice.²³ That study reported a larger reduction in antibiotic prescribing than we observed, but only among those who agreed to participate. Our study included all fever-related consultations and therefore provides results that are more likely to be indicative of real-world effects. Other studies examining the impact of information leaflets on antibiotic prescriptions in primary care have mainly been undertaken among adults and have focused on specific symptoms, such as acute cough.¹²

Ideally, such behavioral interventions should be combined with other interventions aimed at reducing unwarranted antibiotic prescriptions, such as improved diagnostics, point-of-care tests, interactive workshops,²⁴ and peer comparison.²⁵

In conclusion, the low-cost and light-touch intervention evaluated in our CHILI trial focused on the illness experience of parents and would be easy to implement into routine care. We found insufficient evidence to conclude that simply providing access to a booklet on childhood fever during out-of-hours care results in reduced antibiotic prescriptions; however, when correcting for actual use of the booklet, which was low, we found a reduction in antibiotic prescriptions. The reduction in antibiotic prescribing found in this implementation study of all children seen at out-of-hours care with fever seems modest. It provides evidence, however, of the likely real-world benefits of this intervention, and evidence of the intervention’s efficacy when used could probably increase its use. The study is therefore highly relevant to the aim of reducing antimicrobial resistance.