PINCER trial: a cluster randomised trial comparing the effectiveness and cost-effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

Background: Medication errors in general practice are an important source of potentially preventable morbidity and mortality. Building on previous descriptive, qualitative and pilot work, we sought to investigate the effectiveness, cost-effectiveness and likely generalisability of a complex pharm acist-led IT-based intervention aiming to improve prescribing safety in general practice. Objectives: We sought to: • Test the hypothesis that a pharmacist-led IT-based complex intervention using educational outreach and practical support is more effective than simple feedback in reducing the proportion of patients at risk from errors in prescribing and medicines management in general practice. • Conduct an economic evaluation of the cost per error avoided, from the perspective of the National Health Service (NHS). • Analyse data recorded by pharmacists, summarising the proportions of patients judged to be at clinical risk, the actions recommended by pharmacists, and actions completed in the practices. • Explore the views and experiences of healthcare professionals and NHS managers concerning the intervention; investigate potential explanations for the observed effects, and inform decisions on the future roll-out of the pharmacist-led intervention • Examine secular trends in the outcome measures of interest allowing for informal comparison between trial practices and practices that did not participate in the trial contributing to the QRESEARCH database. Methods Two-arm cluster randomised controlled trial of 72 English general practices with embedded economic analysis and longitudinal descriptive and qualitative analysis. Informal comparison of the trial findings with a national descriptive study investigating secular trends undertaken using data from practices contributing to the QRESEARCH database. The main outcomes of interest were prescribing errors and medication monitoring errors at six- and 12-months following the intervention. Results: Participants in the pharmacist intervention arm practices were significantly less likely to have been prescribed a non-selective NSAID without a proton pump inhibitor (PPI) if they had a history of peptic ulcer (OR 0.58, 95%CI 0.38, 0.89), to have been prescribed a beta-blocker if they had asthma (OR 0.73, 95% CI 0.58, 0.91) or (in those aged 75 years and older) to have been prescribed an ACE inhibitor or diuretic without a measurement of urea and electrolytes in the last 15 months (OR 0.51, 95% CI 0.34, 0.78). The economic analysis suggests that the PINCER pharmacist intervention has 95% probability of being cost effective if the decision-maker’s ceiling willingness to pay reaches £75 (6 months) or £85 (12 months) per error avoided. The intervention addressed an issue that was important to professionals and their teams and was delivered in a way that was acceptable to practices with minimum disruption of normal work processes. Comparison of the trial findings with changes seen in QRESEARCH practices indicated that any reductions achieved in the simple feedback arm were likely, in the main, to have been related to secular trends rather than the intervention. Conclusions Compared with simple feedback, the pharmacist-led intervention resulted in reductions in proportions of patients at risk of prescribing and monitoring errors for the primary outcome measures and the composite secondary outcome measures at six-months and (with the exception of the NSAID/peptic ulcer outcome measure) 12-months post-intervention. The intervention is acceptable to pharmacists and practices, and is likely to be seen as costeffective by decision makers.

Effect of three wound dressings on infection, healing comfort, and cost in patients with sternotomy wounds - a randomized trial

Study objective: To compare three dressing types in terms of their ability to protect against infection and promote healing, patient comfort, and cost-effectiveness.

Design: Prospective, randomized controlled trial.

Setting: Major metropolitan, academically affiliated, tertiary referral center.

Patients: Seven hundred thirty-seven patients were randomized to receive a dry absorbent dressing (n = 243) [Primapore; Smith & Nephew; Sydney, NSW, Australia], a hydrocolloid dressing (n = 267) [Duoderm Thin ConvaTec; Mulgrave, VIC, Australia], or a hydroactive dressing (n = 227) [Opsite; Smith & Nephew] in the operating theater on skin closure.

Results: There was no difference in the rate of wound infection or wound healing between treatment groups. The Primapore dressing was the most comfortable and cost-effective dressing option for the sternotomy wound. Duoderm Thin dressings were associated with increased wound exudate (p < 0.001), poor dressing integrity (p < 0.001), more frequent dressing changes (p < 0.001), more discomfort with removal (p < 0.05), and increased cost (p < 0.001).

Conclusions: In the context of no additional benefit for the prevention of wound infection or the rate of wound healing for any of the three dressing products examined, dry absorbent dressings are the most comfortable and cost-effective products for sternotomy wounds following cardiac surgery.

Should older people in residential care receive vitamin D to prevent falls? Results of a randomized trial

Objectives: To determine whether vitamin D supplementation can reduce the incidence of falls and fractures in older people in residential care who are not classically vitamin D deficient.

Design: Randomized, placebo-controlled double-blind, trial of 2 years' duration.

Setting: Multicenter study in 60 hostels (assisted living facilities) and 89 nursing homes across Australia.

Participants: Six hundred twenty-five residents (mean age 83.4) with serum 25-hydroxyvitamin D levels between 25 and 90 nmol/L.

Intervention: Vitamin D supplementation (ergocalciferol, initially 10,000 IU given once weekly and then 1,000 IU daily) or placebo for 2 years. All subjects received 600 mg of elemental calcium daily as calcium carbonate.

Measurements: Falls and fractures recorded prospectively in study diaries by care staff.

Results: The vitamin D and placebo groups had similar baseline characteristics. In intention-to-treat analysis, the incident rate ratio for falling was 0.73 (95% confidence interval (CI)=0.57–0.95). The odds ratio for ever falling was 0.82 (95% CI=0.59–1.12) and for ever fracturing was 0.69 (95% CI=0.40–1.18). An a priori subgroup analysis of subjects who took at least half the prescribed capsules (n=540), demonstrated an incident rate ratio for falls of 0.63 (95% CI=0.48–0.82), an odds ratio (OR) for ever falling of 0.70 (95% CI=0.50–0.99), and an OR for ever fracturing of 0.68 (95% CI=0.38–1.22).

Conclusion: Older people in residential care can reduce their incidence of falls if they take a vitamin D supplement for 2 years even if they are not initially classically vitamin D deficient.

The effectiveness of callback counselling for smoking cessation: a randomized trial

Aims. The development of acceptable, widely available and effective smoking cessation methods is central to public health strategy for tobacco control. We examined the effectiveness of a telephone callback counselling intervention, compared to the provision of self-help resources alone.

Methods. Participants were 998 smokers calling a state-wide "Quitline" service randomly allocated to either callback counselling or ordinary care. The callback condition consisted of a series of brief counselling calls at strategic times in addition to ordinary care. The number of calls varied according to caller needs, and most occurred generally just before the person's quit day and in the week or two after it. The service was delivered by trained telephone counsellors.

Results. At the 3-month follow-up, significantly more participants in the callback group (24%) reported that they were quit, compared to those in the usual care comparison group (13%). The difference in point prevalence of smoking declined to 6% by the 12-month follow-up. Using sustained abstinence there was a significant benefit of callback counselling at 12-month follow-up. Treating dropouts as smokers reduced the overall magnitude of the effects somewhat. The benefit of callbacks was to marginally increase quit attempts and to significantly reduce relapse.

Conclusion. Our findings are consistent with those of other studies demonstrating benefits of callback telephone counselling to facilitate cessation. Such counselling provides a flexible, relatively inexpensive and widely available form of cessation service. It appears to encourage a greater proportion of quit attempts and to reduce the rate of relapse among those quitting. Further research is required to determine ways to enhance effectiveness, particularly studies of how to reduce relapse.

Improving infant sleep and maternal mental health: a cluster randomised trial

Objectives: To determine whether a community-delivered intervention targeting infant sleep problems improves infant sleep and maternal well-being and to report the costs of this approach to the healthcare system.

Design: Cluster randomised trial.

Setting: 49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia.

Participants: 328 mothers reporting an infant sleep problem at 7 months recruited during October–November 2003.

Intervention: Behavioural strategies delivered over individual structured MCH consultations versus usual care.

Main outcome measures: Maternal report of infant sleep problem, depression symptoms (Edinburgh Postnatal Depression Scale (EPDS)), and SF-12 mental and physical health scores when infants were 10 and 12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs.

Results: Prevalence of infant sleep problems was lower in the intervention than control group at 10 months (56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50 (0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference –1.4 (–2.3 to –0.4) and 12 months (–1.7 (–2.6 to –0.7)). SF-12 mental health scores indicated better health at 10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs including intervention design, delivery and use of non-MCH nurse services were £96.93 and £116.79 per intervention and control family, respectively.

Conclusions: Implementing this sleep intervention may lead to health gains for infants and mothers and resource savings for the healthcare system.

Print versus website physical activity programs: a randomized trial.

Background: Mediated physical activity interventions can reach large numbers of people at low cost. Programs delivered through the mail that target the stage of motivational readiness have been shown to increase activity. Communication technology (websites and e-mail) might provide a means for delivering similar programs. Methods: Randomized trial conducted between August and October 2001. Participants included staff at an Australian university (n=655; mean AGE=43, standard deviation, 10 years). Participants were randomized to either an 8-week, stage-targeted print program (Print) or 8-week, stage-targeted website (Web) program. The main outcome was change in self-reported physical activity. Results: There was no significant increase in total reported physical activity within or between groups when analyzed by intention to treat (F [1,653]=0.41, p=0.52). There was a significant increase in total physical activity reported by the Print participants who were inactive at baseline (t [1,173]=−2.21, p=0.04), and a significant decrease in the average time spent sitting on a weekday in the Web group (t [1,326]=2.2, p=0.03). Conclusions: There were no differences between the Print and Web program effects on reported physical activity. The Print group demonstrated slightly larger effects and a higher level of recognition of program materials.

Outcomes of a group-randomized trial to prevent excess weight gain, reduce screen behaviours and promote physical activity in 10-year-old children : switch-play

Objectives : To evaluate the effectiveness of an intervention to prevent excess weight gain, reduce time spent in screen behaviours, promote participation in and enjoyment of physical activity (PA), and improve fundamental movement skills among children.

Participants : In 2002, 311 children (78% response; 49% boys), average age 10 years 8 months, were recruited from three government schools in low socioeconomic areas of Melbourne, Australia.

Design : Group-randomized controlled trial. Children were randomized by class to one of the four conditions: a behavioural modification group (BM; n=66); a fundamental movement skills group (FMS; n=74); a combined BM/FMS group (BM/FMS; n=93); and a control (usual curriculum) group (n=62). Data were collected at baseline, post intervention, 6- and 12-month follow-up periods.

Results : BMI data were available for 295 children at baseline and 268 at 12-month follow-up. After adjusting for food intake and PA, there was a significant intervention effect from baseline to post intervention on age- and sex-adjusted BMI in the BM/FMS group compared with controls (-1.88 kg m-2, P<0.01), which was maintained at 6- and 12-month follow-up periods (-1.53 kg m-2, P<0.05). Children in the BM/FMS group were less likely than controls to be overweight/obese between baseline and post intervention (adjusted odds ratio (AOR)=0.36, P<0.05); also maintained at 12-month follow-up (AOR=0.38, P<0.05). Compared with controls, FMS group children recorded higher levels and greater enjoyment of PA; and BM children recorded higher levels of PA and TV viewing across all four time points. Gender moderated the intervention effects for participation in and enjoyment of PA, and fundamental movement skills.

Conclusion : This programme represents a promising approach to preventing excess weight gain and promoting participation in and enjoyment of PA. Examination of the mediators of this intervention and further tailoring of the programme to suit both genders is required.

A randomized trial of protocol-directed sedation management for mechanical ventilation in an Australian intensive care unit

Objective: To compare protocol-directed sedation management with traditional non-protocol-directed practice in mechanically ventilated patients. Design: Randomized, controlled trial. Setting: General intensive care unit (24 beds) in an Australian metropolitan teaching hospital. Patients: Adult, mechanically ventilated patients (n = 312). Interventions: Patients were randomly assigned to receive sedation directed by formal guidelines (protocol group, n = 153) or usual local clinical practice (control, n = 159). Measurements and Main Results: The median (95% confidence interval) duration of ventilation was 79 hrs (56-93 hrs) for patients in the protocol group compared with 58 hrs (44-78 hrs) for patients who received control care (p = .20). Lengths of stay (median [range]) in the intensive care unit (94 [2-1106] hrs vs. 88 (14-962) hrs, p = .58) and hospital (13 [1-113] days vs. 13 (1-365) days, p = .97) were similar, as were the proportions of subjects receiving a tracheostomy (17% vs. 15%, p = .64) or undergoing unplanned self-extubation (1.3% vs. 0.6%, p = .61). Death in the intensive care unit occurred in 32 (21%) patients in the protocol group and 32 (20%) control subjects (p = .89), with a similar overall proportion of deaths in hospital (25% vs. 22%, p = .51). A Cox proportional hazards model, after adjustment for age, gender, Acute Physiology and Chronic Health Evaluation II score, diagnostic category, and doses of commonly used drugs, estimated that protocol sedation management was associated with a 22% decrease (95% confidence interval 40% decrease to 2% increase, p = .07) in the occurrence of successful weaning from mechanical ventilation. Conclusions: This randomized trial provided no evidence of a substantial reduction in the duration of mechanical ventilation or length of stay, in either the intensive care unit or the hospital, with the use of protocol-directed sedation compared with usual local management. Qualified high-intensity nurse staffing and routine Australian intensive care unit nursing responsibility for many aspects of ventilatory practice may explain the contrast between these findings and some recent North American studies. (C) 2008 Lippincott Williams & Wilkins, Inc.

MOSAIC (MOthers' Advocates In the Community): protocol and sample description of a cluster randomised trial of mentor mother support to reduce intimate partner violence among pregnant or recent mothers

Background : Intimate partner violence (IPV) is prevalent globally, experienced by a significant minority of women in the early childbearing years and is harmful to the mental and physical health of women and children. There are very few studies with rigorous designs which have tested the effectiveness of IPV interventions to improve the health and wellbeing of abused women. Evidence for the separate benefit to victims of social support, advocacy and non-professional mentoring suggested that a combined model may reduce the levels of violence, the associated mental health damage and may increase a woman's health, safety and connection with her children. This paper describes the development, design and implementation of a trial of mentor mother support set in primary care, including baseline characteristics of participating women.

Methods/Design : MOSAIC (MOtherS' Advocates In the Community) was a cluster randomised trial embedded in general practice and maternal and child health (MCH) nursing services in disadvantaged suburbs of Melbourne, Australia. Women who were pregnant or with infants, identified as abused or symptomatic of abuse, were referred by IPV-trained GPs and MCH nurses from 24 general practices and eight nurse teams from January 2006 to December 2007. Women in the intervention arm received up to 12 months support from trained and supported non-professional mentor mothers. Vietnamese health professionals also referred Vietnamese women to bilingual mentors in a sub-study. Baseline and follow-up surveys at 12 months measured IPV (CAS), depression (EPDS), general health (SF-36), social support (MOS-SF) and attachment to children (PSI-SF). Significant development and piloting occurred prior to trial commencement. Implementation interviews with MCH nurses, GPs and mentors assisted further refinement of the intervention. In-depth interviews with participants and mentors, and follow-up surveys of MCH nurses and GPs at trial conclusion will shed further light on MOSAIC's impact.

Discussion : Despite significant challenges, MOSAIC will make an important contribution to the need for evidence of effective partner violence interventions, the role of non-professional mentors in partner violence support services and the need for more evaluation of effective health professional training and support in caring for abused women and children among their populations.

A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures

Background Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use.

Methods We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms (<6 weeks or 6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months.

Results A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (±SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6±2.9 and 1.9±3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, –0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period.

Conclusions We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.)

Evaluation of a decision aid for prenatal testing of fetal abnormalities : a cluster randomised trial [ISRCTN22532458]

Background: By providing information on the relative merits and potential harms of the options available and a framework to clarify preferences, decision aids can improve knowledge and realistic expectations and decrease decisional conflict in individuals facing decisions between alternative forms of action. Decision-making about prenatal testing for fetal abnormalities is often confusing and difficult for women and the effectiveness of decision aids in this field has not been established. This study aims to test whether a decision aid for prenatal testing of fetal abnormalities, when compared to a pamphlet, improves women's informed decision-making and decreases decisional conflict.

Methods/design: A cluster designed randomised controlled trial is being conducted in Victoria, Australia. Fifty General Practitioners (GPs) have been randomised to one of two arms: providing women with either a decision aid or a pamphlet. The two primary outcomes will be measured by comparing the difference in percentages of women identified as making an informed choice and the difference in mean decisional conflict scores between the two groups. Data will be collected from women using questionnaires at 14 weeks and 24 weeks gestation.

The sample size of 159 women in both arms of the trial has been calculated to detect a difference of 18% (50 to 68%) in informed choice between the two groups. The required numbers have been adjusted to accommodate the cluster design, miscarriage and participant lost – to – follow up.

Baseline characteristics of women will be summarised for both arms of the trial. Similarly, characteristics of GPs will be compared between arms.

Differences in the primary outcomes will be analysed using 'intention-to-treat' principles. Appropriate regression techniques will adjust for the effects of clustering and include covariates to adjust for the stratifying variable and major potential confounding factors.

Discussion: The findings from this trial will make a significant contribution to improving women's experience of prenatal testing and will have application to a variety of maternity care settings. The evaluation of a tailored decision aid will also have implications for pregnancy care providers by identifying whether or not such a resource will support their role in providing prenatal testing information.

A cluster randomised trial of a telephone-based intervention for parents to increase fruit and vegetable consumption in their 3-to 5-year-old children : study protocol

Background: Inadequate fruit and vegetable consumption in childhood increases the risk of developing chronic disease. Despite this, a substantial proportion of children in developed nations, including Australia, do not consume sufficient quantities of fruits and vegetables. Parents are influential in the development of dietary habits of young children but often lack the necessary knowledge and skills to promote healthy eating in their children. The aim of this study is to assess the efficacy of a telephone-based intervention for parents to increase the fruit and vegetable consumption of their 3- to 5-year-old children.
Methods/Design: The study, conducted in the Hunter region of New South Wales, Australia, employs a cluster randomised controlled trial design. Two hundred parents from 15 randomly selected preschools will be randomised to receive the intervention, which consists of print resources and four weekly 30-minute telephone support calls delivered by trained telephone interviewers. The calls will assist parents to increase the availability and accessibility of fruit and vegetables in the home, create supportive family eating routines and role-model fruit and vegetable consumption. A further two hundred parents will be randomly allocated to the control group and will receive printed nutrition information only. The primary outcome of the trial will be the change in the child's consumption of fruit and vegetables as measured by the fruit and vegetable subscale of the Children's Dietary Questionnaire. Pre-intervention and post-intervention parent surveys will be administered over the telephone. Baseline surveys will occur one to two
weeks prior to intervention delivery, with follow-up data collection calls occurring two, six, 12 and 18 months following baseline data collection.
Discussion: If effective, this telephone-based intervention may represent a promising public health strategy to increase fruit and vegetable consumption in childhood and reduce the risk of subsequent chronic disease.
Trial registration: Australian Clinical Trials Registry ACTRN12609000820202

Mothers' AdvocateS In the Community (MOSAIC)- non-professional mentor support to reduce intimate partner violence and depression in mothers: a cluster randomised trial in primary care

Background : Effective interventions to increase safety and wellbeing of mothers experiencing intimate partner violence (IPV) are scarce. As much attention is focussed on professional intervention, this study aimed to determine the effectiveness of non-professional mentor support in reducing IPV and depression among pregnant and recent mothers experiencing, or at risk of IPV.

Methods : MOSAIC was a cluster randomised trial in 106 primary care (maternal and child health nurse and general practitioner) clinics in Melbourne, Australia. 63/106 clinics referred 215 eligible culturally and linguistically diverse women between January 2006 and December 2007. 167 in the intervention (I) arm, and 91 in the comparison (C) arm. 174 (80.9%) were recruited. 133 (76.4%) women (90 I and 43 C) completed follow-up at 12 months.

Intervention: 12 months of weekly home visiting from trained and supervised local mothers, (English & Vietnamese speaking) offering non-professional befriending, advocacy, parenting support and referrals.

Main outcome measures: Primary outcomes; IPV (Composite Abuse Scale CAS) and depression (Edinburgh Postnatal Depression Scale EPDS); secondary measures included wellbeing (SF-36), parenting stress (PSI-SF) and social support (MOS-SF) at baseline and follow-up.

Analysis: Intention-to-treat using multivariable logistic regression and propensity scoring.

Results : There was evidence of a true difference in mean abuse scores at follow-up in the intervention compared with the comparison arm (15.9 vs 21.8, AdjDiff -8.67, CI -16.2 to -1.15). There was weak evidence for other outcomes, but a trend was evident favouring the intervention: proportions of women with CAS scores ≥7, 51/88 (58.4%) vs 27/42 (64.3%) AdjOR 0.47, CI 0.21 to 1.05); depression (EPDS score ≥13) (19/85, 22% (I) vs 14/43, 33% (C); AdjOR 0.42, CI 0.17 to 1.06); physical wellbeing mean scores (PCS-SF36: AdjDiff 2.79; CI -0.40 to 5.99); mental wellbeing mean scores (MCS-SF36: AdjDiff 2.26; CI -1.48 to 6.00). There was no observed effect on parenting stress. 82% of women mentored would recommend mentors to friends in similar situations.

Conclusion : Non-professional mentor mother support appears promising for improving safety and enhancing physical and mental wellbeing among mothers experiencing intimate partner violence referred from primary care.