Data feedback and behavioural change intervention to improve primary care prescribing safety (EFIPPS) : multicentre, three arm, cluster-randomised controlled trial

Funding and trial registration: Scottish Government Chief Scientist Office grant CZH/3/17. ClinicalTrials.gov registration NCT01602705.

An Audit and Feedback Intervention for Reducing Antibiotic Prescribing in General Dental Practice : The RAPiD Cluster Randomised Controlled Trial

Funding: This study was conducted as part of the TRiaDS programme of implementation research which is funded by NHS Education for Scotland (NES). The Health Services Research Unit which is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates supported the study. The funder had no influence over the design, conduct, analysis and write up of the study.

“Enjoy your baby” Internet-based CBT for mothers with babies: a feasibility randomised control trial

Background: Postnatal depression is a global health problem with lasting effects on the family. Government policy is focussed on early intervention and increasing access to psychological therapies. There is a growing evidence base for the use of computerised CBT packages and this study investigated the feasibility of a CBT-based self-help internet intervention for new mothers. Objective: To assess the ability to recruit mothers, deliver an internet course, obtain follow-up data and evaluate what mothers think of the course. Design: A feasibility randomised control design was used to compare a waiting list control group (delayed access= DA) to the Enjoy Your Baby course (immediate access= IA). Measures were administered at baseline and 8 week follow-up. Methods: Adverts were placed in the Metro freesheet, on charity web pages, on social media, posters were put up in the community, and leaflets were handed out at mother and baby groups. Participants had to be 18 years old or over with a child less than 18 months old. The IA arm was given access to the course straight away. After 8 weeks all participants were asked to recomplete the original measures and those in the IA arm also gave feedback on the course. Participants in the DA arm were given access after recompleting the questionnaires. Due to a lack of follow-up data a small discussion group was conducted. Intervention: The course contains 4 core modules including helping mothers understand why they feel the way they do and helping them build closeness to their babies. Additional modules, worksheets and homework tasks were available. The DA group were given a list of additional support resources and services, and encouraged to seek additional help if required. All participants received weekly automated emails for 12 weeks as they worked through the course. It was not possible to deliver individualised support. 34 Results: Despite using a number of recruitment strategies, recruitment was lower and slower than anticipated, and attrition was high. 41 women, primarily recruited via the internet, were randomised (IA n=21, DA n=20). No significant differences were observed between participants in either arm at baseline and no statistically significant differences were identified when the demographics and baseline measures of participants who logged-on to the course were compared to those who did not, or when participants who completed follow-up measures were compared to those who did not. Pre and post intervention scores on the EPDS approached statistical significance (P=.059, r=.444) favouring the intervention arm. The discussion group suggested strengths of the course and recommended areas for improvement, including making the course more mobile friendly. Conclusion: Internet interventions show promise; however it is difficult to recruit mothers, engagement is low and attrition high. A number of recommendations are made and a further pilot or an internal pilot of a larger substantive study should be conducted to confirm recruitment and retention. Trial ID: ISRCTN90927910.

Improving access for community health and sub-acute outpatient services: protocol for a stepped wedge cluster randomised controlled trial

BACKGROUND: Waiting lists for treatment are common in outpatient and community services, Existing methods for managing access and triage to these services can lead to inequities in service delivery, inefficiencies and divert resources from frontline care. Evidence from two controlled studies indicates that an alternative to the traditional "waitlist and triage" model known as STAT (Specific Timely Appointments for Triage) may be successful in reducing waiting times without adversely affecting other aspects of patient care. This trial aims to test whether the model is cost effective in reducing waiting time across multiple services, and to measure the impact on service provision, health-related quality of life and patient satisfaction.

METHODS/DESIGN: A stepped wedge cluster randomised controlled trial has been designed to evaluate the impact of the STAT model in 8 community health and outpatient services. The primary outcome will be waiting time from referral to first appointment. Secondary outcomes will be nature and quantity of service received (collected from all patients attending the service during the study period and health-related quality of life (AQOL-8D), patient satisfaction, health care utilisation and cost data (collected from a subgroup of patients at initial assessment and after 12 weeks). Data will be analysed with a multiple multi-level random-effects regression model that allows for cluster effects. An economic evaluation will be undertaken alongside the clinical trial.

DISCUSSION: This paper outlines the study protocol for a fully powered prospective stepped wedge cluster randomised controlled trial (SWCRCT) to establish whether the STAT model of access and triage can reduce waiting times applied across multiple settings, without increasing health service costs or adversely impacting on other aspects of patient care. If successful, it will provide evidence for the effectiveness of a practical model of access that can substantially reduce waiting time for outpatient and community services with subsequent benefits for both efficiency of health systems and patient care.

Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial

BACKGROUND: Radiotherapy for localised prostate cancer has many known and distressing side effects. The efficacy of group interventions for reducing psychological morbidity is lacking. This study investigated the relative benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns and prostate cancer-specific quality of life in men receiving curative intent radiotherapy for prostate cancer.

METHODS: This phase III, two-arm cluster randomised controlled trial included 331 men (consent rate: 72 %; attrition: 5 %) randomised to the intervention (n = 166) or usual care (n = 165). The intervention comprised four group and one individual consultation all delivered by specialist uro-oncology nurses. Primary outcomes were anxious and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale. Unmet needs were assessed with the Supportive Care Needs Survey-SF34 Revised, treatment-related concerns with the Cancer Treatment Scale and quality of life with the Expanded Prostate Cancer Index -26. Assessments occurred before, at the end of and 6 months post-radiotherapy. Primary outcome analysis was by intention-to-treat and performed by fitting a linear mixed model to each outcome separately using all observed data.

RESULTS: Mixed models analysis indicated that group consultations had a significant beneficial effect on one of two primary endpoints, depressive symptoms (p = 0.009), and one of twelve secondary endpoints, procedural concerns related to cancer treatment (p = 0.049). Group consultations did not have a significant beneficial effect on generalised anxiety, unmet needs and prostate cancer-specific quality of life.

CONCLUSIONS: Compared with individual consultations offered as part of usual care, the intervention provides a means of delivering patient education and is associated with modest reductions in depressive symptoms and procedural concerns. Future work should seek to confirm the clinical feasibility and cost-effectiveness of group interventions.

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

Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial

Background

Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP) offered as part of a cluster randomised controlled trial (RCT) of prevention of vascular disease in primary care.

Methods

Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors.

Results

Of 301 eligible patients, 190 (63.1%) were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47), physical inactivity (OR 2.90 95%CI:1.36,6.14), contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03), rural location (OR 12.50 95%CI:1.43, 109.7) and smaller practice size (1–3 GPs) (OR 16.05 95%CI:2.74, 94.24).

Conclusions

Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs.

A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study)

Background
The OPTI-SCRIPT cluster randomised controlled trial (RCT) found that a three-phase multifaceted intervention including academic detailing with a pharmacist, GP-led medicines reviews, supported by web-based pharmaceutical treatment algorithms, and tailored patient information leaflets, was effective in reducing potentially inappropriate prescribing (PIP) in Irish primary care. We report a process evaluation exploring the implementation of the intervention, the experiences of those participating in the study and lessons for future implementation.

Methods
The OPTI-SCRIPT trial included 21 GP practices and 196 patients. The process evaluation used mixed methods. Quantitative data were collected from all GP practices and semi-structured interviews were conducted with GPs from intervention and control groups, and a purposive sample of patients from the intervention group. All interviews were transcribed verbatim and analysed using a thematic analysis.

Results
Despite receiving a standardised academic detailing session, intervention delivery varied among GP practices. Just over 70 % of practices completed medicines review as recommended with the patient present. Only single-handed practices conducted reviews without patients present, highlighting the influence of practice characteristics and resources on variation. Medications were more likely to be completely stopped or switched to another more appropriate medication when reviews were conducted with patients present. The patient information leaflets were not used by any of the intervention practices. Both GP (32 %) and patient (40 %) recruitment rates were modest. For those who did participate, overall, the experience was positively viewed, with GPs and patients referring to the value of medication reviews to improve prescribing and reduce unnecessary medications. Lack of time in busy GP practices and remuneration were identified as organisational barriers to future implementation.

Conclusions
The OPTI-SCRIPT intervention was positively viewed by both GPs and patients, both of whom valued the study’s objectives. Patient information leaflets were not a successful component of the intervention. Academic detailing and medication reviews are important components in changing PIP, and having patients present during the review process seems to be a more effective approach for decreasing PIP.

Case management educational intervention with public health nurses : cluster randomized controlled trial

Aim: This paper is a report of a study conducted to determine the effectiveness of a community case management collaborative education intervention in terms of satisfaction, learning and performance among public health nurses. Background: Previous evaluation studies of case management continuing professional education often failed to demonstrate effectiveness across a range of outcomes and had methodological weaknesses such as small convenience samples and lack of control groups. Method: A cluster randomised controlled trial was conducted between September 2005 and February 2006. Ten health centre clusters (5 control, 5 intervention) recruited 163 public health nurses in Taiwan to the trial. After pre-tests for baseline measurements, public health nurses in intervention centres received an educational intervention of four half-day workshops. Post-tests for both groups were conducted after the intervention. Two-way repeated measures analysis of variance was performed to evaluate the effect of the intervention on target outcomes. Results: A total of 161 participants completed the pre- and post-intervention measurements. This was almost a 99% response rate. Results revealed that 97% of those in the experimental group were satisfied with the programme. There were statistically significant differences between the two groups in knowledge (p = 0.001), confidence in case management skills (p = 0.001), preparedness for case manager role activities (p = 0.001), self-reported frequency in using skills (p = 0.001), and role activities (p = 0.004). Conclusion: Collaboration between academic and clinical nurses is an effective strategy to prepare nurses for rapidly-changing roles.

The SPHERE Study: Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411]

Background: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland.CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines.

Methods: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients. General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD. Patients are invited to attend regular four-monthly consultations over two years, during which targets and goals for secondary prevention are set and reviewed. The analysis will be strengthened by economic, policy and qualitative components.