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Provision of social norm feedback to high prescribers of antibiotics in general practice: a pragmatic national randomised controlled trial.

Michael Hallsworth, Tim Chadborn, Anna Sallis, Michael Sanders, Daniel Berry, Felix Greaves, Lara Clements, Sally Davies

Lancet (London, England) [387:1743-52] (2016)

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Unnecessary antibiotic prescribing contributes to antimicrobial resistance. In this trial, we aimed to reduce unnecessary prescriptions of antibiotics by general practitioners (GPs) in England. In this randomised, 2 × 2 factorial trial, publicly available databases were used to identify GP practices whose prescribing rate for antibiotics was in the top 20% for their National Health Service (NHS) Local Area Team. Eligible practices were randomly assigned (1:1) into two groups by computer-generated allocation sequence, stratified by NHS Local Area Team. Participants, but not investigators, were blinded to group assignment. On Sept 29, 2014, every GP in the feedback intervention group was sent a letter from England's Chief Medical Officer and a leaflet on antibiotics for use with patients. The letter stated that the practice was prescribing antibiotics at a higher rate than 80% of practices in its NHS Local Area Team. GPs in the control group received no communication. The sample was re-randomised into two groups, and in December, 2014, GP practices were either sent patient-focused information that promoted reduced use of antibiotics or received no communication. The primary outcome measure was the rate of antibiotic items dispensed per 1000 weighted population, controlling for past prescribing. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN32349954, and has been completed. Between Sept 8 and Sept 26, 2014, we recruited and assigned 1581 GP practices to feedback intervention (n=791) or control (n=790) groups. Letters were sent to 3227 GPs in the intervention group. Between October, 2014, and March, 2015, the rate of antibiotic items dispensed per 1000 population was 126.98 (95% CI 125.68-128.27) in the feedback intervention group and 131.25 (130.33-132.16) in the control group, a difference of 4.27 (3.3%; incidence rate ratio [IRR] 0.967 [95% CI 0.957-0.977]; p<0.0001), representing an estimated 73,406 fewer antibiotic items dispensed. In December, 2014, GP practices were re-assigned to patient-focused intervention (n=777) or control (n=804) groups. The patient-focused intervention did not significantly affect the primary outcome measure between December, 2014, and March, 2015 (antibiotic items dispensed per 1000 population: 135.00 [95% CI 133.77-136.22] in the patient-focused intervention group and 133.98 [133.06-134.90] in the control group; IRR for difference between groups 1.01, 95% CI 1.00-1.02; p=0.105). Social norm feedback from a high-profile messenger can substantially reduce antibiotic prescribing at low cost and at national scale; this outcome makes it a worthwhile addition to antimicrobial stewardship programmes. Public Health England.


Structured goal planning and supportive telephone followup in rheumatology care: results from a pragmatic stepped-wedge cluster-randomized trial.

Gunnhild Berdal, Ingvild Bø, Turid Dager, Anne Dingsør, Siv Eppeland, Jon Hagfors, Bente Hamnes, Petter Mowinckel, Merete Nielsen, Anne-Lene Sand-Svartrud, Bente Slungaard, Sigrid Wigers, Kåre Hagen, Hanne Dagfinrud, Ingvild Kjeken

Arthritis care & research (2018)

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To evaluate patient-reported health effects of an add-on structured goal planning and supportive telephone followup rehabilitation program compared with traditional rehabilitation programs in patients with rheumatic diseases. In this pragmatic stepped-wedge cluster-randomized controlled trial 389 patients with rheumatic diseases recruited from six rehabilitation centres received either traditional rehabilitation or traditional rehabilitation extended with an add-on program tailored to individual needs. The add-on program comprised a self-management booklet and usage of motivational interviewing in structured individualized goal planning and four supportive followup phone-calls after discharge. Data were collected by questionnaires on admission and discharge from rehabilitation stay, and 6 months and 12 months after discharge. Primary outcome was health-related quality of life (HR-QoL) measured by the Patient Generated Index (PGI, 0-100, 0=low). Secondary outcomes included patient-reported health status, self-efficacy, pain, fatigue, global disease activity and motivation for change. The main statistical analysis was a linear repeated measures mixed model performed on the intention to treat population using all available data. A significant treatment effect of the add-on intervention on HR-QoL was found on discharge (mean difference = 3.32 [95% CI: 0.27, 6.37], p=0.03). No significant between-group differences were found after 6 or 12 months. Both groups showed positive changes in HR-QoL following rehabilitation which gradually declined, although the values remained at higher levels after 6 and 12 months compared with baseline values. The add-on program enhanced the short-term effect of rehabilitation with respect to patient-specific HR-QoL, but it did not prolong the effect as intended. This article is protected by copyright. All rights reserved.


Vitalum study design: RCT evaluating the efficacy of tailored print communication and telephone motivational interviewing on multiple health behaviors.

Hilde M van Keulen, Ilse Mesters, Johannes Brug, Marlein Ausems, Marci Campbell, Ken Resnicow, Paul Zwietering, Gerard van Breukelen, Willem van Mechelen, Johan Severens, Hein De Vries

BMC public health [8:216] (2008)

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A large proportion of adults fail to meet public health guidelines for physical activity as well as fruit, vegetable and fat intake. Interventions are needed to improve these health behaviors. Both computer tailoring and motivational interviewing have shown themselves to be promising techniques for health behavior change. The Vitalum project aims to compare the efficacy of these techniques in improving the health behaviors of adults aged 45-70. This paper describes the design of the Vitalum study. Dutch general medical practices (N = 23) were recruited via a registration network or by personal invitation. The participants were then enrolled through these general practices using an invitational letter. They (n = 2,881) received a written baseline questionnaire to assess health behaviors, and potential psychosocial and socio-demographic behavioral determinants. A power analysis indicated that 1,600 participants who were failing to meet the guidelines for physical activity and either fruit or vegetable consumption were needed. Eligible participants were stratified based on hypertension status and randomized into one of four intervention groups: tailored print communication, telephone motivational interviewing, combined, and control. The first two groups either received four letters or took part in four interviews, whereas the combined group received two letters and took part in two interviews in turns at 5, 13, 30 and 43 weeks after returning the baseline questionnaire. Each letter and interview focused on physical activity or nutrition behavior. The participants also took part in a telephone survey 25 weeks after baseline to gather new information for tailoring. There were two follow-up questionnaires, at 47 and 73 weeks after baseline, to measure short- and long-term effects. The control group received a tailored letter after the last posttest. The process, efficacy and cost-effectiveness of the interventions will be examined by means of multilevel mixed regression, cost-effectiveness analyses and process evaluation. The Vitalum study simultaneously evaluates the efficacy of tailored print communication and telephone motivational interviewing, and their combined use for multiple behaviors and people with different motivational stages and education levels. The results can be used by policymakers to contribute to evidence-based prevention of chronic diseases. Dutch Trial Register NTR1068.


Cost-effectiveness comparison of five interventions to increase mammography screening.

R Saywell, V Champion, C Skinner, D McQuillen, D Martin, M Maraj

Preventive medicine [29:374-82] (1999)

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Mammography is the primary method used for breast cancer screening. However, compliance with recommended screening practices is still below acceptable levels. This study examined the cost-effectiveness of five combinations of physician recommendation and telephone or in-person individualized counseling strategies for increasing compliance with mammography. There were 808 participants who were randomly assigned to one of six groups. A logistic regression model with compliance as the dependent variable and group as the independent variable was used to test for significant differences and a ratio of cost to improvement in mammogram compliance evaluated the cost-effectiveness. Three of the interventions (in-person, telephone plus letter, and in-person plus letter) had significantly better compliance rates compared with the control, physician letter, or telephone alone. However, when considering costs, only one emerged as the superior strategy. The cost-effectiveness ratios for the five interventions show that telephone-plus-letter is the most cost-effective strategy, achieving a 35.6% mammography compliance at a marginal cost of $0.78 per 1% increase in women screened. A tailored phone prompt and physician reminder is an effective and economical intervention to increase mammography. Future research should confirm this finding and address its applicability to practice.


The effectiveness of an enhanced invitation letter on uptake of National Health Service Health Checks in primary care: a pragmatic quasi-randomised controlled trial.

Anna Sallis, Amanda Bunten, Annabelle Bonus, Andrew James, Tim Chadborn, Daniel Berry

BMC family practice [17:35] (2016)

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The National Health Service Health Check (NHS HC) is a population level public health programme. It is a primary prevention initiative offering cardiovascular risk assessment and management for adults aged 40-74 years (every five years). It was designed to reduce the incidence of major vascular disease events by preventing or delaying the onset of diabetes, heart and kidney disease, stroke and vascular dementia . Effectiveness of the programme has been modelled on a national uptake of 75% however in 2012/13 uptake, nationally, was 49%. Ensuring a high percentage of those offered an NHS HC actually receive one is key to optimising the clinical and cost effectiveness of the programme. A pragmatic quasi-randomised controlled trial was conducted in four general practitioner practices in Medway, England with randomisation of 3511 patients. The aim was to compare attendance at the NHS HC using the standard national invitation template letter (control) compared to an enhanced invitation letter using insights from behavioural science (intervention). The intervention letter includes i) simplification - reducing letter content for less effortful processing ii) behavioural instruction - action focused language iii) personal salience - appointment due rather than invited and iv) addressing implementation intentions with a tear off slip to record the date, time and location of the appointment. Logistic Regression explored the association between control and intervention group and attendance at a health check. 29.3% of patients who received the control letter and 33.5% of those who received the intervention letter attended their NHS HC (adjusted odds ratio 1.26, 95% confidence interval 1.09-1.47, p < 0.01). This was an absolute difference in uptake of 4.2 percentage points for those receiving the intervention letter. An invitation letter applying behavioural insights was more effective than the existing national template letter at encouraging attendance at an NHS HC. Making small, no cost behaviourally informed changes to letter invitations can improve uptake of the NHS HC. Further research is required to replicate the effect with more robust methodology and powered for sub-group analysis including socio-economic status. Current Controlled Trials ISRCTN66757664 , date of registration 28/3/2014.


Negotiating Tensions Between Theory and Design in the Development of Mailings for People Recovering From Acute Coronary Syndrome.

Holly Witteman, Justin Presseau, Angl Emily Nicholas, Iffat Jokhio, J Schwalm, Jeremy Grimshaw, Beth Bosiak, Madhu Natarajan, Noah Ivers

JMIR human factors [4:e6] (2017)

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Taking all recommended secondary prevention cardiac medications and fully participating in a formal cardiac rehabilitation program significantly reduces mortality and morbidity in the year following a heart attack. However, many people who have had a heart attack stop taking some or all of their recommended medications prematurely and many do not complete a formal cardiac rehabilitation program. The objective of our study was to develop a user-centered, theory-based, scalable intervention of printed educational materials to encourage and support people who have had a heart attack to use recommended secondary prevention cardiac treatments. Prior to the design process, we conducted theory-based interviews and surveys with patients who had had a heart attack to identify key determinants of secondary prevention behaviors. Our interdisciplinary research team then partnered with a patient advisor and design firm to undertake an iterative, theory-informed, user-centered design process to operationalize techniques to address these determinants. User-centered design requires considering users' needs, goals, strengths, limitations, context, and intuitive processes; designing prototypes adapted to users accordingly; observing how potential users respond to the prototype; and using those data to refine the design. To accomplish these tasks, we conducted user research to develop personas (archetypes of potential users), developed a preliminary prototype using behavior change theory to map behavior change techniques to identified determinants of medication adherence, and conducted 2 design cycles, testing materials via think-aloud and semistructured interviews with a total of 11 users (10 patients who had experienced a heart attack and 1 caregiver). We recruited participants at a single cardiac clinic using purposive sampling informed by our personas. We recorded sessions with users and extracted key themes from transcripts. We held interdisciplinary team discussions to interpret findings in the context of relevant theory-based evidence and iteratively adapted the intervention accordingly. Through our iterative development and testing, we identified 3 key tensions: (1) evidence from theory-based studies versus users' feelings, (2) informative versus persuasive communication, and (3) logistical constraints for the intervention versus users' desires or preferences. We addressed these by (1) identifying root causes for users' feelings and addressing those to better incorporate theory- and evidence-based features, (2) accepting that our intervention was ethically justified in being persuasive, and (3) making changes to the intervention where possible, such as attempting to match imagery in the materials to patients' self-images. Theory-informed interventions must be operationalized in ways that fit with user needs. Tensions between users' desires or preferences and health care system goals and constraints must be identified and addressed to the greatest extent possible. A cluster randomized controlled trial of the final intervention is currently underway.


Effects of a self-determination theory-based mail-mediated intervention on adults' exercise behavior.

Susan Levy, Bradley Cardinal

American journal of health promotion : AJHP [18:345-9] ()

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To examine the effect of a mail-mediated intervention, based on self-determination theory, on adults'exercise behavior. The study was a randomized control trial conducted over a 2-month period. Of the initial 185 volunteer participants, 126 (68.1%) completed questionnaires at baseline, 1 month, and 2 months. Participants in intervention-only and intervention-plus-booster groups received a mail-delivered packet containing strategies designed to promote perceptions of autonomy, competence, and relatedness regarding exercise. Those in a control group received an American Heart Association physical-activity facts packet. After 1 month, those in the intervention-plus-booster group received a booster postcard, reiterating the main points of the initial intervention packet. Exercise behavior was the primary outcome variable. Perceptions of autonomy, competence, and relatedness were evaluated as mediating variables. Separate 3 (group) x 3 (time) repeated measures analyses of variance conducted for men and women revealed that for women, all three groups significantly increased exercise levels over the 2-month period. No significant interactions were found regarding the influence of the intervention on the mediating variables. A process evaluation indicated a lack of compliance regarding completing intervention-packet worksheets. Findings suggested that more intensive interventions and greater fidelity of treatment may be needed to evidence change in exercise behavior.


Personalized mailed feedback for college drinking prevention: a randomized clinical trial.

Mary Larimer, Christine Lee, Jason Kilmer, Patricia Fabiano, Christopher Stark, Irene Geisner, Kimberly Mallett, Ty Lostutter, Jessica Cronce, Maggie Feeney, Clayton Neighbors

Journal of consulting and clinical psychology [75:285-93] (2007)

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The current study was designed to evaluate the efficacy of a mailed feedback and tips intervention as a universal prevention strategy for college drinking. Participants (N = 1,488) were randomly assigned to feedback or assessment-only control conditions. Results indicated that the mailed feedback intervention had a preventive effect on drinking rates overall, with participants in the feedback condition consuming less alcohol at follow-up in comparison with controls. In addition, abstainers in the feedback condition were twice as likely to remain abstinent from alcohol at follow-up in comparison with control participants (odds ratio = 2.02), and feedback participants were significantly more likely to refrain from heavy episodic drinking (odds ratio = 1.43). Neither gender nor severity of baseline drinking moderated the efficacy of the intervention in these analyses, but more conservative analyses utilizing last-observation carryforward suggested women and abstainers benefited more from this prevention approach. Protective behaviors mediated intervention efficacy, with participants who received the intervention being more likely to use strategies such as setting limits and alternating alcohol with nonalcoholic beverages. Implications of these findings for universal prevention of college drinking are discussed.