Living with HIV makes considerable demands on a person in terms of self-management, especially as regards adherence to treatment and coping with adverse side-effects. The online HIV Treatment, Virtual Nursing Assistance and Education (Virus de I’immunodéficience Humaine–Traitement Assistance Virtuelle Infirmière et Enseignement; VIH-TAVIE™) intervention was developed to provide persons living with HIV (PLHIV) with personalized follow-up and real-time support in managing their medication intake on a daily basis. An online randomized controlled trial (RCT) will be conducted to evaluate the efficacy of this intervention primarily in optimizing adherence to combination anti-retroviral therapy (ART) among PLHIV.
A convenience sample of 232 PLHIV will be split evenly and randomly between an experimental group that will use the web application, and a control group that will be handed a list of websites of interest. Participants must be aged 18 years or older, have been on ART for at least 6 months, and have internet access. The intervention is composed of four interactive computer sessions of 20 to 30 minutes hosted by a virtual nurse who engages the PLHIV in a skills-learning process aimed at improving self-management of medication intake. Adherence constitutes the principal outcome, and is defined as the intake of at least 95% of the prescribed tablets. The following intermediary measures will be assessed: self-efficacy and attitude towards antiretroviral medication, symptom-related discomfort, and emotional support. There will be three measurement times: baseline (T0), after 3 months (T3) and 6 months (T6) of baseline measurement. The principal analyses will focus on comparing the two groups in terms of treatment adherence at the end of follow-up at T6. An intention-to-treat (ITT) analysis will be carried out to evaluate the true value of the intervention in a real context.
Carrying out this online RCT poses various challenges in terms of recruitment, ethics, and data collection, including participant follow-up over an extended period. Collaboration between researchers from clinical disciplines (nursing, medicine), and experts in behavioral sciences information technology and media will be crucial to the development of innovative solutions to supplying and delivering health services.
CE 11.184 / NCT 01510340
Randomized controlled trial; Web-based study; People living with HIV; Self-management program; Adherence; Anti-retroviral therapy
Intakes of omega-3 (n-3) fatty acids (FA) are associated with several health benefits. The aim of this study was to verify whether intakes of n-3 FA estimated from a food frequency questionnaire (FFQ) correlate with n-3 FA levels measured in plasma phospholipids (PL).
The study sample consisted of 200 French-Canadians men and women aged between 18 to 55 years. Dietary data were collected using a validated FFQ. Fasting blood samples were collected and the plasma PL FA profile was measured by gas chromatography.
Low intakes of n-3 long-chain FA together with low percentages of n-3 long-chain FA in plasma PL were found in French-Canadian population. Daily intakes of eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA) were similar between men and women. Yet, alpha-linolenic acid (ALA) and total n-3 FA intakes were significantly higher in men compared to women (ALA: 2.28 g and 1.69 g, p < 0.0001, total n-3 FA: 2.57 g and 1.99 g, p < 0.0001; respectively). In plasma PL, DPA and DHA percentages were significantly different between men and women (DPA: 1.03% and 0.88%, p < 0.0001, DHA: 3.00% and 3.43%, p = 0.0005; respectively). Moreover, DHA (men: r = 0.52, p < 0.0001; women: r = 0.57, p < 0.0001) and total n-3 FA (men: r = 0.47, p < 0.0001; women: r = 0.52, p < 0.0001) intakes were positively correlated to their respective plasma PL FA levels. In women, EPA (r = 0.44, p < 0.0001) and DPA (r = 0.23, p = 0.02) intakes were also correlated respectively with EPA and DPA plasma PL FA percentages.
Estimated n-3 long-chain FA intake among this young and well-educated French-Canadian population is lower than the recommendations. Further, FFQ data is comparable to plasma PL results to estimate DHA and total n-3 FA status in healthy individuals as well as to evaluate the EPA and DPA status in women. Overall, this FFQ could be used as a simple, low-cost tool in future studies to rank n-3 FA status of individuals.
Food frequency questionnaire; Plasma phospholipids; n-3 PUFA; Biomarker; Gas chromatography
Continuing professional development (CPD) is one of the principal means by which health professionals (i.e. primary care physicians and specialists) maintain, improve, and broaden the knowledge and skills required for optimal patient care and safety. However, the lack of a widely accepted instrument to assess the impact of CPD activities on clinical practice thwarts researchers' comparisons of the effectiveness of CPD activities. Using an integrated model for the study of healthcare professionals' behaviour, our objective is to develop a theory-based, valid, reliable global instrument to assess the impact of accredited CPD activities on clinical practice.
Phase 1: We will analyze the instruments identified in a systematic review of factors influencing health professionals' behaviours using criteria that reflect the literature on measurement development and CPD decision makers' priorities. The outcome of this phase will be an inventory of instruments based on social cognitive theories. Phase 2: Working from this inventory, the most relevant instruments and their related items for assessing the concepts listed in the integrated model will be selected. Through an e-Delphi process, we will verify whether these instruments are acceptable, what aspects need revision, and whether important items are missing and should be added. The outcome of this phase will be a new global instrument integrating the most relevant tools to fit our integrated model of healthcare professionals' behaviour. Phase 3: Two data collections are planned: (1) a test-retest of the new instrument, including item analysis, to assess its reliability and (2) a study using the instrument before and after CPD activities with a randomly selected control group to explore the instrument's mere-measurement effect. Phase 4: We will conduct individual interviews and focus groups with key stakeholders to identify anticipated barriers and enablers for implementing the new instrument in CPD practice. Phase 5: Drawing on the results from the previous phases, we will use consensus-building methods to develop with the decision makers a plan to implement the new instrument.
This project proposes to give stakeholders a theory-based global instrument to validly and reliably measure the impacts of CPD activities on clinical practice, thus laying the groundwork for more targeted and effective knowledge-translation interventions in the future.
To explore ways to reduce the overuse of antibiotics for acute respiratory infections (ARIs), we conducted a pilot clustered randomized controlled trial (RCT) to evaluate DECISION+, a training program in shared decision making (SDM) for family physicians (FPs). This pilot project demonstrated the feasibility of conducting a large clustered RCT and showed that DECISION+ reduced the proportion of patients who decided to use antibiotics immediately after consulting their physician. Consequently, the objective of this study is to evaluate, in patients consulting for ARIs, if exposure of physicians to a modified version of DECISION+, DECISION+2, would reduce the proportion of patients who decide to use antibiotics immediately after consulting their physician.
The study is a multi-center, two-arm, parallel clustered RCT. The 12 family practice teaching units (FPTUs) in the network of the Department of Family Medicine and Emergency Medicine of Université Laval will be randomized to a DECISION+2 intervention group (experimental group) or to a no-intervention control group. These FPTUs will recruit patients consulting family physicians and residents in family medicine enrolled in the study. There will be two data collection periods: pre-intervention (baseline) including 175 patients with ARIs in each study arm, and post-intervention including 175 patients with ARIs in each study arm (total n = 700). The primary outcome will be the proportion of patients reporting a decision to use antibiotics immediately after consulting their physician. Secondary outcome measures include: 1) physicians and patients' decisional conflict; 2) the agreement between the parties' decisional conflict scores; and 3) perception of patients and physicians that SDM occurred. Also in patients, at 2 weeks follow-up, adherence to the decision, consultation for the same reason, decisional regret, and quality of life will be assessed. Finally, in both patients and physicians, intention to engage in SDM in future clinical encounters will be assessed. Intention-to-treat analyses will be applied and account for the nested design of the trial will be taken into consideration.
DECISION+2 has the potential to reduce antibiotics use for ARIs by priming physicians and patients to share decisional process and empowering patients to make informed, value-based decisions.
The misuse and limited effectiveness of antibiotics for acute respiratory infections (ARIs) are well documented, and current approaches targeting physicians or patients to improve appropriate use have had limited effect. Shared decision-making could be a promising strategy to improve appropriate antibiotic use for ARIs, but very little is known about its implementation processes and outcomes in clinical settings. In this matter, pilot studies have played a key role in health science research over the past years in providing information for the planning, justification, and/or refinement of larger studies. The objective of our study was to assess the feasibility and acceptability of the study design, procedures, and intervention of the DECISION+ program, a continuing medical education program in shared decision-making among family physicians and their patients on the optimal use of antibiotics for treating ARIs in primary care.
A pilot clustered randomised trial was conducted. Family medicine groups (FMGs) were randomly assigned, to either the DECISION+ program, which included three 3-hour workshops over a four- to six-month period, or a control group that had a delayed exposure to the program.
Among 21 FMGs contacted, 5 (24%) agreed to participate in the pilot study. A total of 39 family physicians (18 in the two experimental and 21 in the three control FMGs) and their 544 patients consulting for an ARI were recruited. The proportion of recruited family physicians who participated in all three workshops was 46% (50% for the experimental group and 43% for the control group), and the overall mean level of satisfaction regarding the workshops was 94%.
This trial, while aiming to demonstrate the feasibility and acceptability of conducting a larger study, has identified important opportunities for improving the design of a definitive trial. This pilot trial is informative for researchers and clinicians interested in designing and/or conducting studies with FMGs regarding training of physicians in shared decision-making.
The promotion of physical activity among an overweight/obese population is an important challenge for clinical practitioners and researchers. In this regard, completing a questionnaire on cognitions could be a simple and easy strategy to increase levels of physical activity. Thus, the aim of the present study was to test the effect of completing a questionnaire based on the Theory of Planned Behavior (TPB) on the level of physical activity.
Overall, 452 overweight/obese adults were recruited and randomized to the experimental or control group. At baseline, participants completed a questionnaire on cognitions regarding their participation in leisure-time physical activity (experimental condition) versus a questionnaire on fruit and vegetable consumption (control condition). The questionnaires assessed the TPB variables that are beliefs, attitude, norm, perception of control, intention and a few additional variables from other theories. At three-month follow-up, leisure-time physical activity was self-reported by means of a short questionnaire. An analysis of covariance with baseline physical activity level as covariate was used to verify the effect of the intervention.
At follow-up, 373 participants completed the leisure-time physical activity questionnaire. The statistical analysis showed that physical activity participation was greater among participants in the experimental condition than those in the control condition (F(1,370) = 6.85, p = .009, d = 0.20).
Findings indicate that completing a TPB questionnaire has a significant positive impact on subsequent participation in physical activity. Consequently, asking individuals to complete such a questionnaire is a simple, inexpensive and easy strategy to increase the level of physical activity among overweight/obese adults.
The quest for greater efficiency in the provision of primary healthcare services and the implementation of a "health-promoting school" approach encourage the optimal redefinition of the role of school nurses. School nurses are viewed as professionals who might be significant actors in the promotion of youth health. The aim of this study was to identify the determinants of the intention of elementary school nurses to adopt a new health-promotion role as a strategic option for the health-promoting school.
This study was based on an extended version of the theory of planned behaviour (TPB). A total of 251 respondents (response rate of 70%) from 42 school health programs across the Province of Québec completed a mail survey regarding their intention to adopt the proposed health-promotion role. Multiple hierarchical linear regression analyses were performed to assess the relationship between key independent variables and intention. A discriminant analysis of the beliefs was performed to identify the main targets of action.
A total of 73% of respondents expressed a positive intention to accept to play the proposed role. The main predictors were perceived behavioural control (β = 0.36), moral norm (β = 0.27), attitude (β = 0.24), and subjective norm (β = 0.21) (ps < .0001), explaining 83% of the variance. The underlying beliefs distinguishing nurses who had a high intention from those who had a low intention referred to their feelings of being valued, their capacity to overcome the nursing shortage, the approval of the school nurses' community and parents of the students, their leadership skills, and their gaining of a better understanding of school needs.
Results suggest that leadership is a skill that should be addressed to increase the ability of school nurses to assume the proposed role. Findings also indicate that public health administrators need to ensure adequate nurse staffing in the schools in order to increase the proportion of nurses willing to play such a role and avoid burnout among these human resources.
The electronic health record (EHR) is an important application of information and communication technologies to the healthcare sector. EHR implementation is expected to produce benefits for patients, professionals, organisations, and the population as a whole. These benefits cannot be achieved without the adoption of EHR by healthcare professionals. Nevertheless, the influence of individual and organisational factors in determining EHR adoption is still unclear. This study aims to assess the unique contribution of individual and organisational factors on EHR adoption in healthcare settings, as well as possible interrelations between these factors.
A prospective study will be conducted. A stratified random sampling method will be used to select 50 healthcare organisations in the Quebec City Health Region (Canada). At the individual level, a sample of 15 to 30 health professionals will be chosen within each organisation depending on its size. A semi-structured questionnaire will be administered to two key informants in each organisation to collect organisational data. A composite adoption score of EHR adoption will be developed based on a Delphi process and will be used as the outcome variable. Twelve to eighteen months after the first contact, depending on the pace of EHR implementation, key informants and clinicians will be contacted once again to monitor the evolution of EHR adoption. A multilevel regression model will be applied to identify the organisational and individual determinants of EHR adoption in clinical settings. Alternative analytical models would be applied if necessary.
The study will assess the contribution of organisational and individual factors, as well as their interactions, to the implementation of EHR in clinical settings.
These results will be very relevant for decision makers and managers who are facing the challenge of implementing EHR in the healthcare system. In addition, this research constitutes a major contribution to the field of knowledge transfer and implementation science.
Accumulating evidence suggests that fruit and vegetable intake (FVI) plays a protective role against major diseases. Despite this protective role and the obesity pandemic context, populations in Western countries usually eat far less than five servings of fruits and vegetables per day. In order to increase the efficiency of interventions, they should be tailored to the most important determinants or mediators of FVI. The objective was to systematically review social cognitive theory-based studies of FVI and to identify its main psychosocial determinants.
Published papers were systematically sought using Current Contents (2007-2009) and Medline, Embase, PsycINFO, Proquest and Thesis, as well as Cinhal (1980-2009). Additional studies were identified by a manual search in the bibliographies. Search terms included fruit, vegetable, behaviour, intention, as well as names of specific theories. Only studies predicting FVI or intention to eat fruits and vegetables in the general population and using a social cognitive theory were included. Independent extraction of information was carried out by two persons using predefined data fields, including study quality criteria.
A total of 23 studies were identified and included, 15 studying only the determinants of FVI, seven studying the determinants of FVI and intention and one studying only the determinants of intention. All pooled analyses were based on random-effects models. The random-effect R2 observed for the prediction of FVI was 0.23 and it was 0.34 for the prediction of intention. Multicomponent theoretical frameworks and the theory of planned behaviour (TPB) were most often used. A number of methodological moderators influenced the efficacy of prediction of FVI. The most consistent variables predicting behaviour were habit, motivation and goals, beliefs about capabilities, knowledge and taste; those explaining intention were beliefs about capabilities, beliefs about consequences and perceived social influences.
Our results suggest that the TPB and social cognitive theory (SCT) are the preferable social cognitive theories to predict behaviour and TPB to explain intention. Efficacy of prediction was nonetheless negatively affected by methodological factors such as the study design and the quality of psychosocial and behavioural measures.
Regular physical activity is considered a cornerstone for managing type 2 diabetes. However, in Canada, most individuals with type 2 diabetes do not meet national physical activity recommendations. When designing a theory-based intervention, one should first determine the key determinants of physical activity for this population. Unfortunately, there is a lack of information on this aspect among adults with type 2 diabetes. The purpose of this cross-sectional study is to fill this gap using an extended version of Ajzen's Theory of Planned Behavior (TPB) as reference.
A total of 501 individuals with type 2 diabetes residing in the Province of Quebec (Canada) completed the study. Questionnaires were sent and returned by mail.
Multiple hierarchical regression analyses indicated that TPB variables explained 60% of the variance in intention. The addition of other psychosocial variables in the model added 7% of the explained variance. The final model included perceived behavioral control (β = .38, p < .0001), moral norm (β = .29, p < .0001), and attitude (β = .14, p < .01).
The findings suggest that interventions aimed at individuals with type 2 diabetes should ensure that people have the necessary resources to overcome potential obstacles to behavioral performance. Interventions should also favor the development of feelings of personal responsibility to exercise and promote the advantages of exercising for individuals with type 2 diabetes.
In recent years, there has been growing interest in theoretical studies integrating cognitions and environmental variables in the prediction of behaviour related to the obesity epidemic. This is the approach adopted in the present study in reference to the theory of planned behaviour. More precisely, the aim of this study was to determine the contribution of cognitive and environmental variables in the prediction of active commuting to get to and from work or school.
A prospective study was carried out with 130 undergraduate and graduate students (93 females; 37 males). Environmental, cognitive and socio-demographic variables were evaluated at baseline by questionnaire. Two weeks later, active commuting (walking/bicycling) to get to and from work or school was self-reported by questionnaire. Hierarchical multiple regression analyses were performed to predict intention and behaviour.
The model predicting behaviour based on cognitive variables explained more variance than the model based on environmental variables (37.4% versus 26.8%; Z = 3.86, p < 0.001). Combining cognitive and environmental variables with socio-demographic variables to predict behaviour yielded a final model explaining 41.1% (p < 0.001) of the variance. The significant determinants were intention, habit and age. Concerning intention, the same procedure yielded a final model explaining 78.2% (p < 0.001) of the variance, with perceived behavioural control, attitude and habit being the significant determinants.
The results showed that cognitive variables play a more important role than environmental variables in predicting and explaining active commuting. When environmental variables were significant, they were mediated by cognitive variables. Therefore, individual cognitions should remain one of the main focuses of interventions promoting active commuting among undergraduate and graduate students.
Familial history information could be useful in clinical practice. However, little is known about the accuracy of self-reported familial history, particularly self-reported familial history of obesity (FHO).
Two cross-sectional studies were conducted. The aims of study 1 was to compare self-reported and objectively measured weight and height whereas the aims of study 2 were to examine the relationship between the weight and height estimations reported by the study participants and the values provided by their family members as well as the validity of a self-reported measure of FHO. Study 1 was conducted between 2004 and 2006 among 617 subjects and study 2 was conducted in 2006 among 78 participants.
In both studies, weight and height reported by the participants were significantly correlated with their measured values (study 1: r = 0.98 and 0.98; study 2: r = 0.99 and 0.97 respectively; p < 0.0001). Estimates of weight and height for family members provided by the study participants were strongly correlated with values reported by each family member (r = 0.96 and 0.95, respectively; p < 0.0001). Substantial agreement between the FHO reported by the participants and the one obtained by calculating the BMI of each family members was observed (kappa = 0.72; p < 0.0001). Sensitivity (90.5%), specificity (82.6%), positive (82.6%) and negative (90.5%) predictive values of FHO were very good.
A self-reported measure of FHO is valid, suggesting that individuals are able to detect the presence or the absence of obesity in their first-degree family members.
There is an important gap between the implications of clinical research evidence and the routine clinical practice of healthcare professionals. Because individual decisions are often central to adoption of a clinical-related behaviour, more information about the cognitive mechanisms underlying behaviours is needed to improve behaviour change interventions targeting healthcare professionals. The aim of this study was to systematically review the published scientific literature about factors influencing health professionals' behaviours based on social cognitive theories. These theories refer to theories where individual cognitions/thoughts are viewed as processes intervening between observable stimuli and responses in real world situations.
We searched psycINFO, MEDLINE, EMBASE, CIHNAL, Index to theses, PROQUEST dissertations and theses and Current Contents for articles published in English only. We included studies that aimed to predict healthcare professionals' intentions and behaviours with a clear specification of relying on a social cognitive theory. Information on percent of explained variance (R2) was used to compute the overall frequency-weighted mean R2 to evaluate the efficacy of prediction in several contexts and according to different methodological aspects. The cognitive factors most consistently associated with prediction of healthcare professionals' intention and behaviours were documented.
Seventy eight studies met the inclusion criteria. Among these studies, 72 provided information on the determinants of intention and 16 prospective studies provided information on the determinants of behaviour. The theory most often used as reference was the Theory of Reasoned Action (TRA) or its extension the Theory of Planned Behaviour (TPB). An overall frequency-weighted mean R2 of 0.31 was observed for the prediction of behaviour; 0.59 for the prediction of intention. A number of moderators influenced the efficacy of prediction; frequency-weighted mean R2 varied from 0.001 to 0.58 for behaviour and 0.19 to 0.81 for intention.
Our results suggest that the TPB appears to be an appropriate theory to predict behaviour whereas other theories better capture the dynamic underlying intention. In addition, given the variations in efficacy of prediction, special care should be given to methodological issues, especially to better define the context of behaviour performance.
Intention is a key determinant of action. However, there is a gap between intention and behavioural performance that remains to be explained. Therefore, the aim of this study was to identify moderators of the intention-behaviour and perceived behavioural control (PBC)- behaviour relationships for leisure-time physical activity.
This was tested in reference to Ajzen's Theory of Planned Behaviour. A sample of 300 volunteers, 192 women and 108 men, aged 18 to 55, participated in the study. At baseline, the participants completed a self-administrated psychosocial questionnaire assessing Ajzen's theory variables (i.e., intention and perceived behavioural control). The behavioural measure was obtained by mail three months later.
Multiple hierarchical regression analyses indicated that age and annual income moderated the intention-behaviour and PBC-behaviour relationships. However, in the final model predicting behaviour (R2 = .46), only the interaction term of PBC by annual income (β = .24, p = 0.0003) significantly contributed to the prediction of behaviour along with intention (β = .49, p = 0.0009) and past behaviour (β = .44, p < 0.0001).
Physical activity promotion programs would benefit not only from focusing on increasing the intention of low intenders, but also from targeting factors that moderate the perceived behavioural control-behaviour relationships.
In North America, although it varies according to the specific type of acute respiratory infections (ARI), use of antibiotics is estimated to be well above the expected prevalence of bacterial infections. The objective of this pilot clustered randomized controlled trial (RCT) is to assess the feasibility of a larger clustered RCT aiming at evaluating the impact of DECISION+, a continuing professional development (CPD) program in shared decision making, on the optimal use of antibiotics in the context of ARI.
This pilot study is a cluster RCT conducted with family physicians from Family Medicine Groups (FMG) in the Quebec City area, Canada. Participating FMG are randomised to an immediate DECISION+ group, a CPD program in shared decision making, (experimental group), or a delayed DECISION+ group (control group). Data collection involves recruiting five patients consulting for ARI per physician from both study groups before (Phase 1) and after (Phase 2) exposure of the experimental group to the DECISION+ program, and after exposure of the control group to the DECISION+ program (Phase 3). The primary outcome measures to assess the feasibility of a larger RCT include: 1) proportion of contacted FMG that agree to participate; 2) proportion of recruited physicians who participate in the DECISION+ program; 3) level of satisfaction of physicians regarding DECISION+; and 4) proportion of missing data in each data collection phase. Levels of agreement of the patient-physician dyad on the Decisional Conflict Scale and physicians' prescription profile for ARI are performed as secondary outcome measures.
This study protocol is informative for researchers and clinicians interested in designing and/or conducting clustered RCT with FMG regarding training of physicians in shared decision making.
ClinicalTrials.gov Identifier: NCT00354315
A challenge for implementation researchers is to develop principles that could generate testable hypotheses that apply across a range of clinical contexts, thus leading to generalisability of findings. Such principles may be provided by systematically developed theories. The opportunity has arisen to test some of these theoretical principles in the Ontario Printed Educational Materials (OPEM) trial by conducting a sub-trial within the existing trial structure. OPEM is a large factorial cluster-randomised trial evaluating the effects of short directive and long discursive educational messages embedded into informed, an evidence-based newsletter produced in Canada by the Institute for Clinical Evaluative Sciences (ICES) and mailed to all primary care physicians in Ontario. The content of educational messages in the sub-trial will be constructed using both standard methods and methods inspired by psychological theory. The aim of this study is to test the effectiveness of the TheoRY-inspired MEssage ('TRY-ME') compared with the 'standard' message in changing prescribing behaviour.
The OPEM trial participants randomised to receive the short directive message attached to the outside of informed (an 'outsert') will be sub-randomised to receive either a standard message or a message informed by the theory of planned behaviour (TPB) using a two (long insert or no insert) by three (theory-based outsert or standard outsert or no outsert) design. The messages will relate to prescription of thiazide diuretics as first line drug treatment for hypertension (described in the accompanying protocol, "The Ontario Printed Educational Materials trial"). The short messages will be developed independently by two research teams.
The primary outcome is prescription of thiazide diuretics, measured by routinely collected data available within ICES. The study is designed to answer the question, is there any difference in guideline adherence (i.e., thiazide prescription rates) between physicians in the six groups? A process evaluation survey instrument based on the TPB will be administered pre- and post-intervention (described in the accompanying protocol, "Looking inside the black box"). The second research question concerns processes that may underlie observed differences in prescribing behaviour. We expect that effects of the messages on prescribing behaviour will be mediated through changes in physicians' cognitions.
Trial registration number
Current controlled trial ISRCTN72772651
Randomised controlled trials of implementation strategies tell us whether (or not) an intervention results in changes in professional behaviour but little about the causal mechanisms that produce any change. Theory-based process evaluations collect data on theoretical constructs alongside randomised trials to explore possible causal mechanisms and effect modifiers. This is similar to measuring intermediate endpoints in clinical trials to further understand the biological basis of any observed effects (for example, measuring lipid profiles alongside trials of lipid lowering drugs where the primary endpoint could be reduction in vascular related deaths).
This study protocol describes a theory-based process evaluation alongside the Ontario Printed Educational Message (OPEM) trial. We hypothesize that the OPEM interventions are most likely to operate through changes in physicians' behavioural intentions due to improved attitudes or subjective norms with little or no change in perceived behavioural control. We will test this hypothesis using a well-validated social cognition model, the theory of planned behaviour (TPB) that incorporates these constructs.
We will develop theory-based surveys using standard methods based upon the TPB for the second and third replications, and survey a subsample of Ontario family physicians from each arm of the trial two months before and six months after the dissemination of the index edition of informed, the evidence based newsletter used for the interventions. In the third replication, our study will converge with the "TRY-ME" protocol (a second study conducted alongside the OPEM trial), in which the content of educational messages was constructed using both standard methods and methods informed by psychological theory. We will modify Dillman's total design method to maximise response rates. Preliminary analyses will initially assess the internal reliability of the measures and use regression to explore the relationships between predictor and dependent variable (intention to advise diabetic patients to have annual retinopathy screening and to prescribe thiazide diuretics for first line treatment of uncomplicated hypertension). We will then compare groups using methods appropriate for comparing independent samples to determine whether there have been changes in the predicted constructs (attitudes, subjective norms, or intentions) across the study groups as hypothesised, and will assess the convergence between the process evaluation results and the main trial results.
Trial registration number
Current controlled trial ISRCTN72772651
To determine the prevalence of HIV and hepatitis C virus (HCV) infections and examine risk factors for these infections among inmates in Quebec provincial prisons.
Anonymous cross-sectional data were collected from January to June 2003 for men (n = 1357) and women (n = 250) who agreed to participate in the study and who completed a self-administrated questionnaire and provided saliva samples.
The prevalence of HIV infection was 2.3% among the male participants and 8.8% among the female participants. The corresponding prevalence of HCV infection was 16.6% and 29.2%, respectively. The most important risk factor was injection drug use. The prevalence of HIV infection was 7.2% among the male injection drug users and 0.5% among the male non-users. Among the women, the rate was 20.6% among the injection drug users, whereas none of the non-users was HIV positive. The prevalence of HCV infection was 53.3% among the male injection drug users and 2.6% among the male non-users; the corresponding values among the women were 63.6% and 3.5%.
HIV and HCV infections constitute an important public health problem in prison, where the prevalence is affected mainly by a high percentage of injection drug use among inmates.
Theory-based approaches are advocated to improve our understanding of prescription behaviour. This study is an application of the theory of planned behaviour (TPB) with additional variables. It was designed to assess which variables were associated with the intention to prescribe hormone therapy (HT). In addition, variations in the measures across medical specialities (GPs and gynaecologists) and across countries (France and Quebec) were investigated.
A survey among 2,000 doctors from France and 1,044 doctors from Quebec was conducted. Data were collected by means of a self-administered questionnaire. A clinical vignette was used to elicit doctors' opinions. The following TPB variables were assessed: attitude, subjective norm, perceived behavioural control, attitudinal beliefs, normative beliefs and power of control beliefs. Additional variables (role belief, moral norm and practice pattern-related factors) were also assessed. A stepwise logistic regression was used to assess which variables were associated with the intention to prescribe HT. GPs and gynaecologists were compared to each other within countries and the two countries were compared within the specialties.
Overall, 1,085 doctors from France returned their questionnaire and 516 doctors from Quebec (response rate = 54% and 49%, respectively). In the overall regression model, power of control beliefs, moral norm and role belief were significantly associated with intention (all at p < 0.0001). The models by specialty and country were: for GPs in Quebec, power of control beliefs (p < 0.0001), moral norm (p < 0.01) and cytology and hormonal dosage (both at p < 0.05); for GPs in France, power of control beliefs and role belief (both at p < 0.0001) and perception of behavioural control (p < 0.05) and cessation of menses (p < 0.01); for gynaecologists in Quebec, moral norm and power of control beliefs (both at p = 0.01); and for gynaecologists in France, power of control beliefs (p < 0.0001), and moral norm, role belief and lipid profile (all at p < 0.05).
In both countries, compared with GPs, intention to prescribe HT was higher for gynaecologists. Psychosocial determinants of doctors' intention to prescribe HT varied according to the specialty and the country thus, suggesting an influence of contextual factors on these determinants.
Experts estimate that the prevalence of antibiotics use exceeds the prevalence of bacterial acute respiratory infections (ARIs).
To develop, adapt and validate DECISION+ and estimate its impact on the decision of family physicians (FPs) and their patients on whether to use antibiotics for ARIs.
Two-arm parallel clustered pilot randomized controlled trial.
Setting and participants
Four family medicine groups were randomized to immediate DECISION+ participation (the experimental group) or delayed DECISION+ participation (the control group). Thirty-three FPs and 459 patients participated.
DECISION+ is a multiple-component, continuing professional development program in shared decision making that addresses the use of antibiotics for ARIs.
Main outcome measures
Throughout the pilot trial, DECISION+ was adapted in response to participant feedback. After the consultation, patients and FPs independently self-reported the decision (immediate use, delayed use, or no use of antibiotics) and its quality. Agreement between their decisional conflict was assessed. Two weeks later, patients assessed their decisional regret and health status.
Compared to the control group, the experimental group reduced its immediate use of antibiotics (49 vs. 33% absolute difference = 16%; P = 0.08). Decisional conflict agreement was stronger in the experimental group (absolute difference of Pearson's r = 0.26; P = 0.06). Decisional regret and perceptions of the quality of the decision and of health status in the two groups were similar.
Discussion and conclusions
DECISION+ was developed successfully and appears to reduce the use of antibiotics for ARIs without affecting patients' outcomes. A larger trial is needed to confirm this observation.
acute respiratory infections; continuing medical education; continuing professional development; implementation; randomized control trial; shared decision making