The general purpose of this thesis was the study of tools to enhance health behaviour with patients in primary care waiting rooms. The time patients spent in the waiting room was used as an opportunity for a moment of health education. A systematic review on educative efficiency of audio-visual aids in primary care waiting rooms learned that audio-visual aids broadcasting messages using screens (TVs, computers, tablets, smartphones with Bluetooth® pairing) probably enhance patients’ knowledge, but a change in health behaviour remains controversial. In a second phase the thesis focused on the annual advertisement campaign by posters and pamphlets in general practice (GP) waiting rooms to promote seasonal influenza vaccination as a paradigm to measure the efficacy of posters and pamphlets with a randomized controlled trial (RCT). It is notable that the validity of studies in the field of changes in health behaviour is often invalidated by experimental artefacts, in particular, the so-called Hawthorne effect (HE), related to behavioural changes in patients and in investigators caused by the experimental environment. The thesis sought to update and refine the definition of the HE in medical research and more specifically in primary care. Following our refined definition, the probability of a HE in the RCT was scarce, but no indisputable evidence was strengthening our conclusions. We redesigned our RCT bypassing the limitations of the first and followed over two years our research cohort to obtain an insight of the natural evolution of seasonal influenza vaccination uptake in GPs’ customer base.
Health promotion and patients’ health education are an important part of a GP’s commitments as patients’ health behaviours are crucial factors in life expectancy and good health. Most waiting-rooms have therefore been implemented with audio-visual aids (posters, pamphlets or screens) for health promotion purposes. Posters and pamphlets are present in practically all primary care practices. Few studies have assessed the effect of audio-visual aids in primary care.
Our first objectives, as to scan this research field, was to identify, describe and appraise studies that had investigated the effects of audio-visual aids on health promotion in primary health care waiting-rooms and to identify which factors influence their effect through a systematic literature review.
Databases were searched by two independent researchers using predefined keywords. Additional records were extracted from the reference lists of the selected articles. The selection of the reports was performed on the title and abstract, followed by complete reading and assessment. Bias and level of evidence were analysed.
We collected 909 records. Most of them were not in primary care settings. Fourteen peer-reviewed reports fully meeting the inclusion criteria were retained for analysis. Good quality studies were scarce as it appeared difficult to distinguish the specific effect of the aids from the motivation of investigators. Eight of these articles using videos or slideshows on TV screens or tablets indicated effects: three of them showed a significant improvement of patient knowledge with acceptable evidence and three on health behaviour with surrogate endpoints didn’t show a clear association with the studied outcome. Audio-visual aids seemed to be used or noticed by patients and could induce conversations with physicians. The relevant factors that might influence these effects (duration of exposure, conception quality, theme, target population and time spent in the waiting-room) were insufficiently investigated. Finally, if audio-visual aids broadcasting messages using screens might enhance patients’ knowledge, no effect of posters and pamphlets in waiting rooms was demonstrated. A change in health behaviour remained controversial.
As most GPs use advertising with posters and pamphlets in their waiting rooms for patient’s education purposes without clear evidence of their use, we sought to demonstrate the effect of an advertising campaign using these two media. Patients vaccinated against seasonal influenza have been gradually lessening between 2009 and 2014, and mandatory health insurance companies have implemented in France an advertising campaign using posters and pamphlets displayed in primary care waiting rooms to promote seasonal influenza vaccination uptake, together with incentives in mass-media.
We designed a trial with the objective of assessing the effect of this advertising campaign for influenza vaccination using posters and pamphlets in GPs’ waiting rooms.
This registry based 2/1 cluster randomized controlled trial (RCT), a cluster gathering the enlisted patients aged over 16 years, of 75 GPs, run during the 2014-2015 influenza vaccination campaign. It compared patient’s awareness in 50 GPs’ standard waiting rooms exposed to a lot of information (control group) versus that of patients, spending their time in waiting rooms from 25 GPs, who had received and displayed (in addition to mandatory information) only those pamphlets and one poster about the influenza vaccination campaign (intervention group). The main outcome was the number of vaccination units delivered in community pharmacies. Data were extracted from the SIAM-ERASME claim database of the main mandatory Health Insurance Fund of Lille-Douai (France). The association between the intervention (yes/no) and the main outcome was assessed through a generalized estimating equation.
Seventy-five GPs enrolled 10,597 patients of 65 years and over, or of 16 years and over suffering from long lasting diseases (intervention/control as of 3781/6816 patients) from October 15, 2014 to February 28, 2015. No difference was found regarding the number of influenza vaccination units delivered in community pharmacies (Relative Risk =1.01; 95% Confidence interval: 0.97 to 1.05; p=0.561). A vaccination performed on the previous year increased revaccination probability (RR=5.63; 95%CI: [5.21 to 6.10] p<0.001). Effects of the monothematic campaign promoting vaccination against influenza using a poster and pamphlets displayed in GPs’ waiting rooms could not be demonstrated.
Unexpected, vaccination uptake rose by 3% in both arms of the RCT whereas public health data based on the “generalist sample of beneficiaries” and the SNIIRAM warehouse database indicated a simultaneous decrease of 2%. We wondered if the design of the trial had led to a Hawthorne effect (HE). Searching the literature, we noticed that the definition of the HE was unclear. In medical sciences, the meaning of the HE was drifting towards the interaction of artefacts in an experimental environment. In social sciences, and mainly in psychology, it was more closely bound to the Hawthorne experiments conducted from 1924 to 1933 and the definition given in 1953 by Festinger; for these reasons, its existence was disputed.
Our objectives were 1) to refine a definition of the HE in medical sciences and for primary care and 2) to evaluate its size and to draw consequences for primary care research.
We designed a PRISMA 2020 review and meta-analysis between January 2012 and March 2022. We included original reports defining the HE and reports measuring it without setting limitations. Definitions of the HE were collected and summarized. Main published outcomes were extracted and measures were analysed to evaluate odds ratios (OR) in primary care and close circumstances.
The search led to 180 records, reduced after review on title and abstract and on full reading of the remaining reports to 74 on definition and 15 on quantification. Our refined definition of HE is “an aware or unconscious complex behaviour change in a study environment, related to the complex interaction of four biases affecting the study subjects and investigators: selection bias, commitment and congruence bias, conformity and social desirability bias and observation and measurement bias”. Its size varies in time and depends on the education and professional position of the investigators and subjects, the study environment, and the outcome. There are overlap areas between the HE, placebo effect and regression towards the mean. In binary outcomes, the overall OR of the HE computed in primary care was 1.41 (95% CI: [1.13;1.75]; I²=97%), but the significance of the HE disappears in well-designed studies.
We concluded that the HE results from a complex system of interacting phenomena and appears to some degree in all experimental research. Its size can considerably be reduced by refining study designs, for instance by the submission of research projects to registry platforms. Further, the chance that the increase of the vaccination uptake in both arms of the RCT was related to a HE appeared to be negligible.
As noted above, to conduct our RCT, we used a different database than the SNIIRAM warehouse claim database to collect our data. The SNIIRAM warehouse database merges data from all different mandatory French Health Insurance regimes and is used for public health surveys. By the time of the trial, there was a sufficient number of GPs left on our randomisation list to recruit 100 more GPs that were naïve to the RCT, and thus completely exempt of influence that might lead to a HE. Searching for an explanation of the rise in influenza vaccination uptake, it was possible to follow our trial cohort during three years using the SNIIRAM warehouse database and to constitute a posteriori a second control group, naïve to the trial, as described by Zelen in 1979.
So, in 2019 we deepened the investigations explaining the increased uptake, conducting a registry-based 4/2/1 cluster RCT designed by Zelen with two extra years of follow-up of the study cohort. The study population included 23,024 patients, registered with 175 GPs, eligible to benefit from a free influenza vaccination, that is, aged 65 years and over or 16 years and over with a chronic condition. The main outcome remained the number of vaccination units delivered in community pharmacies per study group. Data were extracted from the SNIIRAM warehouse claim database for the Lille-Douai district (Northern France).
No difference in vaccination uptake was found in the Zelen versus the control group of the initial RCT, closing the debate about the usefulness of posters and pamphlets as health promotion vectors in primary care waiting rooms. Overall, the proportion of vaccinated patients increased in the cohort from 51.4% to 70.4% over the three years. Being vaccinated the previous year was a strong predictor of being vaccinated in a subsequent year. The increase in vaccination uptake can be explained by a cohort effect, especially among people of 65 years and older, reaching 75% of influenza vaccination coverage as determined by the WHO. Health promotion and the promotion of primary health care may play an important role in this increase. However, if promoting health behaviour of patients matches with the commitment and congruence, and conformity and social desirability expected from general practitioners and primary care teams, to reach their objectives these teams also have to meet the expectations of patients who feel concerned by their health outcomes, like sexagenarians regarding the prevention of influenza.
The limitation of this health promotion approach in primary care is the population, mainly represented by persons with a low level of health literacy, whose life priorities don’t meet their health outcomes. This population, roughly representing one quarter of the global population, is difficult to reach by primary health teams, generally shares a low life expectancy in good health, is barely participating in primary healthcare research projects and not represented in routine collected databases (claim databases or databases collecting data in primary care electronic medical records), constituting a research blind spot. One of the most important challenges for the next years in primary healthcare practice and research will be to reach these populations and integrate them in health pathways meeting their expectations: deprived communities, patients at risk of developing chronic conditions or their complications, prefrail or frail aging persons, or young persons not in education, employment or training (NEET).