Project description:IntroductionCervical cancer (CC) is the fourth most common cancer among women. It can be cured if diagnosed at an early stage and treated promptly. The World Health Organization suggests that 70% of women should be screened with a high-performance test by the age of 35. This paper reports a protocol to assess the effect of two modalities of organized CC screening programmes on CC screening uptake.Methods and analysisDesign and setting: The design involves a 3-arm randomized controlled study performed in a French geographic area on the west coast. A total of 1,395 general practitioners will be randomized, depending on their general practice surgeries. Participants: The design is based on a total of 94,393 women aged 40 to 65 years who are eligible for CC screening. Intervention: In the "optimized cancer screening" group, the intervention will combine sending invitation letters to non-adherent women with sending general practitioners (GPs) a list of their non-adherent patients. In the "standard cancer screening" group, the intervention will be limited to sending invitation letters to non-adherent women. In the "usual care" group, no letter will be sent either to women or to their GPs. Primary endpoint: CC screening test uptake will be assessed after a 6-month follow-up period. Statistical analysis: The percentage of women who are up-to-date with their screening at 6 months after the intervention will be compared across arms using a generalized mixed linear model.DiscussionA large-scale randomized trial of this nature is unprecedented. The study will enable us to assess a strategy relying on GPs, identified as the coordinators in this screening strategy. The study results should help policy makers to implement organized CC screening programs in the future.Ethics and disseminationThe study was approved was approved by the Ethics Committee of the National College of Teaching General practitioners (IRB00010804). It was recorded in ClinicalTrials.gov on the number NCT04689178 (28 December 2020). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings.

Project description:BackgroundPreventive primary care programs that aim to reduce morbidity and mortality from lifestyle-related diseases are often affected by low-to-moderate participation rates. Improving participation rates is essential for clinical effectiveness and cost-effectiveness. In 2016-2017, we conducted a pilot study (TOF pilot1) for a preventive primary care intervention (TOF is the Danish abbreviation for "Early Detection and Prevention"). Among 8814 invited patients, 3545 (40.22%) consented to participate, with the highest participation rates among women and patients with higher income, education, and employment.ObjectiveThe aim of this study was to evaluate the effects of a revised invitation strategy on invitation comprehensibility, the overall participation rate, and participant demography. The new strategy specifically targeted men and patients of low educational attainment.MethodsThis study was embedded in the second TOF pilot study (TOF pilot2, initiated in October 2018) that tested an adjusted intervention. The revised invitation strategy comprised a prenotification postcard and a new invitation that specifically targeted men and patients of low educational attainment. The new invitation was developed in a co-design process that included communication professionals and target-group representatives. The study sample consisted of 4633 patients aged between 29 and 59 years, who resided in one of two municipalities in the Region of Southern Denmark. Eligible patients were randomly assigned to one of four invitation groups. The control group (Group 1) received the original invitation used in TOF pilot1. The intervention groups received the original invitation and the prenotification postcard (Group 2), the new revised invitation and the prenotification postcard (Group 3), or the new invitation but no prenotification postcard (Group 4).ResultsOverall, 2171 (46.86%) patients consented to participate. Compared to the control group, participation rates increased significantly in all three intervention groups (all P<.001). Participation across the three intervention groups increased for women and men, as well as for patients with high and low educational attainment and high and low family income. The largest relative increase in participation rates occurred among men, patients with low educational attainment, and patients with low family income. No increase in participation was detected for unemployed patients or patients of non-Danish origin. Most participants found the original (813/987, 82.37%) and new (965/1133, 85.17%) invitations easy to understand with no significant difference (P=.08) in comprehensibility between invitations.ConclusionsThe results suggest that participation in preventive primary care interventions can be greatly increased by implementing a co-design-based invitation strategy that includes prenotification postcards and targeted invitations. Although firm conclusions cannot be made from this study, the observed increased participation rates for men and patients of low socioeconomic status may be relevant in programs that aim to reduce social inequality in health.Trial registrationClinicalTrials.gov NCT03913585; https://clinicaltrials.gov/ct2/show/NCT03913585.

Project description:BackgroundIdentifying strategies to optimize participation in health studies is one of the major concerns for researchers. The purpose of this study was to evaluate the efficiency of different invitation strategies on participation rate in the Employees' Health Cohort Study of Iran (EHCSIR).MethodsTwo cluster-randomized trials were carried out to assess the outcomes of different invitation strategies. In the first phase, 7 units with 1880 employees (3 hospitals, 3 health centers, and 1 office) were assigned to the three parallel modes of invitation: 1) invitation letter, 2) phone call and 3) Short Message Service (SMS). In the second phase, 6 hospitals with 1633 employees were allocated to two invitation methods: 1) invitation letter, 2) invitation letter plus EHCSIR project introduction video. All groups were followed up by phone calls. A logistic mixed-effects model was used to compare the effectiveness of the strategies. The cost-effectiveness of the interventions was also compared.ResultsIn the first phase, the participation rates in the invitation letter, phone call, and SMS groups were 27.04% (182/673), 21.55% (131/608), and 22.54% (135/599), respectively. Using an invitation letter was significantly more successful than SMS (Adjusted Odds Ratio = 1.80, 95% CI =1.14 to 2.85). Average Cost-Effectiveness Ratios (ACER) were $1.37, $1.42, and $1.55 for the invitation letter, phone call, and SMS, respectively. In the second phase, adding a project introduction video to the invitation letter did not significantly influence the participation rate (Adjusted OR = 0.58, 95% CI =0.24 to 1.36). The ACER was $1.21 for the invitation letter only and $2.01 for the invitation letter plus the introduction video.ConclusionsIn comparison with the phone call and SMS, the invitation letter is the most effective invitation method for public sector employees to participate in a cohort study. Sending an introduction video did not significantly increase the participation rate compared to sending an invitation letter only.

Project description:IntroductionThe participation of general practitioners (GPs) in primary care research is variable and often poor. We aimed to develop a substantive and empirical theoretical framework to explain GPs' decision-making process to participate in research.MethodsWe used the grounded theory approach to construct a substantive theory to explain the decision-making process of GPs to participate in research activities. Five in-depth interviews and four focus group discussions were conducted among 21 GPs. Purposeful sampling followed by theoretical sampling were used to attempt saturation of the core category. Data were collected using semi-structured open-ended questions. Interviews were recorded, transcribed verbatim and checked prior to analysis. Open line-by-line coding followed by focus coding were used to arrive at a substantive theory. Memoing was used to help bring concepts to higher abstract levels.ResultsThe GPs' decision to participate in research was attributed to their inner drive and appreciation for primary care research and their confidence in managing their social and research environments. The drive and appreciation for research motivated the GPs to undergo research training to enhance their research knowledge, skills and confidence. However, the critical step in the GPs' decision to participate in research was their ability to align their research agenda with priorities in their social environment, which included personal life goals, clinical practice and organisational culture. Perceived support for research, such as funding and technical expertise, facilitated the GPs' participation in research. In addition, prior experiences participating in research also influenced the GPs' confidence in taking part in future research.ConclusionsThe key to GPs deciding to participate in research is whether the research agenda aligns with the priorities in their social environment. Therefore, research training is important, but should be included in further measures and should comply with GPs' social environments and research support.

Project description:BACKGROUND:Improving response rates in epidemiologic studies is important for the generalizability of the outcome. The aim of this study was to examine whether it can be advantageous for participation to target different versions of the cover letters to different sample subgroups. METHODS:A randomized trial was incorporated in a cross-sectional health survey in Denmark (n =?25,000) where a motivational sentence in the cover letter intended to heighten perceptions of relevance of the survey was varied among 11 sample subgroups (treatment groups). Ten different versions of a sentence outlining questionnaire themes were tested: each mentioned three out of five themes: stress, alcohol, sex, sleep problems, and contact with family and friends. An eleventh group, the control group, omitted this sentence. RESULTS:On average, the additional motivational sentence resulted in a significantly lower response rate overall compared to the control group. However, the additional motivational sentence was found to have heterogeneous effects on survey response. Furthermore, the nature of the heterogeneity differed between the versions of the sentence. Specifically, the additional sentence tended to produce a higher response rate among the youngest age group and a lower response rate in the oldest age group compared to the generic letter. The use of alcohol in the motivational sentence tended to have a positive effect on response in the age group 16-24?years, and stress tended to have a positive effect in the age group ?65?years. On the contrary, sex tended to have a negative effect in the age groups 45-64?years and???65?years. However, a significant interaction was only found between the use of stress and age group (p?=?<?0.0001). CONCLUSION:The findings of significant and heterogeneous effects suggest that there is potential for a targeted approach to improve both response rates and sample composition. The uneven effect of the separate themes across age groups suggests that the selection of themes to be included in the motivational sentence is important for the use of targeted appeals to be successful and warrants further research to better identify which themes works in which contexts, in which subgroups and under which circumstances. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT03046368 , retrospectively registered February 8th, 2017.

Project description:BACKGROUND:In most Western countries, the referral letter forms the basis for establishing the priority of patients for specialised health care and for the coordination of care between the services. To be able to define the quality of referral letters, the potential impact of the quality on the organisation of care, and to improve the quality of the letters, we need a multidimensional definition of the ideal content. The study's aim was to explore what information is seen as most important and should be included in referral letters from primary care to specialised mental health care to facilitate prioritisation and planning of treatment and follow-up of the patients. METHODS:Based on purposive sampling, four mixed discussion groups, which included general practitioners, mental health nurses from primary health care, psychiatrists and psychologists from specialised mental health care, managers and patient representatives, were formed; they were asked to identify the information they considered important in a mental health referral letter. In line with the Delphi technique, the importance of the themes was later individually rated by the participants. The study was conducted within The Western Norway Regional Health Authority. RESULTS:The four groups identified 174 information themes. After excluding themes that were assessed as duplicates, replaceable or less important, 40 themes were suggested, organised in seven units. A set of check-off points of essential information is recommended as an introduction in the referral letter. CONCLUSION:Compared with general guidelines and guidelines for somatic care, the results of this study suggest that the referral letter to specialised mental health care should have a larger emphasis on the overall treatment plan, on the specific role of specialised health care in the continuum of care, and on patient involvement. Further research should evaluate the validity of these findings for other patient groups in need of integrated care and investigate how the quality of referral letters affects patient-related and organisational outcomes. TRIAL REGISTRATION: TRIAL REGISTRATION NUMBER:NCT01374035.

Project description:Colorectal cancer is the 2nd leading cause of cancer mortality in France. However this cancer is preventable in the majority of cases by early detection of adenomas. In France, there is organized colorectal cancer screening, which relies on general practitioners (GPs). Tests delivered by GPs are performed in 89% of cases. However, GPs do not systematically offer the test, for time management and communication reasons. Patients expect their GPs to offer the test and to focus on their expectations. A previous study conducted on GPs showed that training in communication and motivational interviewing increases the number of tests performed by 12.2%. In order to facilitate the promotion of screening, the investigators would like to develop a training programme for GPs focusing on the application of Motivational Interviewing (MI) techniques to the promotion of colorectal cancer screening. Motivational Interviewing is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence. This study is a multicenter trial in general medicine. In this randomized trial the 902 subjects will be included prospectively by the general practitioners (GP) participating in the study. As a first step, general practitioners who have never participated in Motivational Interviewing training will be recruited and split into 2 groups by randomization, an intervention group and a control group. The interventional group will then undergo a 3 times 2-day training in Motivational Interviewing. In a second step, the patients will be included by those GP and a self-questionnaire will be send at the inclusion and after 6, 12 and 24 months. The evaluation of the number of tests performed and the analyse of the Health Belief Model (HBM) self-questionnaire will be carried out. At 24 months, there will be an evaluation of the denial motivation questionnaire for patients who have not participated in organized colorectal cancer screening.

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Effects of personalized invitation letters on research participation among general practitioners: a randomized trial

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