Dataset Information

A Trial of the Implementation of iFOBT in General Practice

ABSTRACT: Background Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many patients present with uncharacteristic or vague symptoms. The faecal marker of human globin, iFOBT, could play an important role in aiding the general practitioner in detecting CRC. Hypothesis It will be possible to implement iFOBT in general practice as a test performed on patients who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose symptoms could indicate an undiagnosed colorectal cancer. Aim To implement iFOBT in general practice and evaluate the uptake and clinical use of the test. Furthermore, we want to investigate the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC, and the clinical implications. Materials and methods The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18 municipalities in the central Denmark Region, and these are randomised when to receive a continuous medical education (CME). The date of inclusion is defined as the first working day in the month the CME is planned to be conducted. The CME is part of an intervention aimed to facilitate the implementation of iFOBT in general practice. Besides a CME, the intervention consist of a start package (iFOBT kits, a guideline and online educational material) that is sent to GPs when they are included in the study, and a status mail that GPs receive approx. one month after inclusion. The inclusion period is during the first 7 month of the study period, the study lasts for one year. Perspectives This study will provide important knowledge on how to improve CRC diagnostics in general practice.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2179622 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: The intervention is a SMS personalised message from the general practice sent to the patient’s smartphone with links to: 1. A message from the general practitioners (GPs) at the general practice (e.g. Hello. xxx This is a health message from the GPs at xxx Medical Practice. Your free bowel cancer screening kit will arrive in the post soon. We strongly encourage you to do this test. If cancer is detected early over 90% of bowel cancers are successfully treated. We recommend that you watch the videos below.) 2. A video of a person talking about their positive experience of doing the National Bowel Cancer Screening Program (NBCSP) Immunochemical Faecal Occult Blood Test (IFOBT) test 3. A animated video demonstrating how to complete the test 4. Links to information from Cancer Council Australia The SMS is sent from the general practice one month prior to patients 50th, 52nd, 54th, 56th, 58th and 60th birthdays. The intervention period is six months long, there will be 6 rounds of SMS sent during that time to any active patient due to receive their NBCSP kit. Patients will only receive one SMS. The number of patients due to be sent the SMS will be recorded in PEN CAT4 clinical audit software and the number of SMS sent is recorded on the GoShare Plus platform. Data, the number of patients due to receive the SMS and the number of SMS sent is recorded at the general practice. This data is collected by the project manager. Primary outcome(s): The primary outcome will be the proportion of patients who complete the NBCSP after six months from the total number of eligible patients who are about to have their 50th, 52nd, 54th, 56th, 58th, or 60th birthdays. This outcome will be measured by the number of FOBT results sent to the general practice for patients in this age group. Aggregate data (number of FOBTs returned in each age group) will be collected from the electronic medical records. [From commencement of the 6 month intervention period to 6 months after completion of the intervention period. ] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Interventions: The ‘general practice-led intervention’ is a multi-component intervention identified in a synthesised evidence review of interventions effective at increasing Colorectal Cancer (CRC) screening participation and co-designed with general practice staff. The co-design was completed in March 2023 with 38 General Practice Staff and from across Australia. Co-design participants discussed implementation barriers and enablers of intervention components with evidence-based effectiveness at increasing CRC screening. The co-design results were analyzed against implementation science frameworks and the barriers assessed against implementation barriers identified in the evidence review. The final intervention to be delivered to general practice healthcare providers will comprise of a combination of the following components: 1.Decision-aid tools adapted from existing source (CRISP tool) Anticipated completion time of 5 minutes per patient. 2.Reminder prompts activated within existing general practice software Medical Director 3. Integration of the National Cancer Screening Register (NCSR) within practice software systems and use of a Cancer Screening Toolkit and clinical audits of patient data using an existing resource developed by the Cancer Institute NSW (Primary Care Cancer Control Quality Improvement Toolkit). Anticipated time by practice staff 1 hr per fortnight for 6-month duration. 4.Learning modules and digital resources to educate on guideline-appropriate screening pathways for GPs: - 2 x 1 hour online self-paced modules developed by GPEx with the learning outcomes: - Be aware why General Practice needs to endorse participation in the National Bowel Cancer Screening Program and be able to explain to patients the risks in not Primary outcome(s): Co-primary Implementation Effectiveness Outcome The co-primary implementation effectiveness outcome is guideline-appropriate CRC screening recommendations provided. The co-primary implementation effectiveness outcome will be assessed using a study specific data collection tool integrated into Clinical Information Systems used in General Practice to undertake audits of medical records. [ Co-primary Implementation Effectiveness Outcome will be measured mid-trial at 6-months duration since trial commencement and at post-trial, 12-months duration since trial commencement. ];Co-primary Clinical Effectiveness Outcome The co-primary clinical effectiveness outcome is guideline-appropriate CRC screening tests completed by practice patients (inc. NBCSP kits, GP-initiated kits & colonoscopies). The co-primary clinical effectiveness outcome will be assessed using Health Analytics software used in General Practice to undertake audits of medical records. [ Co-primary Clinical Effectiveness Outcome will be measured pre-trial and post-trial after 12 months since trial commencement. ] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Background: Colorectal cancer (CRC) is one of the most common types of cancer in Denmark, and mortality among patients is high. Patients presenting with alarm symptoms of CRC are referred to colonoscopy in the cancer patient pathway for CRC. However, the proportion of patients with alarm symptoms who have CRC is below 10%. Simultaneously, the burden on endoscopy units to conduct fast-track colonoscopies is growing. Occult blood in the faeces may be an early sign of cancer or precancerous lesions, and can be detected by an immunochemical faecal occult blood test (iFOBT). Few studies have examined the diagnostic properties of the iFOBT among symptomatic patients, and reported sensitivities ranging from 88%-100%, specificities from 77%-94%, and negative predictive values from 98%-100%. These results were derived from diverse patient populations, and used different cut-offs to define positive test results. Using iFOBT may be a valuable tool for the GP when deciding on referral of the patient to the cancer patient pathway. However, evidence is needed on the diagnostic accuracy of the test to detect CRC among patients presenting with alarm symptoms. Hypothesis: In patients presenting with alarm symptoms of CRC, detection of faecal occult blood by iFOBT is an accurate measure of the presence of colonic lesions. Aim: The aim of the study is to examine the diagnostic accuracy of the iFOBT among symptomatic patients referred to colonoscopy in the cancer patient pathway for CRC. Materials and methods: The project is conducted as a diagnostic accuracy study. Patients appointed for colonoscopy will be invited to collect a faecal sample and mail it for analysis. The iFOBT result will be registered in a computer-based laboratory information system. The result of the colonoscopy will be registered in Danish national health registries. The sensitivity, specificity, positive predictive value and negative predictive value will be calculated as measures of the diagnostic properties of the iFOBT, using the result of colonoscopy as the reference standard. The accuracy of the test by type of alarm symptom will also be assessed. Perspectives: The study will provide new and valuable data to evaluate the referral criteria for the cancer patient pathway. Given a good discriminatory ability of the iFOBT among symptomatic patients, fast-track colonoscopy may not be necessary as a first-choice examination in the diagnostic work-up of these patients.

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.

Project description:Interventions: Brief intervention name: Point-of-care clinical prompt (Prompt) Materials and Procedures: A point-of-care clinical prompt stating Encourage Participation in National Bowel Cancer Screening Program” will be attached to the electronic files of eligible patients (average risk patients turning 50, 60 and 70 years of age) within a general practice. These patients represent a sample of the population who will receive a National Bowel Cancer Screening Program (NBCSP) kit during the 12-month trial period. The prompt will remind General Practitioners (GPs) to talk to their patients about using the free kit when it arrives in the mail on or around the time of their birthday. National Bowel Cancer Screening Program (NBCSP) patient information brochures and posters will be available for general practitioner (GP) use as hard and/or electronic copies. Each GP in the trial will also recieve a sample NBCSP kit to show to patients during the consultation. Mode of delivery: The prompt will be set up by general practice administration staff within the electronic files of eligible patients. The prompt will be delivered to GPs as an electronic pop-up reminder at the start of a consultation. When an eligible patient arrives for their consultation at a practice, the prompt will ‘pop-up’ over the patient’s electronic file. The GP will then decide whether to discuss screening at that point in time or whether to ‘close’ the prompt. If the prompt is closed, it will remain as an outstanding action each time the patient attends the practice until such time as the GP marks the task as ‘performed’ by checking the relevent box. Additional resouces including patient information brochures and a sample/demonstration kit, will be made available by the GP during the consultation. Frequency and duration: The intervention will be trialled over 12 months. It is estimated that a total of 1750 patients will be eligible to have the prompt associated with their electronic file within the five intervention sites. This is the maximum number of times the prompt will be acted on by GPs. Location: The intervention will take place in five Tasmanian general practices located within Outer Regional and Remote Tasmania (Remoteness Areas 3 and 4). Adherence: GP adherence to using the prompt will be determined by the number of prompts that were marked as ‘performed’ compared to the number of prompts that were not.

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A Trial of the Implementation of iFOBT in General Practice

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