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Colorectal Cancer Screening Among Primary Care Physicians of the Swiss Sentinel Surveillance Network

18 giugno 2019 aggiornato da: University of Bern

Colorectal Cancer Testing in Swiss Primary Care: A Cluster Randomized Controlled Trial Among Primary Care Physicians of the Swiss Sentinel Surveillance Network

Colorectal cancer (CRC) is the third leading cause of cancer mortality in Switzerland, and kills 1600 people annually. Most deaths could be prevented by screening, but the 2012 Swiss national health survey found that only 40% of 50-75-year-olds had been tested within recommended intervals (26% with colonoscopy in the last 10 year, 7% with fecal occult blood test [FOBT] in the last 2 years, and 7% with both). If screening starts at age 50, in the average risk population absolute risk of dying from CRC at age 80 can be cut from 2% to 1%, reducing relative risk by 50%. Since 2013, Switzerland has reimbursed screening by colonoscopy every 10 years or FOBT every 2 years for adults 50-69 years old. Conforming to current recommendations, the Federal Office of Public Health (FOPH) officially recognizes both screening modalities.

When patients are offered a choice of screening test (colonoscopy vs. FOBT), they are as likely to opt for one as the other. Patient preferences are unlikely to vary much between PCP practices, so distribution of colonoscopy and FOBT within each practice should also be roughly equal. Family physicians are recognized as the most trusted professional to discuss CRC screening in Switzerland. However, many primary care physicians (PCPs) prefer prescribing colonoscopy over FOBT, but physician preference for method seems to vary widely between regions. If physician preferences and local medical culture currently influence choice of method more strongly than patient preferences, encouraging PCPs to diagnose patient preferences for screening method may reduce the number of PCPs who prescribe only one method. An earlier study in Switzerland showed that training PCPs and giving them educational support and decision aids raised the number who intend to prescribe colonoscopy and FOBT in equal proportions. A randomized controlled trial in the US showed that when patients were offered both FOBT and colonoscopy rather than only colonoscopy alone, more patients were screened for CRC. Offering choice of method may thus increase overall screening rates.

The Swiss Sentinel Surveillance Network (Sentinella) is a cooperative surveillance project including the Federal Office of Public Health (FOPH), PCPs representatives and the five Swiss institutes of family medicine. A sample of 150 to 250 general practitioners, internists and pediatricians in private practices from all regions of Switzerland report weekly morbidity data to the network using irreversibly anonymized patient data collected during consultations. In 2017, 91 out of 129 eligible PCPs of the Sentinella network participated in a cross-sectional data collection on CRC screening. The Sentinella network appears ideally suited to perform an intervention in order to modify screening practices and measure outcomes using the same collection form as in 2017.

This study will test the benefits of a prepackaged training program in participatory medicine sent by post to PCPs in Switzerland. The package is designed to improve their diagnoses of patient preferences for screening and screening method (colonoscopy or FOBT). The study begins with the hypothesis that giving PCPs evidence summaries on CRC screening, decision aids for patients, and performance feedback on the 2017 data collection will increase the number of PCPs whose patients include at least one screened with FOBT, and who will prescribe at least one FOBT/FIT (Fecal Immunochemical Test) instead of prescribing only colonoscopy. This might reduce variation in care between PCP practices by increasing variation in methods of screening prescribed within each PCP practices. Analyses from the 2017 data collection suggest that fewer patients refused CRC testing in practices that offered both methods than in practices that offered only colonoscopy. This intervention might increase screening rates overall, while respecting patient's autonomy to refuse the test and to be prescribed the test they prefer.

The study will compare outcomes among PCPs allocated to the intervention group to those in the control group, and will be measured by collecting anonymous structured patient data on 40 consecutive patients by PCPs and questionnaires filled by PCPs.

The study is designed to fit within the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework for structuring data collection. RE-AIM ensures that a study's outcomes for future implementation and dissemination works are collected. The RE-AIM criteria will be used to identify the translatability and public health impact of this intervention, and for making clear to future stakeholders the internal and external validity of study results.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

109

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Bern, Svizzera, 3012
        • Institute of Primary Health Care (BIHAM), University of Bern

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 50 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Physician-level: PCPs participating in the Swiss Sentinel Surveillance Network (Sentinella) willing to participate in the study
  • Patient-level: Each PCP will collect data on 40 consecutive patients aged 50 to 75 years old seen in PCP offices over a 2 weeks to 2 months period. Patients will be included if there is a face-to-face consultation billed for at least 5 minutes at the practice.

Exclusion Criteria:

  • None except criteria which do not respect inclusion criteria

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Selezione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Gruppo di controllo
Sperimentale: Gruppo di intervento

PCPs from the intervention group will be mailed an intervention package that includes:

  1. 2-page structured evidence summary on CRC screening and information about Colonoscopy & FIT ("Decision box")
  2. patient decision aid (20-page booklet) on CRC screening for distribution to patients (Decision Aid)
  3. video example for the PCP, which illustrates a participatory approach to discussing CRC screening with a patient
  4. 4-page abridged version of the booklet to support PCPs when they discuss CRC screening with patients during a clinical visit ("Decision Board")
  5. individualized 1-page summary of PCP screening practices comparing their individual prescription patterns to group patterns, based on the data collected in 2017 ("Performance card")
  6. 2-page document that encourages PCPs still using the inferior guaiac-based FOBT to switch to FIT and includes list of laboratories from which they can order FIT
  7. sample FIT for PCPs who may not be familiar with its contents and use

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of PCPs who have at least one patient ever tested with FOBT, or who prescribe at least one FOBT to eligible patients (patients not already tested within recommended intervals, with no contra-indication for screening).
Lasso di tempo: At 3 months after intervention
PCPs systematically collect data from 40 consecutive patients, aged 50-75 years
At 3 months after intervention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of PCPs whose proportion of patients previously tested or planning to be tested with FOBT/colonoscopy is at least 40% (the PCP must have discussed screening with these patients, who have no symptoms or risk factors for CRC
Lasso di tempo: At 3 months after intervention
PCPs systematically collect data from 40 consecutive patients, aged 50-75 years
At 3 months after intervention
Number of PCPs who discussed CRC with >50% of their eligible patients (patients not tested within recommended intervals, with no contra-indications for CRC screening)
Lasso di tempo: At 3 months after intervention
PCPs systematically collect data from 40 consecutive patients, aged 50-75 years
At 3 months after intervention
Change in PCPs' future intentions to prescribe CRC screening tests
Lasso di tempo: At 3 months after intervention
A questionnaire completed by participating PCPs
At 3 months after intervention
Change in PCPs' future intentions to prescribe colonoscopy vs. FOBT over the next 6 months
Lasso di tempo: At 3 months after intervention
A questionnaire completed by participating PCPs
At 3 months after intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Reto Auer, MD, MAS, Institute of Primary Health Care (BIHAM), University of Bern

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 aprile 2018

Completamento primario (Effettivo)

1 aprile 2019

Completamento dello studio (Effettivo)

1 aprile 2019

Date di iscrizione allo studio

Primo inviato

25 maggio 2018

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2018

Primo Inserito (Effettivo)

12 giugno 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 giugno 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2019

Ultimo verificato

1 giugno 2019

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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