Quality in Primary Care Open Access

Keywords

General practice; Colorectal neoplasms; Occult blood; Pilot projects; Clinical trials.

Abbreviations

CME: Continuous Medical Education; COM-B: Capability Opportunity Motivation-Behaviour; CRC: Colorectal Cancer; GP: General Practitioner; iFOBT: Immunochemical Faecal Occult Blood Test

Background

It is estimated that 75-80% of all colorectal cancer (CRC) diagnoses are found through symptomatic presentation in general practice.[1,2] Diagnosing CRC at earlier stages is not straightforward as half of patients with CRC present with other symptoms than alarm symptoms.[3]

The immunochemical faecal occult blood test (iFOBT), which detects blood in stools, may be a useful for identification of CRC in general practice.[4-10] However, the test is not a part of the Danish GPs’ diagnostic tools. To investigate the diagnostic value of iFOBT in general practice a large scale randomised study was planned in the Central Denmark Region.[11]

The Behavioural Change Wheel provides researchers with a framework that allows identification of potential barriers when new health care interventions are developed and implemented. Furthermore, it links identified barriers to specific intervention functions. The model assumes that any change is governed by the individual’s capability (C), opportunity (O) and motivation (M) to change behaviour (B) (COM-B).[12] A newly developed intervention model should be pilot-tested and subsequently adjusted before being launched at a large scale.[13,14] (Table 1).

The aim of this study was to develop an intervention which could be used in a large scale study to facilitate quick uptake of the iFOBT in general practice.

Table 1: Identified barriers and planned interventions using COM-B analysis.

Methods

Design

The development process was divided into three steppes. 1) Identification of barriers to iFOBT use and selection of intervention components, 2) pilot testing and 3) adjustment before large scale implementation.

Setting

The study was conducted in the Central Denmark Region, which is covered by 832 GPs working in 383 general practices. Each GP has approx. 1550 persons listed with their practice.[15] GPs in Denmark own their clinic and act as gatekeepers to secondary care.

Developing the intervention

Initially, a research group consisting of primary care researchers, GPs and clinicians from secondary care conducted a COM-B analysis to identify determinants and possible interventions for GPs to start using the iFOBT. The identification of barriers was primarily based on clinical experience from general practice. The most important and feasible intervention components were selected based on the Normalisation Process Theory, local experience and literature reviews of continuous medical education (CME).[16-19] The intervention model was pilot- tested among 10 GPs in seven GP practices from 1 March 2015– 31 May 2015. The pilot period was evaluated both quantitatively by measuring the iFOBT requests and qualitatively by individual GP interviews. Finally, the intervention was adjusted before large scale implementation.

Results

Identification of barriers and selection of intervention components

Three major barriers were identified: 1) the GPs’ capability to start using the test was generally limited by a lack of knowledge about the clinical indications and how to perform the test, 2) their opportunity to start using the test was restricted by cumbersome test ordering procedures and lack of support from practice staff and 3) their motivation was restricted by competing tasks, lack of remuneration and uncertainty about other GPs’ opinions. From this, three intervention components were developed: 1) A clinical guideline on the use of iFOBT in general practice. It defined the target population and listed indications and contraindications for iFOBT use. 2) A focused GP training course to improve knowledge on the iFOBT and familiarise GPs with the test kit and how to order the test. The course was developed as a 45 min small-group interactive presentation with time for comments and discussion. 3) A test kit and an easy online ordering procedure. Furthermore, the Organisation of General Practitioners in the Central Denmark Region negotiated a remuneration fee for using the iFOBT and recommended its use.

Pilot testing

All GPs started using iFOBT during the pilot period and in total, 72 iFOBTs were requested. The interviews revealed that the GPs found the list of indications to be rigid and out of step with the clinical situation, and that the section “contraindications” were considered as unnecessary. Furthermore, the GP training course provided the GPs with the necessary knowledge and skills to use the iFOBT; the GPs reported that they felt motivated to use the iFOBT and confident on how to introduce the test in their clinics. Finally, many GPs found it difficult to find the iFOBT request on the website for ordering laboratory tests.

Adjusting the intervention

The guideline was revised in accordance with the findings of the pilot testing, and it was left to the individual GP’s clinical judgement to decide when to use the iFOBT. The website for ordering iFOBT was modified to make the iFOBT request more easily found and to ensure that the workflow and the instructions for patients would be similar to those already in use.

Discussion

This article describes a rapid theory-based development of an intervention to facilitate quick uptake of a new laboratory test in general practice. The COM-B model linked the analysis of barriers to specific intervention functions and facilitated a common understanding in the research group. We used a pilot study to confirm the importance of the intervention components as recommended in the guidelines for the development of complex interventions.[14] The pilot study also provided us with crucial insights into unforeseen barriers, which probably would have led to project failure in a large scale study. We found that GPs were reluctant to use the iFOBT if they felt obliged to use a rigid general guideline instead of their own clinical judgement. We also found it important to build on existing routines when introducing a new test to facilitate quick uptake.[16].

We believe that the transparency of the process will allow others to interpret our findings and apply them in similar settings. Likewise, our results may help introduce other new tests in similar settings in the future.

Ethical Approval

The study obtained ethical clearance from the Committee on Health Research Ethics in the Central Denmark Region (j.no. 142/2014).

Acknowledgement

The authors would like to thank biomedical laboratory technician Erik Sloth Jørgensen who made the ordering system for iFOBT and Nete Hornung (head of the Department of Clinical Biochemistry at the Regional Hospital of Randers), who was in charge of analysing the iFOBTs in the pilot period. The authors would also like to thank Morten Bondo Christensen and Marie- Louise Heine Jensen, who set up the GP training course and assisted in the data collection. The Cancer in Practice unit in the Central Denmark Region financed the iFOBT kits and played a key role in conducting the pilot test. Søren Laurberg (professor and MD at Department of Surgery, Aarhus University Hospital), Berit Andersen (PhD and MD at Department of Public Health Programs, Regional Hospital of Randers,) and Frede Olesen (professor and MD at Research Unit for General Practice, Aarhus University) were part of the research group together with the authors of this article.

Source of Funding

The study was funded by the Cancer in Practice unit in the Central Denmark Region.

Trial Registration

This study was registered in the NCT Clinical Trial Registry (Clinicaltrials.gov) under NCT02308384 on November 26, 2014.

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