A Feasibility Study of Direct Access to a Newly Developed Abdominal ´Yes-No´ Pathway for Primary Care Patients With Vague and Non-specific Abdominal Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- The proportion of general practices using the abdominal 'yes-no' pathway
Study Overview
Brief Summary
Background To optimise cancer outcome in Denmark, cancer diagnostic pathways should, beside cancer patient pathways (CPP) for alarm symptoms, also include a pathway for patients with vague and non-specific symptoms. Research has demonstrated that 50% of all cancers do not qualify for specific CPPs, although the majority of patients initially present symptoms in general practice.
Hypothesis Direct access to an abdominal 'yes-no' pathway is feasible in general practice. Aim The aim of this study is to assess the implementation and clinical implications of direct access to an abdominal 'yes-no' pathway for primary care patients with vague and non-specific abdominal symptoms Materials and methods The study is a feasibility study in which all general practitioners (GPs) in the municipality of Silkeborg in Central Denmark Region are offered direct access to a newly developed abdominal ´yes-no´ pathway for both men and women aged 30 years or above, who present vague and non-specific abdominal symptoms in primary care. The abdominal ´yes-no´ pathway consists of: 1) Medical and objective examination, 2) Selected blood samples and a Fecal Immunochemical test (FIT), and 3) Abdominal ultrasound (US) and transvaginal US (TVUS) (for women).
Perspectives This study will provide important knowledge on how to improve abdominal cancer diagnostics in general practice.
Detailed Description
Background Danish cancer patients have poorer cancer outcome compared to other European cancer patients. Earlier cancer diagnosis is a pivotal step to improve the prognosis, and there seems to be opportunity for improvement, as e.g. colon cancer is more often diagnosed at an advanced stage in Denmark than in other countries.
In Denmark, more than 11,500 abdominal cancers are registered yearly, which corresponds to 31% of all newly diagnosed cancers. The majority (75-85%) of cancer patients initially present symptoms to their GP. But only half of the patients present an alarm symptom, while 20% present serious non-specific symptoms, and 30% present vague non-specific symptoms. Site-specific CPPs for alarm symptoms were implemented in Denmark in 2008/2009 to optimise the diagnostic route for cancer. In 2012, a new Danish CPP was implemented to target patients with serious non-specific symptoms and signs of cancer (NSSC-CPP). No pathway exists for patients with vague abdominal symptoms.
Presenting in general practice with abdominal symptoms is very common. Most abdominal symptoms presented in general practice can be signs of serious disease in the abdomen and the pelvic region. However, in most cases, the symptoms are benign, self-limiting and harmless. Still, more than ten different cancer types can cause these symptoms, but clinically it is often difficult to distinguish between the symptoms.
For patients presenting vague symptoms to the GP, the ideal strategy could be easy and direct access to relevant investigations rather than a wait-and-see approach or referral to a CPP.
Aim The study sets out to investigate the need for an abdominal 'yes-no' pathway for primary care patients with vague and non-specific abdominal symptoms, how it could be clinically organised and integrated, and whether such pathway is feasible.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •GPs in the municipality of Silkeborg can refer patients with the following criteria to Silkeborg Regional Hospital:
- •Men and women ≥30 years old presenting with vague and non-specific abdominal symptoms for at least 3-4 weeks
Exclusion Criteria
- •Men or women who fulfil access criteria for the CPPs.
Outcomes
Primary Outcomes
The proportion of general practices using the abdominal 'yes-no' pathway
Time Frame: 6 months
In the municipality of Silkeborg, 23 general practices will be offered direct access to the abdominal 'yes-no' pathway.
Indications used for requesting the abdominal 'yes-no' pathway
Time Frame: 6 months
Health care use within 6 months of intervention
Time Frame: 6 months
'Health care use´ is defined as consultations, imaging and endoscopies performed in both primary and secondary care. Data will be collected through the Danish National Patient Registry and the Danish National Health Service Register.
Number of patients referred to the abdominal 'yes-no' pathway
Time Frame: 6 months
The number of patients referred to the abdominal 'yes-no' pathway, both overall from all 23 general practices in the municipality of Silkeborg, and per general practice. We expect one eligible patient from each GP every third week.
Secondary Outcomes
- Number of patients with a diagnosis of cancer or another serious disease in the abdomen(6 months)
- Number of patients with unintended side effects(6 months)