Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03878940
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2019-02-27
Brief Title:
A Feasibility Study of Direct Access to an Abdominal Yes-No Pathway for Primary Care Patients
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg colon cancer is more often diagnosed at an advanced stage in Denmark than in other countries
In Denmark more than 11500 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 20082009 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
Material and methods Prior to the current intervention a developmental part was conducted in 2018 It consisted of focus group meetings with 16 selected specialist with expertise regarding patients with abdominal symptoms in general practice and abdominal cancers and other abdominal diseases
The investigators assembled two focus groups during autumn 2017 each comprising the following experts two GPs a physician with expertise in gastroenterology an abdominal surgeon a radiologist a gynecologist a microbiologist and a physician in clinical biochemistry The focus groups aimed to develop and agree on an abdominal yes-no pathway using the following criteria 1 reduce the time to diagnosis 2 avoid unnecessary tests 3 increase patient safety and minimise missed opportunities 4 order the specific investigations temporally 5 place responsibility and develop a structure and 6 illustrate an optimal pathway
From January to September 2018 the investigators completed two meetings in each focus group after which the investigators compared the results and gathered the groups in a common session From the literature and the preliminary results of an yet unpublished register study the investigators were able to present the clinical challenges to the participants during the meetings Moreover the possible access to investigations was presented laboratory tests imaging endoscopies and access to specialist advice Based on discussions during the meetings the investigators developed an abdominal yes-no pathway The abdominal yes-no pathway consists of three steps 1 Medical and objective examination 2 Selected blood samples and a FIT and 3 Abdominal US and TVUS The GP continues to hold responsibility for follow-up while hospital examinations are performed on an outpatient basis with direct access from general practice After finished investigation the results from the tests will all return electronically to the referring GP
The intervention is planned to initiate as a feasibility study at Silkeborg Regional Hospital from 1 April 2019 Agreements have been made with the hospital management and an information meeting has taken place in March 2019 at the hospital All GPs in the municipality of Silkeborg were invited to participate An illustration to hand out for involved GPs has been developed Prior to investigation all patients referred to the abdominal yes-no pathway will receive a consent form with information of the study The inclusion period is 6 months from 1 April 2019 to 30 September 2019 after which the investigators will monitor the patients for up to 6 months
The study has been approved and is registered in the Record of Processing Activities at the Research Unit of General Practice in Aarhus in accordance with the provisions of the General Data Protection Regulation GDPR The Central Denmark Region Committees on Health Research Ethics has concluded that the study can be conducted without an approval from the Committees Request 162019 Further The committee on multi-practice studies under the Danish College of General Practitioners DSAM and the Organisation of General Practitioners in Denmark PLO have been asked to recommend GPs to participate in the study
The analyses will be descriptive with frequencies and incidence rates of use of the pathway corrected for practice population An overview of all findings in the abdominal yes-no pathway will be provided and possible side effects will be assessed
Perspectives The study will provide new important knowledge of patients with vague and non-specific abdominal symptoms who do not fulfil access criteria for the CPPs but for whom the diagnosis of an abdominal cancer should not be missed This may improve the diagnostics of abdominal cancers or other serious abdominal disease in the future aiming to reduce time to diagnosis
In Denmark more than 11500 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 20082009 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
Material and methods Prior to the current intervention a developmental part was conducted in 2018 It consisted of focus group meetings with 16 selected specialist with expertise regarding patients with abdominal symptoms in general practice and abdominal cancers and other abdominal diseases
The investigators assembled two focus groups during autumn 2017 each comprising the following experts two GPs a physician with expertise in gastroenterology an abdominal surgeon a radiologist a gynecologist a microbiologist and a physician in clinical biochemistry The focus groups aimed to develop and agree on an abdominal yes-no pathway using the following criteria 1 reduce the time to diagnosis 2 avoid unnecessary tests 3 increase patient safety and minimise missed opportunities 4 order the specific investigations temporally 5 place responsibility and develop a structure and 6 illustrate an optimal pathway
From January to September 2018 the investigators completed two meetings in each focus group after which the investigators compared the results and gathered the groups in a common session From the literature and the preliminary results of an yet unpublished register study the investigators were able to present the clinical challenges to the participants during the meetings Moreover the possible access to investigations was presented laboratory tests imaging endoscopies and access to specialist advice Based on discussions during the meetings the investigators developed an abdominal yes-no pathway The abdominal yes-no pathway consists of three steps 1 Medical and objective examination 2 Selected blood samples and a FIT and 3 Abdominal US and TVUS The GP continues to hold responsibility for follow-up while hospital examinations are performed on an outpatient basis with direct access from general practice After finished investigation the results from the tests will all return electronically to the referring GP
The intervention is planned to initiate as a feasibility study at Silkeborg Regional Hospital from 1 April 2019 Agreements have been made with the hospital management and an information meeting has taken place in March 2019 at the hospital All GPs in the municipality of Silkeborg were invited to participate An illustration to hand out for involved GPs has been developed Prior to investigation all patients referred to the abdominal yes-no pathway will receive a consent form with information of the study The inclusion period is 6 months from 1 April 2019 to 30 September 2019 after which the investigators will monitor the patients for up to 6 months
The study has been approved and is registered in the Record of Processing Activities at the Research Unit of General Practice in Aarhus in accordance with the provisions of the General Data Protection Regulation GDPR The Central Denmark Region Committees on Health Research Ethics has concluded that the study can be conducted without an approval from the Committees Request 162019 Further The committee on multi-practice studies under the Danish College of General Practitioners DSAM and the Organisation of General Practitioners in Denmark PLO have been asked to recommend GPs to participate in the study
The analyses will be descriptive with frequencies and incidence rates of use of the pathway corrected for practice population An overview of all findings in the abdominal yes-no pathway will be provided and possible side effects will be assessed
Perspectives The study will provide new important knowledge of patients with vague and non-specific abdominal symptoms who do not fulfil access criteria for the CPPs but for whom the diagnosis of an abdominal cancer should not be missed This may improve the diagnostics of abdominal cancers or other serious abdominal disease in the future aiming to reduce time to diagnosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None