In this study we will assess the applicability of a digital intake in the Dutch colorectal cancer screening program in participants with a positive FIT who are referred for colonoscopy.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Applicability of a digital intake tool for FIT positive screenees in the
national CRC screening program who are referred for colonoscopy in terms of
efficacy defined as:
- Need for repeat or rescheduled colonoscopies due to poor bowel preparation.
Defined as a percentage of >= 90% participants with good bowel cleanliness
during first colonoscopy.
Secondary outcome
Secondary study parameters/endpoints (if applicable)
- Participation rate
- Number of patients that have fully completed the DIT and for who no
face-to-face appointment at the outpatient clinic was needed to be scheduled.
- Anxiety before and after the DIT by using a questionnaire
- Evaluating participants satisfaction by using questionnaires after the DIT
and after screening colonoscopy
- Knowledge transfer to participants by using a questionnaire after DIT
- Colonoscopy adherence rate after the DIT
- Workability for health care staff by using a questionnaire
- Evaluating the motives for choosing a digital tool over a face-to-face
consult to gain more insight into the needs of patients
- Evaluating the economic impact of a DIT by performing a cost-effectiveness
analysis
Background summary
Each year more than 2.2 million people aged 55-75 are invited for the national
colorectal cancer (CRC) screening program. Around 5%, which corresponds to
77.000 screenees, receive a positive FIT and are being referred for
colonoscopy. Currently this population is seen at an outpatient clinic before
colonoscopy is carried out to assess morbidity, risk of complications and
informing patients about the procedure and CRC risk. In symptomatic patients
some endoscopic centers successfully replaced this face-to-face intake for a
digital route, but in the Dutch screening program a face-to-face visit belongs
to standard care. In contrast to symptomatic patients most of the screenees are
healthy. Therefore we assume that it is possible to shift this type of health
care to a more home based setting by using a digital intake in colorectal
cancer screening programs tailored for FIT positives. It facilitates screenees
and health care providers, improves capacity for outpatients visits and reduces
health care costs by providing a safe and validated DIT. Each year more than
2.2 million people aged 55-75 are invited for the national colorectal cancer
(CRC) screening program. Around 5%, which corresponds to 77.000 screenees,
receive a positive FIT and are being referred for colonoscopy. Currently this
population is seen at an outpatient clinic before colonoscopy is carried out to
assess morbidity, risk of complications and informing patients about the
procedure and CRC risk. In symptomatic patients some endoscopic centers
successfully replaced this face-to-face intake for a digital route, but in the
Dutch screening program a face-to-face visit belongs to standard care. In
contrast to symptomatic patients most of the screenees are healthy. Therefore
we assume that it is possible to shift this type of health care to a more home
based setting by using a digital intake in colorectal cancer screening programs
tailored for FIT positives. It facilitates screenees and health care providers,
improves capacity for outpatients visits and reduces health care costs by
providing a safe and validated DIT.
Study objective
In this study we will assess the applicability of a digital intake in the Dutch
colorectal cancer screening program in participants with a positive FIT who are
referred for colonoscopy.
Study design
Prospective observational single centered cohort study and has a future
perspective to extend to a multicenter study.
Study burden and risks
Potential benefit:
Using a digital intake could mean the introduction of a less invasive and
equally effective modality for patients who are being evaluated for screening
colonoscopy. It might facilitate screenees and health care providers, improve
capacity for outpatients visits and reduce health care costs by providing a
safe and validated DIT for FIT positive screenees that can be done at home.
Moreover, a digital intake with health animations improves information
provision to FIT positive screenees. It has been shown that spoken animation is
the best way to communicate complex health information to participants with low
health literacy. Improved knowledge about the substantial CRC (or advanced
precancerous lesions) risk in combination with adequate information regarding
colonoscopy will lead to better shared decision making.
Potential risk
Some studies suggest that shared decision making in a digital setting could be
less effective than a physical visit. However it has been rejected in multiple
studies. Especially regarding to digital tools for colonoscopy. Digital
information provision tools are already implemented for symptomatic patients
and appeared to be as effective as nurse counselling. Patients were even more
satisfied with the amount of information provided by the digital intake as they
demonstrated a better overall comprehension. Another potential risk concerns
loss to follow up regarding colonoscopy in patients who do not fully complete
the digital intake and therefore do not receive an appointment for screening
colonoscopy. This is conquered by the fact every participant will be contacted
by phone after receiving hyperlink to the DIT. Final potential risk is a lack
in the digital tool where questions about the medical status of the patient
does not gain all information that is needed to perform an adequate evaluation
of the patient in work up for colonoscopy. However current screening
colonoscopy intakes are being executed by a nurse who is following a
standardized questionnaire which is compiled by the RIVM. This same documented
questions is used in the digital intake tool. So digital evaluation will be at
least as careful as current evaluation. When the complication risk is
increased, a patient will be referred to a face to face intake or will be
contacted by phone after the digital intake procedure. In this way, outpatient
capacity is tailored to those patients with increased risks.
Burden:
To assess the DIT a number of five questionnaires will be asked to complete on
top of the regular questions about a patient*s medical condition. This can be
done at home at any suitable time, no extra physic visits are needed. No
potential risks are related to these *study* questionnaires.
Altogether we therefore consider the risks and burden low and minimal.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Aged 55 - 75
- Participant of the national colorectal cancer screening program
- Positive result (>47ug/g hemoglobin/g feces) on FIT screening
- A good understanding of the Dutch language of the participant or having a
relative with good understanding of the Dutch language who is able to guide the
participant
- Access to internet and a device which is suitable for use of the digital
intake tool
Exclusion criteria
- Inability or refusal to provide informed consent
- People with a severe visual disability (the digitale intake will contain some
essential visual
information)
- People with a functionally illiteracy and therefore not able to complete and
understand the
Patient Information Form (PIF)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74890.078.20 |