Condition category
Not Applicable
Date applied
22/06/2015
Date assigned
06/07/2015
Last edited
28/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Non-attendance at scheduled appointments in public hospitals is a challenge to the best use of healthcare resources, which could ultimately affect patient health due to longer waiting times. It has been estimated that 7% of all scheduled outpatient appointments in the United Kingdom are not kept by patients. Different reminder systems have been shown to have a moderate effect on reducing the number of patient no-shows whereas the effect of fining people who do not show up for their appointment has not yet been tested in a clinical trial. Such use of financial incentives could however impact access to care differently across different socioeconomic groups (horizontal inequality). The aim of this study is to assess the effect of fines on hospital outpatient non-attendance.

Who can participate?
Patients that have made an appointment at the participating outpatient clinic.

What does the study involve?
All appointments made at the outpatient clinic are randomly assigned to one of two groups; an intervention group and a control group. Appointments assigned to the intervention group includes an attachment to the appointment letter explaining that a fine will be issued in case of non-attendance without giving notice. Appointments assigned the control arm follow usual practice (same system but no letter attachment). The study then compares the number of appointments for which the patients did not show up in each group, along with other analysis.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The Department of Orthopaedic Surgery at Viborg Regional Hospital (Denmark)

When is the study starting and how long is it expected to run for?
March 2014 to June 2017

Who is funding the study?
The Danish Regions, Central Denmark Region and the Ministry of Health and Prevention (Denmark)

Who is the main contact?
1. Ms Emely Ek Blæhr
emebla@rm.dk
2. Dr Ulla Væggemose
Ulla.Vaeggemose@stab.rm.dk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Emely Ek Blæhr

ORCID ID

Contact details

CFK Public Health and Quality
Region House Aarhus
Olof Palmes Allé 15
Aarhus N
8200
Denmark
+45 7841 4370
emebla@rm.dk

Type

Scientific

Additional contact

Dr Ulla Væggemose

ORCID ID

Contact details

CFK Public Health and Quality
Region House Aarhus
Olof Palmes Allé 15
Aarhus N
8200
Denmark
+45 7841 4360
Ulla.Vaeggemose@stab.rm.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of fines on non-attendance in public hospital outpatient clinics: a pragmatic, randomised controlled trial

Acronym

Study hypothesis

In Denmark, introduction of fines for non-attendance in hospital outpatient clinics have been debated over years. Already in 2005, a collaborative agreement between the Danish Regions and the Danish Medical Association opened the opportunity for privately practicing specialists to issue fines for non attendance of DKK 250 for consultations and DKK 500 for surgical procedures. The expected benefits were overall related to better use of resources whereas concerns were expressed about a detrimental effect on horizontal equity due to that fines could have the greatest impact on the most vulnerable individuals. Moreover, the use of fines was seen as a break with the fundamental value of free and equal access to health care as well as a potential threat to the patient-health professional relationship, which should ideally be independent of financial interests. Despite the fact that 10 years have passed since the regulatory context opened for use of fines in the Danish health care system for privately practicing specialists, no systematic evidence on the resulting practice, the efficacy or the effect appears to have been reported. It has therefore been decided by the Danish Regions that the effect of using fines to moderate non-attendance at somatic, hospital-based outpatient clinics in Denmark should be scientifically investigated. This trial is a result of that decision. In accordance, the objective is to investigate the effect of fines on hospital outpatient non-attendance with respect to attendance and efficiency as well as horizontal inequality.

Ethics approval

The Ministry of Health and Prevention in Denmark, 28/11/2014, ref: 303/2014

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

The effect of fines on hospital outpatient non-attendance with respect to attendance and efficiency as well as horizontal inequality.

Intervention

All appointments will be made in accordance with usual practice except for two facts. First, the appointment letter will inform the individual (both intervention and control arms) about the trial. It is explained that the investigation has been initiated by the Danish Regions and approved by the Ministry of Health and that their appointment has been randomly assigned to be subject to a fine, in case of non-attendance without notice, if the appointment letter is attached to letter about the fine system. Second, for appointments randomised to the intervention group only, the letter specifying the conditions is attached to the appointment letter. In this letter it is made clear that a fine will be issued in case of non-attendance without giving notice, at any time, before the time of the appointment. It is also informed that the fine amounts to DKK 250 and that it will be issued by a central office under the local government administration (Corporate Finance, Central Denmark Region), which is open for e-mails and telephone calls during normal office hours in case of questions or complaints.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Proportion of appointments who are attended: All types of appointments are registered in the clinic by the secretariat on a daily basis. All parameters except for sociodemographics are automatically extracted from the electronic patient journal system into a trial registry administrative registered in electronic trial registries. Sociodemographics are extracted from various, individual-level national registries administered by Statistics Denmark.

Secondary outcome measures

1. Proportions of appointments cancelled by the department
2. Proportion of appointments cancelled by the individual
3. Case-mix of individuals in terms of sociodemographics such as age, sex, income, education, distance to hospital, travel time and waiting times and in terms of health problem characteristics such as anatomy, type of appointment and treatment costs will be used as a secondary outcome

All types of appointments are registered in the clinic by the secretariat on a daily basis. All parameters except for sociodemographics are automatically extracted from the electronic patient journal system into a trial registry administrative registered in electronic trial registries. Sociodemographics are extracted from various, individual-level national registries administered by Statistics Denmark.

Overall trial start date

18/03/2014

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria as of 28/06/2016:
1. Consecutive appointments for individuals scheduled for diagnostics, treatment or follow up in the outpatient clinic
2. Appointments for individuals who are booked via an appointment letter sent between 01/05/2015 and 01/12/2015

Original inclusion criteria:
1. Consecutive appointments for individuals scheduled for diagnostics, treatment or follow up in the outpatient clinic
2. Appointments for individuals who are booked via an appointment letter sent between 01/05/2015 and 30/04/2016

Participant type

All

Age group

All

Gender

Both

Target number of participants

Around 6,500 appointments (based on department statistics).

Participant exclusion criteria

Exclusion criteria as of 28/06/2016:
1. As a user may have more than one appointment, only the first appointment during the period was considered
2. Appointments for individuals who are booked without an appointment letter, e.g. via telephone or face-to-face
3. Appointments for individuals receiving physiotherapy or occupational therapy in the outpatient clinic (typically in a group-based setup also without appointment letters)
4. Appointments for individuals with residence in Greenland (requiring an overseas flight)

Original exclusion criteria:
1. Appointments for individuals who are booked without an appointment letter, e.g. via telephone or face-to-face
2. Appointments for individuals receiving physiotherapy or occupational therapy in the outpatient clinic (typically in a group-based setup also without appointment letters)
3. Appointments for individuals with residence in Greenland (requiring an overseas flight)

Recruitment start date

01/05/2015

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Denmark

Trial participating centre

The Department of Orthopaedic Surgery at Viborg Regional Hospital
Viborg Regional Hospital Heibergs Allé 4 8800 Viborg
Viborg
8800
Denmark

Sponsor information

Organisation

DEFACTUM – Public Health & Health Services Research

Sponsor details

Olof Palmes Allé 15
Aarhus N
8200
Denmark
+45 (0)7841 4360
cfk@rm.dk

Sponsor type

Research organisation

Website

http://www.cfk.rm.dk/

Funders

Funder type

Government

Funder name

Danish Regions

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Ministry of Health and Prevention (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Central Denmark Region

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

All results from the trial will be published in the end of 2016 or beginning of 2017.

Intention to publish date

01/01/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27296439

Publication citations

Additional files

Editorial Notes

28/06/2016: The overall trial dates have been updated from 14/03/2014 - 31/12/2016 to 18/03/2014 - 30/06/2017 and the recruitment end date has been updated from 30/04/2016 to 01/12/2015. In addition, the inclusion and exclusion criteria have been updated and the target number of participants has been updated from 23,500 to 6,500. The sponsor has also changed it's name from CFK - Public Health and Quality Improvement to DEFACTUM – Public Health & Health Services Research. Finally, Mr Thomas Kristensen has been removed from the study contacts section as he is no longer associated with the trial, and Miss Emely Ek Blæhr has been added. 15/06/2016: Publication reference added.