Condition category
Not Applicable
Date applied
24/11/2016
Date assigned
14/12/2016
Last edited
14/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Newly arriving asylum-seekers are often dispersed between and within federal states, districts and communities. At each location many people are involved in providing health care, leading to a fragmentation of care and challenges for continuity of care. A patient-held health-record (PHR) for asylum-seekers has been developed and tested in a routine care setting in a reception centre. As this was successful, the regional authorities have decided to introduce the PHR in all reception centres of the administrative area. The aim of this study is to assess the effectiveness of the introduction of the PHR on continuity of care.

Who can participate?
Physicians and asylum-seekers at reception centres with on-site health care clinics

What does the study involve?
The PHR is introduced into the participating reception centres in a random order at 3-week intervals, so that by the end of the study period the PHR has been introduced into all of the reception centres. Physicians at the reception centres are asked to complete questionnaires to assess health-related information, missing essential information, and their satisfaction with the quality of the information for each patient-physician encounter. Interviews are also conducted with physicians, health workers and asylum-seekers using the PHR to gain insights into its applicability, acceptance, and the perceived benefits and risks.

What are the possible benefits and risks of participating?
Participating will help assess the effectiveness of the PHR in a complex healthcare setting for a vulnerable patient group. Physicians participating in the study are asked to complete a one-page questionnaire for each patient they treat which takes 1-2 minutes. There are no risks for participating physicians and participation can be withdrawn at any time throughout the study. Asylum-seekers will be interviewed to gain insights into their experiences of using the PHR. This may require talking about personal histories of illness, which may in turn create emotional distress for the participants. The interviewers will be informed about this possibility and instructed to contact local psychosocial support centres if needed.

When is the study starting and how long is it expected to run for?
August to December 2016

Who is funding the study?
The study receives no specific funding. The principal investigator is funded by the German Federal Ministry for Education and Research (BMBF).

Who is the main contact?
Dr Kayvan Bozorgmehr

Trial website

https://www.gesundheitsheft.info/public/evaluation.jsp

Contact information

Type

Scientific

Primary contact

Dr Kayvan Bozorgmehr

ORCID ID

Contact details

Dept. of General Practice & Health Services Research
University Hospital Heidelberg
INF 130.3
Heidelberg
69120 Heidelberg
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

S-438/2016

Study information

Scientific title

Effectiveness of a patient-held health-record for asylum-seekers in reception centres to improve continuity of care: a cluster-randomised stepped wedge trial in a German federal state

Acronym

PHRASYL

Study hypothesis

The hypothesis of this intervention study is that a patient-held health record for asylum-seekers in reception centres improves the transfer of health-related information between providers and health care sectors and thereby improves continuity of care.

Ethics approval

Ethics committee of the Medical Faculty of Heidelberg University, 29/08/2016, ref: S-438/2016

Study design

Cluster-randomised stepped wedge trial (including qualitative methods in form of a parallel mixed-methods design)

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

The study does not focus on specific conditions

Intervention

The intervention consists of the introduction and routine use of a patient-held health-record (PHR) for asylum-seekers in reception centres. The PHR is a paper-based structured document (DIN A5) consisting of: a cover page with information for asylum-seekers in 10 languages; information for the treating physicians; a flap to insert other documents (e.g. vaccination cards); a form for pre-existing conditions; a medication plan; a form for reasons of encounter, assessment results, diagnoses and therapies; a form for vital parameters; and a personal schedule for appointments. Once the PHR is introduced, it is used continuously in the respective health care setting.

The PHR will be introduced by cluster-randomisation in a stepped wedge design in all reception centres in a large administrative area of the federal state of Baden-Würrtemberg. The sequence of introducing the PHR is randomly determined at level of the reception centres (a total of five clusters). Allocation of clusters to the intervention remains concealed towards the authorities in charge of implementing the PHR. To allow for local preparations to introduce the PHR, authorities will be informed about the allocation of the randomly chosen reception centre towards the intervention 10 days in advance. The PHR will be introduced in 3-week intervals, so that at the end of the study period the PHR will be introduced in all reception centres. Data will be collected for primary and secondary outcomes at the level of each patient-physician encounter on specific dates of the week (+/- 2 days) determined by a random procedure. Due to the stepped wedge design, the number of follow-ups in the post-intervention period (i.e. after the PHR has been introduced) differs between reception centres, ranging from 12 weeks (reception centre in which the PHR was first introduced) to 3 weeks (last reception centre in which the PHR was introduced).

Quantitative evaluation: Based on the turnover of patients in the reception centres, a total of 4,230 patient-physician encounters is anticipated to be assessed quantitatively in 15 weeks. Due to the heterogeneous care settings, the number of participating physicians cannot be determined in advance. Furthermore, it is anticipated that about 80 sentinel practices will be recruited in the three cities.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Prevalence of health-related information in patient-physician encounters, assessed by physician questionnaire throughout the whole evaluation period twice per week at randomly determined days (Monday to Friday +/- 2 days). Measurement occasions are chosen randomly using a simple random procedure. Time-points for each measurement occasion remain concealed until the randomly chosen day and health care providers are not informed in advance of all measurement points. Sentinel practices are asked to measure the primary outcomes for each patient-physician encounter with an asylum-seeker during the 15 weeks.

Secondary outcome measures

1. Prevalence of "missing essential health-related information"
2. Physician satisfaction with the prevalence of health-related information

Secondary outcomes will be measured throughout the whole evaluation period twice per week at randomly determined days (Monday to Friday +/- 2 days). Measurement occasions are chosen randomly using a simple random procedure. Secondary outcomes are measured at the level of patient-physician encounters (physician-rated measurement). Time-points for each measurement occasion remain concealed until the randomly chosen day and health care providers are not informed in advance of all measurement points. Sentinel practices are asked to measure the secondary outcomes for each patient-physician encounter with an asylum-seeker during the 15 weeks.

Overall trial start date

22/08/2016

Overall trial end date

05/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Inclusion criteria for reception centres:
The centres must provide health care services

Inclusion criteria for physicians:
Working in the reception centres

Qualitative evaluation:
Health professionals and asylum-seekers (aged over 18) using the PHR

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

4,230 patient-physician encounters

Participant exclusion criteria

Exclusion criteria for reception-centres:
The centres do not provide health care services on spot

Exclusion criteria for physicians:
Not working in the reception centres

Recruitment start date

22/08/2016

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Germany

Trial participating centre

State Reception Centre Karlsruhe
76137
Germany

Trial participating centre

State Reception Centre Mannheim
68159
Germany

Trial participating centre

Reception Centre Heidelberg
69124
Germany

Sponsor information

Organisation

University Hospital Heidelberg

Sponsor details

Dept. of General Practice & Health Services Research
INF 130.3
Heidelberg
69120
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

University Hospital Heidelberg

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

The protocol of the trial will be published (manuscript in preparation at time of registration). The trial results will be disseminated to local authorities mandating the reception centres and healthcare providers working in the reception centres through personal communication and via workshops. The trial results will be published in a scientific journal (preferably open access). Results will also be made publicly available via the website of the PHR (in German): https://www.gesundheitsheft.info/. Final results will also be presented in national and international conferences.

IPD sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from Dr Kayvan Bozorgmehr

Intention to publish date

05/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes