Condition category
Pregnancy and Childbirth
Date applied
28/03/2017
Date assigned
06/04/2017
Last edited
24/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Current plain English summary as of 24/04/2017:

Background and study aims
Healthcare providers need to maintain good quality patient records. At the same time, they should be able to share meaningful health data with colleagues, supervisors and policy makers in an efficient and secure way. An eRegistry is a type of electronic health information system which provides guidance for such collection and management of data. eRegistries can also support healthcare providers to follow best practices during clinical work, leading to improved quality of care for their clients. The aim of this study is to assess whether such an eRegistry can improve quality of care and health of pregnant women and their babies in Palestine.

Who can participate?
All pregnant women attending antenatal care in 133 primary healthcare clinics in five districts in the West Bank, Palestine.

What does the study involve?
Participating clinics are randomly allocated to one of two groups. Clinics in the first group receive an electronic health information system called the MCH eRegistry. Healthcare workers in these clinics use the eRegistry for care of clients throughout their pregnancy. When healthcare workers enter the client information at the point-of-care into eRegistry, it provides specific actionable advice and recommendations (using interactive checklists with clinical decision support) for the workers. Clinics in the second group continue to use paper-based files and receive the MCH eRegistry after the study is over. Data to measure quality of care and data on birth outcomes of enrolled pregnant women is routinely extracted every month during the study period for clinics in both groups in order to assess the effectiveness of the eRegistry in comparison to paper-based filing.

Substudy eRegTime: The time spent by the care providers in managing health information during their working day, in clinics with and without the eRegistry will be measured.

What are the possible benefits and risks of participating?
Pregnant women may benefit from better quality of healthcare that may lead to improved health outcomes for them and their babies. There are no known risks associated with taking part in the study, and because this is part of a national deployment of the MCH eRegistry, no alternative health information system is provided.

Where is the study run from?
The study is run from the Palestinian National Institute of Public Health, World Health Organization, Ramallah, Palestine and takes place in 133 Primary Healthcare Clinics (Palestine)

When is study starting and how long is it expected to run for?
January 2016 to May 2018

Who is funding the study?
1. European Research Council (European Union)
2. Norwegian Research Council (Norway)
3. Center for Intervention Science in Maternal and Child Health (Norway)
4. Norwegian Institute of Public Health (Norway)
5. Palestinian National Institute of Public Health, World Health Organization (Palestine)

Who is the main contact?
Dr J. Frederik Frøen
frederik.froen@fhi.no

Previous plain English summary:

Background and study aims
Healthcare providers need to maintain good quality patient records. At the same time, they should be able to share meaningful health data with colleagues, supervisors and policy makers in an efficient and secure way. An eRegistry is a type of electronic health information system which provides guidance for such collection and management of data. eRegistries can also support healthcare providers to follow best practices during clinical work, leading to improved quality of care for their clients. The aim of this study is to assess whether such an eRegistry can improve quality of care and health of pregnant women and their babies in Palestine.

Who can participate?
All pregnant women attending antenatal care in 133 primary healthcare clinics in five districts in the West Bank, Palestine.

What does the study involve?
Participating clinics are randomly allocated to one of two groups. Clinics in the first group receive an electronic health information system called the MCH eRegistry. Healthcare workers in these clinics use the eRegistry for care of clients throughout their pregnancy. When healthcare workers enter the client information at the point-of-care into eRegistry, it provides specific actionable advice and recommendations (using interactive checklists with clinical decision support) for the workers. Clinics in the second group continue to use paper-based files and receive the MCH eRegistry after the study is over. Data to measure quality of care and data on birth outcomes of enrolled pregnant women is routinely extracted every month during the study period for clinics in both groups in order to assess the effectiveness of the eRegistry in comparison to paper-based filing.

What are the possible benefits and risks of participating?
Pregnant women may benefit from better quality of healthcare that may lead to improved health outcomes for them and their babies. There are no known risks associated with taking part in the study, and because this is part of a national deployment of the MCH eRegistry, no alternative health information system is provided.

Where is the study run from?
The study is run from the Palestinian National Institute of Public Health, World Health Organization, Ramallah, Palestine and takes place in 133 Primary Healthcare Clinics (Palestine)

When is study starting and how long is it expected to run for?
January 2016 to May 2018

Who is funding the study?
1. European Research Council (European Union)
2. Norwegian Research Council (Norway)
3. Center for Intervention Science in Maternal and Child Health (Norway)
4. Norwegian Institute of Public Health (Norway)
5. Palestinian National Institute of Public Health, World Health Organization (Palestine)

Who is the main contact?
Dr J. Frederik Frøen
frederik.froen@fhi.no

Trial website

www.fhi.no/en/more/international/eregistries/research/; www.eregistries.org

Contact information

Type

Public

Primary contact

Dr J. Frederik Frøen

ORCID ID

http://orcid.org/0000-0001-9390-8509

Contact details

Norwegian Institute of Public Health
PB 4404 Nydalen
Oslo
N-0403
Norway
+47 (0)210 78 194
frederik.froen@fhi.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

eRegQual: an electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care – protocol for a cluster-randomized controlled trial

Substudy eRegTime: Efficiency of health information management using an eRegistry for maternal and child health – protocol for a time-motion study in a cluster randomized trial

Acronym

eRegQual; eRegTime

Study hypothesis

Current study hypothesis as of 24/04/2018:
eRegQual hypotheses:
1. Interactive checklists with clinical decision support in antenatal care improve quality of care for pregnant women
2. Interactive checklists with clinical decision support in antenatal care prevent women from entering into labor with an unknown or unidentified risk of an important condition during pregnancy

eRegTime hypothesis:
Interactive checklists with clinical decision support in antenatal care does not increase the time spent on information management

Previous study hypothesis
1. Interactive checklists with clinical decision support in antenatal care improves quality of care for pregnant women
2. Interactive checklists with clinical decision support in antenatal care prevents women from entering into labor with an unknown or unidentified risk important condition during pregnancy

Ethics approval

Current ethics approval as of 24/04/2018:
1. Regional Committee for Health Research Ethics (REK) - Section South East B, Norway (REK), 02/03/2016, ref: 2016/264 B (eRegQual), 2017/400 (eRegTime)
2. Palestinian Health Research Council, 07/04/2014 (renewed 25/06/2016), ref: PHRC/HC/04/14 (eRegQual), PHRC/HC/208/17 (eRegTime)

Previous ethics approval:
1. Regional Committee for Health Research Ethics (REK) - Section South East B, Norway (REK), 02/03/2016, ref: 2016/264 B
2. Palestinian Health Research Council, 07/04/2014 (reneweed 25/06/2016), ref: PHRC/HC/04/14

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Antenatal care

Intervention

Primary healthcare clinics are randomized to one of two groups, stratified by district and constrained on the following characteristics:
1. Number of new enrollments of pregnancies per year
2. Laboratory availability
3. Proportion of new enrollments above 40 years of age
4. Proportion of primiparous women

Intervention arm: The primary healthcare clinics in the intervention arm receive the intervention - eRegistry’s interactive checklists with clinical decision support for antenatal care. The eRegistry allows for seamless incorporation of clinical workflow and guideline support in addition to reminders of daily clinical procedures and referrals. All intervention primary healthcare clinics are provided with desktop computers to be used by care providers in the consultation rooms. Each user has a unique username and password identifying their authorized access to the eRegistry. Clinics in the intervention arm use the eRegistry for an average of 20 weeks prior to start of recruitment.

Control arm: The primary healthcare clinics in the control arm continue to use the current system of paper files during antenatal care.

The eRegistry’s interactive checklists and the current paper records contain the same datapoints. The period of enrollment is 8 months, followed by another 8 months of follow-up for clinics in both arms.

Added 24/04/2018:
Substudy eRegTime: the clinics included in the data collection were selected using a stratified random sampling. The data collection for the eRegTime study will be conducted April to June 2018.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Adverse pregnancy outcomes are masured using data from hospitals in the eRegistry, registered continuously at point-of-care and exported monthly. This is a composite outcome that includes the following adverse pregnancy outcomes:
1.1. Moderate or severe anemia at admission for labor
1.2. Severe hypertension at admission for labor
1.3. Malpresentation at delivery undetected during pregnancy
1.4. Large for gestational age baby at delivery
1.5. Small-for-gestational age baby at delivery undetected during pregnancy
2. Process (adherence) outcomes are measured using data from primary healthcare clinics in the eRegistry, registered continuously at point-of-care and exported monthly. These include timely and appropriate screening and management of:
2.1. Anemia during pregnancy
2.2. Hypertension in pregnancy
2.3. Diabetes in pregnancy
2.4. Abnormal fetal growth

Secondary outcome measures

Current secondary outcome measures as of 24/04/2018:

eRegQual:
1. Timely ANC visit rate is measured using data from primary healthcare clinics in the eRegistry, registered continuously at point-of-care into the eRegistry and exported monthly
2. Timely and appropriate screening and management of malpresentation ≥ 36 weeks rate is measured using data from primary healthcare clinics in the eRegistry, registered continuously at point-of-care into the eRegistry and exported monthly
3. Stillbirth rate is measured using data from primary healthcare clinics in the eRegistry, registered continuously at point-of-care into the eRegistry and exported monthly

eRegTime:
4. Time spent on health information management per antenatal consultation, measured using data collected by time-motion observations of care providers’ entire work days in the primary healthcare clinics. Health information management is defined as time spent by care providers on accessing, documenting and reporting health information.

Previous secondary outcome measures:
1. Timely ANC visit rate is measured using data from primary healthcare clinics in the eRegistry, registered continuously at point-of-care into the eRegistry and exported monthly
2. Timely and appropriate screening and management of malpresentation ≥ 36 weeks rate is measured using data from primary healthcare clinics in the eRegistry, registered continuously at point-of-care into the eRegistry and exported monthly
3. Stillbirth rate is measured using data from primary healthcare clinics in the eRegistry, registered continuously at point-of-care into the eRegistry and exported monthly

Overall trial start date

15/01/2016

Overall trial end date

15/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Current participant inclusion criteria as of 24/04/2018:
eRegQual - Clinics:
1. Clinics run by the Ministry of Health, Palestine
2. Clinics located in the 5 districts: Bethlehem, Nablus, Jenin, Ramallah/ Al-Bireh, Salfit
3. Clinics run by non-governmental organizations but still reporting to the Ministry of Health, Palestine

eRegTime - Clinics:
4. Clinics that have one nurse or one midwife providing antenatal care services on a given workday
5. Clinics that have, on average, at least one booking visit per workday

Patients:
There are no eligibility criteria based on individual patient characteristics.

Previous participant inclusion criteria:
Clinics:
1. Clinics run by the Ministry of Health, Palestine
2. Clinics located in the 5 districts: Bethlehem, Nablus, Jenin, Ramallah/ Al-Bireh, Salfit
3. Clinics run by non-governmental organizations but still reporting to the Ministry of Health, Palestine

Patients:
There are no eligibility criteria based on individual patient characteristics.

Participant type

Other

Age group

Other

Gender

Female

Target number of participants

120 clusters of clinics and approximately 6000 enrolled pregnant women and their newborns

Participant exclusion criteria

Clinics:
1. Primary healthcare clinics that are defined as level 1
2. Primary healthcare clinics with no pregnant women enrolled in 2013
3. Primary healthcare clinics providing high-risk management
4. Primary healthcare clinics participating in another health systems study addressing the quality of antenatal care

Recruitment start date

15/01/2017

Recruitment end date

15/09/2017

Locations

Countries of recruitment

Palestinian Territory

Trial participating centre

Palestinian National Institute of Public Health, World Health Organization
Ministry of Health Building, 1st Floor Qadora Street
Ramallah/ Al-Bireh
PO Box 4284
Palestinian Territory

Sponsor information

Organisation

Norwegian Institute of Public Health

Sponsor details

Postboks 4404 Nydalen
Oslo
0403
Norway
+47 (0)210 77 000
eregistries@fhi.no

Sponsor type

Government

Website

www.fhi.no

Organisation

Palestinian National Institute of Public Health, World Health Organization

Sponsor details

Ministry of Health Building
1st Floor
Qadora Street
Ramallah/ Al-Bireh
PO Box 4284
Palestinian Territory
+970 (0)2 296 6842/7
info.pniph@gmail.com

Sponsor type

Government

Website

www.pniph.org

Funders

Funder type

Government

Funder name

European Research Council

Alternative name(s)

ERC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Funder name

Norges Forskningsråd

Alternative name(s)

Research Council of Norway, Forskningsrådet, Norwegian Research Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Norway

Funder name

Center for Intervention Science in Maternal and Child Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Current publication and dissemination plan as of 24/04/2018:
The following are the tentative titles of the planned publications related to this trial during 2017- 2018:
1. Quality of antenatal care services in Palestine – an indicator based assessment
2. Design of interactive electronic checklists for antenatal, postpartum and newborn care implemented in an electronic registry in primary
3. Implementation of a mother and child health electronic registry in Palestine
4. eRegQual: An electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care – study protocol for a cluster-randomized controlled trial
5. Substudy eRegTime: Efficiency of health information management using an eRegistry for maternal and child health – study protocol for a time-motion study in a cluster randomized trial
6. eRegQual: An electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care – a cluster-randomized controlled trial
7. eRegQual: Effect of an electronic health registry with interactive checklists and clinical decision support on equity of antenatal care service delivery
8. Substudy eRegTime: Efficiency of health information management using an eRegistry for maternal and child health – a time-motion study in a cluster randomized trial

Previous publication and dissemination plan:
The following are the tentative titles of the planned publications related to this trial during 2017- 2018:
1. Quality of antenatal care services in Palestine – an indicator based assessment
2. Design of interactive electronic checklists for antenatal, postpartum and newborn care implemented in an electronic registry in primary
3. Implementation of a mother and child health electronic registry in Palestine
4. eRegQual: An electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care – study protocol for a cluster-randomized controlled trial
5. eRegQual: An electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care – a cluster-randomized controlled trial
6. eRegQual: Effect of an electronic health registry with interactive checklists and clinical decision support on equity of antenatal care service delivery

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29357912

Publication citations

Additional files

Editorial Notes

24/04/2018: Changes made to the following fields to provide detail on eRegTime, a sub-study within the main trial eRegQual examining the efficiency of the eReg health registry: 1. Plain English summary 2. "Substudy eRegTime: Efficiency of health information management using an eRegistry for maternal and child health – protocol for a time-motion study in a cluster randomized trial" has been added to the 'Scientific title' field 3. "eRegTime" has been added to the 'Acronym' field 4. Study hypothesis 5. Ethics approval 6. Interventions 7. Secondary outcome measures 8. Participant inclusion criteria 9. Publication and dissemination plan 31/01/2018: Publication reference added.