An electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care
| ISRCTN | ISRCTN18008445 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18008445 |
| Protocol serial number | N/A |
| Sponsors | Norwegian Institute of Public Health, Palestinian National Institute of Public Health, World Health Organization |
| Funders | European Research Council, Norges Forskningsråd, Center for Intervention Science in Maternal and Child Health |
- Submission date
- 28/03/2017
- Registration date
- 06/04/2017
- Last edited
- 07/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Public
Norwegian Institute of Public Health
PB 4404 Nydalen
Oslo
N-0403
Norway
 ORCID ID |
0000-0001-9390-8509 |
|---|---|
| Phone | +47 (0)210 78 194 |
| frederik.froen@fhi.no |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | eRegQual; eRegTime |
| Study objectives | 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(s) | 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, 2016/264 B (eRegQual), 19/04/2017 (date added 22/05/2018), 2017/400 (eRegTime) 2. Palestinian Health Research Council, 07/04/2014 (renewed 25/06/2016), PHRC/HC/04/14 (eRegQual), 03/04/2017 (date added 22/05/2018), 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 (renewed 25/06/2016), ref: PHRC/HC/04/14 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 24/04/2018: |
| Completion date | 15/05/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Other |
| Sex | Female |
| Target sample size at registration | 6000 |
| Total final enrolment | 6367 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 15/01/2017 |
| Date of final enrolment | 15/09/2017 |
Locations
Countries of recruitment
- Palestine, State of
Study participating centre
Qadora Street
Ramallah/ Al-Bireh
PO Box 4284
Palestine, State of
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 31/01/2022 | 31/01/2022 | Yes | No | |
| Results article | eRegTime sub-study results | 13/05/2022 | 07/06/2023 | Yes | No |
| Protocol article | protocol | 22/01/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/06/2023: Publication reference and total final enrolment added.
31/01/2022: Publication reference added.
22/05/2018: Ethics approval dates were added for eRegTime.
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.
