Antenatal Care and DeliveryQUALMATNCT01409824
Health Care Intervention Research- Improving Pre-natal and Maternal Care
A study testing CDSS in people with Antenatal Care and Delivery, run by Heidelberg University at 1 site in Germany.
Trial summary
Besides a dramatic lack of financial and human resources in developing countries, health care is additionally endangered by quality deficiencies caused by low staff motivation. This lack of motivation leads to an insufficient translation of knowledge into optimal utilization of resources. Read more about this study
- Who is it for?
- Ages 12 to 45 years, women only
- Conditions the study is for
- Antenatal Care and Delivery
- What is being tested?
- CDSS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- the patient in the primary health care center
Who cannot join
- patients outside the research regions
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg
Heidelberg, 69120
Rainer Sauerborn, Prof., 00496221565859, svetla.loukanova@urz.uni-heidelberg.de
About this study
Official title: Health Care Intervention Research-Quality of Prenatal and Maternal Care: Bridging the Know-do Gap (QUALMAT)
Besides a dramatic lack of financial and human resources in developing countries, health care is additionally endangered by quality deficiencies caused by low staff motivation. This lack of motivation leads to an insufficient translation of knowledge into optimal utilization of resources. The "know-do" gap represents a challenge that must be addressed to strengthen health services performance towards achieving the Millennium Development Goals (MDGs). This is in particular true for some sensitive sectors like pre-natal and maternal health care. General objective of this research is to improve maternal health through better pre-natal and maternal care services offered by better motivated health workers. A computer-assisted clinical decision support system (CDSS) will be developed, implemented and tested aiming at (I) quality improvement of maternal and newborn care and (II) assessment of provider's performance. Based on this tool a commonly agreed incentive scheme to increase motivation will be shaped and tested in three SSA - countries, namely Burkina, Ghana, and Tanzania.
The incentive scheme might contain both non-monetary and monetary incentives and will be designed according to the human resource policy in the three countries. The planned approach is an implementation study with control arms containing one hospital and 6 first line health facilities in each of the study districts and an equal number of facilities in the control arm. A set of indicators for measurement of changes in quality of delivered services will be identified in order to follow up the sustainability and effectiveness of the strategies after their implementation. The study findings will allow understanding the important factors of staff motivation and facilitate adequate management for improvement of maternal and neonatal health care. "Knowing is not enough, we must apply; Wanting to do, is not enough, we must do it1"
- J.W. v. Goethe
- Conditions
- Antenatal Care and Delivery
- Being tested
- CDSS
- Keywords
- clinical decision support system, performance based incentives, quality of maternal health care services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSSOther
Clinical Decision Support System
| Study group | Role | What they receive |
|---|---|---|
| without CDSS | No intervention | This arm includes 6 health facilities in each partner country, where the clinical decision support system will not be implemented Receives: Other: CDSS |
| with CDSS | Experimental | This arm includes 6 health facilities in each partner country, where the clinical decision support system will be implemented, parallel to the performance based incentive package Receives: Other: CDSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
motivation
This research aims to increase the motivation of the health care providers through two parallel intervention packages- implementation of Clinical decision support system and incentive packages, based on the performance.
Measured: 2 years
Secondary outcomes (1)
Improved quality of health services in ANC and delivery
This research aims to improve the quality of the services provided through better motivated health workers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Antenatal Care and DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Centre de Recherche en Sante de Nouna, Burkina Faso, Navrongo Health Research Centre, Ghana, Karolinska Institutet, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409824
- Sponsor's protocol ID
- S-173/2008
- Acronym
- QUALMAT
- Status last verified
- Feb 2010
- First submitted
- 3 Aug 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saronga HP, Duysburgh E, Massawe S, Dalaba MA, Wangwe P, Sukums F, Leshabari M, Blank A, Sauerborn R, Loukanova S. Cost-effectiveness of an electronic clinical decision support system for improving quality of antenatal and childbirth care in rural Tanzania: an intervention study. BMC Health Serv Res. 2017 Aug 7;17(1):537. doi: 10.1186/s12913-017-2457-z.
PubMed 28784130Blank A, Prytherch H, Kaltschmidt J, Krings A, Sukums F, Mensah N, Zakane A, Loukanova S, Gustafsson LL, Sauerborn R, Haefeli WE. "Quality of prenatal and maternal care: bridging the know-do gap" (QUALMAT study): an electronic clinical decision support system for rural Sub-Saharan Africa. BMC Med Inform Decis Mak. 2013 Apr 10;13:44. doi: 10.1186/1472-6947-13-44.
PubMed 23574764
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Intervention Research-Quality of Prenatal and Maternal Care: Bridging the Know-do Gap (QUALMAT)
- ClinicalTrials.gov ID
- NCT01409824
- Acronym / sponsor ID
- QUALMAT / S-173/2008
- Conditions
- Antenatal Care and Delivery
- Keywords
- clinical decision support system, performance based incentives, quality of maternal health care services
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- University Ghent, Centre de Recherche en Sante de Nouna, Burkina Faso, Navrongo Health Research Centre, Ghana, Karolinska Institutet, Muhimbili University of Health and Allied Sciences
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Apr 2014 (estimated)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Besides a dramatic lack of financial and human resources in developing countries, health care is additionally endangered by quality deficiencies caused by low staff motivation. This lack of motivation leads to an insufficient translation of knowledge into optimal utilization of resources. The "know-do" gap represents a challenge that must be addressed to strengthen health services performance towards achieving the Millennium Development Goals (MDGs). This is in particular true for some sensitive sectors like pre-natal and maternal health care. General objective of this research is to improve maternal health through better pre-natal and maternal care services offered by better motivated health workers. A computer-assisted clinical decision support system (CDSS) will be developed, implemented and tested aiming at (I) quality improvement of maternal and newborn care and (II) assessment of provider's performance. Based on this tool a commonly agreed incentive scheme to increase motivation will be shaped and tested in three SSA - countries, namely Burkina, Ghana, and Tanzania.
The incentive scheme might contain both non-monetary and monetary incentives and will be designed according to the human resource policy in the three countries. The planned approach is an implementation study with control arms containing one hospital and 6 first line health facilities in each of the study districts and an equal number of facilities in the control arm. A set of indicators for measurement of changes in quality of delivered services will be identified in order to follow up the sustainability and effectiveness of the strategies after their implementation. The study findings will allow understanding the important factors of staff motivation and facilitate adequate management for improvement of maternal and neonatal health care. "Knowing is not enough, we must apply; Wanting to do, is not enough, we must do it1"
- J.W. v. Goethe
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without CDSS | No intervention | Other: CDSSThis arm includes 6 health facilities in each partner country, where the clinical decision support system will not be implemented |
| with CDSS | Experimental | Other: CDSSThis arm includes 6 health facilities in each partner country, where the clinical decision support system will be implemented, parallel to the performance based incentive package |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- the patient in the primary health care center
Key exclusion criteria (1 listed)
- patients outside the research regions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDSSClinical Decision Support System | Other | with CDSS, without CDSS |
Primary outcome
motivation
Time frame: 2 years
This research aims to increase the motivation of the health care providers through two parallel intervention packages- implementation of Clinical decision support system and incentive packages, based on the performance.
1 secondary outcome
Improved quality of health services in ANC and delivery
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
- Derived from this study: PubMed 28784130Saronga HP, Duysburgh E, Massawe S, Dalaba MA, Wangwe P, Sukums F, Leshabari M, Blank A, Sauerborn R, Loukanova S. Cost-effectiveness of an electronic clinical decision support system for improving quality of antenatal and childbirth care in rural Tanzania: an intervention study. BMC Health Serv Res. 2017 Aug 7;17(1):537. doi: 10.1186/s12913-017-2457-z.
- Derived from this study: PubMed 23574764Blank A, Prytherch H, Kaltschmidt J, Krings A, Sukums F, Mensah N, Zakane A, Loukanova S, Gustafsson LL, Sauerborn R, Haefeli WE. "Quality of prenatal and maternal care: bridging the know-do gap" (QUALMAT study): an electronic clinical decision support system for rural Sub-Saharan Africa. BMC Med Inform Decis Mak. 2013 Apr 10;13:44. doi: 10.1186/1472-6947-13-44.
- Improving pre-natal and maternal careLink provided by the sponsor.
Related trials for Antenatal Care and Delivery
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingObservational study
Cadmium Exposure During Pregnancy and Fetal Growth
Cadmium, Placenta
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSS in people with Antenatal Care and Delivery, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rainer Sauerborn, Prof. (00496221565859, svetla.loukanova@urz.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motivation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01409824, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2011.