Primary Health Care for ChildrenmedAL-mentorNCT05901155
Impact of a Real-time Mentoring Tool on Antibiotic Prescription (medAL-mentor)
A study testing MedAL-mentor in people with Primary Health Care for Children, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 40 sites in Tanzania.
Trial summary
The goal of this ancillary study, part of the DYNAMIC project, is to reduce antibiotic prescription and improve the quality of care for children in primary care in Tanzania using a near real-time mentoring tool (called medAL-mentor), based on a monitoring and benchmarking dashboard and feedback by the monitoring team. Read more about this study
- Who is it for?
- Ages 1 day to 14 years
- Conditions the study is for
- Primary Health Care for Children
- What is being tested?
- MedAL-mentor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37,000 participants
- Where
- 40 sitesTanzania
- Study dates
- 5 Jun 2023to 30 Dec 2023
- 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 1 day to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presenting for an acute medical or surgical condition
Who cannot join
- Presenting for scheduled consultation for a chronic disease (e.g. HIV, tuberculosis, non-communicable diseases, malnutrition)
- Presenting for routine preventive care (e.g. growth monitoring, vitamin supplementation, deworming, vaccination)
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Tanzania40 sites
Chikuti Dispensary
Chikuti, Morogoro
Chirombora Dispensary
Chirombora, Morogoro
Chita Rural Dispensary
Chita, Morogoro
Idete Dispensary
Idete, Morogoro
Idiga Dispensary
Idiga, Mbeya
Idunda Dispensary
Idunda, Morogoro
Kibaoni Health Center
Ifakara, Morogoro
Michenga Dispensary
Ifakara, Morogoro
Sagamaganga Dispensary
Ifakara, Morogoro
Igoma Dispensary
Igoma, Mbeya
Lwanjilo Dispensary
Ilowelo, Mbeya
Inyala Health Center
Inyala, Mbeya
Iwindi Dispensary
Iwindi, Mbeya
Ketaketa Dispensary
Kataketa, Morogoro
Kichangani Dispensary
Kichangani, Morogoro
Kimondo Dispensary
Kimondo, Mbeya
Kisegese Dispensary
Kisegese, Morogoro
Mbalizi Dispensary
Mbalizi, Mbeya
Isyesye Dispensary
Mbeya
Itagano Dispensary
Mbeya
Itensa Dispensary
Mbeya
Itezi Dispensary
Mbeya
Itijy Dispensary
Mbeya
Iyunga Health Center
Mbeya
Ndanyela Dispensary
Mbeya
Nzovwe Health Center
Mbeya
Tembela Dispensary
Mbeya
Mbuga Dispensary
Mbuga, Morogoro
Milola Dispensary
Milola, Morogoro
Mjele Dispensary
Mjele, Mbeya
Mshewe Dispensary
Mjele, Mbeya
Mngeta Health Center
Mngeta, Morogoro
Mwabwowo Dispensary
Mwabwowo, Mbeya
Santilya Health Center
Santilya, Mbeya
Shuwa Dispensary
Shuwa, Mbeya
Songwe viwandani Dispensary
Songwe, Mbeya
Sanje Dispensary
Sonjo, Morogoro
Sonjo Dispensary
Sonjo, Morogoro
Udagaji Dispensary
Udagaji, Morogoro
Utengule Dispensary
Utengule, Morogoro
About this study
Official title: Impact of medAL-mentor, a Real-time Mentoring and Benchmarking Tool, on Antibiotic Prescription Among Children in Primary Health Care Facilities in Tanzania
The goal of this ancillary study, part of the DYNAMIC project, is to reduce antibiotic prescription and improve the quality of care for children in primary care in Tanzania using a near real-time mentoring tool (called medAL-mentor), based on a monitoring and benchmarking dashboard and feedback by the monitoring team. The main question to be answered is: Can real-time mentoring, based on clinical decision support algorithm data, improve healthcare workers' compliance with guidelines - and therefore quality of care for paediatric outpatients? Health providers in participating health facilities will receive either the medAL-mentor tool and feedback from the monitoring team (intervention group), or standard mentoring (control group), so that the impact on antibiotic prescription and other quality of care indicators can be compared between the two arms.
Read the detailed description
ePOCT+ is a paediatric digital clinical decision support algorithm for health workers in primary care facilities in Tanzania. The objective is to improve the integrated management of acutely ill children aged 1 day to 14 years and reduce inappropriate antibiotic prescriptions.
Preliminary findings from the first phase of the DYNAMIC project, an open-label cluster randomized controlled study performed in 40 health facilities, showed a reduction in antibiotic prescription by health providers from about 70% in the control arm to 23% in health facilities using ePOCT+, with similar clinical outcomes in children at day 7. Nevertheless, uptake of ePOCT+ and antibiotic prescription in the intervention arm were very heterogeneous across health facilities.
Benchmarking in healthcare is defined as "a process of comparative evaluation and identification of the underlying causes leading to high levels of performance". The findings and experiences of different institutions are shared, and elements of best practices are adopted to improve performance. Benchmarking has been promoted for years by infectious diseases societies as a component of hospital antimicrobial stewardship programs, to reduce antibiotic prescription. Benchmarking has also been shown to be an effective incentive to improve the quality of care in various settings, including primary care practice. Unfortunately, published initiatives have largely come from high-income countries.
In the context of the DYNAMIC project, we developed a near real-time mentoring tool, medAL-mentor, based on a monitoring and benchmarking dashboard using data collected through ePOCT+. The tool provides direct feedback to health workers on their performance, based on several clinical indicators (including antibiotic prescription), in comparison with data from other health facilities. The monitoring team will target calls and monitoring visits to health facilities based on these indicators and use the dashboard to facilitate discussions with healthcare workers.
This ancillary study, MedAL-mentor, aims to assess whether this real-time mentoring tool based on data generated by a clinical decision support algorithm, as well as feedback from the mentoring team, improves healthcare workers' compliance with guidelines - and therefore the quality of care for sick children at primary care level.
More specifically, the study objectives are :
Primary objective :
To determine whether the provision of medAL-mentor, a digital mentoring tool, decreases antibiotic prescription by primary care clinicians using a clinical decision support algorithm (ePOCT+) for the management of sick children
Secondary objectives are :
- To assess the impact of medAL-mentor on clinicians' uptake of ePOCT+
- To assess the impact of medal-mentor on clinicians in terms of :
- Performance of key measurements and assessment of signs by clinicians
- Compliance with the recommendations related to point-of-care tests (for malaria and haemoglobin)
This open-label, parallel cluster randomized controlled study is embedded in the second phase of the DYNAMIC project in Tanzania. The intervention consists of providing direct access to medAL-mentor to the healthcare workers. The mentoring team will target calls and monitoring visits to health facilities based on medAL-mentor indicators and use the dashboard to facilitate discussions with healthcare workers during the monitoring visits. Since the intervention takes place at the healthcare worker level and their practices are influenced by the context of the health facility they are working in, randomization at the health facility level rather than at the health worker level was chosen.
40 health facilities using ePOCT+ for the first time during the second phase of the DYNAMIC project will be randomly selected and assigned to two groups (randomization 1:1, intervention: control). Health workers in health facilities randomized to the intervention group will receive feedback on their performance through direct access to medAL-mentor and regular mobile messages, as well as targeted phone calls and visits by the monitoring team based on the medAL-mentor dashboard. Health facilities from the control group will receive standard monitoring (regular messages to check for any issues and regular site visits), without access to medAL-mentor (neither for the health workers nor for the monitoring team).
- Conditions
- Primary Health Care for Children
- Being tested
- MedAL-mentor
- Keywords
- Digital health, Antibiotic stewardship, Real-time mentoring, Benchmarking, Clinical decision support algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedAL-mentorDevice
MedAL-mentor is a near real-time monitoring and benchmarking dashboard based on data collected through ePOCT+, providing direct feedback on several clinical indicators (antibiotic prescription, performance of key measurements, signs, and diagnostic tests).
| Study group | Role | What they receive |
|---|---|---|
| MedAL-mentor | Experimental | In health facilities allocated to the medAL-mentor arm, the intervention will consist in :
* Providing tablets with ePOCT+ and initial training for use by healthcare workers
* Access to medAL-mentor for healthcare workers and the monitoring team
* Regular (at least every 2 weeks) supportive messages sent by the monitoring team to healthcare workers providing feedback from medAL-mentor
* Targeted phone calls and health facilities visits by the monitoring team based on medAL-mentor review Monitoring will be performed by the study team. Receives: Device: MedAL-mentor |
| Routine mentoring | No intervention | In health facilities allocated to the control arm, tablets with ePOCT+ will also be provided to healthcare workers with initial training, but subsequent mentoring will be conducted routinely: * No access to medAL-mentor for healthcare workers or the monitoring team * At least one message sent by the monitoring team to healthcare workers every two weeks, to inquire about any issues and trigger a site visit if needed * At least one visit from the monitoring team in each health facility every two months Monitoring will be performed by the study team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children prescribed an antibiotic in the intervention group (medAL-mentor) as compared to the control group (routine mentoring)
Number of children for whom at least one systemic (oral or parenteral) antibiotic has been prescribed during consultation, over all eligible children, as reported by the healthcare workers in a routine registry
Measured: Day 0 (by the end of the consultation)
Secondary outcomes (3)
Percentage of consultations with eligible children performed using ePOCT+
Number of consultations completed with ePOCT+, over all consultations with eligible children as reported in a routine registry
Measured: Day 0 (by the end of the consultation)
Percentage of children in whom key signs have been checked by healthcare workers
Number of children in whom key signs (temperature, weight, mid-upper arm circumference (MUAC), respiratory rate) have been checked by healthcare workers, over the total number of children for whom this was recommended, as reported by healthcare workers in ePOCT+
Measured: Day 0 (by the end of the consultation)
Percentage of children for whom appropriate diagnostic tests have been performed by healthcare workers
Number of children for whom diagnostic tests (haemoglobin and malaria tests) have been performed by healthcare workers, over the total number of children for whom diagnostic tests were recommended, as reported by healthcare workers in ePOCT+
Measured: Day 0 (by the end of the consultation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start5 Jun 2023
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Primary Health Care for ChildrenStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involves two arms: intervention and control. Health facilities will serve as clusters, with half of the facilities (20) receiving the intervention and the other half serving as controls (20). Health facilities will be randomized to their respective study arm. A parallel design (all health facilities start at the same time) will be used.
- Masking
- None (open label)
- Enrolment
- 37,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Ifakara Health Institute, Mbeya Medical Research Centre-National Institute for Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901155
- Sponsor's protocol ID
- 2020-02800_substudymedalmentor
- Acronym
- medAL-mentor
- Status last verified
- Dec 2023
- First submitted
- 11 May 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ellis J. All inclusive benchmarking. J Nurs Manag. 2006 Jul;14(5):377-83. doi: 10.1111/j.1365-2934.2006.00596.x.
PubMed 16787472Thonon F, Watson J, Saghatchian M. Benchmarking facilities providing care: An international overview of initiatives. SAGE Open Med. 2015 Sep 23;3:2050312115601692. doi: 10.1177/2050312115601692. eCollection 2015.
PubMed 26770800Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, Huskins WC, Paterson DL, Fishman NO, Carpenter CF, Brennan PJ, Billeter M, Hooton TM; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.
PubMed 17173212Willmington C, Belardi P, Murante AM, Vainieri M. The contribution of benchmarking to quality improvement in healthcare. A systematic literature review. BMC Health Serv Res. 2022 Feb 2;22(1):139. doi: 10.1186/s12913-022-07467-8.
PubMed 35109824Piccoliori G, Mahlknecht A, Abuzahra ME, Engl A, Breitenberger V, Vogele A, Montalbano C, Sonnichsen A. Quality improvement in chronic care by self-audit, benchmarking and networking in general practices in South Tyrol, Italy: results from an interventional study. Fam Pract. 2021 Jun 17;38(3):253-258. doi: 10.1093/fampra/cmaa123.
PubMed 33184661Hermans MP, Elisaf M, Michel G, Muls E, Nobels F, Vandenberghe H, Brotons C; OPTIMISE International Steering Committee. Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial. Diabetes Care. 2013 Nov;36(11):3388-95. doi: 10.2337/dc12-1853. Epub 2013 Jul 11.
PubMed 23846810Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
PubMed 26864410
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of medAL-mentor, a Real-time Mentoring and Benchmarking Tool, on Antibiotic Prescription Among Children in Primary Health Care Facilities in Tanzania
- ClinicalTrials.gov ID
- NCT05901155
- Acronym / sponsor ID
- medAL-mentor / 2020-02800_substudymedalmentor
- Conditions
- Primary Health Care for Children
- Keywords
- Digital health, Antibiotic stewardship, Real-time mentoring, Benchmarking, Clinical decision support algorithm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37,000 participants (actual)
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Ifakara Health Institute, Mbeya Medical Research Centre-National Institute for Medical Research
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- 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.
The goal of this ancillary study, part of the DYNAMIC project, is to reduce antibiotic prescription and improve the quality of care for children in primary care in Tanzania using a near real-time mentoring tool (called medAL-mentor), based on a monitoring and benchmarking dashboard and feedback by the monitoring team. The main question to be answered is: Can real-time mentoring, based on clinical decision support algorithm data, improve healthcare workers' compliance with guidelines - and therefore quality of care for paediatric outpatients? Health providers in participating health facilities will receive either the medAL-mentor tool and feedback from the monitoring team (intervention group), or standard mentoring (control group), so that the impact on antibiotic prescription and other quality of care indicators can be compared between the two arms.
Detailed description
ePOCT+ is a paediatric digital clinical decision support algorithm for health workers in primary care facilities in Tanzania. The objective is to improve the integrated management of acutely ill children aged 1 day to 14 years and reduce inappropriate antibiotic prescriptions.
Preliminary findings from the first phase of the DYNAMIC project, an open-label cluster randomized controlled study performed in 40 health facilities, showed a reduction in antibiotic prescription by health providers from about 70% in the control arm to 23% in health facilities using ePOCT+, with similar clinical outcomes in children at day 7. Nevertheless, uptake of ePOCT+ and antibiotic prescription in the intervention arm were very heterogeneous across health facilities.
Benchmarking in healthcare is defined as "a process of comparative evaluation and identification of the underlying causes leading to high levels of performance". The findings and experiences of different institutions are shared, and elements of best practices are adopted to improve performance. Benchmarking has been promoted for years by infectious diseases societies as a component of hospital antimicrobial stewardship programs, to reduce antibiotic prescription. Benchmarking has also been shown to be an effective incentive to improve the quality of care in various settings, including primary care practice. Unfortunately, published initiatives have largely come from high-income countries.
In the context of the DYNAMIC project, we developed a near real-time mentoring tool, medAL-mentor, based on a monitoring and benchmarking dashboard using data collected through ePOCT+. The tool provides direct feedback to health workers on their performance, based on several clinical indicators (including antibiotic prescription), in comparison with data from other health facilities. The monitoring team will target calls and monitoring visits to health facilities based on these indicators and use the dashboard to facilitate discussions with healthcare workers.
This ancillary study, MedAL-mentor, aims to assess whether this real-time mentoring tool based on data generated by a clinical decision support algorithm, as well as feedback from the mentoring team, improves healthcare workers' compliance with guidelines - and therefore the quality of care for sick children at primary care level.
More specifically, the study objectives are :
Primary objective :
To determine whether the provision of medAL-mentor, a digital mentoring tool, decreases antibiotic prescription by primary care clinicians using a clinical decision support algorithm (ePOCT+) for the management of sick children
Secondary objectives are :
- To assess the impact of medAL-mentor on clinicians' uptake of ePOCT+
- To assess the impact of medal-mentor on clinicians in terms of :
- Performance of key measurements and assessment of signs by clinicians
- Compliance with the recommendations related to point-of-care tests (for malaria and haemoglobin)
This open-label, parallel cluster randomized controlled study is embedded in the second phase of the DYNAMIC project in Tanzania. The intervention consists of providing direct access to medAL-mentor to the healthcare workers. The mentoring team will target calls and monitoring visits to health facilities based on medAL-mentor indicators and use the dashboard to facilitate discussions with healthcare workers during the monitoring visits. Since the intervention takes place at the healthcare worker level and their practices are influenced by the context of the health facility they are working in, randomization at the health facility level rather than at the health worker level was chosen.
40 health facilities using ePOCT+ for the first time during the second phase of the DYNAMIC project will be randomly selected and assigned to two groups (randomization 1:1, intervention: control). Health workers in health facilities randomized to the intervention group will receive feedback on their performance through direct access to medAL-mentor and regular mobile messages, as well as targeted phone calls and visits by the monitoring team based on the medAL-mentor dashboard. Health facilities from the control group will receive standard monitoring (regular messages to check for any issues and regular site visits), without access to medAL-mentor (neither for the health workers nor for the monitoring team).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study involves two arms: intervention and control. Health facilities will serve as clusters, with half of the facilities (20) receiving the intervention and the other half serving as controls (20). Health facilities will be randomized to their respective study arm. A parallel design (all health facilities start at the same time) will be used.
| Arm | Type | Receives |
|---|---|---|
| MedAL-mentor | Experimental | Device: MedAL-mentorIn health facilities allocated to the medAL-mentor arm, the intervention will consist in : * Providing tablets with ePOCT+ and initial training for use by healthcare workers * Access to medAL-mentor for healthcare workers and the monitoring team * Regular (at least every 2 weeks) supportive messages sent by the monitoring team to healthcare workers providing feedback from medAL-mentor * Targeted phone calls and health facilities visits by the monitoring team based on medAL-mentor review Monitoring will be performed by the study team. |
| Routine mentoring | No intervention | –In health facilities allocated to the control arm, tablets with ePOCT+ will also be provided to healthcare workers with initial training, but subsequent mentoring will be conducted routinely: * No access to medAL-mentor for healthcare workers or the monitoring team * At least one message sent by the monitoring team to healthcare workers every two weeks, to inquire about any issues and trigger a site visit if needed * At least one visit from the monitoring team in each health facility every two months Monitoring will be performed by the study team. |
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Presenting for an acute medical or surgical condition
Key exclusion criteria (2 listed)
- Presenting for scheduled consultation for a chronic disease (e.g. HIV, tuberculosis, non-communicable diseases, malnutrition)
- Presenting for routine preventive care (e.g. growth monitoring, vitamin supplementation, deworming, vaccination)
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 |
|---|---|---|
| MedAL-mentorMedAL-mentor is a near real-time monitoring and benchmarking dashboard based on data collected through ePOCT+, providing direct feedback on several clinical indicators (antibiotic prescription, performance of key measurements, signs, and diagnostic tests). | Device | MedAL-mentor |
Primary outcome
Percentage of children prescribed an antibiotic in the intervention group (medAL-mentor) as compared to the control group (routine mentoring)
Time frame: Day 0 (by the end of the consultation)
Number of children for whom at least one systemic (oral or parenteral) antibiotic has been prescribed during consultation, over all eligible children, as reported by the healthcare workers in a routine registry
3 secondary outcomes
Percentage of consultations with eligible children performed using ePOCT+
Time frame: Day 0 (by the end of the consultation)
Percentage of children in whom key signs have been checked by healthcare workers
Time frame: Day 0 (by the end of the consultation)
Percentage of children for whom appropriate diagnostic tests have been performed by healthcare workers
Time frame: Day 0 (by the end of the consultation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 16787472Ellis J. All inclusive benchmarking. J Nurs Manag. 2006 Jul;14(5):377-83. doi: 10.1111/j.1365-2934.2006.00596.x.
- Background: PubMed 26770800Thonon F, Watson J, Saghatchian M. Benchmarking facilities providing care: An international overview of initiatives. SAGE Open Med. 2015 Sep 23;3:2050312115601692. doi: 10.1177/2050312115601692. eCollection 2015.
- Background: PubMed 17173212Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, Huskins WC, Paterson DL, Fishman NO, Carpenter CF, Brennan PJ, Billeter M, Hooton TM; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.
- Background: PubMed 35109824Willmington C, Belardi P, Murante AM, Vainieri M. The contribution of benchmarking to quality improvement in healthcare. A systematic literature review. BMC Health Serv Res. 2022 Feb 2;22(1):139. doi: 10.1186/s12913-022-07467-8.
- Background: PubMed 33184661Piccoliori G, Mahlknecht A, Abuzahra ME, Engl A, Breitenberger V, Vogele A, Montalbano C, Sonnichsen A. Quality improvement in chronic care by self-audit, benchmarking and networking in general practices in South Tyrol, Italy: results from an interventional study. Fam Pract. 2021 Jun 17;38(3):253-258. doi: 10.1093/fampra/cmaa123.
- Background: PubMed 23846810Hermans MP, Elisaf M, Michel G, Muls E, Nobels F, Vandenberghe H, Brotons C; OPTIMISE International Steering Committee. Benchmarking is associated with improved quality of care in type 2 diabetes: the OPTIMISE randomized, controlled trial. Diabetes Care. 2013 Nov;36(11):3388-95. doi: 10.2337/dc12-1853. Epub 2013 Jul 11.
- Background: PubMed 26864410Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
- Dynamic study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Primary Health Care for Children
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
Not yet recruiting
Evaluating Care Integration Between Pediatric Primary Care Providers and WIC Nutritionists
Weight Gain Trajectory, BMI
Not yet recruiting
AI-Assisted Versus Independent Heart Sound Screening for Congenital Heart Disease in Children
Congenital Heart Disease (CHD), Artifical Intelligence
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.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedAL-mentor in people with Primary Health Care for Children, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 40 sites in Tanzania.
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 2 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: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Tanzania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children prescribed an antibiotic in the intervention group (medAL-mentor) as compared to the control group (routine mentoring) (time frame: Day 0 (by the end of the consultation)). 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 NCT05901155, which also lists 7 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 17 Jan 2024.