Patient CareBHOMANCT01942278
Better Health Outcomes Through Mentoring and Assessment (BHOMA)
A study testing BHOMA in people with Patient Care, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial summary
BHOMA Interventions The purpose of this study is to assess the impact of the BHOMA intervention on health in 3 rural districts of Zambia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Care
- What is being tested?
- BHOMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207,517 participants
- Where
- 1 siteZambia
- Study dates
- Jan 2011to Aug 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Intervention Sites The intervention will involve all of the health facilities in the Chongwe, Kafue and Luangwa districts.
- Exclusion Criteria Hospitals will be excluded from the intervention as they do not have discrete catchment populations. The intervention will be implemented by 6 teams each of which will use 1 facility as a pilot site to test out the intervention. The pilot sites will be excluded from the evaluation. Health facilities with catchment populations exclusively serving the armed forces will be excluded.
- All enumerated adults who are able to give written, informed consent. If an adult is illiterate they may be asked to give consent providing the information is read to them and it is established that they fully understand its contents and there is a witness available to witness the understanding of the information and the fingerprinting of the consent form.
- All adolescents 10-17 years and children 5 years or less who have a parent or responsible guardian who is able to give written, informed consent. If the parent or guardian is illiterate they may be asked to give consent providing the information is read to them and it is established that they fully understand its contents and there is a witness available to witness the understanding of the information and the fingerprinting of the consent form.
Who cannot join
- Any adult who is unable to give informed consent due to mental or other disability
- Any adolescent or child who has no responsible parent or guardian
- Any household member who has been absent from the house for more than 72 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CIDRZ 1229- Better Health Outcomes Through Mentoring and Assessment (BHOMA)
BHOMA Interventions
The purpose of this study is to assess the impact of the BHOMA intervention on health in 3 rural districts of Zambia.
Read the detailed description
The BHOMA study includes systematic program implementation designed to contribute to generalizable knowledge and evaluation of this program. The program aims to improve primary health care through an integrated package of interventions, at both health facility and community level, centered on improving the patient -provider interface which is considered to be key to improving health outcomes. The primary objective of this research is to assess the impact of the BHOMA intervention on health in three rural districts of Zambia.
Objectives include: to understand the causal pathways of the BHOMA interventions by analyzing inputs, processes, outputs, and outcomes; to measure the cost of the BHOMA interventions; and to measure whether the health system has been strengthened by the BHOMA interventions. The endpoints of the study will be measured by a combination of facility surveys, facility health worker and community health worker interviews, quality assessments, qualitative studies and community surveys.
The study involves 7 stepped introduction of the programme in 48 facilities. A step typically involves initiation of a set of selected health facilities and the communities they serve. On average, 6 randomly selected sites are involved in a step. Facility workers are trained; community health workers, clinic support worker and traditional birth attendants are identified and trained through a month-long Ministry of Health (MOH) approved course. Equipment for data collection and electronic capture are set up, filing systems established and the study begins when the tools get implemented. Close supervision is provided for at least a month following initiation; there after regular supervisory visits are done by six quality improvement teams.
Clinic Intervention, implemented by the Centre for Infectious Disease Research in Zambia (CIDRZ) BHOMA program:
The clinic intervention consists of the following 5 components: 1) the implementation of clinical care forms and accompanying job aids, 2) resources, to includes equipment, supplies, staffing and infrastructure, 3) clinic implementation, which involves a quality improvement team working at the clinic to introduce the new patient flow system and to improve the skills of clinic staff, 4) the use of electronic information for performance assessment, which involves implementing an electronic data entry system within the clinics and 5) supportive mentoring, which will involve the Quality Improvement (QI) team reviewing patient charts for appropriate screening, diagnostics, treatment or follow-up, attending patient visits, identifying equipment or infrastructure issues, and reviewing clinic performance reports and updating the clinic's quality improvement strategy.
Community Intervention, implemented by the CIDRZ BHOMA program:
The community intervention aims to expand the availability of community-based health services and improve the quality of these services with the use of three groups:
Community Health Workers:
The investigators will engage one community health worker (CHW) per Neighborhood Health Committee to conduct patient follow-up and household assessments. The CHWs will use two forms - patient follow-up form and a household assessment form, and will be trained to assess which patients need referral to the clinic or hospital.
Traditional Birth Attendants:
The investigators will offer training for traditional birth attendants (TBAs) working near the implementation clinics. The training will review the goals of facility delivery and introduce a pregnancy referral form for TBAs. The investigators will encourage the TBA to help the patient arrive at the clinic, and provide incentives for the TBAs for clinic referrals. The investigators will also train the TBAs to follow up all pregnancies in the first month to assess the infant and teach the mother about when it is appropriate to bring the infant to the clinic. TBAs will complete infant follow-up forms.
Neighborhood Heath Committees (NHC):
These committees will complete a community health event register, during which they will capture information about serious sicknesses and deaths that are not recorded at the clinics. Each NHC will visit households and return their register to the clinic.
These activities will continue throughout the duration of the funded project.
- Conditions
- Patient Care
- Being tested
- BHOMA
- Keywords
- Healthcare, Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHOMAOther
A complex health systems, clinical care, and community intervention to improve outcomes
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Care is delivered according to baseline standard practice |
| BHOMA | Experimental | Care is delivered according to the BHOMA intervention Receives: Other: BHOMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age standardized mortality rates in those aged <60 years.
The sample size is based on a mortality rate for those aged<60 years of 20/1000 person years, each of 3 cross sectional surveys recruits 150 households of whom 6 members are aged <60 years, and births and deaths within the household in the last 12 months are ascertained. For a values of k between 0.2 and 0.3 there is at least 90% power to detect a 35% reduction in mortality, and for k=0.35 there is approximately 87% power.
Measured: 4 years
Secondary outcomes (1)
Mortality in those aged <5 years.
The sample size is based on a mortality rate for those aged<5 years of 35/1000 person years (equivalent to under-5 mortality of 168/1000), each of 3 cross sectional surveys recruits 150 households of whom 2 members are aged <5 years, and births and deaths within the household in the last 12 months are ascertained. For a values of k between 0.2 and 0.3 there is at least 90% power to detect a 35% reduction in mortality, and for k=0.35 there is approximately 84% power.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startJan 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patient CareStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 207,517 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Jeffrey Stringer, MD, Principal investigator, UNC at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942278
- Sponsor's protocol ID
- CIDRZ 1229
- Acronym
- BHOMA
- Status last verified
- Feb 2017
- First submitted
- 10 Sep 2013
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mutale W, Ayles H, Lewis J, Bosompraph S, Chilengi R, Tembo MM, Sharp A, Chintu N, Stringer J. Protocol-driven primary care and community linkage to reduce all-cause mortality in rural Zambia: a stepped-wedge cluster randomized trial. Front Public Health. 2023 Aug 31;11:1214066. doi: 10.3389/fpubh.2023.1214066. eCollection 2023.
PubMed 37727608Mutale W, Cleary S, Olivier J, Chilengi R, Gilson L. Implementing large-scale health system strengthening interventions: experience from the better health outcomes through mentoring and assessments (BHOMA) project in Zambia. BMC Health Serv Res. 2018 Oct 19;18(1):795. doi: 10.1186/s12913-018-3619-3.
PubMed 30340583Mwanza M, Zulu J, Topp SM, Musonda P, Mutale W, Chilengi R. Use of Lot quality assurance sampling surveys to evaluate community health worker performance in rural Zambia: a case of Luangwa district. BMC Health Serv Res. 2017 Apr 17;17(1):279. doi: 10.1186/s12913-017-2229-9.
PubMed 28416009Yan LD, Chirwa C, Chi BH, Bosomprah S, Sindano N, Mwanza M, Musatwe D, Mulenga M, Chilengi R. Hypertension management in rural primary care facilities in Zambia: a mixed methods study. BMC Health Serv Res. 2017 Feb 3;17(1):111. doi: 10.1186/s12913-017-2063-0.
PubMed 28158981Mutale W, Stringer J, Chintu N, Chilengi R, Mwanamwenge MT, Kasese N, Balabanova D, Spicer N, Lewis J, Ayles H. Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia. PLoS One. 2014 Apr 21;9(4):e93977. doi: 10.1371/journal.pone.0093977. eCollection 2014.
PubMed 24751780
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIDRZ 1229- Better Health Outcomes Through Mentoring and Assessment (BHOMA)
- ClinicalTrials.gov ID
- NCT01942278
- Acronym / sponsor ID
- BHOMA / CIDRZ 1229
- Conditions
- Patient Care
- Keywords
- Healthcare, Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207,517 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- Jan 2011 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Sep 2013 (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.
BHOMA Interventions
The purpose of this study is to assess the impact of the BHOMA intervention on health in 3 rural districts of Zambia.
Detailed description
The BHOMA study includes systematic program implementation designed to contribute to generalizable knowledge and evaluation of this program. The program aims to improve primary health care through an integrated package of interventions, at both health facility and community level, centered on improving the patient -provider interface which is considered to be key to improving health outcomes. The primary objective of this research is to assess the impact of the BHOMA intervention on health in three rural districts of Zambia.
Objectives include: to understand the causal pathways of the BHOMA interventions by analyzing inputs, processes, outputs, and outcomes; to measure the cost of the BHOMA interventions; and to measure whether the health system has been strengthened by the BHOMA interventions. The endpoints of the study will be measured by a combination of facility surveys, facility health worker and community health worker interviews, quality assessments, qualitative studies and community surveys.
The study involves 7 stepped introduction of the programme in 48 facilities. A step typically involves initiation of a set of selected health facilities and the communities they serve. On average, 6 randomly selected sites are involved in a step. Facility workers are trained; community health workers, clinic support worker and traditional birth attendants are identified and trained through a month-long Ministry of Health (MOH) approved course. Equipment for data collection and electronic capture are set up, filing systems established and the study begins when the tools get implemented. Close supervision is provided for at least a month following initiation; there after regular supervisory visits are done by six quality improvement teams.
Clinic Intervention, implemented by the Centre for Infectious Disease Research in Zambia (CIDRZ) BHOMA program:
The clinic intervention consists of the following 5 components: 1) the implementation of clinical care forms and accompanying job aids, 2) resources, to includes equipment, supplies, staffing and infrastructure, 3) clinic implementation, which involves a quality improvement team working at the clinic to introduce the new patient flow system and to improve the skills of clinic staff, 4) the use of electronic information for performance assessment, which involves implementing an electronic data entry system within the clinics and 5) supportive mentoring, which will involve the Quality Improvement (QI) team reviewing patient charts for appropriate screening, diagnostics, treatment or follow-up, attending patient visits, identifying equipment or infrastructure issues, and reviewing clinic performance reports and updating the clinic's quality improvement strategy.
Community Intervention, implemented by the CIDRZ BHOMA program:
The community intervention aims to expand the availability of community-based health services and improve the quality of these services with the use of three groups:
Community Health Workers:
The investigators will engage one community health worker (CHW) per Neighborhood Health Committee to conduct patient follow-up and household assessments. The CHWs will use two forms - patient follow-up form and a household assessment form, and will be trained to assess which patients need referral to the clinic or hospital.
Traditional Birth Attendants:
The investigators will offer training for traditional birth attendants (TBAs) working near the implementation clinics. The training will review the goals of facility delivery and introduce a pregnancy referral form for TBAs. The investigators will encourage the TBA to help the patient arrive at the clinic, and provide incentives for the TBAs for clinic referrals. The investigators will also train the TBAs to follow up all pregnancies in the first month to assess the infant and teach the mother about when it is appropriate to bring the infant to the clinic. TBAs will complete infant follow-up forms.
Neighborhood Heath Committees (NHC):
These committees will complete a community health event register, during which they will capture information about serious sicknesses and deaths that are not recorded at the clinics. Each NHC will visit households and return their register to the clinic.
These activities will continue throughout the duration of the funded project.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Care is delivered according to baseline standard practice |
| BHOMA | Experimental | Other: BHOMACare is delivered according to the BHOMA intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Intervention Sites The intervention will involve all of the health facilities in the Chongwe, Kafue and Luangwa districts.
- Exclusion Criteria Hospitals will be excluded from the intervention as they do not have discrete catchment populations. The intervention will be implemented by 6 teams each of which will use 1 facility as a pilot site to test out the intervention. The pilot sites will be excluded from the evaluation. Health facilities with catchment populations exclusively serving the armed forces will be excluded.
- All enumerated adults who are able to give written, informed consent. If an adult is illiterate they may be asked to give consent providing the information is read to them and it is established that they fully understand its contents and there is a witness available to witness the understanding of the information and the fingerprinting of the consent form.
- All adolescents 10-17 years and children 5 years or less who have a parent or responsible guardian who is able to give written, informed consent. If the parent or guardian is illiterate they may be asked to give consent providing the information is read to them and it is established that they fully understand its contents and there is a witness available to witness the understanding of the information and the fingerprinting of the consent form.
Key exclusion criteria (3 listed)
- Any adult who is unable to give informed consent due to mental or other disability
- Any adolescent or child who has no responsible parent or guardian
- Any household member who has been absent from the house for more than 72 hours
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 |
|---|---|---|
| BHOMAA complex health systems, clinical care, and community intervention to improve outcomes | Other | BHOMA |
Primary outcome
Age standardized mortality rates in those aged <60 years.
Time frame: 4 years
The sample size is based on a mortality rate for those aged<60 years of 20/1000 person years, each of 3 cross sectional surveys recruits 150 households of whom 6 members are aged <60 years, and births and deaths within the household in the last 12 months are ascertained. For a values of k between 0.2 and 0.3 there is at least 90% power to detect a 35% reduction in mortality, and for k=0.35 there is approximately 87% power.
1 secondary outcome
Mortality in those aged <5 years.
Time frame: 4 years
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 14 Apr 2017.
- Derived from this study: PubMed 37727608Mutale W, Ayles H, Lewis J, Bosompraph S, Chilengi R, Tembo MM, Sharp A, Chintu N, Stringer J. Protocol-driven primary care and community linkage to reduce all-cause mortality in rural Zambia: a stepped-wedge cluster randomized trial. Front Public Health. 2023 Aug 31;11:1214066. doi: 10.3389/fpubh.2023.1214066. eCollection 2023.
- Derived from this study: PubMed 30340583Mutale W, Cleary S, Olivier J, Chilengi R, Gilson L. Implementing large-scale health system strengthening interventions: experience from the better health outcomes through mentoring and assessments (BHOMA) project in Zambia. BMC Health Serv Res. 2018 Oct 19;18(1):795. doi: 10.1186/s12913-018-3619-3.
- Derived from this study: PubMed 28416009Mwanza M, Zulu J, Topp SM, Musonda P, Mutale W, Chilengi R. Use of Lot quality assurance sampling surveys to evaluate community health worker performance in rural Zambia: a case of Luangwa district. BMC Health Serv Res. 2017 Apr 17;17(1):279. doi: 10.1186/s12913-017-2229-9.
- Derived from this study: PubMed 28158981Yan LD, Chirwa C, Chi BH, Bosomprah S, Sindano N, Mwanza M, Musatwe D, Mulenga M, Chilengi R. Hypertension management in rural primary care facilities in Zambia: a mixed methods study. BMC Health Serv Res. 2017 Feb 3;17(1):111. doi: 10.1186/s12913-017-2063-0.
- Derived from this study: PubMed 24751780Mutale W, Stringer J, Chintu N, Chilengi R, Mwanamwenge MT, Kasese N, Balabanova D, Spicer N, Lewis J, Ayles H. Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia. PLoS One. 2014 Apr 21;9(4):e93977. doi: 10.1371/journal.pone.0093977. eCollection 2014.
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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.
Jeffrey Stringer, MD principal investigator
UNC at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BHOMA in people with Patient Care, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
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 4 inclusion and 3 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 14 Apr 2017. 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 Zambia. 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?
Age standardized mortality rates in those aged <60 years. (time frame: 4 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 NCT01942278, which also lists 5 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 14 Apr 2017.