LeadershipNCT03639961
The Effect of Integrated Leading, Managing and Governing for Result Model Towards Institutional Delivery
A study testing Integrated leading, managing and governing for results model and Traditional model in people with Leadership, run by Bahir Dar University at 1 site in Ethiopia.
Trial summary
The need for leading people, managing work, and governing organizations never changed over the civilization paths of society. However, people in every pole of the globe observe: over-led and under-managed, over-managed and under-governed, and even out of these organizations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leadership
- What is being tested?
- Integrated leading, managing and governing for results model and Traditional model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteEthiopia
- Study dates
- 10 Apr 2018to 30 Oct 2018
- 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
- All staff nominated by the respective districts that have been selected, but not deployed yet, for integrated health system leadership, management and governance for intervention by Amhara regional health office in the study setting have been included.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Integrated Health System Leading, Managing and Governing for Result Model Towards Institutional Delivery Among Staff of Health Facilities in Northwest Ethiopia
The need for leading people, managing work, and governing organizations never changed over the civilization paths of society. However, people in every pole of the globe observe: over-led and under-managed, over-managed and under-governed, and even out of these organizations. These disparities have remained worse in the health system of developing countries like Ethiopia.
To date, Ethiopia put a goal of ending preventable child and maternal death, in achieving universal healthcare by 2035. Nevertheless, the investment on integrated leadership, management and governance is limited.
Therefore, this study hypothesize that institutional delivery are expressively linked with integrated health system leading, managing and governing for results model among health facilities staff in northwest Ethiopia?
Read the detailed description
The investment on integrated health system leading, managing and governing for result model narrow down health system gaps.
The need to integrate these three distinct, but not hostile paths is that mostly: leading is people oriented process, managing is task oriented process and governing is organization oriented path.
Moreover, these paths are reflected even in a single person, task, or organization. Thus, testing and implementing integrated model is cost effective.
- Conditions
- Leadership
- Being tested
- Integrated leading, managing and governing for results model, Traditional model
- Keywords
- Integrated, leading, managing, governing, practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated leading, managing and governing for results modelBehavioural
Integrated leading, managing and governing for results model is an intervention launched to improve institutional delivery.
Traditional modelBehavioural
Traditional model is a health service delivery model already in place in the government health system.
| Study group | Role | What they receive |
|---|---|---|
| Staff of facilities for intervention | Experimental | Intervention: Participants have been trained two times in six months period with integrated leading, managing and governing for results model. Receives: Behavioral: Integrated leading, managing and governing for results model |
| Staff of facilities for control | Active comparator | Intervention: Participants have been trained two times in six months period with traditional model. Receives: Behavioral: Traditional model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Institutional delivery
Increased institutional delivery. These have been assessed by institutional delivery follow up checklist. To declare that integrated leading, managing and governing for result model has an effect on institutional delivery improvement, on which it could be increased at least by 15%.
Measured: Up to six months
Secondary outcomes (1)
Habit of institutional delivery
Improvement on habit of institutional delivery has been explored from key informants, by key informant guideline. The explored data will be analyzed thematically, using the Qualitative Data Analysis (QDA) miner 4 software.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start10 Apr 2018
- Primary completion30 Apr 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeadershipStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The integrated health system leading, managing and governing for results model is constructed from: leading practices, managing practice, and governing practices; moderating factors ; health services performance, and sustainable health outcomes and impact aligned with national health goals and Sustainable Development Goals (SDGs).
- Masking
- None (open label)
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahir Dar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeshambel Agumas Ambelie, Bahir Dar University
- Investigators
- G D Alene, PhD, Study director, Bahir Dar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639961
- Sponsor's protocol ID
- 090/18-04
- Status last verified
- Jun 2019
- First submitted
- 9 Jul 2018
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared up on the intervention study report has been published.
Publications
Silva JAM, Mininel VA, Fernandes Agreli H, Peduzzi M, Harrison R, Xyrichis A. Collective leadership to improve professional practice, healthcare outcomes and staff well-being. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD013850. doi: 10.1002/14651858.CD013850.pub2.
PubMed 36214207
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Integrated Health System Leading, Managing and Governing for Result Model Towards Institutional Delivery Among Staff of Health Facilities in Northwest Ethiopia
- ClinicalTrials.gov ID
- NCT03639961
- Acronym / sponsor ID
- 090/18-04
- Conditions
- Leadership
- Keywords
- Integrated, leading, managing, governing, practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Bahir Dar UniversityUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 21 Aug 2018 (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 need for leading people, managing work, and governing organizations never changed over the civilization paths of society. However, people in every pole of the globe observe: over-led and under-managed, over-managed and under-governed, and even out of these organizations. These disparities have remained worse in the health system of developing countries like Ethiopia.
To date, Ethiopia put a goal of ending preventable child and maternal death, in achieving universal healthcare by 2035. Nevertheless, the investment on integrated leadership, management and governance is limited.
Therefore, this study hypothesize that institutional delivery are expressively linked with integrated health system leading, managing and governing for results model among health facilities staff in northwest Ethiopia?
Detailed description
The investment on integrated health system leading, managing and governing for result model narrow down health system gaps.
The need to integrate these three distinct, but not hostile paths is that mostly: leading is people oriented process, managing is task oriented process and governing is organization oriented path.
Moreover, these paths are reflected even in a single person, task, or organization. Thus, testing and implementing integrated model is cost effective.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The integrated health system leading, managing and governing for results model is constructed from: leading practices, managing practice, and governing practices; moderating factors ; health services performance, and sustainable health outcomes and impact aligned with national health goals and Sustainable Development Goals (SDGs).
| Arm | Type | Receives |
|---|---|---|
| Staff of facilities for intervention | Experimental | Behavioral: Integrated leading, managing and governing for results modelIntervention: Participants have been trained two times in six months period with integrated leading, managing and governing for results model. |
| Staff of facilities for control | Active comparator | Behavioral: Traditional modelIntervention: Participants have been trained two times in six months period with traditional model. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All staff nominated by the respective districts that have been selected, but not deployed yet, for integrated health system leadership, management and governance for intervention by Amhara regional health office in the study setting have been included.
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Integrated leading, managing and governing for results modelIntegrated leading, managing and governing for results model is an intervention launched to improve institutional delivery. | Behavioural | Staff of facilities for intervention |
| Traditional modelTraditional model is a health service delivery model already in place in the government health system. | Behavioural | Staff of facilities for control |
Primary outcome
Institutional delivery
Time frame: Up to six months
Increased institutional delivery. These have been assessed by institutional delivery follow up checklist. To declare that integrated leading, managing and governing for result model has an effect on institutional delivery improvement, on which it could be increased at least by 15%.
1 secondary outcome
Habit of institutional delivery
Time frame: two weeks
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 6 Jun 2019.
- Derived from this study: PubMed 36214207Silva JAM, Mininel VA, Fernandes Agreli H, Peduzzi M, Harrison R, Xyrichis A. Collective leadership to improve professional practice, healthcare outcomes and staff well-being. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD013850. doi: 10.1002/14651858.CD013850.pub2.
- Individual participant dataSharing planned: Yes. The IPD will be shared up on the intervention study report has been published.
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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.
G D Alene, PhD study director
Bahir Dar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated leading, managing and governing for results model and Traditional model in people with Leadership, run by Bahir Dar University at 1 site in Ethiopia.
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: finished, as of the sponsor's last update on 6 Jun 2019. 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 Ethiopia. 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?
Institutional delivery (time frame: Up to six months). 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 NCT03639961, which also lists 1 linked publication.
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 6 Jun 2019.