General Surgery, Costs and Cost AnalysisNCT03604458
Evaluating the Impact of the National Health Insurance Scheme of Ghana on Surgical Care
An observational study of General Surgery, Costs and Cost Analysis, run by University of California, San Francisco at 1 site in Ghana.
Trial summary
Ghana, a Low-Middle Income Country (LMIC) situated in the heart of West Africa started a national health insurance scheme in 2003.The scheme was designed to provide a comprehensive benefit package inclusive of surgical care and to protect against the need to pay out of pocket at the point of service. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Surgery, Costs and Cost Analysis
- How many people
- 203 participants
- Where
- 1 siteGhana
- Study dates
- 1 Feb 2017to 12 Nov 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was conducted in the Korle Bu teaching hospital, which is situated in the southwestern part of Accra, the capital of Ghana. The hospital receives and treats patients referred from other centers all over Ghana and also patients referred from other neighboring West African countries. The population of Accra, which is largely cosmopolitan, has inhabitants who are natives and a large population who have migrated from other parts of the country on account of economic reason as well as educational pursuit. It is also home to a significant population who are nationals of neighboring West African countries and a small proportion of the population being from Europe, Asia and North America. Inhabitants are therefore mostly urban or suburban with a small proportion of rural and slum dwellers. The Department of Surgery at the Korle Bu hospital has four general surgical units and sees a variety of cases in general surgery encompasses colorectal, hepatobilary, and oncology
Who may be able to join
- All adult patients admitted to the general surgery ward between February 1st and October 1st 2017.
Who cannot join
- Patients treated on the subspecialty wards
- Individuals less than 18 years of age.
- If unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of Health Insurance on Financial Risk Protection for Surgical Care: an Analysis of Ghana' Insurance Scheme at Korlebu Teaching Hospital
Ghana, a Low-Middle Income Country (LMIC) situated in the heart of West Africa started a national health insurance scheme in 2003.The scheme was designed to provide a comprehensive benefit package inclusive of surgical care and to protect against the need to pay out of pocket at the point of service. As of 2013, close to 40% of the population of Ghana was actively enrolled and ongoing plans to expand coverage by the government. This study tests the extent to which the national health insurance scheme of Ghana provides financial risk protection against catastrophic payments as a result of access to surgical care.
Read the detailed description
It is estimated that 11%-33% of the global burden of disease is attribute to surgical conditions. Yet, globally 3.7 billion people face financial catastrophe if surgical care is needed. Ghana, a country of 27 million people has a 14-year experience with a national health insurance scheme (NHIS) that provides coverage for 95% of the health conditions afflicting Ghanaians and includes access to surgical care. Despite much progress in providing Universal Health Coverage through NHIS, prior work shows that up to 18% of insured households make catastrophic health payments for routine care which is largely unaffordable for the poor. Particularly in Ghana where 1 out of 4 individuals live on less than 1.25 dollars per day. More importantly in 2015, the Lancet Commission on Global Surgery called for national surgical plans that provide 100% coverage against catastrophic health expenditures as a result of seeking surgical care.
The premise of Dr. Okoroh's GloCal project is to describe the surgical conditions that are included in the health insurance scheme and to evaluate whether insurance protect surgical patients against catastrophic health payments through a single institutional review at Korle-bu Teaching Hospital. With this work she hopes to develop a set of recommendations to the ministry of health and the national health insurance authority on how to improve health-care financing for surgical care in Ghana.
Early results of our study show that NHIS provides coverage for most common surgical conditions including symptomatic hernia, breast cancer, and appendicitis. 70% of the total cost of surgical care was covered by NHIS, yet 56% of insured individuals made catastrophic payments for surgical care. Surgery is unaffordable as on average insured individuals spent close to 40% of their annual income on surgical care. Particularly the coverage of medicines, supplies, imaging, and other ancillary services are sparse which are necessary to the provision of surgical care. Our recommendations include; NHIS increasing the proportion of the total cost of surgical care covered for the poor and addressing the gaps in coverage of ancillary services. Further work includes understanding how households economically cope with making payments and the contribution of borrowing and other financing mechanisms in reducing the burden of cost. Our new study characterizes the cost of trauma care which is a major source of disability and injury for young adults in Ghana. Efforts are being made to engage policymakers on healthcare reform in Ghana.
- Conditions
- General Surgery, Costs and Cost Analysis
- Keywords
- Universal Health Coverage, Surgery in resource limited settings
What is being measured
The primary outcome is the main question the study is designed to answer.
Out of Pocket Expenditure for Surgical Care
Out of pocket expenditure for surgical care is defined as all of the direct and indirect expenses incurred by an individual seeking surgical care at Korlebu Teaching Hospital during the study time period.
Measured: During the hospitalization or episode of surgical care (respondents are interviewed prior to discharge from the hospital, on average less than two weeks)
Secondary outcomes (1)
Catastrophic Health Expenditure for Surgical Care
Catastrophic Health Expenditure for Surgical Care is defined as out of pocket expenditures which exceed 20% of the individual's income, 10% of the household expenditures, or 40% of net food expenditures
Measured: During the hospitalization or episode of surgical care (respondents are interviewed prior to discharge from the hospital, on average less than two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Feb 2017
- Primary completion1 Oct 2017
- Study completion12 Nov 2017
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 General Surgery, Costs and Cost AnalysisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Research on Women's Health (ORWH), Fogarty International Center of the National Institute of Health, University of California Global Health Institute - UCGloCal Program, Brigham and Womens' Hospital, Center for Surgery and Public Health, UC Global Health Institute
- Responsible party
- Sponsor
- Investigators
- Juliet Okoroh, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604458
- Sponsor's protocol ID
- D43TW009343
- Other IDs
- D43TW009343
- Status last verified
- Jul 2018
- First submitted
- 26 Jun 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okoroh J, Sarpong DO, Essoun S, Riviello R, Harris H, Weissman JS. Does insurance protect individuals from catastrophic payments for surgical care? An analysis of Ghana's National Health Insurance Scheme at Korle-Bu teaching Hospital. BMC Health Serv Res. 2020 Jan 17;20(1):45. doi: 10.1186/s12913-020-4887-2.
PubMed 31952520
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Health Insurance on Financial Risk Protection for Surgical Care: an Analysis of Ghana' Insurance Scheme at Korlebu Teaching Hospital
- ClinicalTrials.gov ID
- NCT03604458
- Acronym / sponsor ID
- D43TW009343
- Conditions
- General Surgery, Costs and Cost Analysis
- Keywords
- Universal Health Coverage, Surgery in resource limited settings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Office of Research on Women's Health (ORWH), Fogarty International Center of the National Institute of Health, University of California Global Health Institute - UCGloCal Program, Brigham and Womens' Hospital, Center for Surgery and Public Health, UC Global Health Institute
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 12 Nov 2017 (actual)
- First posted
- 27 Jul 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.
Ghana, a Low-Middle Income Country (LMIC) situated in the heart of West Africa started a national health insurance scheme in 2003.The scheme was designed to provide a comprehensive benefit package inclusive of surgical care and to protect against the need to pay out of pocket at the point of service. As of 2013, close to 40% of the population of Ghana was actively enrolled and ongoing plans to expand coverage by the government. This study tests the extent to which the national health insurance scheme of Ghana provides financial risk protection against catastrophic payments as a result of access to surgical care.
Detailed description
It is estimated that 11%-33% of the global burden of disease is attribute to surgical conditions. Yet, globally 3.7 billion people face financial catastrophe if surgical care is needed. Ghana, a country of 27 million people has a 14-year experience with a national health insurance scheme (NHIS) that provides coverage for 95% of the health conditions afflicting Ghanaians and includes access to surgical care. Despite much progress in providing Universal Health Coverage through NHIS, prior work shows that up to 18% of insured households make catastrophic health payments for routine care which is largely unaffordable for the poor. Particularly in Ghana where 1 out of 4 individuals live on less than 1.25 dollars per day. More importantly in 2015, the Lancet Commission on Global Surgery called for national surgical plans that provide 100% coverage against catastrophic health expenditures as a result of seeking surgical care.
The premise of Dr. Okoroh's GloCal project is to describe the surgical conditions that are included in the health insurance scheme and to evaluate whether insurance protect surgical patients against catastrophic health payments through a single institutional review at Korle-bu Teaching Hospital. With this work she hopes to develop a set of recommendations to the ministry of health and the national health insurance authority on how to improve health-care financing for surgical care in Ghana.
Early results of our study show that NHIS provides coverage for most common surgical conditions including symptomatic hernia, breast cancer, and appendicitis. 70% of the total cost of surgical care was covered by NHIS, yet 56% of insured individuals made catastrophic payments for surgical care. Surgery is unaffordable as on average insured individuals spent close to 40% of their annual income on surgical care. Particularly the coverage of medicines, supplies, imaging, and other ancillary services are sparse which are necessary to the provision of surgical care. Our recommendations include; NHIS increasing the proportion of the total cost of surgical care covered for the poor and addressing the gaps in coverage of ancillary services. Further work includes understanding how households economically cope with making payments and the contribution of borrowing and other financing mechanisms in reducing the burden of cost. Our new study characterizes the cost of trauma care which is a major source of disability and injury for young adults in Ghana. Efforts are being made to engage policymakers on healthcare reform in Ghana.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted in the Korle Bu teaching hospital, which is situated in the southwestern part of Accra, the capital of Ghana. The hospital receives and treats patients referred from other centers all over Ghana and also patients referred from other neighboring West African countries. The population of Accra, which is largely cosmopolitan, has inhabitants who are natives and a large population who have migrated from other parts of the country on account of economic reason as well as educational pursuit. It is also home to a significant population who are nationals of neighboring West African countries and a small proportion of the population being from Europe, Asia and North America. Inhabitants are therefore mostly urban or suburban with a small proportion of rural and slum dwellers. The Department of Surgery at the Korle Bu hospital has four general surgical units and sees a variety of cases in general surgery encompasses colorectal, hepatobilary, and oncology
Key inclusion criteria (1 listed)
- All adult patients admitted to the general surgery ward between February 1st and October 1st 2017.
Key exclusion criteria (3 listed)
- Patients treated on the subspecialty wards
- Individuals less than 18 years of age.
- If unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Out of Pocket Expenditure for Surgical Care
Time frame: During the hospitalization or episode of surgical care (respondents are interviewed prior to discharge from the hospital, on average less than two weeks)
Out of pocket expenditure for surgical care is defined as all of the direct and indirect expenses incurred by an individual seeking surgical care at Korlebu Teaching Hospital during the study time period.
1 secondary outcome
Catastrophic Health Expenditure for Surgical Care
Time frame: During the hospitalization or episode of surgical care (respondents are interviewed prior to discharge from the hospital, on average less than 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 27 Jul 2018.
- Derived from this study: PubMed 31952520Okoroh J, Sarpong DO, Essoun S, Riviello R, Harris H, Weissman JS. Does insurance protect individuals from catastrophic payments for surgical care? An analysis of Ghana's National Health Insurance Scheme at Korle-Bu teaching Hospital. BMC Health Serv Res. 2020 Jan 17;20(1):45. doi: 10.1186/s12913-020-4887-2.
- Individual participant dataSharing planned: No
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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.
Juliet Okoroh, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Surgery, Costs and Cost Analysis, run by University of California, San Francisco at 1 site in Ghana.
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 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 27 Jul 2018. 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 Ghana. 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?
Out of Pocket Expenditure for Surgical Care (time frame: During the hospitalization or episode of surgical care (respondents are interviewed prior to discharge from the hospital, on average less than two weeks)). 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 NCT03604458, 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 27 Jul 2018.