A Trial of Improved Financial Access to Healthcare in Ghana
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Effective control strategies for malaria depend both on preventing disease and on treating
      those who become infected to prevent significant morbidity and mortality. There are many
      barriers to preventing access to prompt and effective treatment, some of which are amenable
      to intervention, others (such as distance to healthcare) less so. This study will concentrate
      on modifiable financial barriers to care.

      With the aim of increasing health service utilization and reducing morbidity and mortality
      among children under five, some governments are currently implementing policies aimed at
      reducing financial barriers to health care. There is at the same time an on-going debate
      concerning the relative importance of cost as a barrier to health care. Though theoretically
      the aim for reducing these barriers should be achieved, its actual impact has not been
      directly assessed or demonstrated by means of an intervention trial.

      This study aims to determine by means of a randomized trial the impact of reducing such
      barriers on morbidity due to severe malaria among children 6 months to five years and on
      outpatient utilization. An existing pre-payment scheme in the study area will be utilized to
      improve financial access for half of 2500 households who have not registered for either year
      I or II. The impact on severe anaemia, mean haemoglobin and anthropometric measurements will
      be assessed. Health service utilisation rates will be measured in both groups by active and
      passive surveillance. Patient perceptions and health-seeking behaviour will be compared. The
      study will contribute to the current debate on the relative importance of cost of care as a
      barrier to health care and the potential for the removal of this barrier as a strategy for
      malaria control, and on methods to optimise this.
    

Detailed description: 
      Objectives

      General:

      To assess by means of a randomized trial, the impact of improving financial access to primary
      health care on morbidity due to severe malaria and utilization of health services among
      children six months to five years of age.

      Specifically:

        1. To compare rates of severe anaemia in children under five years of age from households
           randomized to those with improved financial access and those without for the first year.

        2. To compare the number of admissions to hospital with malaria among children under five
           years of age from households with improved access and households without.

        3. To compare the health service utilization rate among children under five years of age
           from households with improved access and households without.

        4. To compare the reported median period between the onset of febrile (presumed malaria)
           illness and reporting at health facilities among children under five years of age from
           households with improved access and households without.

        5. To document community knowledge, attitude and practice with regards to severe malaria
           user fees, exemptions pre-payment schemes and indicators of poverty.

      Study design and methods

      Study Design:

      The proposed study is a two-arm randomized controlled trial to assess the impact of improved
      financial access to primary health care on morbidity due to severe malaria and utilization of
      services among children 6 months to 5 years. It will have a quantitative element based on
      pre-determined outcomes as well as a qualitative element.

      Intervention The intervention group will be enrolled into a pre-payment scheme operating in
      the area which will allow them free access to primary care including diagnosis and drugs
      whenever they are ill with no limit, and limited access to secondary health care.

      The control group will have to pay user fees for their health care as pertains normally.

      Recruitment and Enrolment Procedures:

      Study participants will be selected using the process outlined in the trial profile in the
      annexe. The actual study participants will be children between 6 months and five years of age
      in the households selected.

      Inclusion Criteria:

        -  Child in household aged between 6 months and 5 years

        -  Informed consent from parents

        -  Household to which child belongs resident in the Dodowa sub-district and intending to
           remain resident until the end of the next two years

      Exclusion Criteria

        -  Parents refuse to participate in the study

        -  Household due to emigrate from study area within two years

        -  Household currently enrolled

      Randomization Procedure A stratified randomization procedure will be used. Households will be
      divided into three strata based on residence being ≤5km, 5-10km, and >10km from the health
      centre respectively since distance from health facility is known to be a major determinant to
      its use and may not be adequately taken care of with simple random allocation. Allocation of
      the intervention will be carried out separately within each stratum.

      Household heads within each stratum will be invited to meetings at which random numbers will
      be allocated to each household. The numbers on raffle tickets will then be dropped into a
      rotating barrel and mixed up thoroughly in the view of all after which the barrel will be
      rotated. A child will be invited to pick the papers which will be allocated to intervention
      or control as they are drawn, alternately. Those in the intervention group will have
      pre-payment made for year one; the others will have it in year 2. After each draw the barrel
      will be rotated once more. This process will be used to make the trial more acceptable to
      community members by showing them the lack of favouritism and randomness of the allocation
      (Adapted from [43]. Since registration would have closed for the year, households will not be
      able to change their group until the study ends.

      Outcome Measures

      Primary:

      • Prevalence of severe anaemia among children under five years of age in both groups after
      one peak malaria transmission season.

      Secondary

        -  Mean haemoglobin count among the two groups at study end

        -  Number of admissions to hospital with malaria among children under five years of age in
           both groups

        -  Average number of visits to per child under five years to primary care facility among
           both groups

        -  Anthropometric measurements of children in the two groups

        -  All cause mortality in both groups

      All households in the Dodowa sub-district with at least one child 6 months to 5 years who do
      not register in the pre-payment scheme for the year will be eligible to participate in the
      study. The information will be obtained from the data base of households at the DHIMT
      offices. This sub-district, which is mainly forest with an estimated 2003 midyear population
      of 30,154, has been selected because earlier studies have shown that it has the highest
      incidence of malaria in the district. Household heads or their representatives will be
      invited to either of three locality meetings based on distance from the health facility,
      where the study will be explained to them and consent sought for their participation in the
      study. Those agreeing to participate will have their particulars recorded and enrolled into
      the study. They will then be randomized into two groups using the procedure already
      described. Baseline data collection including haematological, anthropometric assessments and
      interviews will then be carried out on all participants and slides for parasites in a random
      subset. Background variables about the household including known risk factors for malaria
      such as type of housing, use of insecticide treated materials, use of other preventive
      measures and some indicators of household wealth will be documented. Children found to have
      haemoglobin count less than 6g/dl, fever or a history of fever and patent parasitaemia will
      be treated according to local guidelines; this will not be a reason for withdrawal from the
      study.

      Differences between those who voluntarily registered in the pre-payment scheme and those who
      did not, in terms of health service utilization, health status, household wealth and other
      variables will be documented as a subsidiary part of the study.

      Follow-Up:

      Morbidity monitoring will be carried out through a hospital/clinic based passive case
      detection system throughout the malaria transmission season from May to October. This will be
      complemented by one cross-sectional household survey at the end of the malaria transmission
      season in November during which interviews, haematological, parasitological and
      anthropometric assessments will be repeated. Children found to have severe anemia during the
      second survey will have a haematological work-up comprising Hb electrophoresis, full blood
      count, and stool examination. All study participants who visit the clinic will be treated by
      the health workers as usual in accordance with the current standard treatment guidelines in
      Ghana. In the case of mortality, at a culturally appropriate time, a trained field worker
      will visit the home and a standard questionnaire will be administered to the child's mother
      or caretaker. The results will be reviewed by three independent physicians to arrive at a
      possible diagnosis. If two out of three agree on a diagnosis of malaria, this diagnosis will
      be accepted. For children who visited hospital or died in the hospital, hospital case notes
      will be reviewed and where necessary, the attending physician will be interviewed for more
      complete information on the child's illness.

      Plan for Data Collection

      Interviews:

      Standard clinic record forms will be used to collect data from the primary care clinic or
      hospital through a combination of direct interviews and abstraction of information from their
      case notes by trained research health staff. Any unclear information in the case notes will
      be verified with the clinician concerned immediately. Field data will also be collected by
      means of standard pre-coded questionnaires administered to household heads. Individual
      in-depth interviews will also be administered to respondents using an interview guide. Focus
      groups will be organized by contacting the participants and arranging for a suitable meeting
      date, time and venue, the previous week. Focus groups will consist of 8-12 discussants with a
      moderator and an observer/notetaker. Discussions will be recorded by means of a tape recorder
      with permission from discussants.

      Laboratory Measurements:

      A finger-prick sample of blood will be obtained using a haemocue® microcuvette for
      haemoglobin count estimation. Thick and thin blood films will be obtained from the same
      finger prick sample for parasitological measurements for both surveys.

      Anthropometric Measurements:

      All children will be weighed using infant weighing scales or hanging scales that are usually
      used for weighing children during child welfare clinics for children unable to stand alone
      and a mechanical stand-on scale for older children who can stand alone. Supine length of
      children will be recorded using a measuring board whilst a height measure will be used to
      take the standing height of all children 2 years and above. The mid upper arm circumference
      (MUAC) of each child will be measured with a MUAC tape (TALC Institute of Child Health).

      Data Management and Analysis:

      Quantitative data will be recorded on pre-coded questionnaires or clinical data record forms
      whilst qualitative data will be recorded both on tape recorder and small notebooks. Data will
      be checked daily for accuracy and consistency, correctly labelled, and stored for data entry.

      For quantitative data, data entry clerks will carry out double entry of the raw data from
      questionnaires and clinical record forms in an electronic form into Microsoft Access. After
      data entry, data cleaning will be carried out to identify errors and inconsistencies for
      correction. Analysis will be carried out using Stata version 8. Summary statistics, odds
      ratios, confidence limits and p-values will all be calculated to compare outcomes between the
      two groups for the primary end point and secondary endpoints. Stratified analysis will be
      carried out based on age, sex, distance from health facility and household wealth. Means of
      continuous variables such as rise in haemoglobin count will be compared using the Student
      t-test. Geometric means will be used to compare parasite densities. Qualitative data will be
      analysed using Textbase Alpha after converting the transcribed text file into an ASCII file.
    

Intervention name(s): Free medical treatment
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; Cost; Treatment; Diagnosis; Africa; Ghana