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Improving Nighttime Access to Care and Treatment (Part 2) (INACT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943654
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Universite d'Etat d'Haiti
Information provided by (Responsible Party):
University of Florida

Brief Summary:

Children in resource-limited settings who develop illness at night are often isolated from pre-emergency care, resulting in progression to an emergency because families are forced to wait until morning to seek care. This is especially true in Haiti based on needs assessments (INACT Part 1; INACT1) surrounding access to healthcare. This study (INACT Part 2; INACT2) seeks to improve access to care by establishing a health hotline (healthline) and mobile pharmacy for families with children who become ill at nighttime. The healthline will be staffed by medical professionals and will provide phone based assessment and treatment recommendations based on standard of care practices according to Haitian and WHO guidelines. The healthline will focus on pre-emergency patients (those without danger signs as defined by WHO guidelines). Emergent patients will be advised to bypass the healthline and seek immediate care at the nearest medical facility. In the event that a non-emergent patient requires access to basic medications or fluids and is logistically accessible, the mobile pharmacy service will be offered.

The specific aims of the study are as follows: Aim I. Evaluate congruence between healthline assessment over the phone and in-person assessment of participants (patients using the healthline) 10 years of age and younger. The investigators hypothesize that in-person assessments based on WHO guidelines will be discordant with those made by the healthline because the physical aspects of the call-center assessment will be performed by an untrained parent/ guardian. The study focuses on acute diarrheal disease (ADD) and acute respiratory illness (ARI) but is not exclusive to these two chief complaints. Aim II: Identify determinants that correlate with seeking care at a medical facility over the 8-12 day follow up period after the initial call. The findings from this study will determine if a healthline model is a safe and accurate method of providing high quality access to nighttime healthcare, averting the progression of non-emergent cases to emergencies.


Condition or disease Intervention/treatment
Acute Diarrhea Acute Respiratory Infection Acute Febrile Illness Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone

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Study Type : Observational
Estimated Enrollment : 490 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : May 27, 2021
Estimated Study Completion Date : May 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Group/Cohort Intervention/treatment
Children living within study delivery area w/o danger signs
Families who call the healthline service about a sick child (no danger signs) and live within the mobile pharmacy delivery area will receive illness assessments and treatment recommendations over the phone. Immediately following calls a nurse will conduct household visits to complete in-person assessments of the children. Illness progression will be tracked with a 8-12 day follow up call. The phone and in-person assessments will be compared to evaluate safety and accuracy of the healthline.
Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone
The healthline uses a series of questions (based off of the WHO Integrated Management of Childhood Illness guidelines) asked to the parent of a sick child over the phone to remotely triage and assess the child's illness and then provide a treatment recommendation. MotoMeds is the accompanying motorcycle delivery service for basic medication delivery at nighttime.

Children living outside study delivery area w/o danger signs
Families who call the healthline service about a sick child (no danger signs) and live outside the delivery area will receive illness assessments and treatment recommendations over the phone. Illness progression will be tracked with a 8-12 day follow up call.
Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone
The healthline uses a series of questions (based off of the WHO Integrated Management of Childhood Illness guidelines) asked to the parent of a sick child over the phone to remotely triage and assess the child's illness and then provide a treatment recommendation. MotoMeds is the accompanying motorcycle delivery service for basic medication delivery at nighttime.

Children who are identified as having danger signs
Families who call the healthline service about a sick child and who are identified as having a danger sign will be directed to the nearest medical facility. Illness progression will be tracked with a 8-12 day follow up call.
Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone
The healthline uses a series of questions (based off of the WHO Integrated Management of Childhood Illness guidelines) asked to the parent of a sick child over the phone to remotely triage and assess the child's illness and then provide a treatment recommendation. MotoMeds is the accompanying motorcycle delivery service for basic medication delivery at nighttime.




Primary Outcome Measures :
  1. Congruence between phone and in person clinical assessment. [ Time Frame: Begins when the healthline call is placed and ends once the nurse has completed the household visit; approximately 1-3 hours. ]
    The responses parents give over the phone describing the child's illnesses will be compared to the routine clinical exam that the nurse performs in person. Clinical assessment features include vital signs, signs of work of breathings, and signs of dehydration per WHO and APP guidelines.


Secondary Outcome Measures :
  1. Determinants that correlate with seeking care at a medical facility [ Time Frame: Begins when the healthline call is placed and ends 8-12 days later. ]
    A follow up call will be placed 8-12 days after the initial healthline call to investigate factors associated with seeking care at a medical facility after the initial call to the heathline service.


Biospecimen Retention:   Samples With DNA
Stool samples and nasal swabs will be collected.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The healthine service will be advertised to residents in or approximate to a 5Km radius centered around the healthline office, which is in the community of La Reserve, Gressier, Haiti. There are approximately 12,632 households in this area covering 79 sq km.
Criteria

Inclusion Criteria:

  • age of patient must be 10 years or younger
  • patient must reside inside the study delivery area
  • consent/assent to participate

Exclusion Criteria:

  • emergent illness (danger signs present)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943654


Contacts
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Contact: Eric Neslon, MD PhD 3522948536 eric.nelson@ufl.edu

Locations
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Haiti
University of Florida Public Health Research Laboratory Recruiting
Gressier, Ouest, Haiti
Contact: Molly Klarman, MPH    50946007486    mklarman@ufl.edu   
Sub-Investigator: Chantale Baril, MD         
Sponsors and Collaborators
University of Florida
National Institutes of Health (NIH)
Universite d'Etat d'Haiti
Investigators
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Principal Investigator: Eric Nelson, MD PHD University of Florida
Additional Information:
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03943654    
Other Study ID Numbers: IRB201802920 -N
DP5OD019893 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Telemedicine
Diarrhea
Diarrhoea
mHealth
Healthline
Additional relevant MeSH terms:
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Respiratory Tract Infections
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Infection
Respiratory Tract Diseases