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Text Message Reminders to Health Workers on Malaria, Pneumonia, and Diarrhea Case Management in Malawi

Primary Purpose

Malaria, Pneumonia, Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Malaria text message reminders to health workers
Malaria, pneumonia, and diarrhea text message reminders to health workers
Control
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Malaria focused on measuring mHealth, text message, case management

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

(Health workers will receive the text message reminders. These health workers (and others working in the sampled outpatient department) will be eligible for interviews on the day of the team's visit. In addition, patients visiting the study health facilities will be eligible for exit interviews, which is the primary way that the outcomes will be assessed.)

Inclusion Criteria:

  • For health workers to receive text messages: Providing outpatient care or dispensing drugs at health facility randomized to one of two intervention arms.
  • For health workers to be interviewed during baseline, endline, and follow-up surveys: working in the outpatient department sampled by the team during their visit.
  • For patients to be interviewed during baseline, endline, and follow-up surveys: visiting facility to see a clinician for the first time for current illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Malaria-only text messages

    Malaria, pneumonia, and diarrhea messages

    Control

    Arm Description

    Health workers at facilities in this arm receive twice-daily text message reminders for six months on key reminders related to malaria diagnosis and treatment.

    Health workers at facilities in this arm receive twice-daily text message reminders for six months on key reminders related to diagnosis and treatment of malaria, pneumonia, and diarrhea

    No text message reminders to health workers, just the usual health system supports.

    Outcomes

    Primary Outcome Measures

    Questionnaire measurement of diagnosis and treatment of malaria among outpatients
    Patient exit interviews will be used to assess: 1) whether all suspect malaria patients are tested with a malaria diagnostic test; 2) whether patients with a positive test are prescribed the first- or second-line antimalarial; and 3) whether dosing of antimalarials are correct.

    Secondary Outcome Measures

    Questionnaire measurement of diagnosis and treatment of pneumonia among outpatients
    Patient exit interviews will be used to assess whether patients with surveyor-assessed pneumonia are prescribed the correct first-line antibiotic by health workers
    Questionnaire measurement of diagnosis and treatment of diarrhea among outpatients
    Patient exit interviews will be used to assess whether patients with surveyor-assessed diarrhea are prescribed the first-line diarrhea treatment by health workers.

    Full Information

    First Posted
    December 30, 2015
    Last Updated
    December 11, 2017
    Sponsor
    Centers for Disease Control and Prevention
    Collaborators
    Malaria Alert Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02645513
    Brief Title
    Text Message Reminders to Health Workers on Malaria, Pneumonia, and Diarrhea Case Management in Malawi
    Official Title
    The Effect of Mobile Phone Text Message Reminders on Health Workers' Adherence to Malaria and Other Disease Case Management Guidelines in Malawi
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centers for Disease Control and Prevention
    Collaborators
    Malaria Alert Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess whether twice-daily text message reminders over a six-month period to health workers in Malawi about diagnosis and treatment of malaria, pneumonia, and diarrhea improve case management of these diseases.
    Detailed Description
    Background Mobile health, or m-health includes the use of portable devices, such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices to support medical and public health practice. Mobile phones are widespread in Asia and Africa, and dissemination of health-related messages via mobile phones is an inexpensive way to reach geographically dispersed recipients. Evidence from developing countries, is scarce, particularly for improving health service delivery. Only one rigorously designed study, a randomized controlled trial in Kenya, assessed the use of mobile phone text messaging to improve health worker case management practices, showing that sending daily text message reminders to health workers over six months led to a 24-percentage-point improvement in correct management of uncomplicated malaria. Malaria is endemic throughout Malawi and poses a significant burden for the health system. Malawi changed its malaria case management guidelines in 2011 to require diagnostic confirmation with microscopy or a malaria rapid diagnostic test (RDT) prior to treatment. A health facility survey in 2011 prior to the rollout of RDTs found that only 67% of patients with malaria were correctly treated, primarily due to a missed diagnosis of malaria. Although more recent assessments are lacking, it is likely that Malawi faces similar problems documented in other sub-Saharan African countries: non-systematic diagnostic testing of febrile patients for malaria, poor adherence to negative test results, failure to administer the first dose of antimalarial therapy during the consultation, and gaps in patient counseling. Furthermore, additional assessments have pointed to deficiencies in quality of care for other common illnesses in Malawi, such as pneumonia and diarrhea, which are similar to some of the widespread quality problems found in other developing countries. Study design and objectives This study is a trial of text message reminders to health workers in Malawi to improve case management of malaria and other common illnesses. The study will employ a cluster-randomized, controlled trial design with pre- and post-intervention measures, with health facilities as the cluster and unit of randomization. In several districts of Malawi, health facilities will be randomized to one of three arms: Text messages to health facility-based health workers on the correct management of malaria (patients of all ages) Text messages to health facility-based health workers on the correct management of malaria (patients of all ages) and other common illnesses, per Integrated Management of Childhood Illness guidelines (patients < 5 years) Control health facilities where health workers receive no study intervention (only routine supervision and supports from supervisors and district health management team, which will occur in text message arms as well) Justification This study will add to the small but growing body of literature on the potential for cell phones and text messages to improve malaria case management in different settings. In addition to providing evidence from a rigorously designed study on the effectiveness of text message reminders to health workers to improve malaria case management, this proposed study expands on the promising initial evidence base in the following ways: Assesses the effectiveness of text message reminders in a setting with malaria diagnostic testing Expands the intervention to include patients of all ages, not just children < 5 years Includes messages on common non-malarial illnesses, including pneumonia and diarrhea Methodology All health workers providing clinical care or working in the pharmacy dispensing drugs at facilities randomized to arms 1 or 2 will receive text messages. Before the intervention, data collection via a cross-sectional health facility survey will occur in the three study arms and will include patient exit interviews with a focused history, physical examination, and blood smear; health worker interviews; and a brief facility assessment. Results from this survey will be used to measure the baseline levels of case-management quality for malaria and other diseases and to pinpoint performance deficiencies to target with the text message intervention. Once preliminary baseline results are available, a workshop will be held with key stakeholders, including National Malaria Control Programme staff, researchers, technology specialists, health education specialists, and health workers, to discuss the results and design an appropriate intervention strategy, including message content and timing. Text message reminders on case management of malaria (arm 1) and of malaria and other common illnesses (arm 2) will be sent to health workers twice a day in the intervention groups for six months. At the end of the six-month text message intervention, approximately one year after the baseline survey, follow-up data will be collected with another cross-sectional health facility survey. At this time, in-depth interviews will also be conducted with selected health workers in intervention facilities to better understand their reactions to the text messages and to help determine mechanisms of action of the text message reminders. A second follow-up health facility survey will be conducted six months after the end of the intervention to assess the extent that changes in performance are maintained over time. Cost data on the intervention will also be collected for a cost-effectiveness analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria, Pneumonia, Diarrhea
    Keywords
    mHealth, text message, case management

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    182 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Malaria-only text messages
    Arm Type
    Experimental
    Arm Description
    Health workers at facilities in this arm receive twice-daily text message reminders for six months on key reminders related to malaria diagnosis and treatment.
    Arm Title
    Malaria, pneumonia, and diarrhea messages
    Arm Type
    Experimental
    Arm Description
    Health workers at facilities in this arm receive twice-daily text message reminders for six months on key reminders related to diagnosis and treatment of malaria, pneumonia, and diarrhea
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    No text message reminders to health workers, just the usual health system supports.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Malaria text message reminders to health workers
    Intervention Description
    Text message reminders contain key details from national case management guidelines on diagnosis and treatment of malaria
    Intervention Type
    Behavioral
    Intervention Name(s)
    Malaria, pneumonia, and diarrhea text message reminders to health workers
    Intervention Description
    Text message reminders contain key details from national case management guidelines on diagnosis and treatment of malaria, pneumonia, and diarrhea
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control
    Intervention Description
    No text message reminders
    Primary Outcome Measure Information:
    Title
    Questionnaire measurement of diagnosis and treatment of malaria among outpatients
    Description
    Patient exit interviews will be used to assess: 1) whether all suspect malaria patients are tested with a malaria diagnostic test; 2) whether patients with a positive test are prescribed the first- or second-line antimalarial; and 3) whether dosing of antimalarials are correct.
    Time Frame
    12 months after end of text messages
    Secondary Outcome Measure Information:
    Title
    Questionnaire measurement of diagnosis and treatment of pneumonia among outpatients
    Description
    Patient exit interviews will be used to assess whether patients with surveyor-assessed pneumonia are prescribed the correct first-line antibiotic by health workers
    Time Frame
    12 months after end of text messages
    Title
    Questionnaire measurement of diagnosis and treatment of diarrhea among outpatients
    Description
    Patient exit interviews will be used to assess whether patients with surveyor-assessed diarrhea are prescribed the first-line diarrhea treatment by health workers.
    Time Frame
    12 months after end of text messages

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    (Health workers will receive the text message reminders. These health workers (and others working in the sampled outpatient department) will be eligible for interviews on the day of the team's visit. In addition, patients visiting the study health facilities will be eligible for exit interviews, which is the primary way that the outcomes will be assessed.) Inclusion Criteria: For health workers to receive text messages: Providing outpatient care or dispensing drugs at health facility randomized to one of two intervention arms. For health workers to be interviewed during baseline, endline, and follow-up surveys: working in the outpatient department sampled by the team during their visit. For patients to be interviewed during baseline, endline, and follow-up surveys: visiting facility to see a clinician for the first time for current illness
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Don Mathanga, MD, PhD
    Organizational Affiliation
    Malaria Alert Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21820166
    Citation
    Zurovac D, Sudoi RK, Akhwale WS, Ndiritu M, Hamer DH, Rowe AK, Snow RW. The effect of mobile phone text-message reminders on Kenyan health workers' adherence to malaria treatment guidelines: a cluster randomised trial. Lancet. 2011 Aug 27;378(9793):795-803. doi: 10.1016/S0140-6736(11)60783-6. Epub 2011 Aug 3.
    Results Reference
    result
    PubMed Identifier
    30628566
    Citation
    Steinhardt LC, Mathanga DP, Mwandama D, Nsona H, Moyo D, Gumbo A, Kobayashi M, Namuyinga R, Shah MP, Bauleni A, Troell P, Zurovac D, Rowe AK. The Effect of Text Message Reminders to Health Workers on Quality of Care for Malaria, Pneumonia, and Diarrhea in Malawi: A Cluster-Randomized, Controlled Trial. Am J Trop Med Hyg. 2019 Feb;100(2):460-469. doi: 10.4269/ajtmh.18-0529.
    Results Reference
    derived

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    Text Message Reminders to Health Workers on Malaria, Pneumonia, and Diarrhea Case Management in Malawi

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