Universal Coverage Mode RCT

September 25, 2019 updated by: Ari Johnson, MD

Evaluation of a Mobile Application Tool for Increasing Community Health Worker Home Visit Coverage: A Randomized Controlled Study

Community Health Workers that work in collaboration with the NGO Muso Health and the Malian government in both a peri-urban and a rural site in Mali, provide care proactively to the population they form part of.

To work, they use a smartphone application that was developed as a job aid to support task management, panel management and clinical decision support functions. For this study, a tool called "Universal Health Coverage Mode" was designed to be integrated into the CHW application to help Community Health Workers visit every household at least twice per month.

We hypothesize that Community Health Workers (CHWs) assigned to use Universal Health Coverage (UHC) Mode, a mobile application tool, will achieve higher coverage of homes visited (defined as being visited at least two times in a month) than those without this tool.

Study Overview

Status

Completed

Detailed Description

Community Health Workers participating in the study will be providing care through the Proactive Community Case Management intervention, described in detail elsewhere. Through this package of services, CHWs are required to conduct at least two hours of home visits per day, six days per week, to achieve a goal of at least two home visits per household per month. All CHWs receive monthly individual supervision via a 360 Supervision protocol, described in detail elsewhere, as well as group supervisions weekly (at the Yirimadio site) or twice-monthly (at the Tori site). At the Tori site, households served by each CHW were previously registered via a population census which is updated every year by an independent team of surveyors. Within the Yirimadio site, all households have been registered by the CHW herself to achieve a ratio of approximately 1000 patients per CHW.

CHWs at both sites and both arms of the study will also receive monthly performance feedback via a CHW Performance Dashboard, described elsewhere, which provides personalized feedback on the quantity, speed, and coverage of care. CHW supervisors will be able to see their supervisees' performance data and provide feedback via the monthly supervisions. CHWs at both sites will receive feedback for community care management indicators, but only Yirimadio's CHW supervisors will observe CHWs performance on proactive household visits.

All CHWs at both sites use a CHW App, a free and open source smartphone application developed by Medic Mobile with Muso. The CHW App is a job aid that supports task management, panel management, and clinical decision support functions, while providing a mechanism for data collection and submission. Previously, CHWs had to manage 14 different types of paper forms that their core workflow entails, and the data was entered by hand for each of these forms to carry out monitoring and evaluation tasks. Now, there is no need for photocopying, carrying and stocking all 14 forms, and data is automatically sent to a central database once the smartphones are synchronized. Also, for CHW tracking their patients and the tasks they performed meant a huge organizational challenge. The app was modeled to tackle this problem using a human centered design, allowing the CHWs to easily search for and access their patients registries and histories.

For the control arm, all households within the CHW's household list in the app will have the same appearance. There will be no visual differentiation between households on the list to indicate the frequency of home visits.

In the intervention arm, the CHW's household list will appear differently within the app in the following ways:

The CHW will be able to filter and order households by the date of the most recent home visit, to identify households that have been visited least frequently.

A color-coded visual icon will display the number of home visits in the past month for each household.Red color for 0 home visits for a household in the past month (default at the start of every month).Orange color for 1 home visit for a household in the past month.Blue color for 2 or more visits for a household in the past month.

A red exclamation mark will be displayed for every household that has not reached 2 visits in the past month (default at the start of every month).

Text displayed below each household showing the date of last visit will turn red if more than 30 days have passed since last visit. When more than 60 days have passed since the most recent visit, the text displayed below each household showing the date of last visit will be changed to "date of last visit is unknown" in red.

The family profile will also contain the date of last visit, and the visits they have received in that month.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bamako, Mali
        • Muso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community Health Workers serving the Tori (n=27) and Yirimadio (n=172) catchment areas conducting proactive home visits will be eligible to participate in the study

Exclusion Criteria:

  • CHWs involved in pilot-testing UHC Mode prior to the trial will be excluded from the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Universal Health Coverage Mode
The NGOs Muso and Medic Mobile have partnered to develop Universal Health Coverage Mode, a smartphone app tool that provides visual cues to help CHWs track the quantity of household visits they have conducted at each household in a given month.

In the intervention arm, the CHW's household list will appear differently within the app in the following ways:

The CHW will be able to filter and order households by the date of the most recent home visit.

A color-coded visual icon will display the number of home visits in the past month for each household.

A red exclamation mark will be displayed for every household that has not reached 2 visits in the past month (default at the start of every month).

Text displayed below each household showing the date of last visit will turn red if more than 30 days have passed since last visit. When more than 60 days have passed since the most recent visit, the text displayed below each household showing the date of last visit will be changed to "date of last visit is unknown" in red.

The family profile will also contain the date of last visit, and the visits they have received in that month

No Intervention: Work as usual
For the control arm, all households within the CHW's household list in the app will have the same appearance. There will be no visual differentiation between households on the list to indicate the frequency of home visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome
Time Frame: 4 months
The probability of a household receiving two or more visits per "workflow" month (a month being from the 26th of one month to the 25th of the next month).
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome 1
Time Frame: 4 months
Number of days between household visits for each household served by CHWs
4 months
Secondary outcome 2
Time Frame: 4 months
Number of visits per household per "workflow"month
4 months
Secondary outcome 3
Time Frame: 4 months
Percentage of sick individuals in a household visited within 24 hours (among households with a sick person).
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

July 26, 2019

Study Completion (Actual)

July 26, 2019

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 0219-0619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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