Universal Coverage Mode RCT

Sponsor

Ari Johnson, MD (Other)

Overall Status

Completed

CT.gov ID

NCT04106921

Collaborator

Bill and Melinda Gates Foundation (Other), Medic Mobile (Industry)

199

Enrollment

Location

Arms

5.7

Actual Duration (Months)

34.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Community Health Workers	Other: Universal Health Coverage Mode	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

199 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Difference in differences parallel randomized controlled trial.Difference in differences parallel randomized controlled trial.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Jul 26, 2019

Actual Study Completion Date :

Jul 26, 2019

Arms and Interventions

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.	Other: Universal Health Coverage Mode 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.

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.

Other: Universal Health Coverage Mode

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

Outcome Measures

Primary Outcome Measures

Primary outcome [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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Muso	Bamako		Mali

Sponsors and Collaborators

Ari Johnson, MD
Bill and Melinda Gates Foundation
Medic Mobile

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ari Johnson, MD, MD, University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT04106921

Other Study ID Numbers:

0219-0619

First Posted:

Sep 27, 2019

Last Update Posted:

Sep 27, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ari Johnson, MD, MD, University of California, San Francisco

community health workers

primary health care

mobile applications

Study Results

No Results Posted as of Sep 27, 2019