Condition category
Not Applicable
Date applied
19/11/2020
Date assigned
23/11/2020
Last edited
23/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Surgical access is critically important for strong health systems. Although 30% of the world’s disease burden is surgical, five billion people are unable to access safe, affordable, and timely surgical care. An estimated 143 million necessary surgical procedures are not done every year.
Barriers to accessing surgical care are especially high among the poor worldwide and in low- and middle-income countries (LMICs).
A 2017 retrospective study of surgical patients in West Africa found that they were almost twice as likely to show up for their scheduled surgery if their transportation costs were paid for. Vouchers for transportation have also been successful at increasing facility delivery for mothers in Bangladesh, although the voucher system itself proved difficult to administer.
Cash transfers, in which participants are given small amounts of cash in exchange for salutary behavior, are simpler to administer than vouchers and have shown success in health, nutrition, and education. Cash transfers have not yet been studied in surgery.
Building on a prior study of cash transfers for surgical patients in Guinea, this paper undertook a randomized, controlled trial (RCT) of a cash transfer for surgical patients in the country. We hypothesized that cash transfers would improve patient compliance and that, specifically, cash transfers given before patients faced the barrier of transportation costs would have a significant positive effect.

Who can participate?
Any patient who had been determined to be eligible for surgery by a specialized surgical screening team. There was no age limit, although if the patient was a child, the parent was the participant.

What does the study involve?
Participants in this study were randomized to three trial arms. Group 1 patients received the cash transfer conditional on their arrival for their surgery. Patients in Group 2 received the transfer as a mobile banking deposit 2 – 4 days prior to the day they were scheduled to leave their homes to come to the screening city for transportation to Conakry. The transfer was “labelled” with a concurrent text message. Patients in the control arm received a bag of food and staples on the day of enrollment. No further assistance was given toward their transportation costs.

What are the possible benefits and risks of participating?
Benefits: The patients would be receiving free surgery plus a cash transfer.
Risks: Aside from the minimal risk of unmasking of patient information, no other risks were likely to occur.

Where is the study run from?
Mercy Ships, a surgical charity operating a hospital ship at Conakry (Guinea)

When is the study starting and how long is it expected to run for?
January 2017 to June 2019

Who is funding the study?
Damon Runyon Cancer Research Foundation (USA)

Who is the main contact?
Prof. Mark Shrime
mark.shrime@rcsi.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mark Shrime

ORCID ID

http://orcid.org/0000-0002-3546-9867

Contact details

Institute of Global Surgery
123 St. Stephen's Green
Dublin
D02
Ireland
-
mark.shrime@rcsi.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CI 91-17

Study information

Scientific title

Cash transfers may decrease the no-show rate for surgical patients in low-resource settings: A randomized trial

Acronym

CASH

Study hypothesis

Cash transfers will improve patient compliance with scheduled surgery and, specifically, cash transfers given before patients faced the barrier of transportation costs would have a significant positive effect.

Ethics approval

Approved 12/06/2017, Massachusetts Eye and Ear Infirmary (Massachusetts Eye and Ear Infirmary, 243 Charles Street, Boston, MA 02114, USA; +1 617 523 7900; jan_trott@meei.harvard.edu), ref: 15-166H

Study design

Single center interventional single-blinded randomized trial with three arms

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Utilization of surgical services by surgical patients in Guinea

Intervention

Three arms:
"Conditional cash transfer": these patients will receive 80,000 GNF (approx €7) conditional on them arriving for their scheduled surgical appointment, whether or not the surgery actually happened.

"Unconditional cash transfer": These patients received 80,000 GNF as a mobile banking deposit 2 – 4 days prior to the day they were scheduled to leave their homes to come to the screening city for transportation to Conakry. The transfer was “labeled” with a concurrent text message. If patients in this arm did not have a cell phone or a SIM card, these were provided. All transfer costs were covered.

"Control group": Patients in the control arm received a bag of food and staples on the day of enrollment. No further assistance was given toward their transportation costs.

Patients were recruited once they had been given an appointment for their on-ship screening. Allocation proceeded via simple randomization. Slips each containing a random study identification number and group allocation were concealed in an opaque envelope. Patients drew a number from the envelope in view of the researchers, local staff, and their families. The first author, who performed the data analysis, was blinded to the allocation and randomization.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Number of patients attending scheduled surgical appointment (measured throughout the study)

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

04/01/2017

Overall trial end date

01/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Any patient who had been determined to be eligible for surgery by a specialized surgical screening team. No age limit, although if the patient was a child, the parent was the participant.

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

390

Total final enrolment

453

Participant exclusion criteria

No diagnosed surgical disease

Recruitment start date

16/10/2018

Recruitment end date

07/02/2019

Locations

Countries of recruitment

Guinea

Trial participating centre

Mercy Ships
m/v Africa Mercy
Conakry
-
Guinea

Sponsor information

Organisation

Massachusetts Eye and Ear Infirmary

Sponsor details

243 Charles Street
Boston
02114
United States of America
+1 617 523 7900
jan_trott@meei.harvard.edu

Sponsor type

University/education

Website

http://www.masseyeandear.org/

Funders

Funder type

Charity

Funder name

Damon Runyon Cancer Research Foundation

Alternative name(s)

Cancer Research Fund of the Damon Runyon-Walter Winchell Foundation, Damon Runyon, DRCRF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to lack of consent.

Intention to publish date

30/11/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2020: Trial’s existence confirmed by Massachusetts Eye and Ear REC.