Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002649121 Date of Approval: 28/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Better accountability to stop ill treatment (BASI!)
Official scientific title Better accountability to stop ill treatment; Improving patient experience by leveraging community voices to hold health systems accountable
Brief summary describing the background and objectives of the trial Poor health system experiences negatively affect the lives of poor people throughout the world. Poor quality extends to how people are treated: during a nationally representative survey of outpatient visits for sick children in Tanzania, fewer than half of caregivers were told their child¿s diagnosis and 20% of caregivers reported a major problem with the time they had to wait to see a healthcare provider [Larson et. al 2017]. A particularly egregious case of poor patient experience is disrespect and abuse. The consequences of poor patient experiences are two-fold. First, disrespectful care violates individuals¿ fundamental rights to be treated with dignity. Second, poor patient experiences affect patient behavior. Individuals experiencing poor care are less likely to utilize the health system in the future. Associations between strong patient-provider communication and an increase in patient adherence to prescribed treatments and recommended prevention processes have been extensively documented [Greenfield et al. 1988, Zolnierek et al. 2009]. Two field experiments found large improvements with non-financial interventions. In the first, providing feedback reports on health worker performance led to significant improvements in healthcare delivery and health outcomes [Björkman & Svensson 2009]. In the second, non-financial rewards (social recognition) led to improved performance by public health agents [Ashraf et al. 2014]. Our proposed study builds on these findings in a new context, assessing whether community feedback through feedback reports (with and without social recognition) can improve patient experience. The study objectives are to: 1. Characterize patient experience; 2. Evaluate the effect of private and public patient feedback on patient experience, care seeking behavior, and healthcare provider job satisfaction; 3. Develop a patient experience measurement tool; 4. Assess the feasibility and unintended consequences of feedback
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BASI
Disease(s) or condition(s) being studied Patient experience during outpatient care for sick children
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 07/08/2017
Actual trial start date 07/08/2017
Anticipated date of last follow up 22/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 4350
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation by district. Within each district simple randomization using a random number generator (uniform distribution) in Stata were used. Allocation was determined off site. Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation by district. Within each district simple randomization using a random number generator (uniform distribution) in Stata were used. Allocation was determined off site. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Private feedback Feedback at two time points Half a day Healthcare providers will be given feedback from parents/guardians through report cards. These report cards will pool parent/guardian responses on indicators within the domains of patient experience, are observable by patients, and are addressable by providers. 1450
Experimental Group Social recognition arm Feedback at two time points Half a day Healthcare providers will be given feedback from parents/guardians through report cards. These report cards will pool parent/guardian responses on indicators within the domains of patient experience, are observable by patients, and are addressable by providers. At the second time point, information will also be shared with communities through posters at facilities and village government offices. 1450
Control Group Control Data will be collected from control facilities at the same time as intervention facilities, however feedback will not be provided to the healthcare providers. 1450 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Parent/Guardian surveys: Parents/guardians accompanying children under 13 years of age for a sick child outpatient visit at a study facility; 15 years of age or older; provides informed consent or assent in the case of caregivers aged 15-17 Healthcare provider surveys: Healthcare provider in study facility; is a skilled provider (i.e. cadre is nurse, clinical officer, medical officer, or medical doctor); provides outpatient care for sick children; 18 years of age or older; provides informed consent Parent/Guardian surveys: Not caregivers of children 13 years of age or younger; under 15 years of age; did not provide informed consent Healthcare provider surveys: Not healthcare providers at the study facility; not regularly performing outpatient visits for sick children; under 18 years of age; did not provide informed consent 15 Year(s) 99 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/07/2017 National Institute for Medical Research of Tanzania
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/06/2017 Harvard T. H. Chan School of Public Health
Ethics Committee Address
Street address City Postal code Country
90 Smith Street, 3rd Floor Boston 02120 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Patient experience Baseline Follow-up 1 Follow-up 2
Primary Outcome Patient satisfaction Baseline Follow-up 1 Follow-up 2
Primary Outcome Patient quality rating of visit Baseline Follow-up 1 Follow-up 2
Secondary Outcome Provider satisfaction Baseline Follow-up 1 Follow-up 2
Secondary Outcome Provider perceived quality Baseline Follow-up 1 Follow-up 2
Secondary Outcome Healthcare utilization Follow-up 2
Secondary Outcome Child health Follow-up 2
Secondary Outcome Patient-reported technical quality Baseline Follow-up 1 Follow-up 2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanzania Health Promotion Support 3rd floor Coco Plaza, Plot 254 Masaki Dar es Salaam Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
The Weiss Family Program Fund for Research in Development Economics Littauer Center Boston United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Elysia Larson 665 Huntington Ave., Building 1, 11th floor Boston 02115 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Elysia Larson 665 Huntington Ave. Boston 02115 United States of America
Redempta Mbatia Plot 254, Masaki Dar es Salaam United Republic of Tanzania
Sisty Moshi Plot 254 Masaki Dar es Salaam United Republic of Tanzania
Appolinary Bukuku Plot 254 Masaki Dar es Salaam United Republic of Tanzania
Jessica Cohen 665 Huntington Ave. Boston 02115 United States of America
Margaret Kruk 665 Huntington Ave. Boston United States of America
Eliudi Eliakimu Dar es Salaam United Republic of Tanzania
Godfrey Mbaruku Dar es Salaam United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elysia Larson elarson@mail.harvard.edu +16174321232 665 Huntington Ave.
City Postal code Country Position/Affiliation
Boston 02115 United States of America Harvard T. H. Chan School of Public Health
Role Name Email Phone Street address
Public Enquiries Elysia Larson elarson@mail.harvard.edu +16174321232 665 Huntington Ave., Building 1, 11th floor
City Postal code Country Position/Affiliation
Boston 02115 United States of America Harvard T. H. Chan School of Public Health
Role Name Email Phone Street address
Scientific Enquiries Elysia Larson elarson@mail.harvard.edu +16174321232 665 Huntington Ave., Building 1, 11th floor
City Postal code Country Position/Affiliation
Boston 02115 United States of America Harvard T. H. Chan School of Public Health
Role Name Email Phone Street address
Scientific Enquiries Elysia Larson elarson@mail.harvard.edu +16174321232 665 Huntington Ave., Building 1, 11th floor
City Postal code Country Position/Affiliation
Boston 02115 United States of America Harvard T. H. Chan School of Public Health
REPORTING
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