Health BehaviorD0168NCT02879708
Effect of Social Accountability on Improving Service Delivery and Outcomes in the Public Sector in Uttar Pradesh, India
A study testing Information Only and Information and Facilitation in people with Health Behavior, run by Duke University at 1 site in India.
Trial summary
In several low and middle-income countries, Social Accountability (SA) interventions have been introduced as an innovative approach to governance, aiming to improve delivery of public services. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Information Only and Information and Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105,000 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2015to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- households residing in the villages selected for the evaluation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
India1 site
Uttar Pradesh State Institute of Rural Development
Lucknow, Uttar Pradesh, 226202
About this study
Official title: Effect of Social Accountability on Improving Service Delivery and Outcomes in the Public Sector: a Cluster-Randomized Control Trial in Uttar Pradesh, India
In several low and middle-income countries, Social Accountability (SA) interventions have been introduced as an innovative approach to governance, aiming to improve delivery of public services. These interventions typically include information provision to citizens regarding their rights/entitlements and local provider performance, and additionally, facilitation of community engagement with providers and officials.
The state government of Uttar Pradesh (UP) and the Uttar Pradesh Health Systems Strengthening Project (UPHSSP) have identified 12 districts where the social accountability initiative will be introduced on a priority basis. This study focuses on interventions in 2 of these districts (Sultanpur and Fatehpur), to study mechanisms through which information and collective action lead to improved accountability and outcomes. Within the 2 districts, the study is implemented as a cluster randomized evaluation with 120 villages randomized into 2 treatment arms and one control arm.
This study aims to: (a) measure the causal effect of SA interventions on key outcomes (health status, quality of service); (b) test the effectiveness of social networks based strategies to disseminate information for community engagement; and (c) study individuals' decisions to participate in collective action efforts in the context of social networks and information interventions. In addition to evaluating the impact of the SA interventions, the study aims to generate new knowledge on relative strengths of information seeding strategies, identifying those that maximize the spread of information through the village network, and subsequently estimate peer effects on participation decisions.
Read the detailed description
The World Bank-supported Uttar Pradesh Health System Strengthening Project (UPHSSP) includes a component that calls for the implementation of social accountability (SA) interventions in UP, which aim to stimulate community action to demand better services, enhance positive health behavior and promote social audits of service delivery and resource allocation. Two key channels through which SA interventions operate are through (a) information provision and (b) fostering community engagement that enables grievance redressal. Prior to the implementation of SA interventions at scale in UP, this study aims to conduct rigorous impact evaluation of key components of SA interventions in order to learn about potential impact in the UP context and to learn about critical implementation issues regarding optimal methods to deliver information in the state with available technology and social networks.
The evaluation's overarching research questions are whether SA interventions in UP improve (1) objective measures of health service quality in practice, (2) village-level satisfaction with health services, and (3) village-level health outcomes. Importantly, the evaluation will seek to identify whether the information provision that is a standard part of social accountability interventions has an independent effect on outcomes that is comparable to the effect of the combined information and community engagement components. The investigators also test the effectiveness of alternative models of delivering information in order to inform implementation of accountability interventions at large scale in public policy settings. Given that the community health workers targeted by the intervention focus on maternal and child health, our measures of health system performance along these three dimensions will also emphasize maternal and child health. Measures of health service quality include availability of services such as immunization and primary care services, distribution of food and nutritional supplementation as recommended in the national nutrition program, and provider absenteeism. Measures of satisfaction with local health services will include process measures including availability of service, waiting time for services and whether or not community members perceive that they are treated by providers with respect as well as general subjective assessments of satisfaction with services. Health outcome measures will include child anthropometrics (weight-for-age and weight-for-height), self-reported morbidity in the preceding two weeks (diarrhea, cough, fever, headache, days of usual activities lost due to illness), and neonatal (0-28 days), infant (under age one), and child (under age five) mortality as well as maternal health indicators such as percentage of facility deliveries among mothers who gave birth in the past year.
Within the 2 study districts (Sultanpur and Fatehpur), in 120 villages that were selected at random, the SA interventions aim to distinguish the effect of provision of information and facilitated engagement of community members, from that of the effect of information alone. The 120 villages are randomized to either a control arm, or one of two treatment arms described below.
TREATMENT ARM 1 - Information \& Awareness:
Community members will receive information about their rights, roles and responsibilities of healthcare providers, and also about health-related activities and programs taking place in their village. Importantly, besides assessing the effect of providing information on health service delivery and various health outcomes, our evaluation will also determine how best to provide the information.
Another innovation in this project is to disseminate monthly information about health system related issues using interactive voice response messages (IVRs), phone calls, or home visits to households in the treatment villages. IVRs include a brief message about a health (or health system) indicator, or information regarding upcoming Village Health, Sanitation and Nutrition Committee (VHSNC) meetings or VHNDs, as well as a response option that can be used to collect data on what information households have received and about their participation in VHSNC meetings/VHNDs. These IVRs will be sent out over multiple months to cover approximately 24,000 households in 80 treatment villages each time. During preparatory phase that was conducted in parallel with the baseline survey, detailed data on social networks was collected in each village and identified central individuals in the village.
The investigators will use the data on networks in villages, combined with the information that is disseminated on a monthly basis to econometrically estimate how information dissemination within networks affects awareness and participation in social accountability activities as well as in utilization of health services.
TREATMENT ARM 2 - Information PLUS Community Engagement:
In addition to all the information interventions listed in treatment arm 1, community engagement will be facilitated in Arm 2 villages. The community engagement component aims to enhance the participation of the community in creating social accountability. The intervention will provide trained facilitators to help community members engage in a participatory process with Village Health, Sanitation, and Nutrition Committees (VHSNCs) and identify key deficiencies for improvement in health services that most concern community members. The facilitators are trained to help organize meetings and are provided a detailed checklist of activities that need to be undertaken prior to the day of the meetings such as inviting the block level officers and ensuring that logistics requirements for Village Health and Nutrition Days (VHNDs) are conveyed to VHSNC members in advance of the meetings. The facilitated meetings with healthcare providers and local and block level representatives aim to empower community members to demand better health services and convey these demands more effectively to providers and officials. The three key health workers at the village level (ASHA, ANM, and AWW) report to the local (village level) elected representatives and block level authorities, who receive feedback from the community in the accountability interventions. Moreover, through repeated community meetings village-level health workers are expected to respond to transparency and accountability innovations by improving quality of services delivered to their local constituents resulting in improvements in population health outcomes.
These interventions will focus on services delivered by village-level health workers including those providing primary care and maternal and child health services. The households surveyed in the project will be those with children less than 5 years of age. The interventions will cover and include all population subgroups, castes, and religious minorities in the treatment villages, and also collect data on all of these subgroups.
- Conditions
- Health Behavior
- Being tested
- Information Only, Information and Facilitation
- Keywords
- Social Accountability, Healthcare Quality, Health System Strengthening, Child Health, Childhood pneumonia, Childhood diarrhea
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information OnlyOther
Households will receive information regarding their rights and entitlements pertaining to healthcare, certain health outcomes specific to their village, as well as health-related activities happening in their village (such as the VHSNC meetings and Village Health and Nutrition Days). Information will be disseminated through an initial visit to all households, and from then on either through (1) broadcast messages sent to households via mobile phone, (2) central individuals in the village social network who will be asked to spread that information, or (3) public officials charged with spreading the information throughout the village.
Information and FacilitationOther
In addition to the information interventions described above, this intervention will provide trained facilitators to help community members engage in a participatory process with VHSNCs and identify key deficiencies for improvement in health services that most concern community members. The facilitators are trained to help organize meetings and are provided a detailed checklist of activities to be undertaken prior to the the meetings. The three key health workers at the village level (ASHA, ANM, and AWW) report to the local (village level) elected representatives and block level authorities, who receive feedback from the community in the accountability interventions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 40 (of 120) randomly selected villages receive no intervention |
| Information Only | Other | 40 randomly selected villages are assigned to the "information only" arm where households will receive information regarding their rights and entitlements pertaining to healthcare, certain health outcomes specific to their village, as well as health-related activities happening in their village. Receives: Other: Information Only |
| Information and Facilitation | Other | The remaining 40 villages will receive similar information as the villages in the Information Only Arm, but will also have facilitators present that ensure the existence of the VHSNC at the village level as well as the occurrence of VHSNC monthly meetings. Receives: Other: Information and Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-for-height Z scores
Measured: 12 months after intervention implementation
Secondary outcomes (5)
Satisfaction with providers - averaged from a rating index and/or constructed by a PCA on the rating index
Level of satisfaction with local healthcare providers, as estimated by (1) averaging rating scores across a satisfaction index (questions asking the respondent to rate aspects of their last experience with the provider on a scale of 1-5); and/or (2) running a principal components analysis on the same index and taking the first component.
Measured: 12 months after intervention implementation
Participation - as measured from self-report
household participation in VHSNC meetings and attendance at VHNDs, measured by self-report
Measured: 4 months, measured each month, and at 1 year during endline survey
U5 mortality rate
under 5 mortality rates
Measured: 12 months after intervention implementation
incidence of diarrhea
Measured: 12 months after intervention implementation
duration of diarrhea illness
Measured: 12 months after intervention implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startApr 2015
- Primary completionJul 2018
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank, University of North Carolina, Chapel Hill, Stanford University
- Responsible party
- Principal investigator, Manoj Mohanan, Duke University
- Investigators
- Manoj Mohanan, PhD, MSPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879708
- Sponsor's protocol ID
- 2017-0417
- Other IDs
- IE-P150365
- Acronym
- D0168
- Status last verified
- Dec 2024
- First submitted
- 25 Jul 2016
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators plan to make the de-identified data set publicly available.
Publications
Ringold, D., Holla, A., Koziol, M., & Srinivasan, S. (2012).
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Social Accountability on Improving Service Delivery and Outcomes in the Public Sector: a Cluster-Randomized Control Trial in Uttar Pradesh, India
- ClinicalTrials.gov ID
- NCT02879708
- Acronym / sponsor ID
- D0168 / 2017-0417
- Conditions
- Health Behavior
- Keywords
- Social Accountability, Healthcare Quality, Health System Strengthening, Child Health, Childhood pneumonia, Childhood diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105,000 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- World Bank, University of North Carolina, Chapel Hill, Stanford University
- Study start
- Apr 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In several low and middle-income countries, Social Accountability (SA) interventions have been introduced as an innovative approach to governance, aiming to improve delivery of public services. These interventions typically include information provision to citizens regarding their rights/entitlements and local provider performance, and additionally, facilitation of community engagement with providers and officials.
The state government of Uttar Pradesh (UP) and the Uttar Pradesh Health Systems Strengthening Project (UPHSSP) have identified 12 districts where the social accountability initiative will be introduced on a priority basis. This study focuses on interventions in 2 of these districts (Sultanpur and Fatehpur), to study mechanisms through which information and collective action lead to improved accountability and outcomes. Within the 2 districts, the study is implemented as a cluster randomized evaluation with 120 villages randomized into 2 treatment arms and one control arm.
This study aims to: (a) measure the causal effect of SA interventions on key outcomes (health status, quality of service); (b) test the effectiveness of social networks based strategies to disseminate information for community engagement; and (c) study individuals' decisions to participate in collective action efforts in the context of social networks and information interventions. In addition to evaluating the impact of the SA interventions, the study aims to generate new knowledge on relative strengths of information seeding strategies, identifying those that maximize the spread of information through the village network, and subsequently estimate peer effects on participation decisions.
Detailed description
The World Bank-supported Uttar Pradesh Health System Strengthening Project (UPHSSP) includes a component that calls for the implementation of social accountability (SA) interventions in UP, which aim to stimulate community action to demand better services, enhance positive health behavior and promote social audits of service delivery and resource allocation. Two key channels through which SA interventions operate are through (a) information provision and (b) fostering community engagement that enables grievance redressal. Prior to the implementation of SA interventions at scale in UP, this study aims to conduct rigorous impact evaluation of key components of SA interventions in order to learn about potential impact in the UP context and to learn about critical implementation issues regarding optimal methods to deliver information in the state with available technology and social networks.
The evaluation's overarching research questions are whether SA interventions in UP improve (1) objective measures of health service quality in practice, (2) village-level satisfaction with health services, and (3) village-level health outcomes. Importantly, the evaluation will seek to identify whether the information provision that is a standard part of social accountability interventions has an independent effect on outcomes that is comparable to the effect of the combined information and community engagement components. The investigators also test the effectiveness of alternative models of delivering information in order to inform implementation of accountability interventions at large scale in public policy settings. Given that the community health workers targeted by the intervention focus on maternal and child health, our measures of health system performance along these three dimensions will also emphasize maternal and child health. Measures of health service quality include availability of services such as immunization and primary care services, distribution of food and nutritional supplementation as recommended in the national nutrition program, and provider absenteeism. Measures of satisfaction with local health services will include process measures including availability of service, waiting time for services and whether or not community members perceive that they are treated by providers with respect as well as general subjective assessments of satisfaction with services. Health outcome measures will include child anthropometrics (weight-for-age and weight-for-height), self-reported morbidity in the preceding two weeks (diarrhea, cough, fever, headache, days of usual activities lost due to illness), and neonatal (0-28 days), infant (under age one), and child (under age five) mortality as well as maternal health indicators such as percentage of facility deliveries among mothers who gave birth in the past year.
Within the 2 study districts (Sultanpur and Fatehpur), in 120 villages that were selected at random, the SA interventions aim to distinguish the effect of provision of information and facilitated engagement of community members, from that of the effect of information alone. The 120 villages are randomized to either a control arm, or one of two treatment arms described below.
TREATMENT ARM 1 - Information \& Awareness:
Community members will receive information about their rights, roles and responsibilities of healthcare providers, and also about health-related activities and programs taking place in their village. Importantly, besides assessing the effect of providing information on health service delivery and various health outcomes, our evaluation will also determine how best to provide the information.
Another innovation in this project is to disseminate monthly information about health system related issues using interactive voice response messages (IVRs), phone calls, or home visits to households in the treatment villages. IVRs include a brief message about a health (or health system) indicator, or information regarding upcoming Village Health, Sanitation and Nutrition Committee (VHSNC) meetings or VHNDs, as well as a response option that can be used to collect data on what information households have received and about their participation in VHSNC meetings/VHNDs. These IVRs will be sent out over multiple months to cover approximately 24,000 households in 80 treatment villages each time. During preparatory phase that was conducted in parallel with the baseline survey, detailed data on social networks was collected in each village and identified central individuals in the village.
The investigators will use the data on networks in villages, combined with the information that is disseminated on a monthly basis to econometrically estimate how information dissemination within networks affects awareness and participation in social accountability activities as well as in utilization of health services.
TREATMENT ARM 2 - Information PLUS Community Engagement:
In addition to all the information interventions listed in treatment arm 1, community engagement will be facilitated in Arm 2 villages. The community engagement component aims to enhance the participation of the community in creating social accountability. The intervention will provide trained facilitators to help community members engage in a participatory process with Village Health, Sanitation, and Nutrition Committees (VHSNCs) and identify key deficiencies for improvement in health services that most concern community members. The facilitators are trained to help organize meetings and are provided a detailed checklist of activities that need to be undertaken prior to the day of the meetings such as inviting the block level officers and ensuring that logistics requirements for Village Health and Nutrition Days (VHNDs) are conveyed to VHSNC members in advance of the meetings. The facilitated meetings with healthcare providers and local and block level representatives aim to empower community members to demand better health services and convey these demands more effectively to providers and officials. The three key health workers at the village level (ASHA, ANM, and AWW) report to the local (village level) elected representatives and block level authorities, who receive feedback from the community in the accountability interventions. Moreover, through repeated community meetings village-level health workers are expected to respond to transparency and accountability innovations by improving quality of services delivered to their local constituents resulting in improvements in population health outcomes.
These interventions will focus on services delivered by village-level health workers including those providing primary care and maternal and child health services. The households surveyed in the project will be those with children less than 5 years of age. The interventions will cover and include all population subgroups, castes, and religious minorities in the treatment villages, and also collect data on all of these subgroups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –40 (of 120) randomly selected villages receive no intervention |
| Information Only | Other | Other: Information Only40 randomly selected villages are assigned to the "information only" arm where households will receive information regarding their rights and entitlements pertaining to healthcare, certain health outcomes specific to their village, as well as health-related activities happening in their village. |
| Information and Facilitation | Other | Other: Information and FacilitationThe remaining 40 villages will receive similar information as the villages in the Information Only Arm, but will also have facilitators present that ensure the existence of the VHSNC at the village level as well as the occurrence of VHSNC monthly meetings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- households residing in the villages selected for the evaluation
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information OnlyHouseholds will receive information regarding their rights and entitlements pertaining to healthcare, certain health outcomes specific to their village, as well as health-related activities happening in their village (such as the VHSNC meetings and Village Health and Nutrition Days). Information will be disseminated through an initial visit to all households, and from then on either through (1) broadcast messages sent to households via mobile phone, (2) central individuals in the village social network who will be asked to spread that information, or (3) public officials charged with spreading the information throughout the village. | Other | Information Only |
| Information and FacilitationIn addition to the information interventions described above, this intervention will provide trained facilitators to help community members engage in a participatory process with VHSNCs and identify key deficiencies for improvement in health services that most concern community members. The facilitators are trained to help organize meetings and are provided a detailed checklist of activities to be undertaken prior to the the meetings. The three key health workers at the village level (ASHA, ANM, and AWW) report to the local (village level) elected representatives and block level authorities, who receive feedback from the community in the accountability interventions. | Other | Information and Facilitation |
Primary outcome
Weight-for-height Z scores
Time frame: 12 months after intervention implementation
5 secondary outcomes
Satisfaction with providers - averaged from a rating index and/or constructed by a PCA on the rating index
Time frame: 12 months after intervention implementation
Participation - as measured from self-report
Time frame: 4 months, measured each month, and at 1 year during endline survey
U5 mortality rate
Time frame: 12 months after intervention implementation
incidence of diarrhea
Time frame: 12 months after intervention implementation
duration of diarrhea illness
Time frame: 12 months after intervention implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- BackgroundRingold, D., Holla, A., Koziol, M., & Srinivasan, S. (2012).
- Individual participant dataSharing planned: Yes. The investigators plan to make the de-identified data set publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Mohanan, PhD, MSPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information Only and Information and Facilitation in people with Health Behavior, run by Duke University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-for-height Z scores (time frame: 12 months after intervention implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.