This is a cluster randomized control trial, which uses a pre-post test design to measure the impact of: (i) a health and social literacy intervention delivered to women of reproductive years and (ii) a teambuilding intervention to improve interprofessional collaboration of the primary healthcare team. The secondary aim of the project is to: (i) develop an electronic health database with health and social indicators, which can also be used to develop an index for Maternal Health and Wellbeing, and (ii) to develop a community needs assessment report which identifies environmental and social needs in the community which prevent optimal health outcomes. Senior peer consultancy has been taken from experienced researchers and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist [46] has been used to plan this project. All surveys and intervention material will be translated in the Urdu language by team members who are bilingual through the forward backward method.
Recruitment and selection criterion of data collectors and intervention facilitators
We will be recruiting and training existing LHWs to collect the electronic health and social data and to conduct the pretest-posttest questionnaire. The selection criterion for LHWs will be (i) currently employed and under contract with the government of Pakistan, (ii) with work experience of at least 5 years, (iii) married with children, (iv) permanent residents of the community. Help from the LHWs will be taken for the recruitment of CSWs to deliver the social and health literacy intervention. This will help in the following ways: (i) LHWs will be able to identify women within the community who are accepted by the participants as ‘insider’ members of the community, (ii) LHWs will be able to identify women who are interested in working on the project and remain with the project for the next two years, and (iii) there will be higher chance of LHWs and CSWs working congenially together and providing support to each other. The selection criterion for CSWs will be: (i) married with children, (ii) permanent residents of the community, and (iii) minimum schooling of secondary years or 10th grade. The recruitment for participants, data collectors, and intervention facilitators started in July 22 and training for a month was conducted in August 2022. The intervention started in September 2022.
Training and fidelity of data collectors and intervention facilitators
The LHWs and CSWs will be trained over a one-month period through online videos and calls. A cascade-based approach of training will be followed. The LHWs will be trained first by the PIs using in-person (Fig. 1) and online sessions, including Skype meetings, Zoom meetings, and a WhatsApp group (Fig. 2), which will allow exchange of written text, audio messages, and video calls. The training support and communication will remain through the 24-month study period and PIs will be in daily contact with the LHWs and CSWs through the Whatsapp group.
Video tutorials will be recorded and sent to the LHWs and CSWs, so that they can watch these videos more than once and when needed (Supplementary File 1: Youtube links to training videos). After recruitment of the CSWs, the PIs and LHWs will train the CSWs together. When the CSWs will deliver the literacy intervention, the LHWs will be available in person and the PIs will be available online for support. CSWs will also be provided laminated content material so they can use and share it with participants through the intervention period for reinforcement. The continuous communication through online means and periodic visits by different PIs to site will give a chance for clarification, feedback and trouble-shooting of any problems during the intervention. One or two members of the PIs will be available on Whatsapp during the monthly group literacy sessions to support the CSWs and communicate with the women participants when and if needed. The LHWs will be collecting data on their smartphones and will also use these phones to show the principal investigator trainings, for each module, to the group participants. The PIs will also be able to communicate with participants online and answer questions if needed.
Randomization and masking of participants for health and social literacy intervention
The selection criteria for the women participants are: (i) women of reproductive years, (ii) who are currently enrolled in the LHW programme, and (iii) who reside in the selected underdeveloped communities (having low literacy and poverty). We will be sampling women from Punjab, which is the most populated province of Pakistan with an estimated women population of 55 million [18]. The existing list of women clients enrolled with LHWs will be used to randomly select every third woman participant for inclusion in the study. Consenting women participants will be allocated to a control and experiment group. The experiment group will be sampled from three BHUs across three cities (Lahore, Faisalabad, and Multan) and two CSWs will be recruited in each area to deliver the intervention (Table 1). To prevent contamination, three BHUs from three other cities (Islamabad, Gujranwala, and Sialkot) will be sampled to include women in the control group. All six cities in the study are comparable in terms of population size and level of development. The sample size has been derived through the Taro Yamane formulae: n = N/ (1 + N (e) 2); where ‘N’ signifies the population under study. We estimated the women population receiving services from LHWs at 65.4 million women, as it is reported that 100,000 LHWs are working in the country to serve an estimated 60% of the women population [47]. Based on the formulae, and budget limitations, we targeted a final sample of 360 women of reproductive years- 180 in the experiment group and 180 in the control group. The CSWs, or intervention facilitators, and the women participants will know which group they are allocated to, however, they will not know the study hypotheses.
Table 1
Proposed data collection plan from Punjab, which is almost 60% of the population of Pakistan
City
|
Community Social Worker*
|
Lady Health Worker
|
BHU
|
Sampled women
(Experiment)
|
Sampled women
(Control)
|
Lahore
|
2
|
1
|
1
|
60
|
|
Islamabad
|
|
1
|
1
|
|
60
|
Faisalabad
|
2
|
1
|
1
|
60
|
|
Gujranwala
|
|
1
|
1
|
|
60
|
Multan
|
2
|
1
|
1
|
60
|
|
Sialkot
|
|
1
|
1
|
|
60
|
Total
|
06
|
06
|
06
|
180
|
180
|
Note: Each community social worker (CSW) will deliver an intervention to 30 women, in monthly group sessions with 10 women each (a ratio of 1 CSW: 10 women clients).
|
Baseline and pre-post test data collection
The health and social literacy intervention will be a 24-month project, which will start in August 2022 and last till August 2024. The electronic health and social data and the pretest-posttest data will be collected by LHWs, at the door-step of women respondents, through the assisted method as participants will be illiterate or semi-literate. Google survey forms will be developed for the project with different tabs for each data category to store relevant data. The data will be collected on LHW smartphones and then transferred to PIs, who will monitor data entry through shared google drive. The CSWs will deliver their monthly group sessions to 10 women participants and they will coordinate to include women living closest to each other in each group. The monthly group session will take place at the most convenient location for the participants, which may include the open space outside the BHU, or the home garden or veranda area of the CSW or a volunteer participant from the group, or a volunteer from the community. The choice will depend on permission, convenient distance for all participants, and the space that provides the most privacy. Table 2 includes information related to the project intervention stages, the deliverables, the PIs responsible for project part, and the budget allocation.
Table 2
Summary of the intervention steps, with details, deliverables, investigator responsibility and funding allocation
Intervention / Activity
|
Brief Details
|
Deliverables
|
PI Responsible
|
Database development using digital app
|
- Collection of health and social data at baseline and development of an electronic database
- Finalization and communication of Index for Maternal Health & Wellbeing
|
- Socio-demographic predictors for health outcomes and index will be published in a paper
- Electronic data and index will be shared with policymakers & healthcare professionals
|
LHWs
+
Supervisor PIs:
SRJ, HA, AM & FNM
|
Community needs Assessment
|
- Assessment and observation notes by PIs, with FGDs and IDIs with community members and stakeholders will be conducted over a two-month period in the first 6 months of the project start
|
- A detailed community needs assessment report
- Meetings & seminars with community stakeholders and policy makers will be held for advocacy of needs
|
PIs:
SKB, RRD & SRJ
|
Team-building intervention for BHU health workers
|
- Three training workshops for BHU health workers will be arranged to improve communication, information-sharing and improved care plan development for clients
- A pretest and posttest survey will be administered at the beginning and end of the training
|
- Impact results of intervention will be published in a paper
- Findings will be used to guide policy makers and BHU team about improvement in interprofessional collaboration
|
PIs:
AM, SKB & SRJ
|
Health and social literacy intervention
|
- Monthly groups sessions with participants and family members will be held over a 24-month period
- A pretest and posttest survey will be administered at the beginning and end of the intervention
|
- Impact results of intervention will be published in a paper
|
CSWs
+
Supervisor PIs:
SRJ, HA, AM,
AJ, RRD, & SKB
|
Sampling and data collection for community needs assessment and team-building intervention
The community needs assessment and the intervention for team-building to improve interprofessional collaboration of the primary healthcare team will be conducted by the PIs, who have diverse specialties and experience in delivering training for team-building and collecting data for community needs assessment reports. Six BHUs will be sampled from underserved areas of Lahore, which are known to have urban slum zones. Data for the community needs assessment report will be collected over a two-month period, with visits by PIs twice a week during the data collection period. The data will include assessment and observation notes by PIs, along with focus group discussions (FGDs) and in-depth interviews (IDIs) with LHWs, community elders, women of reproductive years, and local government officials from each city area, to gather the relevant data. The selection criterion for the BHU team-building intervention will be currently employed BHU healthcare providers who are under contract with the government of Pakistan. We will ensure that all team members including the doctor, nurse and LHWs of the BHU center are part of the workshop. A joint certificate from University of Health Sciences, University of the Punjab, and Forman Christian College University will be given to the participants, as an incentive to make them participate. The workshop will consist of a three-day training which will be interactive, include presentations by different experts, and including team-building and care plan development activities.
Project phases
The project phases have been summarized in Fig. 3 and described below.
1.Electronic Health and Social Data Collection and Index Development
The electronic health and social data collection will be done at six BHUs across Pakistan, where the intervention for social and health literacy is planned. The data will be collected by the LHWs once at the start of the study. Three resources will be used to select key health and social variables to be collected, including: (i) Demographic and Health Survey [48], (ii) ‘Multimorbidity Assessment Questionnaire for Primary Care’[49], and (iii) A Practical Guide to Measuring Women’s and Girls’ Empowerment in Impact Evaluations [50]. The following domain areas will be measured: (i) Wellbeing, personal growth, and financial strain; (ii) Lifestyle, early life experiences, stress and trauma; (iii) Social relationships, closeness, and household tasks; (iv) Personality, conscientiousness, and extreme behavior; (v) Work satisfaction and work-life balance; and (vi) Self-related beliefs, constraints and social status (Appendix A). Based on this data we will also be able to screen participants for risk and determine need for specific services and further referral, such as therapy, chronic disability management, or other health risk. This data will be used to develop an index for Maternal Health and Wellbeing.
2. Community needs assessment
A community needs assessment will take place for three underserved BHU areas of Lahore city. The detailed and recommended guidelines and resources by University of Kansas: The Community Tool Box (2015) will be used for the assessment of the communities [51]. This is an adequate tool to assess underdeveloped regions and identify problems facing women and families. The report will include key areas related to existing services and quality of: (i) housing and sanitation, (ii) water and food security, (iii) waste disposal and sewerage system, (iv) transport services, (v) schooling and education services, (vi) safety and security, and (vii) availability of loan, entrepreneurial and poverty schemes.
3. Team-building intervention for BHU health workers
Training workshops for team-building will be arranged for three BHU teams (including the doctor, nurse and LHW) of Lahore over a three-day period. The aim will be to improve teamwork and collaboration and help BHU providers to develop improved care plans for their clients. The agenda will also include opportunity to share challenges and trouble shoot. A pretest and posttest survey will be used to measure the impact of the workshop on the BHU team, using the “Performance of interprofessional primary health care teams” survey [52]. The domain areas that will be measured include: (i) Workload measurement and Staff experiences; (ii) Patient experience and patient health status; (iii) Collaboration and peer feedback; (iv) Patient goals; (v) Care coordination; and (vi) Co-treatment and referral (Appendix B).
4. Health and Social Literacy Intervention
The health and social literacy intervention will be delivered to the participants in the experiment group over a 24-month period across three different cities. Each CSW will be responsible for 30 participants and deliver monthly group sessions at a ratio of 1 CSW:10 women participants. In this way, each CSW will host 3 group sessions per month to cover all their allocated participants. In alternative months a target of 10 women community members and family members, including husband and mothers-in-law, of the intervention participants will be included in the group sessions. The impact of the intervention will be measured based on the results from a pretest and posttest survey (Appendix C).
The literacy content for each of the six sub-areas of the intervention have been summarized in Appendices D-I. Each of the six literacy sub-areas will be covered in monthly group sessions comprising of 24 points of contact, and each literacy sub-area will be covered minimum 7 times to maximum 9 times (Appendix J). The guidelines for the intervention literacy content have been prepared by the PIs and include checklists, case-studies, group activities, brainstorming sessions, and community social services information (example, local loan services and insurance providers) which will help to elaborate on the training, promote understanding, reinforce knowledge areas, and help in absorption and retention. We believe this will help to promote transfer of literacy to practice in the long-run. The six sub-areas of the health and social literacy include:
i. Health Awareness & Literacy: Reproductive and child health
We will use the following standardized international survey, with modification and regional relevancy, for the health awareness and literacy intervention for reproductive and child health: “Knowledge and Reported Practices of Women on Maternal and Child Health” [53]. The following domain areas will be measured including: (i) Pregnancy and antenatal care; (ii) Health knowledge; (iii) Accessing health care; (iv) Vaccination coverage; (v) Child’s father/husband’s involvement in maternal and child care; and (vi) Household factors (e.g., hygiene, water and food preparation, waste disposable, and toilet quality).
ii Health Awareness & Literacy: Hygiene and sanitation & nutrition and immunity building
The following two surveys will be used for the health awareness and literacy for hygiene and sanitation and nutrition and immunity building intervention, with modification and regional relevancy: (a) “National Sanitation and Hygiene Knowledge, Attitudes, and Practices Survey” [54] and (b) “The Dutch Nutrition Centre Survey” [55].The following domain areas will be measured including: (i) Awareness of hygiene and sanitation; (ii) Practices for hygiene and sanitation; (iii) Knowledge and salience of nutrition; (iv) Preoccupation with nutrition and immunity building; and (v) Deliberate control of nutrition behavior.
iii. Health Awareness & Literacy: Health-risk behavior modification
The following standardized international survey will be used for the health awareness and literacy for health -risk behavior modification intervention: “Kilifi Health Risk Behavior Questionnaire” (KRIBE-Q) [56]. The following domain areas will be measured including: (i) prevention for Injury and Violence; (ii) Use of intoxicants; (iii) Neglect of chronic disease management; (iv) Physical Activity Behaviors; and (v) Seeking health consultancy and follow-up.
iv. Social Awareness and Literacy: Mental accounting and savings habits
We will be using a scale from Bangladesh to measure mental accounting and saving habits in women [57]. These questions have been developed by the authors along with the support of Abdul Jameel Latif Poverty Action Lab. The following domain areas will be measured including: (i) habits for formal and informal savings; (ii) planning and budgeting according to house and family needs, for short-run and long-run; and (iii) habits for loan repayment and future income-earning possibilities.
v. Social Awareness & Literacy: Attitudes about women’s role and knowledge of women’s rights
We will be using items from a study conducted to measure attitudes about women’s role and knowledge of women’s rights [58]. These items have have also been used by Abdul Jameel Latif Poverty Action Lab to measure women’s role and knowledge of women’s rights [42]. The following domain areas will be measured including: (i) Attitudes about women’s roles, compared to men; (ii) Attitudes about daughter’s roles; and (iii) Knowledge of women’s rights.
vi. Social Awareness & Literacy: Women’s critical thinking ability
Items from two studies will be used to measure women’s critical thinking ability [59, 60]. These studies have also been used by Abdul Jameel Latif Poverty Action Lab to measure women’s critical thinking ability [42]. The following domain areas will be measured related to skills for: (i) Interpretation; (ii) Analysis; (iii) Evaluation; and (iv) Inference.
Data analysis
The data will be analyzed using SPSS and STATA. There will be quantitative data from the health and social data and the pretest-posttest survey, which will be analyzed using descriptive statistics and multivariate regression. The health and social data will be used to prepare results about the sociodemographic characteristics of respondents and predictors for improved health. The health and social data will also be used to develop an Index for Maternal Health and Wellbeing based on four domains: (i) Physical and Reproductive Health, (ii) Mental and Emotional Wellbeing (iii) Social Wellbeing and (iv) Financial Wellbeing.
The pretest-posttest results will be used to show impact of the intervention on: (i) women participants health and social literacy, and (ii) the BHU team-building and interprofessional collaboration. For the former (impact on health and social literacy), the dependent variables will be ‘health literacy’ and ‘social literacy’ of women respondents, and the independent variables will be the ‘sociodemographic characteristics’ of the women. For the latter (impact on BHU team-building), the dependent variables will be ‘patient care plans’ and ‘team building collaboration’, and the independent variables will be the ‘sociodemographic characteristics’ and the ‘job satisfaction’ of the BHU team. Multiple linear regression will be used to show the higher odds of improvement in participants post the intervention. P values of less than 0.05 will be considered significant for this study and confidence intervals will be reported.
The qualitative data from the community needs assessment, including participation observation notes, FGDs and IDIs will be analyzed using thematic analysis. Notes and interviews will be transcribed and transferred to an Excel file and NVIVO. Both the software and manual theme generation will be used to discover areas of needs and challenges in the community which impact the health and wellbeing of women. The manual theme generation will be done independently by three PIs and then discussions will be held to merge the information and finalize the findings. The final themes will then be shared with independent community members who were not part of the original sample to confirm findings and ensure reliability of data.
Cost analysis
The PIs have received a grant award of USD 8,030.38 for this project. The budget head for payment to intervention facilitators is USD 2,178.48. The PIs will be transferring their allocated share of grant money to pay the LHWs and CSWs a total monthly stipend of for their work on the project of USD 30.25 per month for the project. LHWs will be paid for collecting electronic baseline data and pre-post test data; whereas the CSWs will be paid monthly for the 24 months of the intervention. The limitation of intervention budgets for social science, public health projects, and women’s health projects is a well-documented problem in Pakistan [61]. The final publications will include a detailed cost analysis to advise policymakers about role allocation and salary expectations of community health workers of Pakistan.
Data audit
The research project and data analysis will be conducted by the PI team. The funding body will not be involved in the research stages, data collection or data analysis. The project and data will be audited by Forman Christian College University (FCCU), Department of Office of Research, Innovation and Commercialization (ORIC). A six-monthly progress report will be shared with FCCU ORIC, the senior consultants for the project, and the sectoral collaborators for audit, for feedback during intervention and for overall assessment at the end of the project.
Data storage and sharing
All the data related to the project, and the soft copies (google drive data) and hard copies (observation and FGD notes from community needs assessment report), will be stored safely with the lead PI of the team (SRJ). Names of participants will be coded and anonymized before datasets will be shared with other researchers or publication bodies.
Patient and public involvement
This study includes perception-based surveys and literacy interventions, and do not involve any clinical interventions or any risks to the participants.
Pilot test
A pilot test of the baseline survey (including health and social data) and pretest and posttest survey will be held with the LHWs and approximately 15 women participants. These participants will not be part of the final intervention. This will help in finalizing the questions and the translation and providing feedback for improvement. The pilot test is scheduled in the month of July 2022.
Project investigators
An interdisciplinary team from the social sciences (sociology, education, economics, public health, and clinical psychology), humanities (mass communications, English language center), and life sciences (medical physician) will oversee the project. Senior researchers from FCCU will support the project for peer review, consultancy, budget supervision, and audit. Sectoral consultancy and support for sampling of BHUs and recruitment of LHWs and CSWs will be provided by The Primary & Secondary Healthcare Department, Punjab, Office of the Director General Health Services, Policy and Strategic Planning unit (PSPU).
Dissemination
We intend to have workshops and seminars to disseminate results with key stakeholders, policymakers and the health sector. We also intend to disseminate our findings in international and open access academic journals of repute. We would have to publish results in separate academic papers related to: (i) the impact results for the social and health literacy, (ii) the results for health and social data and predictors for health outcomes, and the index for Maternal Health and Wellbeing, (iii) the community needs assessment report, and (iv) the impact results for the team-building workshops for BHU healthcare providers.