PregnancyNCT02938936
Waiting Time. Wasting Time
A study testing Pre-natal visit scheduling in people with Pregnancy, run by Harvard School of Public Health (HSPH).
Trial summary
Our study's principle purpose is to determine whether decreasing waiting time before being seen for antenatal care increases demand for and use of antenatal care services in Mozambique. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Pre-natal visit scheduling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Jul 2017
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for individual study participants enrolled after delivery:
- 1. Women who delivered at the health facility during the weeks of recruitment
- Inclusion criteria for women whose waiting time is measured:
- 1. Women at the health facility to seek care for antenatal care or another reproductive health service (anticipate total enrollment of 800 women)
- Inclusion criteria for the health care provider survey is that the provider
- Have worked in the health facility for at least 6 months
- The health care worker provides ANC as part of their routine duties (anticipate total enrollment of 4 health care workers)
Who cannot join
- Exclusion criteria for individual study participants enrolled after delivery:
- Women under 18 years of age will be excluded
- Women whose babies die during labor or childbirth from the delivery exit interviews
- There are no exclusion criteria for the sample of women whose waiting time will be measured There are no exclusion criteria for the health care provider survey
About this study
Official title: Waiting Time. Wasting Time: A Randomized Control Trial to Investigate the Health Impacts of Improving the Quality of Antenatal Care in Mozambique
Our study's principle purpose is to determine whether decreasing waiting time before being seen for antenatal care increases demand for and use of antenatal care services in Mozambique.
Read the detailed description
This protocol describes a pilot study that will test the impact of a scheduling intervention intended to reduce waiting times for antenatal care. The study will include one intervention health clinic and one control clinic in Maputo, Mozambique. In the intervention facility women attending antenatal care will be informed that if they return at their scheduled date and time they will be seen within one hour by clinic staff rather than having to wait for an indefinite amount of time before being seen for care. Appointment cards will be clipped into ANC cards, which collect routine health data and are kept by women at the end of their ANC visit. Health facility staff will be trained to identify women who return at their scheduled time and to manage patient flow such that scheduled women are received quickly. After the start date of the intervention, all women attending ANC at the health facility will be provided a scheduled return date and time window. Baseline and endline exit interview surveys will be conducted in both intervention and control facilities to compare changes in waiting time, number of ANC visits, and provider satisfaction over the course the study period between clinics.
- Conditions
- Pregnancy
- Being tested
- Pre-natal visit scheduling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-natal visit schedulingOther
This intervention will include a scheduled date and time for prenatal care follow-up visits. Women in the intervention group seeking care for their first ANC appointment will be offered several appointment slots on their return date by the nurse providing their first ANC visit. Women will be able select among the time options and will be provided an appointment card with their scheduled date and time. Staff will limit the number of scheduled women per hour by maintaining an appointment book. Clinic staff will be trained to differentiate between women returning for a scheduled visit from first prenatal visits, emergencies, and unscheduled return visits. First visits and emergencies will be seen during the first 2 hours after clinic opening and unscheduled women will be seen during a one-hour time slot midday. When women return on their date, they will be seen within one hour of their appointment time by clinic staff.
| Study group | Role | What they receive |
|---|---|---|
| Scheduling Intervention | Experimental | Pre-natal visit scheduling Receives: Other: Pre-natal visit scheduling |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent of women completing at least 4 prenatal care visits before and after intervention
Measured: During most recent pregnancy, as reported in an exit survey conducted at discharge from delivery at baseline and six months after the start of the scheduling intervention
Change in average waiting time before being seen for prenatal care before and after intervention
Measured: Measured for 4 weeks at baseline before the start of the intervention, and for 4 weeks, 3 months after the start of the intervention
Secondary outcomes (2)
Change in nurses satisfaction with their job (1-5 scale)
Measured: Measured before the start of the intervention, and 6 months after the start of the intervention
Change in proportion of key ANC services respondent reports receiving at most recent prenatal care visit, 9 possible services measured in exit survey at discharge from delivery.
9 key services include:
- IPTP dose provided, measured by self-report
- Delivery plan discussed, measured by self-report
- Hemoglobin test measured by patient report of having had their blood drawn
- Recommendations for family planning and breast feeding provided, measured by self-report
- Detection of breech measured by report of the provider palpating the tummy
- Blood pressure
- Measurement of uterine height
- Urine test
- Recommendation for what to do in emergencies
Measured: Measured at baseline and 6 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
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 PregnancyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Economics and Political Science
- Responsible party
- Principal investigator, Margaret McConnell, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938936
- Sponsor's protocol ID
- 0344
- Status last verified
- Apr 2018
- First submitted
- 17 Oct 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Steenland M, Dula J, de Albuquerque A, Fernandes Q, Cuco RM, Chicumbe S, Gudo ES, Sequeira S, McConnell M. Effects of appointment scheduling on waiting time and utilisation of antenatal care in Mozambique. BMJ Glob Health. 2019 Nov 25;4(6):e001788. doi: 10.1136/bmjgh-2019-001788. eCollection 2019.
PubMed 31803509
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waiting Time. Wasting Time: A Randomized Control Trial to Investigate the Health Impacts of Improving the Quality of Antenatal Care in Mozambique
- ClinicalTrials.gov ID
- NCT02938936
- Acronym / sponsor ID
- 0344
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- London School of Economics and Political Science
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 19 Oct 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.
Our study's principle purpose is to determine whether decreasing waiting time before being seen for antenatal care increases demand for and use of antenatal care services in Mozambique.
Detailed description
This protocol describes a pilot study that will test the impact of a scheduling intervention intended to reduce waiting times for antenatal care. The study will include one intervention health clinic and one control clinic in Maputo, Mozambique. In the intervention facility women attending antenatal care will be informed that if they return at their scheduled date and time they will be seen within one hour by clinic staff rather than having to wait for an indefinite amount of time before being seen for care. Appointment cards will be clipped into ANC cards, which collect routine health data and are kept by women at the end of their ANC visit. Health facility staff will be trained to identify women who return at their scheduled time and to manage patient flow such that scheduled women are received quickly. After the start date of the intervention, all women attending ANC at the health facility will be provided a scheduled return date and time window. Baseline and endline exit interview surveys will be conducted in both intervention and control facilities to compare changes in waiting time, number of ANC visits, and provider satisfaction over the course the study period between clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduling Intervention | Experimental | Other: Pre-natal visit schedulingPre-natal visit scheduling |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Women who delivered at the health facility during the weeks of recruitment
- 1. Women at the health facility to seek care for antenatal care or another reproductive health service (anticipate total enrollment of 800 women)
- Inclusion criteria for the health care provider survey is that the provider
- Have worked in the health facility for at least 6 months
- The health care worker provides ANC as part of their routine duties (anticipate total enrollment of 4 health care workers)
Key exclusion criteria (4 listed)
- Women under 18 years of age will be excluded
- Women whose babies die during labor or childbirth from the delivery exit interviews
- There are no exclusion criteria for the sample of women whose waiting time will be measured There are no exclusion criteria for the health care provider survey
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 |
|---|---|---|
| Pre-natal visit schedulingThis intervention will include a scheduled date and time for prenatal care follow-up visits. Women in the intervention group seeking care for their first ANC appointment will be offered several appointment slots on their return date by the nurse providing their first ANC visit. Women will be able select among the time options and will be provided an appointment card with their scheduled date and time. Staff will limit the number of scheduled women per hour by maintaining an appointment book. Clinic staff will be trained to differentiate between women returning for a scheduled visit from first prenatal visits, emergencies, and unscheduled return visits. First visits and emergencies will be seen during the first 2 hours after clinic opening and unscheduled women will be seen during a one-hour time slot midday. When women return on their date, they will be seen within one hour of their appointment time by clinic staff. | Other | Scheduling Intervention |
Primary outcome
Change in percent of women completing at least 4 prenatal care visits before and after intervention
Time frame: During most recent pregnancy, as reported in an exit survey conducted at discharge from delivery at baseline and six months after the start of the scheduling intervention
Change in average waiting time before being seen for prenatal care before and after intervention
Time frame: Measured for 4 weeks at baseline before the start of the intervention, and for 4 weeks, 3 months after the start of the intervention
2 secondary outcomes
Change in nurses satisfaction with their job (1-5 scale)
Time frame: Measured before the start of the intervention, and 6 months after the start of the intervention
Change in proportion of key ANC services respondent reports receiving at most recent prenatal care visit, 9 possible services measured in exit survey at discharge from delivery.
Time frame: Measured at baseline and 6 months after the start of the intervention
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 2 May 2018.
- Derived from this study: PubMed 31803509Steenland M, Dula J, de Albuquerque A, Fernandes Q, Cuco RM, Chicumbe S, Gudo ES, Sequeira S, McConnell M. Effects of appointment scheduling on waiting time and utilisation of antenatal care in Mozambique. BMJ Glob Health. 2019 Nov 25;4(6):e001788. doi: 10.1136/bmjgh-2019-001788. eCollection 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-natal visit scheduling in people with Pregnancy, run by Harvard School of Public Health (HSPH).
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 7 inclusion and 4 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in percent of women completing at least 4 prenatal care visits before and after intervention (time frame: During most recent pregnancy, as reported in an exit survey conducted at discharge from delivery at baseline and six months after the start of the scheduling intervention). The study lists 2 primary outcomes in all. 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 NCT02938936, 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 2 May 2018.