Quality of Health CareNCT01885858
Measuring Ethnic Disparities in Family Planning Services in Peru
A study testing Indigenous profile and Mestizo profile in people with Quality of Health Care, run by Universidad Peruana Cayetano Heredia.
Trial summary
This study is designed as a crossover randomized controlled trial, to investigate the effects of client's ethnic characteristics on the quality of family planning services. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Quality of Health Care
- What is being tested?
- Indigenous profile and Mestizo profile
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Oct 2013
- 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
- Clinic operated by the Ministry of Health
- Clinic must provide family planning services
Who cannot join
- Primary health clinics with the lowest degree of specialization (categorized as I-1) and thus lacking the number of patients required to enable the simulated patient to pass through the facilities undetected.
About this study
Official title: Quality of Health Services in Indigenous Communities in Peru
This study is designed as a crossover randomized controlled trial, to investigate the effects of client's ethnic characteristics on the quality of family planning services.
Read the detailed description
The study aims at evaluating, in a causal way, whether health providers in Peru might be contributing to ethnic health disparities in the provision of family planning services. We perform a field experiment that combines audit studies and simulated patient methodologies. The study population consists of clinics in Metropolitan Lima that are administered by the Ministry of Health and which provide family planning counseling services. The sample in our study includes 351 clinics. The primary outcome measured in the study was a composite of service provider compliance to guideline technical tasks in family planning counseling. We pre-defined indigenous and mestizo profiles using distinctive cultural attributes such as clothing, styling of hair, posture and patterns of speech. With a 1:1 allocation as per a computer generated randomization schedule, and using permuted blocks of four, clinics were assigned to a sequence of ethnic profiles, either to receive the indigenous then the mestizo profile (sequence 1) or mestizo and then the indigenous profile (sequence 2) in two periods. The trial comprises two treatment periods each of five week's duration. The second treatment period followed the same sequence of visits than the first one to obtain at least a five-week 'wash-out' period to mask the study.
- Conditions
- Quality of Health Care
- Being tested
- Indigenous profile, Mestizo profile
- Keywords
- health services research, family planning, ethnicity, healthcare disparities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigenous profileBehavioural
Clinics receive simulated patients (SPs) enacting the indigenous profile, and interpreting a standardized script with a biographical and clinical background. The indigenous SP wears a lliclla (a traditional woven cloth that covers the back and shoulders), long braids, a woven cardigan and loose pants; she uses no make-up and, her patterns of speech are slower and her posture and movement more rigid than the mestizo SP. The script indicates that SPs do not want to have any more children and that her choice of method is the pill.
Mestizo profileBehavioural
Clinics receive simulated patients (SPs) enacting the mestizo profile, and interpreting a standardized script with a biographical and clinical background. The mestizo SP does not wear a lliclla (a traditional woven cloth that covers the back and shoulders) or long braids, but a pony tail or loose hair; she wears make-up and, a vest made of polar fleece, tight pants and culturally salient accessories; her patterns of speech are faster and her posture and movement less rigid than the indigenous SP. The script indicates that SPs do not want to have any more children and that her choice of method is the pill.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Other | Clinics receive first the indigenous and then the mestizo profile. Receives: Behavioral: Indigenous profile; Behavioral: Mestizo profile |
| Sequence 2 | Other | Clinics receive first the mestizo and then the indigenous profile. Receives: Behavioral: Indigenous profile; Behavioral: Mestizo profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean differences between ethnic profiles in the proportion of items on which providers exchanged information with simulated patients during counseling session
Measured: within the first 30 minutes after counseling session
Secondary outcomes (4)
Mean differences between ethnic profiles in the proportion of items on which providers complied with standards of interpersonal relations during counseling session
Measured: Within the first 30 minutes after counseling session
Mean differences between ethnic profiles in the length counseling session
Measured: Within the first 30 minutes after counseling session
Mean differences between ethnic profiles in the length of visit to the clinic
Measured: Within the first 30 minutes after counseling session
Mean differences between ethnic profiles in costs of appointment for counseling session
Measured: Within the first 30 minutes after counseling session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Health CareStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Inter-American Development Bank
- Responsible party
- Principal investigator, Maria-Elena Planas, Universidad Peruana Cayetano Heredia
- Investigators
- Patricia J Garcia, PhD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885858
- Sponsor's protocol ID
- UPCH-IADB 2012-2013
- Other IDs
- 59922
- Status last verified
- Nov 2013
- First submitted
- 15 Jun 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Health Services in Indigenous Communities in Peru
- ClinicalTrials.gov ID
- NCT01885858
- Acronym / sponsor ID
- UPCH-IADB 2012-2013
- Conditions
- Quality of Health Care
- Keywords
- health services research, family planning, ethnicity, healthcare disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Inter-American Development Bank
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Jun 2013 (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.
This study is designed as a crossover randomized controlled trial, to investigate the effects of client's ethnic characteristics on the quality of family planning services.
Detailed description
The study aims at evaluating, in a causal way, whether health providers in Peru might be contributing to ethnic health disparities in the provision of family planning services. We perform a field experiment that combines audit studies and simulated patient methodologies. The study population consists of clinics in Metropolitan Lima that are administered by the Ministry of Health and which provide family planning counseling services. The sample in our study includes 351 clinics. The primary outcome measured in the study was a composite of service provider compliance to guideline technical tasks in family planning counseling. We pre-defined indigenous and mestizo profiles using distinctive cultural attributes such as clothing, styling of hair, posture and patterns of speech. With a 1:1 allocation as per a computer generated randomization schedule, and using permuted blocks of four, clinics were assigned to a sequence of ethnic profiles, either to receive the indigenous then the mestizo profile (sequence 1) or mestizo and then the indigenous profile (sequence 2) in two periods. The trial comprises two treatment periods each of five week's duration. The second treatment period followed the same sequence of visits than the first one to obtain at least a five-week 'wash-out' period to mask the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Other | Behavioral: Indigenous profile, Behavioral: Mestizo profileClinics receive first the indigenous and then the mestizo profile. |
| Sequence 2 | Other | Behavioral: Indigenous profile, Behavioral: Mestizo profileClinics receive first the mestizo and then the indigenous profile. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinic operated by the Ministry of Health
- Clinic must provide family planning services
Key exclusion criteria (1 listed)
- Primary health clinics with the lowest degree of specialization (categorized as I-1) and thus lacking the number of patients required to enable the simulated patient to pass through the facilities undetected.
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 |
|---|---|---|
| Indigenous profileClinics receive simulated patients (SPs) enacting the indigenous profile, and interpreting a standardized script with a biographical and clinical background. The indigenous SP wears a lliclla (a traditional woven cloth that covers the back and shoulders), long braids, a woven cardigan and loose pants; she uses no make-up and, her patterns of speech are slower and her posture and movement more rigid than the mestizo SP. The script indicates that SPs do not want to have any more children and that her choice of method is the pill. | Behavioural | Sequence 1, Sequence 2 |
| Mestizo profileClinics receive simulated patients (SPs) enacting the mestizo profile, and interpreting a standardized script with a biographical and clinical background. The mestizo SP does not wear a lliclla (a traditional woven cloth that covers the back and shoulders) or long braids, but a pony tail or loose hair; she wears make-up and, a vest made of polar fleece, tight pants and culturally salient accessories; her patterns of speech are faster and her posture and movement less rigid than the indigenous SP. The script indicates that SPs do not want to have any more children and that her choice of method is the pill. | Behavioural | Sequence 1, Sequence 2 |
Primary outcome
Mean differences between ethnic profiles in the proportion of items on which providers exchanged information with simulated patients during counseling session
Time frame: within the first 30 minutes after counseling session
4 secondary outcomes
Mean differences between ethnic profiles in the proportion of items on which providers complied with standards of interpersonal relations during counseling session
Time frame: Within the first 30 minutes after counseling session
Mean differences between ethnic profiles in the length counseling session
Time frame: Within the first 30 minutes after counseling session
Mean differences between ethnic profiles in the length of visit to the clinic
Time frame: Within the first 30 minutes after counseling session
Mean differences between ethnic profiles in costs of appointment for counseling session
Time frame: Within the first 30 minutes after counseling session
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 13 Nov 2013.
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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.
Patricia J Garcia, PhD principal investigator
Universidad Peruana Cayetano Heredia
Questions about this trial
What is this clinical trial studying?
A study testing Indigenous profile and Mestizo profile in people with Quality of Health Care, run by Universidad Peruana Cayetano Heredia.
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 2 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 13 Nov 2013. 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?
Mean differences between ethnic profiles in the proportion of items on which providers exchanged information with simulated patients during counseling session (time frame: within the first 30 minutes after counseling session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2013.