- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01885858
Measuring Ethnic Disparities in Family Planning Services in Peru
November 11, 2013 updated by: Maria-Elena Planas, Universidad Peruana Cayetano Heredia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
351
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinic operated by the Ministry of Health
- Clinic must provide family planning services
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Sequence 1
Clinics receive first the indigenous and then the mestizo profile.
|
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.
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.
|
Other: Sequence 2
Clinics receive first the mestizo and then the indigenous profile.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
within the first 30 minutes after counseling session
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
Within the first 30 minutes after counseling session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Patricia J Garcia, PhD, Universidad Peruana Cayetano Heredia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
June 15, 2013
First Submitted That Met QC Criteria
June 20, 2013
First Posted (Estimate)
June 25, 2013
Study Record Updates
Last Update Posted (Estimate)
November 13, 2013
Last Update Submitted That Met QC Criteria
November 11, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- UPCH-IADB 2012-2013
- 59922 (Other Identifier: UPCH-SIDISI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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