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Trial record 35 of 1403 for:    Peru

Measuring Ethnic Disparities in Family Planning Services in Peru

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ClinicalTrials.gov Identifier: NCT01885858
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : November 13, 2013
Sponsor:
Collaborator:
Inter-American Development Bank
Information provided by (Responsible Party):
Maria-Elena Planas, Universidad Peruana Cayetano Heredia

Brief 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.

Condition or disease Intervention/treatment Phase
Quality of Health Care Behavioral: Indigenous profile Behavioral: Mestizo profile Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Quality of Health Services in Indigenous Communities in Peru
Study Start Date : September 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Sequence 1
Clinics receive first the indigenous and then the mestizo profile.
Behavioral: 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.

Behavioral: Mestizo profile
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.

Sequence 2
Clinics receive first the mestizo and then the indigenous profile.
Behavioral: 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.

Behavioral: Mestizo profile
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Mean differences between ethnic profiles in the length counseling session [ Time Frame: Within the first 30 minutes after counseling session ]
  3. Mean differences between ethnic profiles in the length of visit to the clinic [ Time Frame: Within the first 30 minutes after counseling session ]
  4. Mean differences between ethnic profiles in costs of appointment for counseling session [ Time Frame: Within the first 30 minutes after counseling session ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885858


Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Inter-American Development Bank
Investigators
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Principal Investigator: Patricia J Garcia, PhD Universidad Peruana Cayetano Heredia

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Responsible Party: Maria-Elena Planas, PhDc, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT01885858     History of Changes
Other Study ID Numbers: UPCH-IADB 2012-2013
59922 ( Other Identifier: UPCH-SIDISI )
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Keywords provided by Maria-Elena Planas, Universidad Peruana Cayetano Heredia:
health services research
family planning
ethnicity
healthcare disparities