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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01885858
Other study ID # UPCH-IADB 2012-2013
Secondary ID 59922
Status Completed
Phase N/A
First received June 15, 2013
Last updated November 11, 2013
Start date September 2012
Est. completion date October 2013

Study information

Verified date November 2013
Source Universidad Peruana Cayetano Heredia
Contact n/a
Is FDA regulated No
Health authority Peru: Ethics Committee
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 351
Est. completion date October 2013
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Universidad Peruana Cayetano Heredia Inter-American Development Bank

Outcome

Type Measure Description Time frame Safety issue
Primary Mean differences between ethnic profiles in the proportion of items on which providers exchanged information with simulated patients during counseling session within the first 30 minutes after counseling session No
Secondary Mean differences between ethnic profiles in the proportion of items on which providers complied with standards of interpersonal relations during counseling session Within the first 30 minutes after counseling session No
Secondary Mean differences between ethnic profiles in the length counseling session Within the first 30 minutes after counseling session No
Secondary Mean differences between ethnic profiles in the length of visit to the clinic Within the first 30 minutes after counseling session No
Secondary Mean differences between ethnic profiles in costs of appointment for counseling session Within the first 30 minutes after counseling session No
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