NCT01885858

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

2 months

First QC Date

June 15, 2013

Last Update Submit

November 11, 2013

Conditions

Keywords

health services researchfamily planningethnicityhealthcare disparities

Outcome Measures

Primary Outcomes (1)

  • 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

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

    Within the first 30 minutes after counseling session

  • Mean differences between ethnic profiles in the length counseling session

    Within the first 30 minutes after counseling session

  • Mean differences between ethnic profiles in the length of visit to the clinic

    Within the first 30 minutes after counseling session

  • Mean differences between ethnic profiles in costs of appointment for counseling session

    Within the first 30 minutes after counseling session

Study Arms (2)

Sequence 1

OTHER

Clinics receive first the indigenous and then the mestizo profile.

Behavioral: Indigenous profileBehavioral: Mestizo profile

Sequence 2

OTHER

Clinics receive first the mestizo and then the indigenous profile.

Behavioral: Indigenous profileBehavioral: Mestizo profile

Interventions

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.

Sequence 1Sequence 2
Mestizo profileBEHAVIORAL

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 1Sequence 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinic operated by the Ministry of Health
  • Clinic must provide family planning services

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Patricia J Garcia, PhD

    Universidad Peruana Cayetano Heredia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhDc

Study Record Dates

First Submitted

June 15, 2013

First Posted

June 25, 2013

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

October 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11