Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Brief Summary: Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.


Options:
A: Inclusion Criteria:

* For physician intervention inclusion criteria included; 1)primary care (general internist or family) physician in HealthPartners Medical Group. 2)Provided ongoing care to 20 or more adult patients with diabetes.
* For patients inclusion criteria included; An established diagnosis of diabetes based on either (a) two or more ICD-9 diagnosis codes for diabetes in a 12-month period of time, or (b) a filled prescription for a diabetes-specific drug within a 12-month period of time.

In addition, participating patients met all of the following criteria: (a) age less than 75 years, (b) Charlson comorbidity score of 3 or less, (c) linked to the a primary care physician who was participating in the study in two consecutive calendar years, (d) had pharmacy coverage at the time of the intervention and for the previous 12-month period, and (e) had either HBA1c \> 7% or LDL \> 130 mg/dl (or LDL \> 100 mg/dl if the patient also had CHD).

Exclusion Criteria:

* none
B: Inclusion Criteria:

Hospital: Treat \> 30 AMI/CHF cases/patients per year in Ontario

Patient:

* AMI Most responsible diagnosis of acute myocardial infarction(ICD-9 code 410)
* CHF Most responsible diagnosis of heart failure(ICD-9 code 428)

Exclusion Criteria:

Patient

* AMI Not admitted to an acute care hospital
* AMI Age \< 20 or \> 105 years
* AMI Invalid health card number
* AMI Admitted to non-cardiac surgical service
* AMI Transferred from another acute care facility
* AMI coded as an in-hospital complication
* AMI admission within the past year
* CHF Not admitted to an acute care hospital
* CHF Age \< 20 or \> 105 years
* CHF Invalid health card number
* CHF Admitted to surgical service
* CHF Transferred from another acute care facility
* CHF coded as an in-hospital complication
* CHF admission within the past three years
C: Inclusion/exclusion criteria are based on practice characteristics. Practices are considered the study participants. However, because of the individual nature of the intervention tool, individual healthcare providers in the participating practices will be asked to participate voluntarily in the intervention and data collection. We anticipate approximately 320 healthcare providers to be included in these 64 practices. The research study will not directly intervene on patients of participating healthcare providers. However, patient charts will be assessed to evaluate changes in the practice's screening and management behaviors. Patient records will be included in this project in proportion to patient representation in participating primary care practices in NC and in proportion to their rates of cholesterol screening.

Potentially eligible patients for the chart abstraction sample will be adults, ages 21 through 84 years, seen in the participating primary care practices during the baseline (July 1, 2001 - June 30, 2003) or follow-up (March 1, 2004 - February 28, 2006) periods. We are examining two-year periods to increase the proportion of patients that has been screened. We can include "year 0" (July 1, 2001 - June 30, 2002), because ATPIII was published in May 2001. Although the guidelines do not exclude persons older than 84 years, at present we propose to restrict the evaluation sample to the aforementioned age group, due to acknowledged controversies regarding the appropriate preventive strategies in the very old.

Practice Inclusion Criteria:

Primary Care Practices (Internal Medicine or Family Medicine) Within 3-hour driving radius of WFUSM At least 50% of practice's providers willing to participate in study Willingness to accept randomization assignment Willingness to participate in chart audit Have a computer suitable for connectivity with the PDAs for installation of software upgrades and for printing of patient-specific reports for medical record documentation purposes

Practice Exclusion Criteria:

Academic practices

Provider Inclusion Criteria:

Practicing healthcare provider affiliated with a primary care practice participating in GLAD Heart.

Willingness to participate

Provider Exclusion Criteria:

None

Potentially eligible patients for the chart abstraction sample will be adults, ages 21 through 84 years, seen in the participating primary care practices during the baseline (July 1, 2001 - June 30, 2003) or follow-up (March 1, 2004 - February 28, 2006) periods. We are examining two-year periods to increase the proportion of patients that has been screened. We can include "year 0" (July 1, 2001 - June 30, 2002), because ATPIII was published in May 2001. Although the guidelines do not exclude persons older than 84 years, at present we propose to restrict the evaluation sample to the aforementioned age group, due to acknowledged controversies regarding the appropriate preventive strategies in the very old.
D: Inclusion Criteria for Hospitals

Hospitals were invited to participate in the study if they fulfill the following criteria:

* have an Institutional Review Board (IRB), or existing committee which could serve as such, or have an agreement with an IRB which reviews the research protocols implemented in the hospital;
* have at least 500 vaginal deliveries per year;
* do not have an explicit policy for selective episiotomy and for active management of third stage of labor;
* are located within the study area in Argentina and Uruguay; and
* agree to participate in the study.

Exclusion Criteria for Hospitals

Preselected hospitals are performing baseline data collection. According to the results of the analysis of the baseline data collection, hospitals will be excluded if the episiotomy rate is low or the rate of active management of the third stage of labor is high, according to the following cut-off points:

* Episiotomy rate in spontaneous vaginal deliveries below 20%
* Rate of active management of third stage of labor over 25%

The sample size of the study was increased to allow for exclusions.

Expectant management is defined as "a hands-free policy" during third stage of labor until the placenta is expelled: no use of uterotonics or special maneuvers.

Sampling, Recruitment, and Screening Procedures

Latin American Center for Perinatology (CLAP) coordination team will be responsible for the hospital selection. The hospitals' fulfillment of selection criteria will be obtained through a survey of the Heads of the Obstetrical Departments.

Besides the selection criteria, the coordination unit will invite the hospitals to participate according to:

* their participation in previous trials coordinated by CLAP,
* their participation in other trials or research activities, and
* their location.

Of particular interest are the characteristics of each preselected hospital regarding the structure of the professional staff, number of deliveries, and clinical guidelines policy.

Answer: D