Utilizing a Promotora Model for Rural Adult Hispanics Diagnosed With Metabolic Syndrome: A Clinical Trial

The following research questions will be investigated in this study:

1. For adult rural Hispanic patients who have been diagnosed with metabolic syndrome, does
adding the services of a promotora to a standard care model significantly change the
metrics associated with metabolic syndrome to a greater extent than a standard care
model only?

2. For adult rural Hispanic patients who have been diagnosed with metabolic syndrome, does
adding the services of a promotora to a standard care model significantly change the
attitude of trust in medical providers and the health care system to a greater extent
than a standard care model only?

3. For adult rural Hispanic patients who have been diagnosed with metabolic syndrome, does
adding the services of a promotora to a standard care model significantly change the
attitudes associated with comfort with seeking care in the health care system to a
greater extent than a standard care model only?

4. For adult rural Hispanic patients who have been diagnosed with metabolic syndrome, does
adding the services of a promotora to a standard care model significantly change the
perception of cultural bias in regard to treatment as compared with patients using the
standard care model only?

5. For adult rural Hispanic patients who have been diagnosed with metabolic syndrome, does
adding the services of a promotora to a standard care model significantly change the
attitudes associated with feelings of procedural fairness in health care treatment to a
greater extent than a standard care model only?

6. For adult rural Hispanic patients who have been diagnosed with metabolic syndrome, does
adding the services of a promotora to a standard care model significantly change the
Patient Activation Measure (PAM) score over time as compared with patients utilizing
only the standard care model?

7. For adult rural Hispanic patients who have been diagnosed with metabolic syndrome, does
adding the services of a promotora to a standard care model significantly change the
doctor-patient communication score over time as compared with patients utilizing only
the standard care model?

8. For rural Hispanic patients who have been diagnosed with metabolic syndrome, does
adding the services of a promotora to a standard care model significantly change the
perception of the cultural competence of providers as compared with patients
experiencing the standard care model only?

The proposed study utilizes a randomized clinical trial design to assess the efficacy of
combining community health worker/ promotora services plus standard clinical care versus a
standard clinical care model only for rural Hispanic patients diagnosed with metabolic
syndrome. This design has been selected because: 1) it best protects against possible
confounding, 2) there are no ethical issues with the study as all participants receive at a
minimum the current standard of care for metabolic syndrome, 3) three years is enough time
to assess results, and 4) sufficient staffing is available. In order to answer the research
questions posed earlier, primary data must be collected since a design that analyzes
secondary data is not sufficient in this instance.

Patients will be identified from three primary care clinics in Southern Idaho where they
receive care. The clinics are located in Caldwell, Nampa, and Jerome, Idaho. Caldwell has a
population of 47,000 (50.6% female) with 35% being Hispanic and 26% speaking Spanish as
their primary language. Nampa has a population of 81,000 (51% female) with 23% being
Hispanic and 17% of homes not having English as their primary language. Jerome has a
population of 11,000 (49.5% female) with 34% being Hispanic and approximately 24% of the
homes with Spanish as the primary language spoken.32 The Family Medicine Residency of Idaho
(FMRI) has two Rural Training Track (RTT) programs that will be participating, one in
Caldwell and one in Jerome (about 130 miles east of Caldwell). A third site will be a clinic
(35% of patients are Hispanic) in rural Nampa, a community located about 15 miles outside of
Boise. Each of these rural clinics sees between 1,000 (Nampa and Jerome) and 1,800
(Caldwell) unduplicated adult Hispanic patients per year, and an estimated 10-20% have
metabolic syndrome or are at extreme risk for developing this condition. After a review of
medical records, those patients identified with metabolic syndrome will be sent a letter
inviting participation in the study. Patients from outside the clinics will also be eligible
to participate by being notified of the opportunity through community advertising on Spanish
language radio and in churches, restaurants, and grocery stores frequented by members of the
Hispanic community. A patient recruitment coordinator will be employed for this purpose, and
he/she will continue to recruit until the number of patients needed to reach an adequate
sample size and who agree to participate is reached. No more than one patient per family
will be allowed to participate in the study. The Caldwell Clinic will seek to have 128
patients in each of the intervention and control groups (four cohorts of 32 in each of the
intervention and control groups). Each of the other two clinics will have a goal of 60
patients in each of the groups (three cohorts of 20 in each of the intervention and control
groups). The cumulative number of 248 per group (sum of total enrollments from each clinic)
is to allow for a 10-12% attrition rate throughout the study timeframe and still retain
statistical power to detect differences that might exist between groups. If the 10%
attrition occurs, each group would still have an "n" of 225 which is the value used to
determine the statistical power in the analysis subsection of this plan. A chart in the
appendices illustrates the study sites, cohort sizes, and dates of data collection. Although
discussed in detail in Section Four, only those patients meeting the inclusion criteria and
who consent to participate will be included in the study.

All participants in this study will be adult rural residing patients of Hispanic ethnicity
diagnosed with metabolic syndrome. Patients from each clinic will be randomized into a
control group (total three clinic n = 248) and an intervention group (total three clinic n =
248) with the intervention group receiving education from a promotora in addition to the
standard treatment and the control group receiving the standard treatment protocol. All
patients will receive annual physical exams and appropriate lab tests (lab tests every six
months) and regular MD follow up. At time of introduction into the study and at six month
intervals for a period of one year, all participants will complete a patient activation
measure (PAM) and other qualitative attitude measures that will be described in more detail
later in this section. Initiation of the study will be staggered with the Caldwell clinic
starting in January 2014 and the other two clinics starting in April of 2015. Again, please
see the appendices for a detailed study plan chart complete with timelines. The use of
multiple clinics helps minimize (or at least allows for control for) the potential influence
of clinic environment and provider effects and enables better control for possible cohort
and history effects.

Using the Caldwell clinic as an example, each of the two promotoras will work with 16
patients over a three month period. During this timeframe, they will conduct four home
education visits with each patient and four group sessions with their entire 16 member
cohort. At the conclusion of the first three months, a new 16 patient cohort/promotora will
be started with new intervention patients. This three month intense contact sequence for
Caldwell patients will be repeated over four cycles until all 128 intervention patients have
experienced promotora exposure. Following their three month intense promotora exposure all
intervention patients will experience once monthly large group sessions with a promotora for
a total of nine months and will complete qualitative questionnaires and laboratory tests at
six month intervals until one year from their start date arrives. After a patient's one year
anniversary of beginning the study protocol, the study will end for that person. Each
intervention cohort will be accompanied by a control group of patients equal in number. The
one year timeframe for each clinic helps reduce the chances of an elevated drop-out rate.

This pattern will repeat itself in year two with the Nampa clinic and the Jerome clinic each
having one promotora with 20 intervention patient cohorts beginning on April 1, 2015.
Because each of these clinics is smaller than Caldwell, three cycles (instead of four) of
three month intense promotora exposure (4 individual and 4 group sessions) will be held and
fewer patients will be recruited. Of course, each 20 person cohort will be mirrored by a 20
patient control group. Again after the intense promotora exposure, all intervention patients
will experience once monthly large group sessions with a promotora and will complete
qualitative questionnaires and laboratory tests at six month intervals until one year from
their start date arrives.

For all clinics, patients assigned to the control group will have an entrance physical
screening and complete their qualitative questionnaires and PAM instrument and have
laboratory tests at the start of the study, at six month intervals, and an exit physical
exam one year after enrolling in the study.

Promotoras will be recruited from each community with significant input from members of the
Hispanic Community Advisory Board (CAB) that has been actively involved in the Companeros en
Salud (CES) or Partners in Health (PIH) program through the Idaho Partnership for Hispanic
Health for the past five years. The promotora training model for this study is adapted from
the established curriculum for that project. Standard templates for recruitment and training
have been developed by Linda Powell, Principal Investigator of the Companeros en Salud
project. Co-PI Lynda Bennett of Mountain States Group will direct the recruitment, training
and ongoing support/oversight of promotoras to ensure consistency of delivery of
intervention trainings across the three communities, as well as timeliness and fidelity to
the topics they are to discuss with group members and their families.

Inclusion Criteria:

- Adult

- Rural dwelling Hispanics who have been diagnosed with metabolic syndrome

Exclusion Criteria:

- All others