PROCEDIMIENTO TÉCNICO DE LA CVS

6.2.1 Overview

REdesigning MEDication Intensification Effectiveness Study for Diabetes is a multi- practice, clustered, randomized, clinical trial that took place in non-academic, stand-alone, primary care practices in Allegheny, Butler, and Westmoreland counties in Pennsylvania.

6.2.2 Population

After approval from the University of Pittsburgh Institutional Review Board, participant recruitment began in late 2012 and continued until February 2014. In order to be considered eligible for the study, participants had to be over the age of 18; diagnosed with T2D for at least one year; visited their primary care physician within the last 12 months; and have at least one of their most recent clinical values for HbA1c (≥7%), blood pressure (SBP≥140 mm/Hg or DBP≥80 mm/Hg), or LDLc (≥100 mg/dL) above goal. Patients who were not ambulatory; had gestational diabetes, were pregnant or planning on becoming pregnant in the next year; were moderately or severely cognitively impaired; had a scheduled surgery; were on dialysis; or were not able to read or comprehend English were excluded from the study. In total, 240 participants consented to the study, 175 in the intervention group and 65 in the control group.

Demographic characteristics, including age, sex, race, education, and income, as well as medical ones, such as duration of diabetes, smoking status, HbA1c, blood pressure, and LDLc values, were collected. Except for race, HbA1c, diastolic blood pressure, systolic blood pressure, and depression severity, there were no significant differences between groups. The

intervention group had more racial diversity; was more likely to have moderately severe depression; and was more likely to have higher HbA1c values compared with the control group. The control group was more likely to have higher diastolic and systolic blood pressure values and more likely to have severe depression scores compared with the intervention group.

6.2.3 Setting

All primary care practices owned by the University of Pittsburgh Medical Center that had at least fifty patients with T2D and had an electronic medical record system were considered eligible. Thirty-four practices were contacted in early 2012, with a goal of enrolling twenty practices. If practices declined to participate, more were contacted until eventually, fifteen practices agreed to participate. After agreeing to participate, the principal investigator, the CDEs, and the study coordinator met with the providers(s), office managers and staff to discuss the study and review the informed consent. Once informed consent was obtained from each physician within the practice, they were stratified into one of three groups, according to the number of patients with diabetes in the practice (under 200, 200-500, greater than 500). After stratification, practices were randomized, by flip of a coin, to either intervention or usual care. Practices were stratified so that a more balanced patient recruitment may be achieved.

All practices were located in southwestern Pennsylvania, in Allegheny, Butler, and Westmoreland counties. Of the fifteen practices, three were urban while the rest were suburban. All but one of the practices had more than one provider, and two-thirds of the practices had nursing staff. All of the practices had medical assistants, clerical support, and access to a case manager. None of the practices had certified diabetes educators (CDEs) working in the practice though diabetes education programs were available at local hospitals.

6.2.4 Intervention

The REMEDIES4D intervention is based around the use of allied health care providers employing evidence-based diabetes care protocols. These protocols were derived from the work previously done by Mayer Davidson(218), ADA Standards of Medical Care(65; 239-241), Standards for Diabetes Self-Management Education and Training(242), American Association of Clinical Endocrinologists Guidelines(243), National Cholesterol Educational Program Adult Treatment Plan III(244), and Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure 7 and 8(245; 246). Prior to implementation, the protocols were reviewed by the primary care providers participating in the study who were encouraged to provide feedback about the protocols which were presented to the medical director for the study, Dr. Francis Solano. The protocols were updated throughout the trial as evidence changed. The protocols were also altered to provide lower-cost alternatives if medication cost was a concern, as well as alternative therapies for those unable to tolerate statins. Any medical issue, such as depression or neuropathy, which fell outside the purview of the REMEDIES4D protocol, was referred to the participant’s primary care provider for follow up.

Participants randomized to the intervention group had a 12-month long intervention period. The participants had one-on-one research visits scheduled with the CDEs at baseline, and then at 3 months, 6 months, and 12 months after baseline. At the baseline visit, participants had their blood pressure taken, received a foot exam, and had a review of their medical history. The first research visit lasted approximately two hours. At every clinical visit, clinical values were assessed, and any gaps in care, such as eye exams or lab tests, were addressed and subsequently ordered. Following the REMEDIES4D protocol, the participant’s hyperglycemia, hypertension, and hypercholesterolemia medications were reviewed and, if required, changed

accordingly. All orders were written by the CDE and sent to the primary care provider electronically for approval. Other documentation relevant to the patient’s clinical condition was recorded in the electronic health record for the provider to review. While the protocols provide a step by step approach to medication intensification, the CDEs utilized a patient-centered approach that considered the patient’s attitude and expected treatment efforts, personalized goals, disease duration, support systems (including resources), risk for hypoglycemia or other adverse events, life expectancy and any comorbidities. If a medication change was ordered, CDEs followed up with the patient by phone or in person to see if any adjustment was needed. Though only four research visits were scheduled for each participant, they were encouraged to contact the CDE between visits either over the phone, via e-mail, or schedule an in person visit. All communication between the CDE and the participant, lab orders, and medication changes were recorded in the electronic medical record.

Participants randomized to the control group continued to receive standard diabetes care from their primary care providers. These participants were also offered a monthly patient- centered support group that was held at their primary care practice for the duration of the study. This support group was facilitated by one of the study’s CDEs.

Regardless of randomization assignment, all participants completed surveys related to the study at each research visit. These surveys collected information pertaining to demographics, medical history, quality of life, diabetes distress, self-care activities, health care utilization, treatment satisfaction, medication adherence, cognitive status, and depression.

6.2.5 Measurements

Table 6-1 REMEDIES4D timeline and measurements relative to aims 1-3 Assessment Timepoint (month)

Assessment Instruments Baseline 3 6 12 Data Source Clinical outcome and process

outcome measures

X X X X Medical Record

Sociodemographic Characteristics This instrument was developed by the investigators for the REMEDIES4D study.

X Survey

Medication Satisfaction Questionnaire

Based off of validated questionnaires, this instrument was developed by the investigators for the REMEDIES4D study.

X X X X Survey

AHRQ-CAHPS* Clinician & Group Survey: Diabetes Clinic Satisfaction Survey (244)

A subset of the validated AHRQ- CAHPS survey focusing on diabetes clinic satisfaction was used in REMEDIES4D.

X X X X Survey

Morisky Medication Adherence Scale (MMAS)(245)

Used to assess patient adherence to medication, this measurement has been repeatedly validated in different populations with different

medications.

Table 6 1 (Continued)

Patient Health Questionnaire-9 (PHQ- 9)(246)

A brief, validated survey that assesses the severity of depression. This instrument has 88% specificity and 88% sensitivity for detecting major depression.

X X X X Survey

Montreal Cognitive Assessment (MoCA)(247; 248)

An interview tool used to assess mild cognitive impairment(MCI) . Among older adults, using a cut off score of 23 the MoCA has 96% sensitivity and 95% specificity in detecting MCI.

X X Interview

Digit Symbol Substitution Test (DSST)(249)

The DSST measures attention, psychomotor speed, and executive function. This test is sensitive but not specific to brain dysfunction.

X X Interview

Participant medication alterations X X X X Medical Record * Agency for Healthcare Research and Quality-Consumer Assessment of Healthcare Providers and Systems.