Table 1 The WIN Project Design using the PRECIS Domains

Eligibility criteria for participants

Trial enrollment limited to individuals with co-occurring physical and behavioral health conditions and/or SMI, and current enrollment in the Texas Medicaid STAR + PLUS Program in the Harris Service Delivery Area. The strict enrollment criteria used are typically seen in explanatory trials.

Extent of flexibility in application of the intervention

The combination of personal navigators, use of MI, and the $1150 annual flexible wellness account is prescribed and must be followed. However, the self-directed nature of the intervention components reflects a participant-centered, tailored intervention. The intervention is pragmatic in that the navigators were embedded in Medicaid managed care plans were health care is normally delivered and the health and wellness goals and strategies were developed based on participant preferences.

Degree of personal navigator expertise in applying and monitoring the intervention

All personal navigators underwent an initial 1.5-day MI training by a psychologist who is an expert in MI. Following this training, navigators participated in 5 weeks of constructive phone calls addressing specific taped interactions. The personal navigators also undergo annual MI refresher training. An expert psychologist also monitors 2 randomly selected appointments using the Motivational Interviewing Treatment Integrity (MITI) coding scheme to assess navigator competency and adherence to MI on 6 dimensions (Global Rating, Giving Information, Questions, Simple Reflections, Complex Reflections, Spirit). The psychologist then provides feedback and refresher information to the personal navigators if their scores fall below minimal requirements for competency. The navigators adapt their approach to their participants’ needs but are required to follow MI techniques. This component of WIN has both pragmatic and explanatory elements.

Extent of flexibility in application of standard care for the control group

The standard care provided to the control group represents the usual care provided through the Medicaid Managed Care Plans. The State has contractual requirements for the Medicaid Managed Care Plans but the Plans have latitude in how they meet those requirements. This component of WIN is pragmatic.

Degree of practitioner expertise in applying and monitoring the application of standard care for the control group

Each Medicaid Managed Care Plan has a provider network and the providers must meet a set of licensure and state standards to be part of the network. However, the practitioners likely vary widely in how care is delivered to the Medicaid enrollees. This component of WIN is pragmatic.

Intensity of follow-up of trial participants

Trial participants are monitored closely through continued contact with study personnel. Intervention participants are contacted monthly by navigators and if not successfully contacted, a number of retention efforts are planned to re-engage this member back into the trial. Control and comparison participants are contacted monthly by mail and phone to provide updated contact information. This component of WIN is explanatory.

Nature of the primary outcomes

The primary outcomes are participant reported physical and mental health related quality of life using the SF12, which is measured in a standardized format; and clinical variables including blood pressure; HDL, LDL-C, Hba1c results for those who are diabetic; and BMI, which are obtained from the participants’ medical records. In addition, inpatient, emergency department, outpatient and total health care expenditures are obtained from the Medicaid claims and encounter data. The primary outcome is collected using methods consistent with an explanatory trial. The medical record and health care expenditure results are pragmatic in that the information is gathered for purposes other than the WIN Project.

Participant protocol compliance

The participants meet in-person with their personal navigators once every three months and have monthly teleconference calls where wellness goals and strategies are reviewed and discussed. Participants who have not completed appointments are contacted in a number of ways to ensure continued and timely completion. The participants are monitored monthly in terms of the spending on their flexible wellness accounts. Participants who are not using their flexible wellness accounts as planned receive additional support from the personal navigator in purchasing items to support their wellness goals. This component of WIN is explanatory.

Navigator protocol compliance

In addition to the monthly monitoring of MI-adherence, navigators are closely monitored for the number of participants successfully completing appointments each month. Navigators falling below recommended study standards are further consulted to discuss barriers for success. This component of WIN is explanatory.

Specification and scope of analysis of primary outcomes

The analysis plan was pre-specified and models follow an intent-to-treat structure to alleviate the bias in randomization of participants.