Registry for Integrative Medicine Interventions Effectiveness

Rationale:

According to the Agency for Healthcare Research and Quality (AHRQ), observational databases
provide an opportunity for simultaneous exploration of the impact of integrative medicine on
various medical conditions. As opposed to selecting a single condition for which patients
may seek care at our sites, the project will allow us to collect prospective
patient-reported outcomes on a number of frequently seen medical conditions. By clustering
participants at the multiple IM clinical sites with the same medical condition, we will be
able to compare the impact of various integrative therapies on patient-reported outcomes.

Objectives:

Primary Objective

1. To evaluate the change in patient-reported outcomes (e.g. quality of life, mood and
stress) over time

Secondary Objectives

1. To evaluate whether patient-reported outcomes differ by baseline characteristics of the
participants (e.g. demographics, clinical condition, intervention sought)

2. In a subset of clinics, to collect cost data from patient encounters to allow cost
comparisons among the interventions and outcomes

OUTCOME ASSESSMENTS Patient Reported Outcomes (PROs) The PRIMIER Registry will use the
Research Electronic Data Capture (REDCap) as an online research management tool that can be
used to collect PRO data. REDCap is a free, online research management tool that enables
researchers to create study-specific Web sites for capturing participant data securely.

Patient-Reported Outcomes (PROs) is the term used to denote health data that is provided by
the patient through a system of reporting. A PRO is basically a patient's feedback on their
feelings or functions as they are dealing with chronic diseases or conditions. PROs can also
be measured when patients are undergoing treatment or are participating in a clinical trial.

The Patient-Reported Outcome Measurement Information System (PROMIS®), funded by the
National Institutes of Health, aims to provide clinicians and researchers access to
efficient, valid, and responsive self-reported measures of health, including symptoms,
function and well-being. PROMIS® instruments (short forms, computerized adaptive tests
(CATs), profiles) are a central feature of the Assessment Center instrument library.

PROMIS® is unique from other PRO systems in four ways:

1. PROMIS® data is comparable because there are common measurements across domains

2. PROMIS® measures are reliable and valid. They have been subjected to rounds of rigorous
review and testing to ensure that the measurements are precise, consistent, and
accurate.

3. PROMIS® is flexible: PRO tools or measures can be obtained by way of in-person
interviews, written questionnaires or computer-assisted tools.

4. PROMIS® is inclusive in that all people regardless of literacy, language, physical
function and life status can use its tools

The PRIMIER Registry will use the PROMIS-29 as the core data PRO collection tool along with
the Perceived Stress Scale-4 (PSS-4)and the Patient Activation Measure (PAM).

Cost Indicators

In a subset of sites, we will collect cost indicators of healthcare resource utilization,
including prescription medications, over-the-counter medications, physician and ER visits,
as well as measures of patient functionality such as work productivity. This analysis will
use the treatment utilization data obtained from the patient visit questionnaires as these
data allowed us to count the specific number of treatments each patient reported over the
course of the study. Patients will be asked to report the number of each type of IM
treatment session received at every data collection time point. In the event that a patient
skipped an interim study visit, they will be asked to report cumulative counts of IM
treatment sessions received since their previous visit. We recognize that patients may not
readily recall this information, so to ensure accuracy of this measure, research
coordinators (or other research staff) will review the patients' medical record to quantify
the type and number of visits to the participating integrative medicine clinical sites
during study participation.

Statistical Design

Primary Analysis The main analyses of the PRIMIER Registry will be descriptive and summary.

Major Secondary Analyses Since the PRIMIER Registry will collect many of the same variables
over a 2 year period, the secondary analyses will include examining the repeated variables
and changes from baseline.

General Statistical Methods We will summarize descriptive statistics using frequencies
(percentages) for categorical variables. We will report means, standard deviations, medians,
quartiles, minimums, and maximums for all continuous variables.

We will use univariate analyses to detect outliers which will be subsequently submitted as
queries to sites to ensure clean data. Questionnaires that can be aggregated into a score
will be scored and the scores will be used for summarizing.

We will perform repeated-measures analyses of variance to detect changes in PRO and cost
indicators over time. We will summarize results with a point estimate of mean change in the
outcome measures between baseline and any specified follow-up visit with 95% confidence
intervals. We will report P values for overall model summary, indicating any difference
between any two given points. If the P value is significant (<0.05), we will perform
follow-up linear regression analyses to verify that the trends are consistent in direction
throughout all study visits, indicating constant improvement or decline from visit to visit.

Exploratory Analyses We will look for variables and trends that are of interest to the
collaborating investigators to explore. The appropriate analysis plan will be developed to
take advantage of the wealth of data that will be collected in the PRIMIER Registry. At this
time, we do not know what future analyses will be conducted.

We do not know the medical conditions for which individual participants in this PRIMIER
Registry will seek help at the IM clinic, nor will we know in advance which IM interventions
patients will receive. With these limitations, we cannot predefine subgroups for statistical
analyses at present. However, in the future we will define post-hoc groups by clinical
condition (e.g., participants with cancer, chronic pain, headaches, etc.) or IM intervention
received (e.g., acupuncture, meditation, massage, etc.) for further analyses.

Inclusion Criteria:

- Be seen as a clinical patient in one of the participating Integrative Medicine (IM)
clinics and willing to participate in the Registry

- Be 18 years of age or older

- Have access to a computer with internet connection and a valid email address

- Be willing to be contacted in the future by study investigators

Exclusion Criteria:

- Not being seen by a provider for clinical purposes, but only involved in an education
program or one-time activity