Treat and Track Observational Study of Patients Prescribed Topical Pain Creams (T&T-Pain)
A two-year + 3 Mo. observational study to track compliance and outcomes in adult patients prescribed compounded pharmaceutical creams for the treatment of pain. The project is designed to accumulate tracking information from both patients and physicians over the course of therapy as a supplement to the ordinary care that the patients will normally receive. We seek to discover aspects of successful and unsuccessful treatment using topical pain creams. This information will be analyzed and reports prepared of observations and emergent findings. These reports will be sent during the study every 1 or 2 months to patients, physicians and pharmacists who are participating in the Study. A final compilation of findings and observations will be circulated to participating patients, physicians and pharmacists.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Years|
|Official Title:||Treat and Track: Tracking Patient and Physician Experiences During Treatment of Pain With Compounded Pharmaceuticals|
- Change in patient reported pain levels following treatment [ Time Frame: One year following first patient enrolled ] [ Designated as safety issue: No ]Across active subjects who have a Baseline pain level AND a followup pain level as of 1 year following first patient enrolled (FPI). Applies to the intended use of the pain cream as established by the diagnosis and area to be treated.
- Patient global impression of benefit [ Time Frame: One year after first patient enrolled ] [ Designated as safety issue: No ]Assessed by a structured VAS for completion at followup and final visits. Will be assessed for all patients who have reported on the first followup visit. Mean and distribution will be reported.
- Frequency that patients do NOT use the pain cream as instructed [ Time Frame: One year following first patient enrolled (FPI). ] [ Designated as safety issue: No ]Both incidence (a count and percentage) and 5 most common reasons given by patients for not following the prescription will be reported. The information is proactively captured at followup visits. Baseline establishes prescribed use. Followup items probe for uses inconsistent with prescription. The population will include all subjects as of 1 year following FPI who have reported a followup visit.
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Prescribed Compounded Pain Cream
The study is limited to patients who have been prescribed treatment with a topical compounded pain cream as a component of their ordinary care by a qualified physician.
Other: Compounded Pain Cream
All patients will have been prescribed a topical pain cream prepared by a qualified compounding pharmacy
Description Of Data Relevant to Objectives:
The primary objective of this study is to document clinical experience. Specifically, the study will collect:
- The expectations from both patient and physician. These underlie patient willingness to use a topical therapy, and the physician's motivation in prescribing.
- What is prescribed and used. The composition of compounded creams vary. Is there an association between the agents / concentrations and the effects on different types of pain?
- Patterns of use of the creams. Do patients follow the prescription; do they adapt frequency and location of application? Why?
- What happens with use? Do pain scores change? How quickly, and in what ways do pain scores change with different diagnoses? What is the impact on patient lives? Are expectations typically fulfilled and/or are there surprises and emergent findings?
- Observations and structured assessments to tabulate the aspects of successful and unsuccessful treatment using topical pain creams of various compositions and for diverse underlying complaints.
- The level of satisfaction and perceived benefit. If treatment is discontinued, is it because the problem has been resolved? Or is there burden, cost or lack of benefit?
- Separate confidential information from patients and physicians so that the study team can learn how closely the patients' observations match those of the physicians. The level and nature of the correspondence between patient observations and clinician observations (or lack of it) will be shared in reports sent to study participants. Such reports will not disclose the identities of either physicians or patients.
- Comments on reports. An area of interest for the study is to investigate the interest in physicians and patients in the reports to be generated concerning the observations from other patients and other physicians. Will patients be interested in their trajectory of treatment? Will sharing the information impact the perceived value of treatment?
- Data capture is done at visits using structured forms developed in consultation with treating physicians.
- Patient data is captured to encoded forms sent by mail directly to the T&T data entry service to reduce bias that would otherwise influence self assessments of treatment benefit because of the desire of the patient to please the treating physician.
- Diagnostic standards: International Statistical Classification of Diseases and Related Health Problems, Ninth Revision (ICD9) or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision ( ICD10) codes for diagnosis of pain conditions to be treated are required.
- Checklists for each visit are completed as part of the trial record to ensure standard processes are followed by treating physicians.
- If missing or illegible data are not resolvable, then there will be NO imputation. Reports and analysis will be based only on entries where source values were clear. Data entry forms include range and completeness checks, prevention of illogical entry. Free text fields are important for capturing unexpected events and observations. These will be recorded verbatim into the database.
- There is no primary hypothesis under test. Observations reported will include counts for instances and trends. Assessments and ratings will be reported as averages and distributions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02195752
|Contact: Stephen A. Raymond, PhD||617 549 email@example.com|
|United States, California|
|Epic Aesthetic Medical Inst.||Not yet recruiting|
|Encino, California, United States, 91346|
|Contact: Jasmin Javaherian, MD 818-501-3366|
|Principal Investigator: Jasmin Javaherian, DO|
|Albeer Ibrahim, MD||Recruiting|
|Encino, California, United States, 91436|
|Contact: Albeer Ibrahim, MD 818-789-7937 firstname.lastname@example.org|
|Contact: Yensy Calero 818 789 7937|
|Principal Investigator: Albeer Ibrahim, MD|
|Carl K. Jonokuchi, MD||Not yet recruiting|
|Newbury Park, California, United States, 91320|
|Contact: Natasha Cox 805-499-3252 NCox.JonokuchiMD@gmail.com|
|Principal Investigator: Karl K Jonokuchi, MD|
|Arroyo Oaks Medical Group||Not yet recruiting|
|Thousand Oaks, California, United States, 91360|
|Contact: Daniel Tavari, DO 805-495-1066|
|Principal Investigator: Daniel Tavari, DO|
|Venturina Medical Care||Not yet recruiting|
|Thousand Oaks, California, United States, 91360|
|Contact: Arturo P. Venturina, MD 805-492-1255|
|Principal Investigator: Arturo P. Venturina, MD|
|Dan E. Dardashti, MD||Not yet recruiting|
|Valley Village, California, United States, 91607|
|Contact: Dan E. Dardashti, MD 818-508-9190 email@example.com|
|Principal Investigator: Dan E. Dardashti, MD|
|Advanced Pain Management||Not yet recruiting|
|Vista, California, United States, 92083|
|Contact: Anuj Gupta, MD 619-330-8771 firstname.lastname@example.org|
|Principal Investigator: Anuj Gupta, MD|
|CA Spine & Pain Institute||Not yet recruiting|
|West Hills, California, United States, 91307|
|Contact: Magued R. Fadly, MD 818-225-0045|
|Principal Investigator: Magued R. Fadley, MD|
|Woodland Hills Urgent Care||Not yet recruiting|
|Woodland Hills, California, United States, 91364|
|Contact: Boris Vaisman, MD 818-225-1255 doctor@thedoctorV.com|
|Principal Investigator: Boris Vaisman, MD|
|Study Director:||Stephen A. Raymond, PhD||Research and Marketing Consultants|