Clinical trial NCT02195063: Survey Study for Pain Management, Wound Care, Scar Care or UDT
Official title: Survey of Patients Who Have Been Prescribed a Topical Compound for Pain Management, Wound Care or Scar Care or to Patients Who Have Been Requested to do a Urinary Drug Test (UDT) by Their Provider.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Scars
Wounds
Urinary Drug Testing
Keywords: Pain management
Scar care
Wound care
UDT
Urinary drug testing
Lead sponsor: Rahm Foundation
Sponsor class: OTHER
Collaborators: name: Datum Research, LLC
First posted: 2014-07-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are given a prescription for topical compound for pain, scar care, or wound care, and agree to complete the surveys

or

Patients who are given a UDT and agree to complete the surveys.

Patients will be recruited into the study if their providers prescribe a topical cream for pain, scar care or wound care or if the provider performs a UDT prior to treatment or surgery. The providers will follow their office procedure for UDT. If they perform a UDT and the patient agrees to participate in the survey study, they will have the patient complete the surveys.

Brief summary: This is a survey study that will be given to patients who have been prescribed a topical compound for pain management, wound care or scar care or to patients who have been requested to do a urinary drug test (UDT) by their provider.

The initial survey for pain management, wound care, scar care or UDT will be given to the patient by their providers during their office visit.

Detailed description: We have designed a survey study that will be given to patients who have been prescribed a topical compound for pain management, wound care or scar care or to patients who have been requested to do a urinary drug test (UDT) by their provider.

The initial survey for pain management, wound care, scar care or UDT will be given to the patient by their providers during their office visit.

Follow-up surveys will be given at 30, 60, and 90 days. These surveys will be collected by e-mail or follow-up calls from Datum Research, LLC, contract research organization.

Data collection for this study will be derived through the 4 patient surveys (initial, 30 day, 60 day, and 90 day) and the prescription written by the provider.

The survey study will enroll patients until December 31, 2014, or until sufficient numbers have been achieved.

Rahm Foundation will continue the study until:

* Sufficient information has accumulated to meet the scientific objectives of the Study (i.e. numeric targets or effect size)
* The feasibility of collecting sufficient information diminishes to unacceptable levels, poor enrollment, loss to follow-up and/or
* Other methods of gathering appropriate information become achievable or are deemed preferable.

Datum Research will need to have access to the prescription to see what compound was prescribed.

Eligibility criteria: Inclusion Criteria:

* Prescribed a topical cream for pain, scar care, or wound OR Provider preforms urinary drug test

Exclusion Criteria:

* Subjects with legally authorized representatives
* Minors
* Prisoners

Primary outcomes:
measure: Change in pain survey results from baseline at 30 days
timeFrame: baseline and 30 days
measure: Change in pain survey results from baseline at 60 days
timeFrame: baseline and 60 days
measure: Change in pain survey results from baseline at 90 days
timeFrame: baseline and 90 days
measure: Change in scar care survey results from baseline at 30 days
timeFrame: baseline and 30 days
measure: Change in scar care survey results from baseline at 60 days
timeFrame: baseline and 60 days
measure: Change in scar care survey results from baseline at 90 days
timeFrame: baseline and 90 days
measure: Change in wound care survey results from baseline at 30 days
timeFrame: baseline and 30 days
measure: Change in wound care survey results from baseline at 60 days
timeFrame: baseline and 60 days
measure: Change in wound care survey results from baseline at 90 days
timeFrame: baseline and 90 days
measure: Change in UDT survey results from baseline at 30 days
timeFrame: baseline and 30 days
measure: Change in UDT survey results from baseline at 60 days
timeFrame: baseline and 60 days
measure: Change in UDT survey results from baseline at 90 days
timeFrame: baseline and 90 days
Secondary outcomes:
measure: Change in pain survey results from 30 days at 60 days
timeFrame: 30 days and 60 days
measure: Change in pain survey results from 30 days at 90 days
timeFrame: 30 days and 90 days
measure: Change in pain survey results from 60 days at 90 days
timeFrame: 60 days and 90 days
measure: Length of hospital stay
timeFrame: at baseline
measure: Change in scar care survey results from 30 days at 60 days
timeFrame: 30 days and 60 days
measure: Change in scar care survey results from 30 days at 90 days
timeFrame: 30 days and 90 days
measure: Change in scar care survey results from 60 days at 90 days
timeFrame: 60 days and 90 days
measure: Change in wound care survey results from 30 days at 60 days
timeFrame: 30 days and 60 days
measure: Change in wound care survey results from 30 days at 90 days
timeFrame: 30 days and 90 days
measure: Change in UDT survey results from 60 days at 90 days
timeFrame: 60 days and 90 days
measure: Change in UDT survey results from 30 days at 60 days
timeFrame: 30 days and 60 days
measure: Change in UDT survey results from 30 days at 90 days
timeFrame: 30 days and 90 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Blueprint Pathways
state: Tennessee
Study officials:
References: