Survey Study for Pain Management, Wound Care, Scar Care or UDT

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.

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Scars; Wounds; Urinary Drug Testing

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Blueprint Pathways
      • Contact: Christina R Cook, PhD; Phone Number: 615-712-9574; Email: ccook@blueprintpathways.com
      • Contact: Risa Tyo, PharmD; Phone Number: 615-712-9574; Email: rtyo@datumcro.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Pain management; patients undergoing transdermal treatment for pain
Scar care; patients undergoing transdermal treatment for scars
Wound care; patients undergoing transdermal treatment for wounds
UDT; patients receiving urinary drug tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain survey results from baseline at 30 days	Survey on pain management	baseline and 30 days
Change in pain survey results from baseline at 60 days	Survey on pain management	baseline and 60 days
Change in pain survey results from baseline at 90 days	Survey on pain management	baseline and 90 days
Change in scar care survey results from baseline at 30 days	Survey on scar care	baseline and 30 days
Change in scar care survey results from baseline at 60 days	Survey on scar care	baseline and 60 days
Change in scar care survey results from baseline at 90 days	Survey on scar care	baseline and 90 days
Change in wound care survey results from baseline at 30 days	Survey on wound care	baseline and 30 days
Change in wound care survey results from baseline at 60 days	Survey on wound care	baseline and 60 days
Change in wound care survey results from baseline at 90 days	Survey on wound care	baseline and 90 days
Change in UDT survey results from baseline at 30 days	Survey on urinary drug testing	baseline and 30 days
Change in UDT survey results from baseline at 60 days	Survey on urinary drug testing	baseline and 60 days
Change in UDT survey results from baseline at 90 days	Survey on urinary drug testing	baseline and 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain survey results from 30 days at 60 days	Survey on pain management	30 days and 60 days
Change in pain survey results from 30 days at 90 days	Survey on pain management	30 days and 90 days
Change in pain survey results from 60 days at 90 days	Survey on pain management	60 days and 90 days
Length of hospital stay	if applicable	at baseline
Change in scar care survey results from 30 days at 60 days	Survey on scar care	30 days and 60 days
Change in scar care survey results from 30 days at 90 days	Survey on scar care	30 days and 90 days
Change in scar care survey results from 60 days at 90 days	Survey on scar care	60 days and 90 days
Change in wound care survey results from 30 days at 60 days	Survey on wound care	30 days and 60 days
Change in wound care survey results from 30 days at 90 days	Survey on wound care	30 days and 90 days
Change in UDT survey results from 60 days at 90 days	Survey on urinary drug testing	60 days and 90 days
Change in UDT survey results from 30 days at 60 days	Survey on urinary drug testing	30 days and 60 days
Change in UDT survey results from 30 days at 90 days	Survey on urinary drug testing	30 days and 90 days

Collaborators and Investigators

• Sponsor: Rahm Foundation
• Collaborators: Datum Research, LLC

Publications and helpful links

Helpful Links

• Blueprint Pathways
• The Rahm Foundation

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Estimate): January 28, 2015
• Last Update Submitted That Met QC Criteria: January 27, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Pain management; Wound care; Scar care; UDT; Urinary drug testing
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: RAHM 1001