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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02195063
• Other study ID #: RAHM 1001
• Status: Recruiting
• Phase: Phase 4
• First received: July 15, 2014
• Last updated: January 27, 2015
• Start date: November 2013

Study information

• Verified date: January 2015
• Source: Rahm Foundation
• Contact: Christina R Cook, PhD
• Phone: 615-712-9574
• Email: ccook[@]blueprintpathways.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain
• Scars
• Urinary Drug Testing
• Wounds

Locations

Country	Name	City	State
United States	Blueprint Pathways	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Rahm Foundation	Datum Research, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain survey results from baseline at 30 days	Survey on pain management	baseline and 30 days	No
Primary	Change in pain survey results from baseline at 60 days	Survey on pain management	baseline and 60 days	No
Primary	Change in pain survey results from baseline at 90 days	Survey on pain management	baseline and 90 days	No
Primary	Change in scar care survey results from baseline at 30 days	Survey on scar care	baseline and 30 days	No
Primary	Change in scar care survey results from baseline at 60 days	Survey on scar care	baseline and 60 days	No
Primary	Change in scar care survey results from baseline at 90 days	Survey on scar care	baseline and 90 days	No
Primary	Change in wound care survey results from baseline at 30 days	Survey on wound care	baseline and 30 days	No
Primary	Change in wound care survey results from baseline at 60 days	Survey on wound care	baseline and 60 days	No
Primary	Change in wound care survey results from baseline at 90 days	Survey on wound care	baseline and 90 days	No
Primary	Change in UDT survey results from baseline at 30 days	Survey on urinary drug testing	baseline and 30 days	No
Primary	Change in UDT survey results from baseline at 60 days	Survey on urinary drug testing	baseline and 60 days	No
Primary	Change in UDT survey results from baseline at 90 days	Survey on urinary drug testing	baseline and 90 days	No
Secondary	Change in pain survey results from 30 days at 60 days	Survey on pain management	30 days and 60 days	No
Secondary	Change in pain survey results from 30 days at 90 days	Survey on pain management	30 days and 90 days	No
Secondary	Change in pain survey results from 60 days at 90 days	Survey on pain management	60 days and 90 days	No
Secondary	Length of hospital stay	if applicable	at baseline	No
Secondary	Change in scar care survey results from 30 days at 60 days	Survey on scar care	30 days and 60 days	No
Secondary	Change in scar care survey results from 30 days at 90 days	Survey on scar care	30 days and 90 days	No
Secondary	Change in scar care survey results from 60 days at 90 days	Survey on scar care	60 days and 90 days	No
Secondary	Change in wound care survey results from 30 days at 60 days	Survey on wound care	30 days and 60 days	No
Secondary	Change in wound care survey results from 30 days at 90 days	Survey on wound care	30 days and 90 days	No
Secondary	Change in UDT survey results from 60 days at 90 days	Survey on urinary drug testing	60 days and 90 days	No
Secondary	Change in UDT survey results from 30 days at 60 days	Survey on urinary drug testing	30 days and 60 days	No
Secondary	Change in UDT survey results from 30 days at 90 days	Survey on urinary drug testing	30 days and 90 days	No

External Links

•   Blueprint Pathways
•   The Rahm Foundation