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

January 27, 2015 updated by: Rahm Foundation

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in pain survey results from baseline at 30 days
Time Frame: baseline and 30 days
Survey on pain management
baseline and 30 days
Change in pain survey results from baseline at 60 days
Time Frame: baseline and 60 days
Survey on pain management
baseline and 60 days
Change in pain survey results from baseline at 90 days
Time Frame: baseline and 90 days
Survey on pain management
baseline and 90 days
Change in scar care survey results from baseline at 30 days
Time Frame: baseline and 30 days
Survey on scar care
baseline and 30 days
Change in scar care survey results from baseline at 60 days
Time Frame: baseline and 60 days
Survey on scar care
baseline and 60 days
Change in scar care survey results from baseline at 90 days
Time Frame: baseline and 90 days
Survey on scar care
baseline and 90 days
Change in wound care survey results from baseline at 30 days
Time Frame: baseline and 30 days
Survey on wound care
baseline and 30 days
Change in wound care survey results from baseline at 60 days
Time Frame: baseline and 60 days
Survey on wound care
baseline and 60 days
Change in wound care survey results from baseline at 90 days
Time Frame: baseline and 90 days
Survey on wound care
baseline and 90 days
Change in UDT survey results from baseline at 30 days
Time Frame: baseline and 30 days
Survey on urinary drug testing
baseline and 30 days
Change in UDT survey results from baseline at 60 days
Time Frame: baseline and 60 days
Survey on urinary drug testing
baseline and 60 days
Change in UDT survey results from baseline at 90 days
Time Frame: baseline and 90 days
Survey on urinary drug testing
baseline and 90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain survey results from 30 days at 60 days
Time Frame: 30 days and 60 days
Survey on pain management
30 days and 60 days
Change in pain survey results from 30 days at 90 days
Time Frame: 30 days and 90 days
Survey on pain management
30 days and 90 days
Change in pain survey results from 60 days at 90 days
Time Frame: 60 days and 90 days
Survey on pain management
60 days and 90 days
Length of hospital stay
Time Frame: at baseline
if applicable
at baseline
Change in scar care survey results from 30 days at 60 days
Time Frame: 30 days and 60 days
Survey on scar care
30 days and 60 days
Change in scar care survey results from 30 days at 90 days
Time Frame: 30 days and 90 days
Survey on scar care
30 days and 90 days
Change in scar care survey results from 60 days at 90 days
Time Frame: 60 days and 90 days
Survey on scar care
60 days and 90 days
Change in wound care survey results from 30 days at 60 days
Time Frame: 30 days and 60 days
Survey on wound care
30 days and 60 days
Change in wound care survey results from 30 days at 90 days
Time Frame: 30 days and 90 days
Survey on wound care
30 days and 90 days
Change in UDT survey results from 60 days at 90 days
Time Frame: 60 days and 90 days
Survey on urinary drug testing
60 days and 90 days
Change in UDT survey results from 30 days at 60 days
Time Frame: 30 days and 60 days
Survey on urinary drug testing
30 days and 60 days
Change in UDT survey results from 30 days at 90 days
Time Frame: 30 days and 90 days
Survey on urinary drug testing
30 days and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rahm Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Datum Research, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RAHM 1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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