Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol

Cancer Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230515
• Other study ID #: VICC SUPP 0566
• Secondary ID: P30CA068485
• Status: Completed
• Phase: N/A
• First received: October 11, 2010
• Last updated: September 7, 2012
• Start date: January 2006
• Est. completion date: March 2008

Study information

• Verified date: September 2012
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to modify the opioid titration order sheet to meet the needs of the outpatient hospice population and to conduct a pilot trial to assess feasibility, utility, and derive preliminary efficacy data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patient eligibility includes:

• Alive Hospice outpatient

• Diagnosis of carcinoma

• Pain requiring fixed dose opioids

• Age > 21 years

• Not pregnant or lactating

• Willing and able to sign informed consent

• Able to speak/comprehend English

Caregiver eligibility will include:

• Caregiver for an Alive Hospice patient

• Willing and able to sign informed consent

• Able to speak/comprehend English

Hospice Staff eligibility will include:

• Currently on staff at Alive Hospice

• Willing and able to sign informed consent

• Able to read/speak English.

Referring Physician eligibility will include:

• Having recently referred patients to Alive Hospice

• Willing and able to sign informed consent and able to read/speak English.

Exclusion Criteria:

• patients < 21 years of age

• pregnant or lactating

• patients, caregiver and or Hospice staff that does not speak/comprehend English

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Other:
• Individual patient interview, focus group and structured survey

• interview, focus group and structured survey

• interview, focus group and structured survey

• interview, focus group and structured survey

Locations

Country	Name	City	State
United States	Vanderbilt-Ingam Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate pain control		Until death.	No