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

September 7, 2012 updated by: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

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

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt-Ingam Cancer Center

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

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospice Staff Caregiver Patient Referring Physician

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Caregiver
Family members will be asked to complete a demographic survey, an assessment of the patient's current pain, and a series of questionnaires including: Caregiver Pain Medicine Questionnaire, the Stressful Caregiving Adult Reactions To Experiences of Dying Scale, and the Caregivers' Self Efficacy in Pain Management Questionnaire. Upon completion of the questionnaires, patients and caregivers will be interviewed separately.
Other: interview, focus group and structured survey
Hospice staff
Hospice staff will be asked to complete the Pain Knowledge and Attitudes survey. They will also complete the Technology Acceptance Model (TAM) questionnaire to assess the perceived utility of an opioid titration order sheet to help manage pain control. A demographic survey will also be completed.
Other: interview, focus group and structured survey
Referring physician
Referring physicians will be asked to complete the Pain Knowledge and Attitudes survey as well as the TAM questionnaire and Demographic Survey.
Other: interview, focus group and structured survey
Patient
Demographic information includes education, marital status, number in household, and employment status will be obtained from patient. Clinical data will be obtained from the patient's medical records. Information to be obtained will include information about the type of cancer, stage of disease, time since diagnosis, current treatment for cancer, type of pain, time since onset of pain, and time of first opioid prescription. The patient will also take a pain assessment survey.
Other: Individual patient interview, focus group and structured survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adequate pain control
Time Frame: Until death.
Until death.

Collaborators and Investigators

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

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

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

January 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

October 11, 2010

First Submitted That Met QC Criteria

October 27, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 7, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC SUPP 0566
  • P30CA068485 (U.S. NIH Grant/Contract)

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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