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

Completed

• Conditions: Cancer Pain
• Interventions: Other: interview, focus group and structured survey; Other: Individual patient interview, focus group and structured survey

• Registration Number: NCT01230515
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-11
• Study Completion: 2008-03
• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-29
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-07
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Referring physician	interview, focus group and structured survey	Referring physicians will be asked to complete the Pain Knowledge and Attitudes survey as well as the TAM questionnaire and Demographic Survey.
Patient	Individual patient interview, focus group and structured survey	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.
Caregiver	interview, focus group and structured survey	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.
Hospice staff	interview, focus group and structured survey	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.

Primary Outcome Measures

Name	Time	Method
Adequate pain control	Until death.

Trial Locations

Locations (1)

Vanderbilt-Ingam Cancer Center; 🇺🇸 Nashville, Tennessee, United States