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

NCT01230515 | Completed

• 2 other identifiers: VICC SUPP 0566P30CA068485
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain

Keywords

Oncology Pain Management in outpatient hospice setting

Outcome Measures

Primary Outcomes (1)

• Adequate pain control

  Until death.

Study Arms (4)

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

Interventions

Individual patient interview, focus group and structured survey OTHER

Patient

interview, focus group and structured survey OTHER

Caregiver

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospice Staff Caregiver Patient Referring Physician

You may qualify if:

• 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

You may not qualify if:

• patients \< 21 years of age
• pregnant or lactating
• patients, caregiver and or Hospice staff that does not speak/comprehend English

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingam Cancer Center

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Cancer Pain

Interventions

Focus Groups; Interviews as Topic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Barbara Murphy, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 29, 2010
• Study Start: January 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: March 1, 2008
• Last Updated: September 10, 2012

Record last verified: 2012-09

Locations

US (1)