Know Cancer

or
forgot password

Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol Stage 2, Part A


N/A
21 Years
N/A
Not Enrolling
Both
Pain, Solid Tumor

Thank you

Trial Information

Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol Stage 2, Part A


OBJECTIVES:

- To obtain prospective data describing standard pain management methods and outcomes in
the hospice setting.

OUTLINE: Data regarding pain and pain management is obtained from three sources: the
patient, the caregiver(s), and the medical records.

- Patient assessment*: At baseline, patients provide demographic data and complete the
Pain Assessment Form verbally via interview. The form addresses average pain, worst
pain, pain relief, hours in pain, pain-related distress, and barriers to pain control.
Patients are asked to rate pain control. Patients also complete the Pain Communication
Survey to assess how they communicate with health care providers about their pain.
After the baseline assessment is completed, pain is assessed by the research nurse
through home visits* 3 times weekly and telephone interviews twice weekly. During each
visit or telephone contact, patients are interviewed to complete the Pain Assessment
Form. Patients are followed until the time of death.

NOTE: *If a patient is not available for the scheduled home visit, the interview will take
place over the phone; if a patient is hospitalized or transferred to the inpatient hospice
facility, the patient interview will take place there.

- Primary caregiver assessment**: At baseline, primary caregivers complete a demographic
survey, a Pain Assessment Form, the Pain Communication Survey, Caregiver Self-Efficacy
in Pain Management Scale (CSEPMS), the Caregiver Pain Management Questionnaire (CPMQ),
and the Stressful Caregiver Adult Reactions to Experiences of Dying (SCARED).
Caregivers are then interviewed by the study nurse using the Pain Assessment Form as a
guideline. Follow-up data from caregivers is obtained through a daily diary,
interviews, and structured surveys. Primary caregivers complete the Pain Assessment
Form daily and are instructed to provide their assessment of the patient's pain. In
addition, caregivers are interviewed daily by a study nurse, who reviews the daily Pain
Assessment Form and obtains detailed information regarding the adequacy of patient pain
control, side effects of medication, barriers to pain control, and caregiver concerns
and burdens. Primary caregivers also complete CSEPMS, CPMQ, and SCARED questionnaires
at the end of weeks 1, 2, and 4 as part of follow-up. Primary caregivers are contacted
after the patient's death to assess pain control at the time of death.

- Secondary caregiver assessment: At baseline, secondary caregivers complete the same
baseline evaluation as primary caregivers over the phone. They complete the Pain
Assessment Form weekly and the CSEPMS, CPMQ, and SCARED questionnaires at the end of
weeks 1, 2, and 4. Secondary caregivers also undergo a post-mortem interview based on
the Pain Assessment Form.

- Chart review: Chart review is conducted by the research Nurse after a patient's death.
Cancer and cancer-related treatment are obtained and documentation about pain
management is recorded. From the time of study entry, all staff notes are reviewed to
document: pain assessment, calls to physicians or other support personnel (including
pharmacy calls), identified barriers to pain control, and treatment modifications
(including medications to treat side effects).

NOTE: **Patients and primary caregivers are interviewed independently.


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

Exclusion Criteria:

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Description of standard pain management methods and outcomes in the hospice setting

Outcome Time Frame:

date on study to death

Safety Issue:

No

Principal Investigator

Barbara A. Murphy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC SUPP 0731

NCT ID:

NCT00609297

Start Date:

July 2007

Completion Date:

May 2011

Related Keywords:

  • Pain
  • Solid Tumor
  • unspecified adult solid tumor, protocol specific
  • pain

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838