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

21 Years
Not Enrolling
Pain, Solid Tumor

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Trial Information

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

Objective 1:

To assess barriers to pain control in the hospice setting.

Using a mixed methods approach, key stakeholders including physicians, nurses, patients and
caregivers were queried about pain control in the hospice setting, barriers to pain control
and the desirability of an order set to address this issue.

Objective 2:

To develop and conduct pilot testing of an order set designed to improve pain control in the
hospice setting.

An opioid titration order sheet based on our previous R0-1 was modified based on the
information derived from the interviews and questionnaires completed by the physicians,
nurses, patients and caregivers.

A cohort of 20 patients were enrolled on the first phase of the pilot study in order to test
the modified pain assessment form and the feasibility administration of the study materials
to be completed by the patient and caregiver. Forms are as follows:

- Patient assessment: At baseline, patients provide demographic data and complete the
Pain Assessment Form and the Pain Communication Survey. The pain assessment 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 healthcare
providers about their pain. After the baseline assessment is completed, patients
complete the Pain Assessment form on a daily basis. Pain is also assessed by the
research nurse at least 3 times weekly (1 home visit* and 2 telephone interviews).
Patients are followed until the time of death.

NOTE: *If a patient is hospitalized or transferred to the inpatient hospice facility, the
patient interview will take place there.

- Caregiver assessment: At baseline, caregivers complete a demographic survey, a Pain
Assessment Form, the Pain Communication Survey, Caregiver Self-Efficacy in Pain
Management Scale (CSEPMS), 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 to
obtain more detailed information about adequacy of the patient's pain control, side
effects of medication, barriers to pain control, and caregiver concerns and burden.
Follow-up data from caregivers is obtained through completion of CSEPMS, CPMQ, and
SCARED questionnaires and their assessment of patient's pain form at the end of weeks
1, 2, and 3.

- Chart review: A research nurse conducts a chart review after patient's death. Cancer
and cancer-related treatment data is 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 physician or other support personnel (including pharmacy
calls), identified barriers to pain control, and treatment modifications (including
medications to treat side effects).

After 20 patients, it was deemed not feasible to complete the study forms and to recruit
adequately for the trial. The study was suspended.

Inclusion Criteria


- Meets 1 of the following criteria:

- Outpatient at the Alive Hospice in the State of Tennessee

- Diagnosed with carcinoma

- Pain requiring fixed-dose opioids

- Caregiver for an Alive Hospice patient

- Any caregiver who is identified by the patient is eligible


- Not pregnant or nursing

- Able to speak/comprehend English

- Lives within a 60-mile radius of Alive Hospice


- See Disease Characteristics

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To obtain determine the safety and feasibility of an opioid titration order sheet in the hospice setting.

Outcome Description:

Pain assessments will be completed at baseline and daily for 4 weeks. Survey instruments will be completed at the end of weeks 1, 2, and 3.

Outcome Time Frame:

at 4 weeks

Safety Issue:


Principal Investigator

Barbara A. Murphy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2008

Completion Date:

May 2009

Related Keywords:

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