Opioids Titration in Hospice Patients

This study has been withdrawn prior to enrollment.
(Issues with Hospice)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01007422
First received: November 3, 2009
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

RATIONALE: Opioids lessen pain caused by cancer. Titration of opioids in the hospice setting is suboptimal due to numerous barriers. Order sets may help to provide timely and effective medical and pharmaceutical intervention.

PURPOSE: The purpose of this study was to identify barriers to good pain control in the hospice setting and to develop an order set that would safely address these barriers.


Condition Intervention
Pain
Solid Tumor
Behavioral: telephone-based intervention
Other: communication intervention
Other: intervention by caregiver
Other: medical chart review
Other: survey administration
Procedure: end-of-life treatment/management
Procedure: pain therapy
Procedure: psychosocial assessment and care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Opioid Titration In the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol Stage 2, Part B

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • To obtain determine the safety and feasibility of an opioid titration order sheet in the hospice setting. [ Time Frame: at 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 0
Study Start Date: June 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Supportive Care Behavioral: telephone-based intervention Other: communication intervention Other: intervention by caregiver Other: medical chart review Other: survey administration Procedure: end-of-life treatment/management Procedure: pain therapy Procedure: psychosocial assessment and care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Out-patient hospice patients.

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Able to speak/comprehend English
  • Lives within a 60-mile radius of Alive Hospice

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007422

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Barbara A. Murphy, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Barbara Murphy, MD, Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01007422     History of Changes
Other Study ID Numbers: VICC SUPP 0822, P30CA068485, VU-VICC-SUPP-0822, VU-VICC-IRB-IRB-080370
Study First Received: November 3, 2009
Last Updated: March 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
unspecified adult solid tumor, protocol specific
pain

Additional relevant MeSH terms:
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 22, 2014