Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2008-06-30
2009-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Supportive Care
telephone-based intervention
communication intervention
intervention by caregiver
medical chart review
survey administration
end-of-life treatment/management
pain therapy
psychosocial assessment and care
Interventions
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telephone-based intervention
communication intervention
intervention by caregiver
medical chart review
survey administration
end-of-life treatment/management
pain therapy
psychosocial assessment and care
Eligibility Criteria
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Inclusion Criteria
* Not pregnant or nursing
* Able to speak/comprehend English
* Lives within a 60-mile radius of Alive Hospice
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Barbara Murphy, MD
Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist
Principal Investigators
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Barbara A. Murphy, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Other Identifiers
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VU-VICC-SUPP-0822
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-IRB-IRB-080370
Identifier Type: -
Identifier Source: secondary_id
VICC SUPP 0822
Identifier Type: -
Identifier Source: org_study_id
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