PainNCT01007422
Opioids Titration in Hospice Patients
An observational study of Pain and Solid Tumor, run by Vanderbilt-Ingram Cancer Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pain, Solid Tumor
- What is being tested?
- telephone-based intervention, communication intervention and intervention by caregiver
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out-patient hospice patients.
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
About this study
Official title: Opioid Titration In the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol Stage 2, Part B
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.
Read the 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.
- Conditions
- Pain, Solid Tumor
- Being tested
- telephone-based intervention, communication intervention, intervention by caregiver, medical chart review, survey administration
- Keywords
- unspecified adult solid tumor, protocol specific, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-based interventionBehavioural
communication interventionOther
intervention by caregiverOther
medical chart reviewOther
survey administrationOther
end-of-life treatment/managementProcedure or surgery
pain therapyProcedure or surgery
psychosocial assessment and careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain determine the safety and feasibility of an opioid titration order sheet in the hospice setting.
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.
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Issues with Hospice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Barbara A. Murphy, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007422
- Sponsor's protocol ID
- VICC SUPP 0822
- Other IDs
- P30CA068485, VU-VICC-SUPP-0822, VU-VICC-IRB-IRB-080370
- Status last verified
- Mar 2013
- First submitted
- 3 Nov 2009
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Titration In the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol Stage 2, Part B
- ClinicalTrials.gov ID
- NCT01007422
- Acronym / sponsor ID
- VICC SUPP 0822
- Conditions
- Pain, Solid Tumor
- Keywords
- unspecified adult solid tumor, protocol specific, pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Issues with Hospice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out-patient hospice patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone-based intervention | Behavioural | Supportive Care |
| communication intervention | Other | Supportive Care |
| intervention by caregiver | Other | Supportive Care |
| medical chart review | Other | Supportive Care |
| survey administration | Other | Supportive Care |
| end-of-life treatment/management | Procedure or surgery | Supportive Care |
| pain therapy | Procedure or surgery | Supportive Care |
| psychosocial assessment and care | Procedure or surgery | Supportive Care |
Primary outcome
To obtain determine the safety and feasibility of an opioid titration order sheet in the hospice setting.
Time frame: at 4 weeks
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara A. Murphy, MD principal investigator
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Solid Tumor, run by Vanderbilt-Ingram Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To obtain determine the safety and feasibility of an opioid titration order sheet in the hospice setting. (time frame: at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.