- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01007422
Opioids Titration in Hospice Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Supportive Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara A. Murphy, MD, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VICC SUPP 0822
- P30CA068485 (U.S. NIH Grant/Contract)
- VU-VICC-SUPP-0822
- VU-VICC-IRB-IRB-080370
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on medical chart review
-
Mayo ClinicNational Cancer Institute (NCI)CompletedMalignant Central Nervous System Neoplasm | Malignant Skull Base NeoplasmUnited States
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterRecruitingCutaneous MelanomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHead and Neck CarcinomaUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Uterine Corpus Sarcoma | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus Cancer | Recurrent Cervical Carcinoma | Stage III Uterine Sarcoma | Stage IV Uterine Sarcoma | Stage I Uterine... and other conditionsUnited States
-
AIDS Malignancy ConsortiumNational Cancer Institute (NCI); University of Arkansas; The Emmes Company, LLCCompletedIncidence and Prevalence of Cancer in People Living With HIV/AIDS at Cancer Centers in Latin AmericaHIV Infection | Malignant Neoplasm | Recurrent Malignant Neoplasm | Human Immunodeficiency Virus 1 PositiveMexico, Argentina, Brazil
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedInvasive Breast CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMalignant Neoplasm | Malignant Respiratory Tract Neoplasm | Malignant Thoracic NeoplasmUnited States, Cyprus
-
M.D. Anderson Cancer CenterNational Institute of Allergy and Infectious Diseases (NIAID)RecruitingEvaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans SyndromeBronchiolitis ObliteransUnited States