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.
調査の概要
状態
詳細な説明
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.
研究の種類
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Supportive Care
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To obtain determine the safety and feasibility of an opioid titration order sheet in the hospice setting.
時間枠: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
|
協力者と研究者
捜査官
- 主任研究者:Barbara A. Murphy, MD、Vanderbilt-Ingram Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- VICC SUPP 0822
- P30CA068485 (米国 NIH グラント/契約)
- VU-VICC-SUPP-0822
- VU-VICC-IRB-IRB-080370
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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