Outcomes Registry After Ketamine Infusions for Chronic Pain: A Longitudinal Evaluation (ORACLE)
Nationwide Observational Registry of Patient Outcomes Following Ketamine Infusion Therapy for Chronic Pain
Ketamine is an anesthetic drug that is sometimes used to relieve chronic pain. The goal of this observational study is to learn about how patients respond to ketamine infusions for chronic pain.
Note: This study does not provide ketamine - instead, this study uses surveys to follow patients who are already scheduled to receive ketamine infusions as part of their regular medical care.
We will also follow a second group of patients who were recommended ketamine infusions by their doctor but were denied insurance coverage for this treatment. These participants will complete the same surveys for up to 16 weeks, starting from when their treatment was originally scheduled. Comparing this group to patients who received ketamine will help researchers better understand ketamine's effects and how insurance denials affect chronic pain patients.
調査の概要
詳細な説明
Some key questions this study would like to answer:
- How do patients respond to ketamine over time? This study will use surveys to track pain, sleep, mood, function, and other experiences for up to 16 weeks after a ketamine infusion.
- Does the dose matter? This study aims to find out whether patients who get higher doses of ketamine have longer-lasting pain relief, and whether there is a point of diminishing returns.
- What makes some patients respond better than others? For example, there are some early data suggesting that patients who worry more about their pain might have more trouble reducing their opioids after ketamine treatment even if they had pain relief.
- Are ketamine infusions addictive when used for pain treatment? This study will track cravings and drug liking for up to 16 weeks after a ketamine infusion. Addiction risk is expected to be low, but this study will document this risk systematically.
- What happens to patients who were recommended ketamine but denied insurance coverage? This study will compare their outcomes to patients who received ketamine, to better understand the impact of insurance denials and the real-world effects of ketamine treatment.
STUDY PROCEDURES SUMMARY
Upon consenting to the study, eligible participants will be asked to share their contact information, some background health information, details about their scheduled infusion, prior ketamine experience, and baseline symptoms. All personal information will be kept private and secure. Participants will be assigned a unique study number, and their name and contact details will not be shared with anyone outside the core study team.
Afterwards, participants will:
- Complete an online survey a few days before their infusion; then one survey each week for up to 16 weeks after their infusion. These surveys will track pain, mood, sleep, medication use, and other symptoms over time.
- Optionally allow the study team to review medical records related to their ketamine treatment (such as the ketamine dose, side effects, and diagnoses linked with treatment).
- Patients who were recommended ketamine but denied insurance coverage will have to opportunity to complete the same surveys
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Protocol Director
- 電話番号：650-264-9442
- メール：tlii@stanford.edu
研究場所
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California
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Stanford、California、アメリカ、94305
- Stanford Health Care
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コンタクト：
- Protocol Director
- 電話番号：650-264-9442
- メール：tlii@stanford.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Planning to receive an intravenous ketamine infusion for the treatment of chronic pain
Exclusion Criteria:
- Unable to read or understand English questionnaires
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 |
|---|---|
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Ketamine Treated Cohort
Observational cohort of patients who received ketamine infusion therapy for the treatment of chronic pain
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Intravenous ketamine infusion delivered as part of routine clinical care
他の名前：
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Denied Treatment Cohort
Observational cohort of patients who were recommended ketamine infusion therapy but did not receive this treatment due to lack of insurance coverage
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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 |
時間枠 |
|---|---|
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Change in PROMIS Pain Interference Score From Baseline
時間枠：8, 10, and 12 weeks after the ketamine infusion
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8, 10, and 12 weeks after the ketamine infusion
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change in Opioid Use From Baseline, Patient-Rated Global Assessment
時間枠：From enrollment to 12 weeks after the ketamine infusion
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From enrollment to 12 weeks after the ketamine infusion
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Pain Intensity From Baseline, 0-10 Numeric Rating Scale
時間枠：From enrollment to 16 weeks after the ketamine infusion
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From enrollment to 16 weeks after the ketamine infusion
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Change in PROMIS Physical Function Score From Baseline
時間枠：From enrollment to 16 weeks after the ketamine infusion
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From enrollment to 16 weeks after the ketamine infusion
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Change in PROMIS Sleep Disturbance Score From Baseline
時間枠：From enrollment to 16 weeks after the ketamine infusion
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From enrollment to 16 weeks after the ketamine infusion
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Change in PROMIS Anxiety Score From Baseline
時間枠：From enrollment to 16 weeks after the ketamine infusion
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From enrollment to 16 weeks after the ketamine infusion
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Change in PROMIS Depression Score From Baseline
時間枠：From enrollment to 16 weeks after the ketamine infusion
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From enrollment to 16 weeks after the ketamine infusion
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Change in PROMIS Social Isolation Score From Baseline
時間枠：From enrollment to 16 weeks after the ketamine infusion
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From enrollment to 16 weeks after the ketamine infusion
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Change in Pain Catastrophizing Scale Score From Baseline
時間枠：From enrollment to 16 weeks after the ketamine infusion
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From enrollment to 16 weeks after the ketamine infusion
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Change in Pain Self-Efficacy Questionnaire Score From Baseline
時間枠：From enrollment to 16 weeks after the ketamine infusion
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From enrollment to 16 weeks after the ketamine infusion
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Baseline Pain Medication Beliefs
時間枠：Pre-Treatment Baseline
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From the medication subscale of the Survey of Pain Attitudes (SOPA-Med) Scale
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Pre-Treatment Baseline
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Average Drug Liking and Craving Score
時間枠：From 1 to 16 weeks after the ketamine infusion
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Drug Liking and Craving Questionnaire items modified for ketamine
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From 1 to 16 weeks after the ketamine infusion
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 87368
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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