Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study (TPC)
調査の概要
状態
条件
詳細な説明
The purpose of the proposed research is to design and evaluate a technology enhanced transitional palliative care (TPC) intervention for patients living in rural locations. The contributions of the proposed research are expected to address the gap in palliative care services and transitions of care for rural patients. This research is significant because it addresses the challenges of three independently important health care foci - needs of rural patients, care transitions, and the evolving field of palliative care. The study will not simply address the critical barrier imposed by distance, but also extend PC practice by improving transition management for the impending dramatic increase in seriously ill and dying patients in rural areas through evolving demographic shifts. The goal of the proposed research is to advance the development of transitional care strategies for rural PC patients and caregivers, and provide evidence of new ways to support continuity of care for patients with life-limiting conditions.
The study is guided by the "Transitional Care Model" or "TCM" as developed by Naylor which combines quality, cost, and satisfaction. The TCM has a solid evidence base from more than 15 years of multidisciplinary research. Unique features of the model include care that is delivered and coordinated by the same nurse across hospital and home settings 7 days per week for an average of 2 to 3 months using evidence-based protocols with a focus on long term outcomes. Core components of the model include a holistic, person/family centered approach and protocol guided care. The nurse functions as part of an interdisciplinary team with shared accountability, however, the nurse is the single "point person" across an episode of care providing the vital link from hospital to home. Inherent within the model is shared communication systems that span care settings.
A randomized control trial design will be used. Community dwelling adult patients and their caregivers who receive a palliative care consult while hospitalized in the hospital will be enrolled in the study, then randomized to group membership and followed for a total of 8 weeks after hospital discharge. Following a detailed protocol for TPC, the intervention group will receive weekly video session visits (using computer software that allows audio/visual contact through the computer screen) by the study nurse. The investigators will determine the feasibility and acceptability of the TPC intervention and study methods and procedures when engaging palliative care patients and their caregivers. The investigators will compare patient and caregiver reported outcomes and determine effect size for patients receiving technology-enhanced TPC (intervention group) to patients in the control group, and they will explore the impact of the technology-enhanced TPC intervention on health care service utilization.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Minnesota
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Mankato、Minnesota、アメリカ、56001
- Mayo Health System
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adult patients hospitalized at study site, and their designated caregiver (if available)
- Receiving palliative care
- Returning home or to a facility for short term (30 days) rehabilitation
- Able to provide informed consent
- Able to complete self-reported questionnaires without assistance
Exclusion Criteria:
- Long-term placement in skilled nursing facility after hospitalization
- Receiving hospice
- Living within city limits of hospital
- Cognitive impairments
- Non-English speaking
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
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Technology-Enhanced TPC
In addition to receiving usual palliative care service in the hospital setting, Technology-Enhanced Transitional Palliative Care patients will receive Transitional Care from the Palliative Care consulting team beginning in the hospital within 24 hours of study enrollment and continuing post discharge for eight weeks in their homes in rural locations by means of video visits with the Palliative Care consulting team.
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The Transitional Care intervention will be initiated within 24 hours after enrollment, and will include initial transitional care planning, daily hospital visits, crisis prevention planning by an experienced Palliative Care nurse.
The intervention will continue after the patient is discharged to home or short term skilled nursing facility, and it will involve an in-person visit between 24-48 hours post discharge, weekly virtual visits via iPad and video conference technology, and additional home visits as needed.
Care plans established during initial planning will be implemented and adjusted under the guidance of the palliative care nurse delivering the intervention.
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他の：Usual standard of care
The control group will receive only the current standard palliative care service in the hospital setting, which includes standard in-hospital palliative care consultation and standard discharge planning.
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Usual care includes routine hospital discharge planning and usual physician care in primary and specialty outpatient clinics post hospital discharge.
The PC consulting service provides consulting services in the inpatient setting.
There are no standardized, intentional services provided to outpatients by the PC consulting team.
Services provided to outpatients may occur sporadically as initiated by the patient.
The majority of PC follow-up if any is a single phone call to the patient/caregiver.
To account for the time spent and number of contacts made with the intervention group, the control group will be contacted by phone weekly by a non-nurse member of the study team not involved with the intervention, asked to relate what, if any, medically-related events occurred.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in mean scores on FACIT-Pal Questionnaire
時間枠：Baseline, 1 month post-enrollment, 2 months post-enrollment
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The patient's quality of life will be determined by the change in mean scores from baseline to 1 month and 2 months post enrollment, using the Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal).
The FACIT-Pal palliative subscale contains 19 questions specific to persons with life-limiting illness.
Each item is rated on a 5 point numeric rating scale from 9 (not at all) to 4 (very much).
Scores range from 0-76.
Higher scores indicate better quality of life.
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Baseline, 1 month post-enrollment, 2 months post-enrollment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in mean scores on ESAS-r Questionnaire
時間枠：Baseline, 1 month post-enrollment, 2 months post-enrollment
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The patient's symptom intensity will be determined by the change in mean scores from baseline to 1 month and 2 months post enrollment, as measured by the Edmonton Symptom Assessment System (revised) ESAS-r scale, The ESAS-r captures the patient's perspective on 9 symptoms that are common in palliative care (pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, wellbeing).
An optional 10th symptom can be reported.
Each symptom is rated on an 11 point numeric rating scale from 0 (symptom absent or best) to 10 (worst possible).
Scores range from 0-100, with lower scores indicating patient perceives fewer or no symptoms and higher scores indicating patient perceives worse symptoms.
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Baseline, 1 month post-enrollment, 2 months post-enrollment
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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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Health Care Service Utilization
時間枠：Baseline to 6 months after enrollment
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Health Services information will be summarized by review of medical records and administrative databases for number of unplanned hospitalizations, number of intensive care unit days, total length of hospital stay (days), number of emergency department visits, number of clinic office visits, number of home healthcare visits, time (in days) to hospice admission, and time (days) receiving hospice.
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Baseline to 6 months after enrollment
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Diane E Holland, PhD, RN、Mayo Clinic
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
- 13-006242
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