Evaluation of the Project "Improvement of Nurse-led Self-management Support for Patients With Cancer-related Pain": An Accompanying Cluster Randomized Study With a Stepped Wedge Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 5
- 主要终点
- pain interference with daily activities TP2
研究概览
简要总结
Background: Significant barriers to cancer pain management are patient-related. So far, cancer pain self-management support interventions have only been tested in strictly controlled settings of randomized controlled trials (RCT) and thus evidence for comparative effectiveness is lacking.
Methods: This study includes a multicenter cluster RCT with a stepped wedge design and a qualitative substudy. The aim of the study is to evaluate the implementation of ANtiPain in clinical practice. The primary patient-related aim is to improve pain interference with daily activities. Secondary patient-related aims are pain intensity, barriers to pain management, self-efficacy, and quality of life. Secondary organization-related aims are nurse proficiency and satisfaction with cancer pain self-management support, participation rates, and implementation fidelity.
Inclusion and exclusion criteria: On 17 wards in 3 hospitals in Vienna adult oncology patients will be included (n=150 pre-, n=150 post-implementation) if they are admitted to one of the participating wards, have pain ≥3 (0=no pain to 10=worst imaginable pain) or regular pain medication, able to understand German, discharged with pain self-management, and give informed consent. Patients with signs of disorientation that may severely limit pain self-management will be excluded.
Interventions: Pre-implementation, patients receive standard care. Post-implementation, patients receive ANtiPain which is based on 3 key strategies: information, skills building and nurse coaching and consists of in-hospital sessions by staff nurses and follow-up phone calls after discharge. The implementation process will include training of the designated staff nurses, case discussions, as well as measures to ensure sustainability of the implementation (e.g., training of clinical nurse specialists).
Procedures: Wards are randomized according to the stepped wedge plan. Patients will complete questionnaires at admission, and 2, 4 and 8 weeks after discharge. Nurse-level data will be collected before implementation and 1 and 3 months after implementation. Data on ward and hospital level will be collected at the beginning of the study.
Statistical analysis: The statistical analysis will be conducted based on mixed models, with a random intercept for the respective ward and time as a covariate.
Qualitative substudy: The qualitative substudy will comprise interviews with head and intervention nurses about their views of the implementation.
详细描述
Background Despite highly effective treatment options, adequate pain control is a persistent problem in oncology patients. As cancer treatment is shifted increasingly towards the outpatient setting, patients' self-management is vital for successful pain treatment. ANtiPain (Advanced Nursing Practice cancer pain self-management support) is a cancer pain self-management support intervention for patients with cancer that is already available and tested in a German speaking setting. So far, cancer pain self-management support interventions have only been tested in the rigorously controlled setting of a randomized controlled trial (RCT) and thus evidence for its comparative effectiveness is lacking.
Objective This study is unique in that it aims to evaluate the implementation of the ANtiPain intervention in routine clinical practice in view of its effectiveness for patients and nurses in realistic clinical settings.
Methods Design, setting and sample In the context of routine quality improvement, AntiPain will be implemented on designated wards at three hospitals in Vienna. To evaluate the implementation, an accompanying multicenter cluster randomized trial with a stepped wedge design will be supplemented with embedded qualitative evaluations. The stepped wedge design will involve the sequential rollout of the intervention. The order in which ANtiPain will be implemented on the wards will be determined at random. By the end of the study, all wards will have implemented the intervention.
Patients will be recruited on 17 wards. With an effect size of d=.77 and an expected drop-out rate of 20%, a sample size of 150 patients will be needed before and after implementation to demonstrate a difference at the 5% level with 90% power. With 17 wards and a study duration of 15 months, approximately 1.3 patients will be recruited per month on each of the participating wards.
Objective and specific aims In congruence with the Reach Efficacy Adoption Implementation and Maintenance (RE-AIM) framework, the implementation of ANtiPain will be evaluated on two levels: (i) patient-related outcomes (e.g., pain interference with daily activities, pain intensity, patient related barriers to cancer pain management), and (ii) organization-related outcomes (e.g., nurses' self-rated perceived proficiency with pain management, application fidelity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥20% of oncology patients
- •pre-selection by nursing director and clinical nurse specialists
- •willing to participate
- •Inclusion Criteria:
- •admission to one of the participating wards
- •cancer-related pain ≥3 on 11-point numeric rating scale within the last week or
- •have regular pain medication because of cancer-related pain
- •are able to read and write German
- •likely to be discharged with pain self-management
- •willing to participate
排除标准
- •if patients are showing signs of disorientation that may limit their ability to perform pain self-management at home as assessed by staff nurse
研究组 & 干预措施
standard care
Standard care will be described as part of the study.
ANtiPain intervention
ANtiPain is a cancer pain self-management support intervention administered by nurses in an intervention session while the patient is still hospitalized and via phone calls after discharge. ANtiPain is based on three key strategies: information, skill building and nurse coaching.
干预措施: ANtiPain (Behavioral)
结局指标
主要结局
pain interference with daily activities TP2
时间窗: Change from Baseline in pain interference with daily activities at 4 weeks after discharge
7-item scale from Brief pain Inventory
pain interference with daily activities TP1
时间窗: Change from Baseline in pain interference with daily activities at 2 weeks after discharge
7-item scale from Brief pain Inventory
次要结局
- pain intensity TP2(Change from Baseline in pain intensity at 4 weeks after discharge)
- BQII-G TP1(Change from Baseline in BQII-G scores at 2 weeks after discharge)
- Self Efficacy Scale TP1(Change from Baseline in Self Efficacy Scale scores at 2 weeks after discharge)
- pain intensity TP1(Change from Baseline in pain intensity at 2 weeks after discharge)
- BQII-G TP2(Change from Baseline in BQII-G scores at 4 weeks after discharge)
- Self Efficacy Scale TP2(Change from Baseline in Self Efficacy Scale scores at 4 weeks after discharge)
- Health-Related Quality of Life TP1(Change from Baseline in Health-Related Quality of Life scores at 2 weeks after discharge)
- Health-Related Quality of Life TP2(Change from Baseline in Health-Related Quality of Life scores at 4 weeks after discharge)
- participation rate(count during study)
- pain interference with daily activities TP3(Change from Baseline in pain interference with daily activities at 8 weeks after discharge)
- pain intensity TP3(Change from Baseline in pain intensity at 8 weeks after discharge)
- nurse-related outcomes 1 and 3 months after implementation(Change from before implementation of ANtiPain until 1 and 3 months after implementation)
研究者
Antje Koller, PhD
PhD
University of Vienna