Praxis Evaluation of a Pain Self-management Support Intervention for Oncology Patients: A Stepped Wedge Design Study

Summary

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.

Conditions

• Cancer Pain Self-management

Interventions

BEHAVIORAL

ANtiPain

After the implementation of ANtiPain, patients will receive cancer pain self-management support by trained staff nurses who follow the ANtiPain protocol. ANtiPain is based on 3 key strategies: Provision of information, skill building and nurse coaching. It consists of an in-hospital one-to-one session before discharge and a telephone follow up according to a clinical algorithm based on pain intensity, patient satisfaction with pain management and patient adherence. Patients will be given a booklet with corresponding info. The implementation process will include training of designated staff nurses, coaching activities based on case discussions on the ward, as well as measures to ensure sustainability of the implementation (e.g., training of ward managers and clinical nurse specialists).

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg

  collaborator OTHER

• University of Lausanne

  collaborator OTHER

• University of Vienna

  lead OTHER

Principal Investigators

• Antje Koller, PhD · University of Vienna, Faculty of Social Sciences, Institute of Nursing Science

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-05

Primary Completion

2018-07-31

Completion

2018-07-31

Countries

• Austria

Study Locations