Rationale, design, and implementation protocol of the Dutch clinical practice guideline pain in patients with cancer: a cluster randomised controlled trial with Short Message Service (SMS) and Interactive Voice Response (IVR)

Abstract

Background: One-half of patients with cancer have pain. In nearly one out of two cancer patients with pain, this was undertreated. Inadequate pain control still remains an important problem in this group of patients. Therefore, in 2008 a national, evidence-based multidisciplinary clinical practice guideline 'pain in patients with cancer' has been developed. Yet, publishing a guideline is not enough. Implementation is needed to improve pain management. An innovative implementation strategy, Short Message Service with Interactive Voice Response (SVS-IVR), has been developed and pilot tested. This study aims to evaluate on effectiveness of this strategy to improve pain reporting, pain measurement and adequate pain therapy. In addition, whether the active role of the patient and involvement of caregivers in pain management may change.

Methods/design: A cluster randomised controlled trial with two arms will be performed in six oncology outpatient clinics of hospitals in the Southeastern region of the Netherlands, with three hospitals in the intervention and three in the control condition. Follow-up measurements will be conducted in all hospitals to study the long-term effect of the intervention. The intervention includes training of professionals (medical oncologists, nurses, and general practitioners) and SMS-IVR to report pain in patients with cancer to improve pain reporting by patients, pain management by medical oncologists, nurses, and general practitioners, and decrease pain intensity.

Discussion: This innovative implementation strategy with technical tools and the involvement of patients, may enhance the use of the guideline 'pain in patients with cancer' for pain management. Short Message Service alerts may serve as a tool to support self-management of patients. Therefore, the SMS-IVR intervention may increase the feeling of having control over one's life.

Trial registration: [corrected] Netherlands Trial Register (NTR): NTR2739.

Figure 1

Flowchart cluster randomisation of clinics. Figure 1 shows the cluster randomisation of clinics. A cluster RCT with two arms will be performed in six oncology outpatient clinics of hospitals, with three hospitals in the intervention and three in the control condition. Clusters of hospitals will be determined based on number of beds and number of medical oncologists. We require 35 patients per hospital, a total of 210 patients.

Figure 2

Overall time chart of the study and per patient (M = month). Figure 2 shows the overall time-chart of the study and per patient. Each hospital has a period of twelve months to include 35 patients in the study. The total intervention period of hospitals is fifteen months (per patient twelve weeks). The first follow-up period is six months after the intervention period (M15) and the second, twelve months after the intervention period (M27). Each patient will be included in the study for 15 months.

Figure 3

Workflow SMS alerts. Figure 3 shows the workflow of the SMS-IVR intervention. Patients receive SMS-IVR minimal once a week (Tuesdays), twice a day, during 12 weeks. SMS alerts are used as a reminder that they will receive an automatic telephone call 15 minutes later with IVR. SMS alerts will be received at 09.45 a.m. and at 2.45 p.m. At 10.00 a.m. and at 3.00 p.m. the patients will be called and invited to rate their pain on a scale of 0 (no pain) to 10(worst pain imaginable). If the highest pain score is 5 or more, the research nurse will contact the patient. If a patient has five or higher on an NRS on Tuesday he/she will again receive two SMS alerts the next day (Wednesday); the procedure will be repeated. For those who still have a pain score of five or higher on Wednesday, the procedure will be repeated again at Thursday. The whole procedure of the SMS-IVR system described in figure 1 will start again the next week at Tuesday.