Implementation of a nurse-led self-management support intervention for patients with cancer-related pain: a cluster randomized phase-IV study with a stepped wedge design (EvANtiPain)

Silvia Raphaelis, Florian Frommlet, Hanna Mayer, Antje Koller, Silvia Raphaelis, Florian Frommlet, Hanna Mayer, Antje Koller

Abstract

Background: Pain self-management support interventions were effective in controlled clinical trials and meta analyses. However, implementation of these complex interventions may not translate into identical effects. This paper evaluates the implementation of ANtiPain, a cancer pain self-management support intervention in routine clinical practice according to the Reach Efficacy-Adoption Implementation Maintenance framework.

Methods: In this cluster randomized study with a stepped wedge design, N = 153 adult patients with cancer-related pain were recruited from 01/17 to 05/18 on 17 wards of 3 hospitals in Vienna, Austria. ANtiPain entailed a face-to-face in-hospital session by a trained nurse to prepare discharge according to key strategies, information on pain self-management, and skills building. After discharge, cancer-pain self-management was coached via phone calls. Patient-level data were collected at recruitment, and 2, 4 and 8 weeks after discharge via postal or online questionnaire. Primary outcome was pain interference with daily activities. Secondary outcomes included pain intensity, self-efficacy, and patient satisfaction. Organizational-level data (e.g., on implementation procedures) were collected by study or intervention nurses. The mixed model to analyze patient-level data included a random intercept and a random slope for individual and a random intercept for ward.

Results: Recruitment was slower than expected and unevenly distributed over wards and hospitals. The face-to-face session was clinically feasible (mean duration = 33 min) as well as the mean amount (n = 2) and duration of phone calls (mean = 17 min). Only 16 (46%) of 35 trained nurses performed the intervention on nine wards. To deal with the loss of power, analyses were adapted. Overall effects on pain interference were not significant. However, effects were significant in sub analyses of the nine wards that recruited patients in the intervention period (p = .009). Regarding secondary outcomes, the group-by-time effect was significant for self-efficacy (p = .033), and patient satisfaction with information on pain-self-management (p = .002) and in-hospital pain management (p = .018).

Conclusions: The implementation of ANtiPain improved meaningful patient outcomes on wards that applied the intervention routinely. Our analyses showed that the implementation benefited from being embedded in larger scale projects to improve cancer pain management and that the selection of wards with a high percentage of oncology patients may be crucial.

Trial registration: ClinicalTrials.gov Identifier: NCT02891785 Date of registration: September 8, 2016.

Keywords: Neoplasms; Oncology nursing; Pain; Patient education as topic; Randomized controlled trials; Self-management.

Conflict of interest statement

One author declares financial activities with drug companies outside the submitted work. All other authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
Stepped wedge plan and recruitment during 17-months study period. 1the columns represent the study periods of the stepped wedge study, one study period was 24 days (data collection from Jan 2017 to May 2018). 2During the summer, recruitment was paused for two periods. 3H: hospital; H1 shaded dark grey, H2 shaded lighter grey, H3 shaded lightest grey; the order of the implementation was randomized over all three settings. 4Number of recruited patients in the respective cell (time period on the respective ward). 5Date of actual ANtiPain training for intervention nurses on respective ward, steps were planned every 24 days. 6Shaded areas indicate that no patient was recruited on that ward during that time
Fig. 2
Fig. 2
Flow of participants during study
Fig. 3
Fig. 3
Regression lines of pain interference with daily activities (time in weeks). Each line represents the regression line of one ward per recruitment period. The light blue lines belong to the 9 wards that did not provide any patients in the intervention period. Line thickness represents the number of patients for the respective ward
Fig. 4
Fig. 4
Line diagrams on original scale of secondary outcomes

References

    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013;50(5):587–592.
    1. Peters DH, Adam T, Alonge O, Agyepong IA, Tran N. Implementation research: what it is and how to do it. BMJ. 2013;347:f6753.
    1. Bennett MI, Bagnall AM, Closs SJ. How effective are patient-based educational interventions in the management of cancer pain? Systematic review and meta-analysis. Pain. 2009;143(3):192–199.
    1. Sheinfeld Gorin S, Krebs P, Badr H, Janke EA, Jim HSL, Spring B, Mohr DC, Berendsen MA, Jacobsen PB. Meta-analysis of psychosocial interventions to reduce pain in patients with cancer. J Clin Oncol. 2012;30(5):539–547.
    1. Adam R, Bond C, Murchie P. Educational interventions for cancer pain. A systematic review of systematic reviews with nested narrative review of randomized controlled trials. Patient Educ Couns. 2015;98(3):269–282.
    1. Oldenmenger WH, Geerling JI, Mostovaya I, Vissers KCP, de Graeff A, Reyners AKL, van der Linden YM. A systematic review of the effectiveness of patient-based educational interventions to improve cancer-related pain. Cancer Treat Rev. 2018;63:96–103.
    1. Marie N, Luckett T, Davidson PM, Lovell M, Lal S. Optimal patient education for cancer pain: a systematic review and theory-based meta-analysis. Support Care Cancer. 2013;21(12):3529–3537.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, Medical Research Council G Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.
    1. Breivik H, Cherny N, Collett B, Fd C, Filbet M, Foubert AJ, Cohen R, Dow L. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol. 2009;20(8):1420–1433.
    1. Spichiger E, Muller-Frohlich C, Denhaerynck K, Stoll H, Hantikainen V, Dodd M. Prevalence of symptoms, with a focus on fatigue, and changes of symptoms over three months in outpatients receiving cancer chemotherapy. Swiss Med Wkly. 2011;141:w13303.
    1. van den Beuken-van Everdingen MHJ, Hochstenbach LMJ, Joosten EAJ, Tjan-Heijnen VCG, Janssen DJA. Update on prevalence of pain in patients with cancer: systematic review and meta-analysis. J Pain Symptom Manag. 2016;51(6):1070–90 e1079.
    1. Jacobsen R, Moldrup C, Christrup L, Sjogren P. Patient-related barriers to cancer pain management: a systematic exploratory review. Scand J Caring Sci. 2009;23(1):190–208.
    1. Koller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. Testing an intervention designed to support pain self-management in cancer patients: a mixed methods study. Basel: University of Basel; 2012.
    1. Miaskowski C, Dodd M, West C, Schumacher K, Paul SM, Tripathy D, Koo P. Randomized clinical trial of the effectiveness of a self-care intervention to improve cancer pain management. J Clin Oncol. 2004;22(9):1713–1720.
    1. Koller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. Results of a randomized controlled pilot study of a self-management intervention for cancer pain. Eur J Oncol Nurs. 2013;17(3):284–291.
    1. Koller A, Gaertner J, De Geest S, Hasemann M, Becker G. Testing the implementation of a pain self-management support intervention for oncology patients in Clinical Practice: a randomized controlled pilot study (ANtiPain) Cancer Nurs. 2018;41(5):367–378.
    1. Koller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. Testing of an intervention to support pain self-management in oncology patients: a mixed methods pilot study [Testung einer intervention zur Unterstützung des Schmerzselbstmanagements bei onkologischen Patienten: Eine mixed-methods Pilotstudie] Pflege. 2012;25(4):305–306.
    1. Koller A, Hasemann M, Jaroslawski K, De Geest S, Becker G. Testing the feasibility and effects of a self-management support intervention for patients with cancer and their family caregivers to reduce pain and related symptoms (ANtiPain): study protocol of a pilot study. Open J Nurs. 2014;4(2):85–94.
    1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–1327.
    1. Rycroft-Malone J, Seers K, Chandler J, Hawkes CA, Crichton N, Allen C, Bullock I, Strunin L. The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework. Implement Sci. 2013;8:28.
    1. Pinnock H, Epiphaniou E, Taylor SJ. Phase IV implementation studies. The forgotten finale to the complex intervention methodology framework. Ann Am Thorac Soc. 2014;11(Suppl 2):S118–S122.
    1. Harden SM, Gaglio B, Shoup JA, Kinney KA, Johnson SB, Brito F, Blackman KCA, Zoellner JM, Hill JL, Almeida FA, et al. Fidelity to and comparative results across behavioral interventions evaluated through the RE-AIM framework: a systematic review. Syst Rev. 2015;4:155.
    1. Beard E, Lewis JJ, Copas A, Davey C, Osrin D, Baio G, Thompson JA, Fielding KL, Omar RZ, Ononge S, et al. Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014. Trials. 2015;16:353.
    1. Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015;350:h391.
    1. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50.
    1. NCCN Clinical Practice Guidelines TM. Adult cancer pain. 2016. . Accessed 20 Nov 2018.
    1. Dodd M, Janson S, Facione N, Faucett J, Froelicher ES, Humphreys J, Lee K, Miaskowski C, Puntillo K, Rankin S, et al. Advancing the science of symptom management. J Adv Nurs. 2001;33(5):668–676.
    1. Bandura A. Self-efficacy mechanisms in psychological activation and health promoting behavior. In: Madden J, Matthysse S, Barchas, editors. Adaptation, learning and affect. New York: Raven; 1989. pp. 1–51.
    1. Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990;263(4):549–556.
    1. Koller A, Jahn P. Developing a short form of the German barriers questionnaire-II: a validation study in four steps. J Pain Symptom Manag. 2018;55:458–467.
    1. Radbruch L, Loick G, Kiencke P, Lindena G, Sabatowski R, Grond S, Lehmann KA, Cleeland CS. Validation of the German version of the brief pain inventory. J Pain Symptom Manag. 1999;18(3):180–187.
    1. Ward SE, Goldberg N, Miller-McCauley V, Mueller C, Nolan A, Pawlik-Plank D, Robbins A, Stormoen D, Weissman DE. Patient-related barriers to management of cancer pain. Pain. 1993;52(3):319–324.
    1. Gunnarsdottir S, Donovan HS, Serlin RC, Voge C, Ward S. Patient-related barriers to pain management: the barriers questionnaire II (BQ-II) Pain. 2002;99(3):385–396.
    1. Mangels M, Schwarz S, Sohr G, Holme M, Rief W. An adaptation of the pain self-efficacy questionnaire for the German speaking context [Der Fragebogen zur Erfassung schmerzspezifischer Selbstwirksamkeit (FESS)] Diagnostica. 2009;55(2):84–93.
    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, JCJMd H, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international Clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.
    1. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the eastern cooperative oncology group. Am J Clin Oncol. 1982;5(6):649–655.
    1. Spichiger E, Muller-Frohlich C, Denhaerynck K, Stoll H, Hantikainen V, Dodd M. Symptom prevalence and changes of symptoms over ten days in hospitalized patients with advanced cancer: a descriptive study. Eur J Oncol Nurs. 2011;15(2):95–102.
    1. Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2) J Psychosom Res. 2005;58(2):163–171.
    1. Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (standards for QUality improvement reporting excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016;25(12):986–992.
    1. Oldenmenger WH, Sillevis Smitt PAE, de Raaf PJ, van der Rijt CCD. Adherence to analgesics in oncology outpatients: focus on taking analgesics on time. Pain Pract. 2017;17(5):616–624.
    1. Zhan Z, van den Heuvel ER, Doornbos PM, Burger H, Verberne CJ, Wiggers T, de Bock GH. Strengths and weaknesses of a stepped wedge cluster randomized design: its application in a colorectal cancer follow-up study. J Clin Epidemiol. 2014;67(4):454–461.
    1. Gunnarsdottir S, Zoega S, Serlin RC, Sveinsdottir H, Hafsteinsdottir EJG, Fridriksdottir N, Gretarsdottir ET, Ward SE. The effectiveness of the pain resource nurse program to improve pain management in the hospital setting: a cluster randomized controlled trial. Int J Nurs Stud. 2017;75:83–90.
    1. Jahn P, Kuss O, Schmidt H, Bauer A, Kitzmantel M, Jordan K, Krasemann S, Landenberger M. Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: a cluster-randomized multicenter trial. Pain. 2014;155(4):746–754.
    1. Luckett T, Davidson PM, Green A, Boyle F, Stubbs J, Lovell M. Assessment and Management of Adult Cancer Pain: a systematic review and synthesis of recent qualitative studies aimed at developing insights for managing barriers and optimizing facilitators within a comprehensive framework of patient care. J Pain Symptom Manag. 2013;46(2):229–253.
    1. Hemming K, Taljaard M. Sample size calculations for stepped wedge and cluster randomised trials: a unified approach. J Clin Epidemiol. 2016;69:137–146.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe