Methodological Challenges of Multiple-Component Intervention: Lessons Learned from a Randomized Controlled Trial of Functional Recovery After Hip Fracture

Abstract

We conducted a randomized controlled trial to assess the efficacy and safety of a multiple-component intervention designed to improve functional recovery after hip fracture. One hundred seventy-six patients who underwent surgery for a primary unilateral hip fracture were assigned randomly to receive usual care (control arm, n = 86) or a brief motivational videotape, supportive peer counseling, and high-intensity muscle-strength training (intervention arm, n = 90). Between-group differences on the physical functioning, role-physical, and social functioning domains of the SF-36 were assessed postoperatively at 6 months. At the end of the trial, 32 intervention and 27 control patients (34%) completed the 6-month outcome assessment. Although patient compliance with all three components of the intervention was uneven, over 90% of intervention patients were exposed to the motivational videotape. Intervention patients experienced a significant (P = 0.03) improvement in the role-physical domain (mean change, −11 ± 33) compared to control patients (mean change, −37 ± 41). Change in general health (P = 0.2) and mental health (P = 0.1) domain scores was also directionally consistent with the study hypothesis. Although our findings are consistent with previous reports of comprehensive rehabilitation efforts for hip fracture patients, the trial was undermined by high attrition and the possibility of self-selection bias at 6-month follow-up. We discuss the methodological challenges and lessons learned in conducting a randomized controlled trial that sought to implement and assess the impact of a complex intervention in a population that proved difficult to follow up once they had returned to the community.

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Acknowledgments

We thank James Hollenberg, MD, the late Lawren Daltroy, DrPH, William Evans, PhD, and Joseph Lane, MD, for consultative assistance during the early phases of planning the study. We are also indebted to Antonia Augurt, BA, Sherry Backus, MA, PT, Betty Chow, PT, James Dempsey, PT, Elena Elkin, PhD, Donna Kent, RN, Pat Marcus, PT, JeMe Cioppa-Mosca, PT, MBA, Linda Murray, OT, Douglas O’Connell, BA, Jean O’Doherty, RN, MA, and Janey Peterson, RN, MA, EdD, for their numerous contributions throughout the study, and Ray Marks, EdD, for reviewing and commenting on drafts of the manuscript. We also thank an anonymous reviewer for an extraordinarily thorough review and valuable suggestions for revision. This research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS 2P60-AR38520).

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Correspondence to John P. Allegrante PhD.

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Allegrante, J.P., Peterson, M.G.E., Cornell, C.N. et al. Methodological Challenges of Multiple-Component Intervention: Lessons Learned from a Randomized Controlled Trial of Functional Recovery After Hip Fracture. HSS Jrnl 3, 63–70 (2007). https://doi.org/10.1007/s11420-006-9036-x

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Key words

  • functional recovery
  • hip fracture
  • methodology
  • psychosocial intervention
  • randomized controlled trial
  • rehabilitation