HSS Journal

, Volume 3, Issue 1, pp 63–70

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

  • John P. Allegrante
  • Margaret G. E. Peterson
  • Charles N. Cornell
  • C. Ronald MacKenzie
  • Laura Robbins
  • Roberta Horton
  • Sandy B. Ganz
  • Hirsch S. Ruchlin
  • Pamela Williams Russo
  • Stephen A. Paget
  • Mary E. Charlson
Original Article

DOI: 10.1007/s11420-006-9036-x

Cite this article as:
Allegrante, J.P., Peterson, M.G.E., Cornell, C.N. et al. HSS Jrnl (2007) 3: 63. doi:10.1007/s11420-006-9036-x

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.

Key words

functional recoveryhip fracturemethodologypsychosocial interventionrandomized controlled trialrehabilitation

Copyright information

© Springer Verlag 2006

Authors and Affiliations

  • John P. Allegrante
    • 1
    • 2
  • Margaret G. E. Peterson
    • 3
  • Charles N. Cornell
    • 4
  • C. Ronald MacKenzie
    • 5
  • Laura Robbins
    • 6
  • Roberta Horton
    • 7
  • Sandy B. Ganz
    • 8
  • Hirsch S. Ruchlin
    • 9
  • Pamela Williams Russo
    • 10
  • Stephen A. Paget
    • 5
  • Mary E. Charlson
    • 11
  1. 1.Department of Health and Behavior Studies, Teachers CollegeColumbia UniversityNew YorkUSA
  2. 2.Department of Sociomedical Sciences, Mailman School of Public HealthColumbia UniversityNew YorkUSA
  3. 3.Research DivisionHospital for Special SurgeryNew YorkUSA
  4. 4.Department of Orthopedic SurgeryHospital for Special SurgeryNew YorkUSA
  5. 5.Department of MedicineHospital for Special SurgeryNew YorkUSA
  6. 6.Education DivisionHospital for Special SurgeryNew YorkUSA
  7. 7.Department of Patient Care and Quality ManagementHospital for Special SurgeryNew YorkUSA
  8. 8.The Virginia F. and William R. Salomon Rehabilitation DepartmentHospital for Special SurgeryNew YorkUSA
  9. 9.Department of Public HealthWeill Medical College of Cornell UniversityNew YorkUSA
  10. 10.The Robert Wood Johnson FoundationPrincetonUSA
  11. 11.Department of MedicineWeill Medical College of Cornell UniversityNew YorkUSA