Original Article

HSS Journal

, Volume 3, Issue 1, pp 63-70

First online:

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

  • John P. AllegranteAffiliated withDepartment of Health and Behavior Studies, Teachers College, Columbia UniversityDepartment of Sociomedical Sciences, Mailman School of Public Health, Columbia University Email author 
  • , Margaret G. E. PetersonAffiliated withResearch Division, Hospital for Special Surgery
  • , Charles N. CornellAffiliated withDepartment of Orthopedic Surgery, Hospital for Special Surgery
  • , C. Ronald MacKenzieAffiliated withDepartment of Medicine, Hospital for Special Surgery
  • , Laura RobbinsAffiliated withEducation Division, Hospital for Special Surgery
  • , Roberta HortonAffiliated withDepartment of Patient Care and Quality Management, Hospital for Special Surgery
  • , Sandy B. GanzAffiliated withThe Virginia F. and William R. Salomon Rehabilitation Department, Hospital for Special Surgery
  • , Hirsch S. RuchlinAffiliated withDepartment of Public Health, Weill Medical College of Cornell University
  • , Pamela Williams RussoAffiliated withThe Robert Wood Johnson Foundation
    • , Stephen A. PagetAffiliated withDepartment of Medicine, Hospital for Special Surgery
    • , Mary E. CharlsonAffiliated withDepartment of Medicine, Weill Medical College of Cornell University

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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 recovery hip fracture methodology psychosocial intervention randomized controlled trial rehabilitation