BMJ open · 2026
Implementation of a complex intervention for hip fracture care: a protocol for an embedded mixed-methods process evaluation of a multicentre cluster randomised trial in India, Nepal, the Philippines, Thailand and Vietnam.
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Armstrong Elizabeth, Ivers Rebecca, Bui Thuy Anh, Sa-Ngasoongsong Paphon, Tongta Saowalak, Phrommai Maneemon, Pinyo Watcharida, Pandey Dipendra, Dahal Pranab, Manandhar Situ, Shrestha Reshika, Joshi Sunil Kumar, Jagnoor Jagnoor, Beri Deepti, Gupta Medhavi, Sharma Vijay, La Quang, Pham Cuong, Cortez Kiko, Tabu Irewin, Costa Matthew L, Palagyi Anna, HIPCARE Investigators
Аннотация
INTRODUCTION: The HIPCARE Study is a cluster randomised trial to determine whether the introduction of a multidisciplinary model of hip fracture care in five low- and middle-income countries (LMICs) in Asia can improve quality of life and reduce healthcare costs for older people undergoing surgery. An embedded process evaluation will provide detailed information on the contextual factors influencing the implementation of HIPCARE to explain what works, for whom and why. This paper describes the protocol for the HIPCARE process evaluation.
METHODS AND ANALYSIS: A mixed-methods process evaluation will be embedded in the HIPCARE trial, informed by two theoretical frameworks: the realist framework (context, mechanism, outcome) and the reach, effectiveness, adoption, implementation and maintenance framework. Two intervention hospitals from each of the five implementation countries will be selected as sites for the process evaluation (10 sites in total). For each site, quantitative data from the HIPCARE implementation dashboard and main trial outcomes will be used to examine relationships between implementation processes and patient outcomes, care processes and intervention delivery. Qualitative data will comprise ~100 interviews or mini focus group discussions with multidisciplinary team members, administrators and trial staff at site setup and recruitment midpoint and endpoint, alongside patient and caregiver focus groups (two per site, 6–8 participants each) at 60- and 120-days post-surgery. Quantitative and qualitative data will be triangulated through an explanatory integration approach, in which implementation process measures and outcomes are interpreted alongside patient and provider experiences and contextual insights to identify convergent and divergent findings. This triangulation will enable identification of mechanisms linking intervention delivery to outcomes and clarify how contextual factors shape adoption, implementation and sustainability across settings.
ETHICS AND DISSEMINATION: The study has been approved by the Oxford Tropical Research Ethics Committee (OxTREC Reference: 520–23) and ethics committees in each participating country. Findings will be shared with policy makers, healthcare workers and community representatives through social media, webpages, peer-reviewed publications, presentations and printed resources.
TRIAL REGISTRATION NUMBER: ISRCTN23534273.
METHODS AND ANALYSIS: A mixed-methods process evaluation will be embedded in the HIPCARE trial, informed by two theoretical frameworks: the realist framework (context, mechanism, outcome) and the reach, effectiveness, adoption, implementation and maintenance framework. Two intervention hospitals from each of the five implementation countries will be selected as sites for the process evaluation (10 sites in total). For each site, quantitative data from the HIPCARE implementation dashboard and main trial outcomes will be used to examine relationships between implementation processes and patient outcomes, care processes and intervention delivery. Qualitative data will comprise ~100 interviews or mini focus group discussions with multidisciplinary team members, administrators and trial staff at site setup and recruitment midpoint and endpoint, alongside patient and caregiver focus groups (two per site, 6–8 participants each) at 60- and 120-days post-surgery. Quantitative and qualitative data will be triangulated through an explanatory integration approach, in which implementation process measures and outcomes are interpreted alongside patient and provider experiences and contextual insights to identify convergent and divergent findings. This triangulation will enable identification of mechanisms linking intervention delivery to outcomes and clarify how contextual factors shape adoption, implementation and sustainability across settings.
ETHICS AND DISSEMINATION: The study has been approved by the Oxford Tropical Research Ethics Committee (OxTREC Reference: 520–23) and ethics committees in each participating country. Findings will be shared with policy makers, healthcare workers and community representatives through social media, webpages, peer-reviewed publications, presentations and printed resources.
TRIAL REGISTRATION NUMBER: ISRCTN23534273.