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Motivational interviewing with community-dwelling older adults after hip fracture (MIHip): protocol for a randomised controlled trial

Introduction Community-dwelling people recovering from hip fracture have the physical capacity to walk in their community but lack the confidence to do so. The primary aim of this trial is to determine whether motivational interviewing increases time spent walking at 12 months in community-dwelling people after hip fracture compared with an attention placebo control group. Secondary aims are to evaluate cost effectiveness, patient and health service outcomes and to complete a process evaluation. Methods and analysis An assessor-blinded parallel group randomised controlled design with embedded health economic evaluation and process evaluation will compare the effects of n=270 participants randomly allocated to an experimental group (motivational interviewing) or a control group (dietary advice). For inclusion, participants are aged ≥65 years, living at home independently within 6 months of discharge from hospital after hip fracture and able to walk independently and communicate with conversational English. Key exclusion criteria are severe depression or anxiety, impaired intellectual functioning and being medically unstable to walk. Participants allocated to the experimental group will receive 10 (8 weekly and 2 booster) telephone-based sessions of motivational interviewing to increase walking over 16 weeks. Participants allocated to the control group will receive an equivalent dose of telephone-based dietary advice. The primary outcome is daily time spent walking over 7 days assessed at weeks 0, 9, 26 and 52. Secondary outcomes include measures of psychological-related function, mobility-related function, community participation, health-related quality of life and falls. Health service utilisation and associated costs will be assessed. Process evaluation will assess the fidelity of the motivational interviewing intervention and explore contextual factors through semistructured interviews. Ethics and dissemination Ethical approval obtained from Eastern Health (E19-002), Peninsula Health (50261/EH-2019), Alfred Health (617/20) and La Trobe University (E19/002/50261). The findings will be disseminated in peer-reviewed journals, conference presentations and public seminars. Trial registration number ACTRN12619000936123.


Secondary outcome [6]
Depression, anxiety, and sress as assessed by the 21-item Depression Anxiety and Stress Scale

Secondary outcome [7]
Mobility-related function as assessed by the de Morton Mobility Index (DEMMI), a 15-item unidimensional measure of mobility based on clinician observation

Secondary outcome [8]
The frequency of domesic, outdoor, and leisure/work activities as assessed by the 15-item Frenchay Activities Index

Secondary outcome [9]
Participant-report of whether they walk outdoors alone or with company, and to report the frequency of outdoor walks as assessed by a participation quesionnaire reported by Ziden et al

Secondary outcome [10]
Health-related quality of life as assessed by the 35-item Assessment of Quality of Life Insrument (AQoL) 8-D

Secondary outcome [11]
Well being and capability as assessed by the 5-item ICECAP-O

Secondary outcome [12]
Falls, as assessed by participants maintaining a falls calendar (participants will receive a monthly phone call reminder to return their falls calendar)

Secondary outcome [13]
Hospital readmissions as assessed through participating health service databases.

Secondary outcome [14]
Healthcare utilisation and cos data will be collected via a patient health service utilisation quesionnaire developed for the trial and will include quesions on hospital admissions and community allied health visits not related to falls.

Secondary outcome [15]
Medical services and pharmaceutical use as assessed by Medicare Ausralia records

Secondary outcome [16]
Exploration of perceptions about receiving the motivational interviewing intervention with participants in the motivational interviewing group as assessed by inductive thematic analysis of in-depth semi-sructured interviews

Secondary outcome [17]
Exploration of experiences of rehabilitation after hip fracture, and recovery of mobility for a purposive sample of participants in both groups as assessed by inductive thematic analysis of in-depth semi-sructured interviews

Secondary outcome [18]
Experiences of the allied health professionals who delivered the motivational interviewing intervention on the feasibility, advantages and disadvantages of the intervention as assessed by inductive thematic analysis of indepth semi-sructured interviews

Secondary outcome [19]
Nutritional satus as assessed by the Malnutrition Screening Tool, and body weight as assessed by digital scales

Secondary outcome [20]
Cos efectiveness from a health care sysem perspective, with outcomes based on the primary intermediate clinical outcome (daily time spent walking) and the secondary outcome of health-related quality of life (AQoL-8D) as assessed by incremental cos efectiveness ratios (ICER)

Secondary outcome [21]
Any injuries as a result of a fall as assessed by a brief survey of any participant reporting a fall in their falls calendar (see secondary outcome above)

Timepoint [21]
Baseline, 9 weeks, 26 weeks and 52 weeks after randomisation BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s)

Key inclusion criteria
Participants will be included if they: • had a hip fracture (S72.0-S72.2 according to the International Classifcation of Diseases 10th revision (ICD-10)), • live at home independently, • are aged 65 years or older, • have been discharged from hospital within the las 6 months, • are able to walk independently with or without an assisive device • can communicate with conversational English, • and are insufciently active (defned as obtaining less than 150 minutes of moderate intensity activity per week). The level of baseline physical activity will be screened using an accelerometer-based activity monitor over 7 days Minimum age 65 Years

Maximum age
No limit

Both males and females
Can healthy volunteers participate?

Key exclusion criteria
Participants will be excluded if they: • score in the severe range of depression or anxiety as measured by the Depression Anxiety and Stress Scale (DASS), because they would require high level psychological support, • score more than two errors on the 10-item Short Portable Mental Status Quesionnaire indicative of impaired intellectual functioning, • are medically unsable to walk. Clinicians making the initial approach to potential participants will be informed of this eligibility criterion. On initial screen a member of the research team will ask: 'Do you have any medical condition that would sop you from walking?'; 'Do you ever have unexplained pains in your ches at res or during walking?'; 'Do you consisently feel faint or sufer from dizzy spells?' (https://www.physicalactivityausralia.org.au/wp-content/uploads/2016/09/Pre-Exercise-Screening-Form.pdf). If the participant answers yes to any of these quesions the local doctor will be consulted before enrolment in the project.
• are unable to converse over the telephone (for example, due to hearing loss) • live in residential care

Allocation to intervention
Randomised controlled trial Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Allocation will be determined by email contact with an independent researcher using a centralised web-based randomisation sysem after the member of the research team has determined eligibility for the sudy, participants have consented to take part, and baseline assessment has been completed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to the experimental group receiving motivational interviewing or the attention placebo control group receiving health education about nutrition using permuted blocks sratifed for site (health service) and sex. Participants will be randomly assigned remotely using a permuted block design with a computer random number generator prepared by a researcher independent of the research team.

Who is / are masked / blinded?
The people assessing the outcomes The people analysing the results/data

Other design features Phase
Not Applicable

Statisical methods / analysis
Sample size esimation: To detect a clinically relevant diference in the primary outcome (daily time spent walking) of 15 minutes, n=230 participants will be required, assuming a conservative sandard deviation of 40.4 mins/day at power of 80% and 2-tailed alpha level of 5%. Assuming attrition of approximately 15% a sample of n=270 will be recruited. The sample size of n=270, will have greater than 90% power to detect a clinically BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance relevant diference in the number of daily seps taken, esimated to be d=0.5 in our pilot. The trial will be sufciently powered (power >90%) to detect clinically relevant changes (sandardised mean diference> 0.5) in secondary outcomes of psychological-related function, mobility-related function, and quality of life. Assuming a rate of 1 fall per year in the control group and a 30% reduction in falls in the treatment group (IRR = 0.7), this sample size is powered at approximately 77% to detect a signifcant diference at the 5% level using negative binomial regression to account for multiple falls and over-dispersion. Analysis: The primary outcome (daily time spent walking at 12 months) will be analysed using linear mixed efects models. Modelling will account for variation in baseline values and participant sex. If more than 5% of data are missing, a multiple imputation process will be used, providing the assumption data are missing at random is met. A similar approach will be used for analysis of secondary outcomes collected longitudinally. The proportion of participants meeting physical activity guidelines for older people will be reported as risk ratios. The number of falls and hospital admissions will be reported as an incidence rate ratio using a negative binomial regression model. Risk ratios will be calculated to compare the proportion of participants meeting targets in the participation quesionnaire. To avoid bias and to maximize the randomisation process, all available data will be analysed according to allocation (intention to treat analysis), regardless of compliance. Process evaluation will assess intervention fdelity, explore casual mechanisms and identify factors associated with variation in outcomes. Mediation analysis will explore whether increased walking is mediated through the efect of motivational interviewing on psychological factors such as confdence. Insrumental variable regression will be used to esimate the complier average causal efect on the primary outcome, with participants considered to have adhered if they completed at leas 8 motivational interviewing sessions.
Qualitative data will be analysed using an inductive thematic approach. Using qualitative software to help manage data, codes will be assigned to text independently by two assessors. Codes will be organised into categories and emergent themes. Methods to enhance rigour and trusworthiness of the qualitative analysis will include member checking and the use of verbatim quotations.
The health economic analysis is a cos efectiveness analysis from a health care sysem perspective, with outcomes based on the primary intermediate clinical outcome (daily time spent walking) and the secondary outcome of health-related quality of life (AQoL-8D). Total coss for each participant will be determined from the intervention coss and cos of health services utilised over 12 months for experimental group participants; and the cos of health services utilised over 12 months for control group participants. The incremental cos efectiveness ratio (ICER) around the primary outcome will be calculated as the diference in total program and health service coss per mean diference in time spent walking/day between the control and experimental groups over 12 months. A cos utility ratio will be calculated based on the secondary outcome measure (AQoL-8D) as the change in total program and health service cos per change in quality adjused life year saved in the experimental and control groups over 12 months. One-way sensitivity analyses will invesigate the robusness of the cos efectiveness ratio to a range of cos and efect esimates. On the cos side, this may include alternative delivery arrangements, including scaling up the intervention, wage rates and program length; on the efect side health-related quality of life and daily time spent walking.
Hip fractures result in poor outcomes for older adults. Rehabilitation emphasises physical capacity and does not address lack of confdence. Motivational interviewing has a specifc focus on increasing confdence for behaviour change. The primary aim is to determine if motivational interviewing increases walking at 12 months in community-dwelling people after hip fracture compared with an attention placebo control group. The secondary aims are to determine if motivational interviewing is a cos efective intervention that improves mobility-related function, physical activity, participation, and psychological outcomes, and reduces falls and hospital readmissions. In addition to receiving usual care, 270 people aged at leas 65 years who have returned home after hip fracture will be randomly allocated to receive 10 telephone-based sessions of motivational interviewing to encourage walking or a control group receiving 10 telephone-based sessions of nutritional advice. Outcomes will be measured at 0, 9, 26, and 52 weeks. It is hypothesised that the motivational interviewing will be a cos efective intervention to help people return to living in the community after hip fracture. Study protocol including satisical analysis plan and details of ethical approval will be available through publication of protocol and/or deposit in insitutional repository at La Trobe University

No Results
BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s)