The current study shows that the HIP-REP is feasible in terms of retention, adherence, and adverse events, while recruitment, the screening and approaching of eligible participants, the completion of outcome measures, and the duration of self-reported questionnaires need to be optimized in a future RCT.
The desired number of older adults with HFs for the present study was 20, and 18 were recruited. Although the research progression criteria (15) were met for the overall recruitment, no exact information was gathered on why eleven participants identified as eligible were not invited into the
project. However, there was considerable uncertainty regarding the identification of potential eligible patients during weekends and holidays from patient lists at the orthopedic ward, and new procedures taking this into account should be considered in a future RCT to ensure that the desired number of older adults with HFs is reached. Of the 19 who met the inclusion criteria and were informed at the ward with an invitation to participate in the study, only one patient declined due to family circumstances. This indicating that the older adults understand the purpose of the intervention and are motivated to participate in the development of the study. At the design stage of the intervention (8) it was important to consider that the participants in the study are frail older adults (27), and that their vulnerable situation is likely to influence the recruitment rate. A Cochrane review (28) highlights that a suitable recruitment strategy could be a face-to-face meeting between the patient and a staff member dedicated to the recruitment tasks. Furthermore, the review highlights the fact that making a specific staff member responsible might increase the chance of recruitment, and this is a strategy that will be contemplated in a future RCT. Regarding the oral and written information, the strategy of being in direct contact with the eligible older adult was deliberately chosen during the design phase of the intervention and was confirmed as a good measure by the HCPs at a focus group meeting. Issues regarding how many sessions and how much time the intervention was expected to take, including face-to-face sessions either at the rehabilitation center or in their own homes (and excluding transportation time), were highlighted and clarified, as recommended by Treweek (29) and Prescott et al (30).
Thirteen older adults completed the 8 weeks of intervention. Two participants died because of other underlying diseases, which is normal considering the population. Three dropped out during the study, two because they found themselves sufficiently independent in performing ADL tasks and another due to relocation outside of the municipality. The reasons for drop-out are difficult to predict and prevent, and therefore it is recommended that a future RCT takes possible drop-outs into account when establishing the desired sample size. A friendly and safe atmosphere is essential for preventing drop-outs (31). Based on feedback from focus groups, such an atmosphere was achieved in this study, and thus was not a reason for the dropouts.
During the data collection, the HCPs questioned whether to follow the manual’s planned sessions for specific weeks. Some participants regained their pre–hip-fracture independence in ADL before the end of the 12 weeks, and for others it took longer because adjacent complications occurred. Furthermore, vacations, appointments with doctors, and other obligations could cause a session to be moved to another date. However, it was agreed that the older adults should receive their planned sessions as close as possible to the timeline described in the manual.
Completion of outcome measures
The included participants were all living in their own homes before the HF incidence, five living alone and thirteen with a partner or family member. All thirteen remaining participants provided outcome data at 12 weeks post operation, and the results showed that participants had improved in ADL motor and ADL process abilities. The mean changes in the participants’ ADL ability measures showed that they performed ADL tasks with less effort, increased efficiency, less safety risk, and less need of assistance. This suggests that AMPS is sensitive to patients with HF and can be used in a definitive RCT. However, feedback from HCPs highlighted that selecting tasks with the appropriate degree of difficulty from those suggested in the AMPS manual may be a challenge, especially for men, either because they may never have performed the suggested tasks or because their spouses usually perform them. Comparing pre- and post-intervention AMPS measures provides the objective evidence needed to determine if an improvement occurred. Due to the individual calibration of AMPS testers, the OT does not have to observe the older adults performing the same or even similar AMPS tasks, and different OTs can administer the AMPS observations from baseline to follow-up. However, the study also showed the importance of the baseline AMPS measurements, when the OT gathers information about the older adult’s current performance, context and to prepare the types of ADL tasks that possibly will be appropriately challenging and realistic to observe when reevaluating the AMPS follow-up(17).
To clarify the Specific Task Contract (18), the OT must determine if the older adult is familiar with the Environment, ensure that appropriate tools and materials are available, and select two appropriately challenging ADL tasks to observe. The selection of AMPS tasks is presented by the OT AMPS tester, although it can be a challenge to select tasks that motivate the older adult, especially older men with HFs, as many of the tasks are based on meal preparation and are not necessarily ADL tasks they usually perform. This preparation takes time, which suggests that an additional hour is needed for the follow-up test visit when planning for a future RCT.
Some improvements were also observed in the EQ5D-5L, but none in the VRS, FRS, SDO, or OBQ. The baseline of these latter three outcome measures was based on the participants’ pre-fracture function. The result of the FRS at the 12-week follow-up endpoint showed that most participants did not regain their pre-fracture function levels. This might indicate that a 6- or 12-month follow-up measurement would be more appropriate. According to a review by Dyer et al. (32), 34-59% of all HF patients regain their basic ADL after three months and 42-71% after six months. Another study by Moerman et al. reports that less than one-third of HF patients return to their pre-fracture level of instrumental ADL, and the three-month follow-up was not sufficient to see a change in functional recovery, especially in IADL (33).
The duration of baseline and follow-up assessments was beyond the pre-defined acceptable level of < 60 min. Both the HCPs and the older adults found the assessments too time-consuming and too tiring for the older adults. The participants pointed out that there were some repeated questions in the assessments, such as self-rated health questions and questions regarding ADL experienced in the SDO and OBQ assessments. The SDO assessment was especially exhausting, with many questions and ratings.
Adherence to intervention
Considering the target group of older, vulnerable adults, studies highlight the importance of not overburdening participants with excessive physical exercise and information (34). The information presented when participants are invited to take part in the study should be beneficial, short, and to the point, otherwise they will turn down the offer. During the feasibility study, the older adults quickly understood the purpose of the study and expressed relief when told that sessions would take place where they were situated, either at a rehabilitation center or at home.
Possible barriers for successful adherence, especially regarding performing ADL tasks during the hospital stay, include the time and the surroundings needed to perform the intervention (35, 36). Due to the need to incorporate time to consider consent, collect baseline measurements while at the hospital, attend to prioritized examinations such as x-rays, and participate in mobilization sessions with the physiotherapist, little time was left to plan and perform ADL tasks at the ward. To increase adherence, adjustments to the HIP-REP program may be beneficial. In the municipality, the OT-supervised interventions were performed at the rehabilitation centre or at the older adult’s own home. Eliminating travel and travel-related expenses for the older adult was contemplated in the design phase as a way to minimize adherence barriers, as Treweek (29) suggests. The shared responsibilities between the OTs in the municipalities and rehabilitations centers need to be coordinated to a greater extent for interventions with the older adults in the HIP-REP program. The OTs experienced issues with their shifting roles between being in a rehabilitation center and being in a home setting, due to the differences in physical environment and different degrees of access to technical aids.
When implementing new interventions, HCPs can be challenged in learning new procedures and skills (37). Although the HIP-REP program is described in the intervention manual, further written
information for the provider of an intervention should be included in the introduction, along with ongoing support from research staff to ensure intervention adherence (38). Furthermore, there was a need to simplify the OTs’ registration of interventions in the REDCap system to reduce workload and avoid confusion, e.g., to categorize ADL tasks in domains in the REDCap system to streamline registration of the intervention carried out.
Only one minor event occurred in connection with a home visit, and the participants expressed that they felt safe during the intervention and that the follow-up phone call improved their feeling of safety in everyday life. However, they still found it necessary to have enhanced focus on barriers in the home and adjustments to improve accessibility in the home environment, such as a grab bar at the balcony or a mobility device for outdoor activities.
Strengths and limitations
Our study has some limitations, as the effectiveness of the HIP-REP program cannot be evaluated, due to the lack of a control group receiving usual care. This was a deliberate decision, since the intention was to evaluate feasibility rather than effectiveness. Regarding statistics normal distribution would require more participants to be valid and should therefore be interpreted with caution. However, due the sensitivity of our main outcome, the AMPS test makes the number of participants sufficient (17).
When conducting multicenter trials, the feasibility of different elements in the study can act as an opportunity to test whether collaboration can be developed, and processes can run across sectors and multiple centers (39). To further enhance external validity consecutive sampling was used in the selection of the participants, including 18 from 35 eligible participants. This ensured controlling sampling bias because all available subjects were included.
Furthermore, allowing the calculation of a response rate (40). Comparing the 18 included participants’ age, gender and fracture type with data from the Danish Multidisciplinary Hip Fracture Registry (41), shows similarity in age, gender and mostly medial and pertrochanteric femur fracture. Another strength of our study was the use of specifically trained and calibrated AMPS raters to address interventions aiming at improving ADL ability. All were experienced in planning, implementing, and evaluating interventions focusing on ADL ability.
Engaging the OTs early in determining the feasibility of the research and the complex intervention increased the chances that the research will inform a change in future practice (42). Collecting both quantitative (psychometric properties) and qualitative (focus groups) data ensured a deeper understanding of the participants’ experience with the intervention (43, 44). Hence, to evaluate to what extent the data collection procedures and outcome measures were feasible and appropriate for the study, the focus group method was chosen to collect qualitative data from the older adults and the HCPs. However, it was difficult to recruit participants, as the travel distance to the meetings and the duration of the interviews made the focus group process time consuming for the HCPs and exhausting for the older adults. A larger number of the older adults and HCPs may have further qualified the feedback on the HIP-REP intervention. However, the contribution using patient and HCP inputs to process evaluation cross-sectoral from the involved older adults and HCP’s in focus groups gave invaluable information to the study.
In conclusion, the HIP-REP program is feasible and safe for older adults with HFs. Clarifying the worksheets for the user manual and REDCap will further optimize the use of the written instructions for the HCPs. During an RCT, we recommend that the recruitment procedure is followed more carefully to increase the number of participants included. Furthermore, it is necessary to decrease the number of outcome measures, in order to reduce the burden and duration of the test. However, even though the study was able to detect clinically important changes in ADL ability and to a certain extent in self-reported health variables, we can only consider the potential effects of the intervention after a full-scale evaluation of the intervention in a clinical trial has been completed.