Trial feasibility
Recruitment of clusters
Recruitment of clusters took place between February and April 2019 and was time-consuming due to the GPs’ limited reachability, issues in receiving the information via email, whereas the use of a fax was proved to be more practical. Since most GPs cancelled the initially planned collective information event for time reasons, we visited each practice for presentation of further information (mean duration: 22 minutes). GPs classified the information documents as complete and sufficient.
For further information and an overview of barriers and facilitators subdivided in all domains see Additional file 3.
A total of 18 GP practices were approached via telephone calls, nine interested GP practices were visited on site and finally five practices with a total of seven GPs agreed to take part. The mean age of GPs was 54.6 years and 14.3% of them were women (for further information see Table 2).
Table 2
Characteristics of health professionals at baseline
|
GPs (n = 7)
|
PTs (n = 11)
|
Age, mean ± SD, Var (range)
|
54.6 ± 10.7, 113.6 (37.0–66.0)
|
41.3 ± 13.2, 174.8 (24.0–61.0)
|
Sex, n female (%)
|
1 (14.3)
|
9 (81.8)
|
Years of professional activity, mean ± SD, Var (range)
|
21.1 ± 10.4, 107.8 (7.0–35.0)
|
18.3 ± 13.1, 170.8 (1.0–40.0)
|
GP = general practitioner, PT = physical therapist, SD = standard deviation, Var = Variance
|
Reasons for non-participation were mostly lacking time (for further information see Fig. 4), whereas for the practices cancelling by telephone no further information is available. Reasons for participation were mostly perceiving the topic as being interesting and of practical relevance, improving treatment quality through a structured approach, but also intra-professional exchange and general interest in research projects.
All clusters completed the study. For flow of participants through this study see Fig. 4.
Recruitment of PTs
Telephone requests of PT practices and internal forwarding of information went without issues, but the short-term inquiry before educational training due to the delay in GPs’ recruitment postponed the PTs invitation. PTs were satisfied with the recruitment approach including the structure, content and the extent of the information material.
Recruitment of PT practices took place between April and May 2019. As seven of the 15 PT practices mentioned by GPs declined to participate, we invited further 11 identified by geographical screening. Finally, 10 PT practices with 11 therapists (one practice with two PTs) agreed to participate (see Fig. 4). The PTs’ mean age was 41.3 years and most of them were women (81.8%) (for further information see Table 2).
Reasons for non-participation were mostly lacking interest and time (for further information see Fig. 4), whereas reasons for participation were perceiving the topic as interesting and of practical relevance, the chance to improve quality, and interest in educational trainings and in research projects in general.
For further information and an overview of barriers and facilitators subdivided in all domains see Additional file 3.
All PTs completed the study.
Recruitment and reach in individuals
Several problems in the implementation of the intended recruitment approach of patients occurred since GPs started with a considerable delay despite of repeated reminders. It was particularly difficult for GPs to apply the inclusion criteria and invited younger patients (n = 2) and those with cognitive impairment (n = 1). Hence, the initial planned recruitment period was extended by three months. It was noted, that that timing was unfavourable e.g. due to holiday season.
88.2% of potential eligible patients were identified via practice software as required, 5.9% were invited in direct contact in GP practice.
“I think that is always much more convincing for the patient than if he somehow gets a letter. [...] That is why it would have been the natural course of action for me to give it to him immediately.” (GP1, male, 45 years)
For this purpose, “a kind of one-pager I have at my desk […] where I quickly have the essential points ready to tell the patient what to expect. So, in the next step, if he shows interest, I can simply give him the whole stuff, because the difficulty then was to change the daily routine and quickly convey the five or six important points of the study to him.” (GP04, male, 57 years)
An additional person was needed for the time-consuming search via practice software. One GP assigned an office assistant to inform the potential participants about the study by telephone before sending the documents.
As well as with recruitment process, patients were satisfied with information documents regarding comprehensibility, content and extent, but problems in readability occurred due to visual impairment. During the group discussion with GPs it was suggested that patients should receive an additional sheet summarising the most important information.
GPs identified 68 patients (60 via practice software; 4 in direct contact, 4 missing data) between May and September 2019. A total of 46 declined participation, most of them gave no reasons for denial. A total of 23.9% sent back the cancellation form giving reasons as a poor health status or no interest (for further information see Fig. 4). A total of 22 patients (32.4%) consented to participate (range: 3–8 per practice), which undershot the planned number of 25 to 60 patients (5–10 per practice). GPs estimated the high expenditure of time and overload on study participation, concerns about devices and some patients’ resignation regarding VDB for the poor willingness to participate.
“Especially with these patients, who had been complaining about dizziness for a long time, the willingness to take part and to take on […] a longer examination, then also the announcement that someone is coming to them or they should possibly go to Rosenheim […] is suddenly low. I think that if I had said 'Look, I have a pill here, take it and then we will see how it gets better' - then I would have had no problems.” (GP3, male, 66 years)
Participants gave mostly personal suffering under VDB associated with the hope to improve the own or other affected persons’ situation and general interest as reasons for participation. GPs noted that persuasion and motivation promoted the patients’ participation.
For further information and an overview of barriers and facilitators subdivided in all domains see Additional file 3.
The patients’ mean age was 78.7 years, most of them were women (63.6%) and four (18.2%) were rated with a level of care dependency as assessed by expert raters of the medical service of the German statutory health insurance system (0=“minor”, 1=“considerable”, 2=“severe”, 3=“most severe”; here: degree 2: n = 3, degree 3: n = 1). Half of the patients received help from family members, friends, relatives or neighbours and one person received care by a home care nursing service within the last four months. Three patients used aids like walking sticks (n = 2) or a walker (n = 1). For further information of patients’ characteristics see Table 3.
Table 3
Characteristics of patients at baseline
Cluster
|
C01
|
C02
|
C03
|
C04
|
C05
|
Total
|
|
general practitioners, n (%)
|
1 (14.3)
|
1 (14.3)
|
1 (14.3)
|
1 (14.3)
|
3 (42.8)
|
7 (100.0)
|
|
patients, n (%)
|
4 (18.2)
|
8 (36.4)
|
4 (18.2)
|
3 (13.6)
|
3 (13.6)
|
22 (100.0)
|
Age, mean ± SD, Var (range)
|
72.5 ± 7.5, 57.0
(65.0–79.0)
|
81.3 ± 5.1, 25.6
(73.0–88.0)
|
78.0 ± 2.2,4.7
(75.0–80.0)
|
79.0 ± 2.0, 4.0
(77.0–81.0)
|
81.0 ± 1.7, 3.0
(80.0–83.0)
|
78.7 ± 5.4, 28.7
(65.0–88.0)
|
Woman, n (%)
|
3 (75.0)
|
5 (62.5)
|
2 (50.0)
|
1 (33.3)
|
3 (100.0)
|
14 (63.6)
|
Current housing situation, n (%)
|
|
|
|
|
|
|
|
living alone
|
3 (75.0)
|
4 (50.0)
|
2 (50.0)
|
0 (0)
|
2 (66.7)
|
11 (50.0)
|
|
living together with others
|
1 (25.0)
|
4 (50.0)
|
2 (50.0)
|
3 (100.0)
|
1 (33.3)
|
11 (50.0)
|
Due to the health status, assistance was received within the last 3 months, via, n (%)
|
|
|
|
|
|
|
|
care by a home care nursing
service
|
0 (0)
|
0 (0)
|
0 (0)
|
0 (0)
|
1 (33.3)
|
1 (4.5)
|
|
paid domestic help
|
0 (0)
|
1 (12.5)
|
2 (50.0)
|
0 (0)
|
1 (33.3)
|
4 (18.2)
|
|
help from family members, friends, relatives or neighbours
|
2 (50.0)
|
4 (50.0)
|
2 (50.0)
|
1 (33.3)
|
2 (66.7)
|
11 (50.0)
|
Areas where assistance from other people is usually needed, n (%)
|
|
|
|
|
|
|
|
dressing and undressing
|
1 (25.0)
|
2 (25.0)
|
1 (25.0)
|
0 (0)
|
0 (0)
|
4 (18.2)
|
|
body care
|
1 (25.0)
|
1 (12.5)
|
1 (25.0)
|
0 (0)
|
1 (33.3)
|
4 (18.2)
|
|
get up
|
1 (25.0)
|
0 (0)
|
0 (0)
|
0 (0)
|
0 (0)
|
1 (4.5)
|
|
food and drink
|
0 (0)
|
1 (12.5)
|
2 (50.0)
|
0 (0)
|
0 (0)
|
3 (13.6)
|
|
walking
|
1 (25.0)
|
3 (37.5)
|
1 (25.0)
|
0 (0)
|
0 (0)
|
5 (22.7)
|
|
domestic help
|
2 (50.0)
|
4 (50.0)
|
3 (75.0)
|
0 (0)
|
2 (66.7)
|
11 (50.0)
|
|
shopping
|
2 (50.0)
|
5 (62.5)
|
2 (50.0)
|
0 (0)
|
1 (33.3)
|
10 (45.5)
|
|
takeover of driving services
|
1 (25.0)
|
6 (75.0)
|
3 (75.0)
|
1 (33.3)
|
1 (33.3)
|
12 (54.5)
|
|
drug intake
|
0 (0)
|
5 (62.5)
|
3 (75.0)
|
0 (0)
|
2 (66.7)
|
10 (45.5)
|
|
other
|
1 (25.0)
|
1 (12.5)
|
0 (0)
|
1 (33.3)
|
0 (0)
|
3 (13.6)
|
Degree of care, n (%)
|
1 (25.0)
|
1 (12.5)
|
2 (50.0)
|
0 (0)
|
0 (0)
|
4 (18.2)
|
|
degree 0
|
0 (0)
|
0 (0)
|
0 (0)
|
0 (0)
|
0 (0)
|
0 (0)
|
|
degree 1
|
0 (0)
|
0 (0)
|
0 (0)
|
0 (0)
|
0 (0)
|
0 (0)
|
|
degree 2
|
0 (0)
|
1 (12.5)
|
2 (50.0)
|
0 (0)
|
0 (0)
|
3 (13.6)
|
|
degree 3
|
1 (25.0)
|
0 (0)
|
0 (0)
|
0 (0)
|
0 (0)
|
1 (4.5)
|
SD = standard deviation, Var = variance
No missing values
|
Overall, 20 patients (90.9%) completed the trial; two patients dropped out: one due a poor health status and one fell due to dizziness and was hospitalized (see Fig. 4).
Outcome measures and data collection procedures
Data collection in patients
For data collection, the majority of the participants preferred domestic setting due to mobility restrictions and their health status, only three patients opted for assessment in the study centre. Patients were satisfied with the measurement dates.
Since most patients estimated the general effort of study participating as rather low or even non-existent, the duration of measurement appointments (1:20 hours on average) was adequate for them.
In some patients (T0: n = 8; T1: n = 6; T2: n = 2) a relative was present during the measurement.
Organisational issues did not allow to realise the intended intervals between the measurement points in all patients: Thus, the intended interval of 42 days was reached in 57.1% (range: -6 to + 10 days) between T0 and T1 and in 30% (range: -1 to + 14 days) between T1 and T2.
Patients rated the difficulty of the questionnaires completing as simple (mean: 2.0), some patients needed support from relatives or the study assistant. Patients had the most problems with the IPAQ. Thus, they needed the most help (Post T0: 55%, T1: 46.7%, T2: 61.1%) and time (T0: 13.2, T1: 11.5, T2: 9.9 minutes) for its completion. The amount of missing values in evaluation forms (total blank questionnaires: n = 9, single missing item: n = 1) limited the interpretability, while the response rate in DHI and EQ-5D-5L was 100%. For further information about results of standardised evaluation forms see Table 4.
Table 4
Results of standardised evaluation forms for the patients’ questionnaires (DHI, EQ-5D-5L, IPAQ)
|
T0 post (1 week)
|
|
T1 (6 weeks/7 weeks*)
|
|
T2 (12 weeks/13 weeks*)
|
|
IPAQ (n = 20)
|
|
DHI (n = 21)
|
EQ-5D-5L (n = 21)
|
IPAQ* (n = 15)
|
|
DHI (n = 20)
|
EQ-5D-5L (n = 20)
|
IPAQ* (n = 18)
|
Independent completion possible, n (%)
|
9 (45.0)
|
|
14 (66.7)
|
12 (57.1)
|
8 (53.3)
|
|
16 (80.0)
|
14 (70.0)
|
7 (38.9)
|
Dependent completion with, n (%)
|
11 (55.0)
|
|
7 (33.3)
|
9 (42.9)
|
7 (46.7)
|
|
4 (20.0)
|
6 (30.0)
|
11 (61.1)
|
|
relative
|
5 (25.0)
|
|
3 (14.3)
|
4 (19.0)
|
1 (6.7)
|
|
2 (10.0)
|
3 (15.0)
|
3 (16.7)
|
|
acquaintance
|
0 (0)
|
|
0 (0)
|
0 (0)
|
0 (0)
|
|
0 (0)
|
0 (0)
|
0 (0)
|
|
study assistant
|
6 (30.0)
|
|
4 (19.0)
|
5 (23.8)
|
6 (40.0)
|
|
1 (5.0)
|
3 (15.0)
|
7 (38.9)
|
Difficulty of completing1,
median, IQR (range)
|
2.0, 1.8 (1.0–5.0)
|
|
2.0, 0.5 (1.0–5.0)
|
2.0, 1.5 (1.0–5.0)
|
2.0, 1.0 (1.0 – 5.0)
|
|
2.0, 0 (1.0–5.0)
|
2.0, 1.8 (1.0–5.0)
|
2.0, 2.0 (1.0–5.0)
|
Time (minutes) of completion,
mean ± SD, Var (range)
|
13.2 ± 14.3, 203.3
(3.0–60.0)
|
|
9.0 ± 6.8, 46.0
(3.0–30.0)
|
8.4 ± 4.7, 22.4
(2.0–20.0)
|
11.5 ± 8.0, 63.8
(1.0–30.0)
|
|
10.1 ± 6.7, 44.8
(3.0–30.0)
|
8.1 ± 5.4, 28.8
(2.0–22.0)
|
9.9 ± 9.2, 85.2
(2.0–30.0)
|
EQ-5D-5L=5-level EuroQol-5-dimensions, DHI=Dizziness Handicap Inventory, IPAQ=International Physical Activity Questionnaire, IQR=interquartile range, SD=Standard deviation, Var=Variance
* IPAQ measurement times: T0 post (1 week), T1 (7 weeks), T2 (13 weeks)
1Coding: 1="very simple", 2="simple", 3="difficult", 4="very difficult", 5="impossible without aid"
Missing values: IPAQ: total blank questionnaires T0 (n=1), T1 (n=6), T2 (n=2); single missing item T0 (n=1)
|
Most participants rated the miniBEST as feasible, but some felt insecure depending on the daily form or any physical handicaps. Barriers to its performance in domestic setting were narrow rooms and potential stumbling blocks, whereas the study assistants’ basic qualification as a PT was an advantage in terms of safety.
The results of DHI, EQ-5D-5L, IPAQ and miniBEST during the study process of interventions implementation are presented in Table 5. Missing values occurred in DHI and IPAQ. Due to the high number of missing values, no detailed analysis of IPAQ is given in Table 5.
Table 5
Results of primary and secondary outcomes during the study
|
Pre T0
(n = 22)
|
T0: baseline* (n = 22)
|
T1: 6 weeks* (n = 21)
|
T2: 12 weeks* (n = 20)
|
T0 – T2
|
mean of the differences ± SD
(95%-CI)
|
DHI, median, IQR (range)
|
-
|
38.0, 25.5
(4.0–84.0)
|
38.0, 38.0
(12.0–82.0)
|
39.0, 49.0
(6.0–80.0)
|
1.0
|
-2.9 ± 14.9
(-10.1–4.3)
|
EQ-5D-5L, mean ± SD, Var (range)
|
|
Health state index
|
-
|
2.0 ± 0.4, 0.1
(1.6–2.5)
|
2.1 ± 0.4, 0.1
(1.8–2.6)
|
2.0 ± 0.4, 0.2 (1.5–2.5)
|
0
|
-0.03 ± 0,5
(-0.3–0.2)
|
|
VAS
|
-
|
65.9 ± 18.7, 351.5
(30.0–90.0)
|
67.6 ± 16.9, 286.5
(20.0–90.0)
|
59.9 ± 20.6, 422.6
(10.0–90.0)
|
-6.0
|
7.2 ± 14.2
(0.3–14.0)
|
miniBEST,
median, IQR (range)
|
-
|
17.5, 7.0
(7.0–27.0)
|
20.0, 5.5
(12.0–25.0)
|
19.0, 7.3
(11.0–27.0)
|
1,5
|
-1,1 ± 3.8
(-2,9–0.8)
|
IPAQ, mean ± SD, Var (range)
|
3523.6 ± 3454.3, 1.25*106
(66–12798)
|
5793.4 ± 5456.0, 3.16*106
(198–17598)
|
4495.8 ± 4249.7, 1.93*106
(146–16160)
|
1730.8 ± 1366.5, 2,04*106
(198–4377)
|
-
|
-
|
CI = confidence interval, IQR = interquartile range, SD = standard deviation, Var = Variance
DHI = Dizziness Handicap Inventory; coding: 0="no", 2="sometimes", 4="yes"; missing values: T0 (n = 1, item = 1), T1 (n = 1, item = 5), T2 (n = 1, item = 4)
EQ-5D-5L = 5-level EuroQol-5-dimensions; coding health state index (see distinct item descriptions): 1="no problem", 2="slight problem", 3="moderate problem", 4="severe problem", 5="extreme problem"; no missing values
miniBEST = Mini Balance Evaluation Systems Test; coding (see distinct item descriptions): 0="not possible", 1="medium", 2="normal"; no missing values
IPAQ = International Physical Activity Questionnaire; coding: Metabolic Equivalent Task minutes per week (METmin/week), missing values: preT0 (n = 1), T0 (n = 5), T1 (n = 5), T2 (n = 8)
* one week after measurement point (IPAQ)
|
Response rate for the use of both sensors was rather high (T0: 81.8%, T1: 85.7%, T2: 80%) and patients wore the devices mostly without experiencing any restrictions in daily life, which indicates a good acceptance. While wearing the StepWatch4, patients reported sliding down, itching, skin irritations and mild oedema and skin irritation. Move4 required less patient compliance, as this sensor did not need to be removed and replaced by the patients (e.g. before and after taking a shower) during the week of data recording, and allowed better data handling and processing. The lower demands for this sensor might have led to a higher amount of obtained valid days of recording for the Move4 vs. the StepWatch sensor: data sets of eight (Move4) versus five (StepWatch4) patients could be analyzed across all time points. In general, both sensors revealed similar time courses of physical activity, with Move4 tending to count a higher number of steps in active phases as compared to StepWatch4. Qualitative analysis of physical activity diary entries suggest that the Move4 sensor better represent differences in physical activity levels within individuals. Thus, further outcomes will only be reported for the Move4 sensor. On average, the eight patients with valid data sets across all three time points took 6148 steps a day at T0, 5482 steps at T1 and 5306 steps at T2. This difference was statistically non-significant. Analysis of activity patterns revealed that patients spent most of their time sedentary, i.e. sitting, lying or standing. This held true for the percentage share of sedentarism as compared to activity, as well as for the bout length of sedentary phases (see Table 6). Importantly, while total step count was within the range of that reported in other studies [45], the proportion and bout length of sedentary phases was substantially higher as compared to healthy elderly [46].
Table 6
Activity pattern in percent of time of the day spent in each class and mean bout length
Activity class
|
|
T0
|
T1
|
T2
|
Sitting/lying
|
Proportion,
mean bout length
|
74%
30.1 min
|
69%
38.2 min
|
72%
35.8 min
|
Standing
|
Proportion,
mean bout length
|
2%
1.4 min
|
9%
2.9 min
|
5%
1.3 min
|
Moving
|
Proportion,
mean bout length
|
6%
2.0 min
|
6%
1.8 min
|
6%
1.6 min
|
Please note that the remaining percent of the day was classified as non-wear time
|
Participants evaluated the physical activity diary as understandable, but also as time consuming.
“I have entered this once every hour. I do not do that anymore. If I am completely honest, I calculate that as an average. When I am on the road or out for a walk, I can of course record it exactly. But what I walk or sit around at home is more or less estimated.” (P15, male, 77 years)
Response rate for fulfilment of the diary was rather high (T0: 91.0%, T1: 81.0%, T2: 90.0%), reasons for denial were overload or inability to complete it without assistance, e.g. due to visual impairment or writing problems. Despite the different levels of accuracy of the descripted activities, the diary was a helpful and necessary aid for the interpretation of the sensor data.
All participants took part in the telephone interviews (each one after T1 and T2), partly (n = 4) supported by relatives in both interviews.
There were no further problems in scheduling of personal or telephone appointments and in the transfer of study documents and actigraphy to study centre by patients.
The telephone hotline was frequently used by patients and their relatives before and during enrolment in the topics of organisational aspects (e.g. study duration, scheduling postponements) and mostly about actigraphy (e.g. weight, size), indicating this approach to be feasible.
For further information and an overview of barriers and facilitators subdivided in all domains see Additional file 3.
Data collection in clusters
All GPs submitted their completed questionnaires (QCPC, evaluation forms of training and recruitment process) and for 90.9% of patients (n = 20) the filled checklist as required.
GPs frequently used the study centres’ hotline mostly with regard to the topic of recruitment, but also for the request for further recruitment documents.
There was neither a prior relationship to any of the participants nor knowledge about the interviewers in group interview. Despite the commitment of all GPs, only five of them (71.4%) attended the agreed date, so that one cluster was not represented. In the additional individual telephone interview about recruitment procedure, one GP out of each practice took part.
Additional involved resources in study participation were personnel (office staff) and time, but however, they arranged well so that study participation seems to be integrated in daily practice in an acceptable and feasible way.
For further information and an overview of barriers and facilitators subdivided in all domains see Additional file 3.
Data collection in PTs
There were no further problems in filling and submitting the standardized questionnaires. All PTs transferred the filled guides and in 84.6% the additional treatment documentation as required.
Individual telephone interviews with PTs took place as planned.
Time expenditure and organizational efforts were limited and study participation was easy to integrate in daily practice. Study centres’ hotline was mainly contacted for organisational issues (fill the prescription, study procedures, further informational and educational flyers).
Data collection (DHI and miniBEST) was reported as feasible as it was the transfer of these questionnaires via handing over by the patients and additional emails from the research team.
For further information and an overview of barriers and facilitators subdivided in all domains see Additional file 3.
Feasibility of intervention components and implementation strategy
The Context: Characteristics GP and PT practices
GP practices treated between over 500 and 2000 patients per quarter, which were older than 60 years in 39% and had at least two chronic diseases (32.8%) (see Table 7).
Table 7
Baseline characteristics of GP practices
|
C01
|
C02
|
C03
|
C04
|
C05
|
mean
|
Patients in practice per
quarter
|
|
|
|
|
|
|
|
total number, predefined range
|
> 1,000–1,500
|
> 500–1,000
|
> 500–1,000
|
> 1,000–1,500
|
> 1,500–2,000
|
|
|
over 60 years old, %
|
40.0
|
33.0
|
30.0
|
57.0
|
35.0
|
39.0
|
|
with at least 2
chronic diseases, %
|
20.0
|
40.0
|
NA
|
26.0
|
45.0
|
32.8
|
Missing values: n = 1
|
PT practices treated between less than 500 to more than 2000 patients per quarter (modus < 500 patients). Most patients (56.9%) were over 60 years old and had at least two chronic diseases (46.9%) (see Table 8).
Table 8
Baseline characteristics of PT practices
|
PTP01
|
PTP02
|
PTP03
|
PTP04
|
PTP05
|
PTP06
|
PTP06
|
PTP08
|
PTP09
|
PTP10
|
mean
|
Patients in practice per quarter
|
|
|
|
|
|
|
|
|
|
|
|
|
total number, predefined range
|
< 500
|
> 2,000
|
< 500
|
> 2,000
|
< 500
|
> 500–1,000
|
< 500
|
> 500–1,000
|
> 1,000–1,500
|
< 500
|
|
|
over 60 years old, %
|
50.0
|
NA
|
70.0
|
65.0
|
65.0
|
NA
|
45.0
|
65.0
|
25.0
|
70.0
|
56.9
|
|
with at least 2 chronical diseases, %
|
20.0
|
NA
|
60.0
|
70.0
|
45.0
|
NA
|
30.0
|
55.0
|
70.0
|
25.0
|
46.9
|
Missing values: n = 4
|
During the implementation, low treatment adherence, lacking awareness of the interventions impact and visual, writing or comprehension problems were reported as barriers for patients, whereas social support by relatives was a facilitator.
For the health professionals’ motivation, positive expectations and familiarity with the intervention, and support via helplines were reported as facilitators. Lacking interdisciplinary exchange was rated as a barrier.
Organisational aspects (lacking time, short treatment units in PT practices, long waiting times for appointments with medical specialists/PTs) were rated as barriers. Intra-professional exchange was a facilitator.
For further information and an overview of barriers and facilitators subdivided in all domains see Additional file 3.
Delivery to and response of clusters
All GPs took part in one of the offered training sessions in May/June and rated all learning objectives to be achieved as entirely true to partly true (total score value in mean: 1.3 ± 0.5), indicating its good acceptance. GPs especially emphasized the practical exercises, the good atmosphere and the small group size, but additionally requested the application of the checklist on a dummy patient. However, all GPs felt competent for practical application of the checklist (see evaluation domain no. 8). One GP appreciated a repetition of the educational training. Due to the scheduled time for study issues in training sessions were too short, one GP suggested to build up a separation of professional training and technical study procedure information. For further information about results of evaluation forms see Table 9.
Table 9
Evaluation of educational training of GPs
No.
|
Evaluation area and domain
|
1st educational training date (n = 5)
|
2nd educational training date
(n = 2)
|
Total
(n = 7)
|
Dissemination of knowledge, median, IQR (range)
|
|
|
|
|
At the training I was systematically taught
|
|
|
|
1
|
|
differentiations of the most important vertigo syndromes.
|
2.0, 1.5 (1.0–3.0)
|
1.5, n.a. (1.0–2.0)
|
2.0, 1.0 (1.0–3.0)
|
2
|
|
methods for diagnosing positional vertigo.
|
1.0, 0 (1.0–1.0)
|
1.5, n.a. (1.0–2.0)
|
1.0, 0 (1.0–2.0)
|
3
|
|
forms of therapy and their instructions for the most important vertigo syndromes.
|
2.0, 2.0 (1.0–4.0)
|
1.5, n.a. (1.0–2.0)
|
2.0, 1.0 (1.0–4.0)
|
4
|
|
how to apply the checklist in practice.
|
1.0, 0.5 (1.0–2.0)
|
1.0, n.a. (1.0–1.0)
|
1.0, 0 (1.0–2.0)
|
Gain in know-how skills, median, IQR (range)
|
|
|
|
5
|
At the training I was systematically taught a neurological screening.
|
2.0, 1.0 (1.0–3.0)
|
1.5, n.a. (1.0–2.0)
|
2.0, 1.0 (1.0–3.0)
|
6
|
After the training I feel able to apply the demonstrated examination techniques.
|
2.0, 1.0 (1.0–2.0)
|
1.0, n.a. (1.0–1.0)
|
1.0, 1.0 (1.0–2.0)
|
7
|
The contents of the training were adequate for the independent practical application of the checklist.
|
2.0, 1.0 (1.0–2.0)
|
1.0, n.a. (1.0–1.0)
|
1.0, 1.0 (1.0–2.0)
|
8
|
The workshop was well-structured and organized for practical application of the checklist.
|
2.0, 1.0 (1.0–2,0)
|
1.0, n.a. (1.0–1.0)
|
1.0, 1.0 (1.0–2.0)
|
Temporal organization, median, IQR (range)
|
|
|
|
9
|
The temporal extend of the workshop was appropriate.
|
1.5, 1.0 (1.0–2.0)
|
1.0, n.a. (1.0–1.0)
|
1.0, 1.0 (1.0–2.0)
|
Total quality of educational training (No 1–9), mean ± SD, Var (range)
|
1.7 ± 0.4, 0.2
(1.0–2.0)
|
1.2 ± 0.3, 0.1
(1.0–1.5)
|
1.3 ± 0.5, 0.3
(1.0–2.0)
|
Other, median, IQR (range)
|
|
|
|
10
|
In your opinion, is there a need for such training among GPs?
|
1.0, 0.5 (1.0–2.0)
|
1.0, n.a. (1.0–1.0)
|
1.0, 0 (1.0–2.0)
|
11
|
Do you already use the presented techniques for vertigo syndromes?
|
3.0, 2.0 (1.0–4.0)
|
2.5, n.a. (2.0–3.0)
|
3.0, 2.0 (1.0–4.0)
|
IQR = interquartile range, SD = standard deviation, Var = variance
Coding: 1="entirely true", 2="partly true", 3="rather not true", 4="completely untrue"
Missing values: Item 9 (n = 1)
Note: Besides these 11 domains, the following 3 questions could be answered in free text form (qualitative analysis): What did you particularly like about the training? What did you not like about the training? What else would you have liked?
|
As additional materials, GPs received instructions for the positioning manoeuvres during the training sessions. Further, they asked for a brief summary of the whole examination procedure for patients with VDB in form of a written handout with pictures or a homepage with videos.
The checklist was applied to 90.9% of study participants (n = 20) at least once. The expectations of the participating GPs were not in line with the initial aim of the checklist. GPs rather expected a comprehensive guideline for anamnesis and diagnosis than a short checklist.
“If the patient goes and says 'He asked me three questions and then sent me to an otolaryngologist' then he feels as usual that someone has not really taken him seriously and has not even examined him in a structured way.” (GP01, male, 45 years)
GPs stated, that a chronological structure with a more detailed anamnesis section, e.g. in a two-sided document to combine anamnesis, examination and consequences as referrals would be preferable. They rated the paper material in DIN A4 format as feasible, one GP stated that a digital form would be too complicated and could not be used in daily practice.
According to GPs, problems in the checklist’s completition arose due to unclear instructions. Overall, GPs filled the checklist rather incomplete and made partly incomplete entries, e.g. they did not note the referral to physical therapy.
Further deviations from intervention protocol occurred in the timing of checklist application. GPs frequently combined recruitment with its first use, so that T0 could not be performed prior to the intervention as intended. According to the completed checklists, 40.9% of patients attended all GP appointments as required (initial diagnostics, follow-up after four weeks, follow-up after eight weeks/three months), 13.6% were seen by their GP twice and 36.4% only kept the initial appointment. According to the GPs, reasons for this were forgetting active re-ordering, but mostly due to the patients’ poor adherence on their request to make an appointment after a certain time. Whereas patients reported lacking scheduling by the GP, as most of them proactively contacted them due to the need for a follow-up prescription to PT. In two patients (9.1%) the checklist was not used at all.
A total of 14 patients (63.6%) were referred to physical therapy. In 78.6% GPs used an VDB specific ICD code (3 missings) and in 71.4% the VDB specific indication code (1 missing) as intended. Mostly GPs referred to physical therapy (n = 11, 78.6%; 3 missings) and in two patients (14.3%) the GP additionally prescribed classical therapeutic massage. Mostly, there was no explicit interdisciplinary exchange between GPs and PTs.
A total of 45.5% of study participants received a referral to at least one medical specialist. Apart from personal contact with medical specialists by the GPs in urgent cases, there was no differentiated exchange.
All GPs stated that the high time expenditure of the checklist application (range: 20–30 minutes) made an appointment outside office hours necessary. Routine was mentioned to be beneficial for its application in daily practice.
“If you do it more often, you can easily get it done in 15 to 20 minutes. […] And these are worthwhile 20 minutes [...]. So, you save a lot of time afterwards.” (GP01, male, 45 years)
Despite the required adaptations to enhance user-friendliness, GPs saw an added value due to the standardised procedure gave them security in dealing with affected persons and the exclusion of dangerous constellations gave the patients security in turn. This indicates a change of their competence and behaviour in treatment of VDB patients.
Although all GPs appreciated the offered telephone helpline, only one GP used it for a question in filling in the checklist (call duration < 5 minutes).
GPs were pleased with the qualification certificate and the certificate for study participation, which some of them hung up in their practice.
For further information and an overview of barriers and facilitators subdivided in all domains see Additional file 3.
Delivery to and response of PTs
All PTs attended educational training in May. All learning objectives to be achieved were rated as entirely true (total score value mean: 1.0), indicating a very good acceptance of the workshop. They especially highlighted the interplay between of theoretical and practical parts. However, all PTs felt competent for the practical application of the guide (see evaluation domain no 8). For further information about results of evaluation forms see Additional file 4.
PTs rated the supportive materials as helpful for understanding the content, whereas they requested further summaries of treatment techniques in written form or video tutorials.
The guide was applied to all study participants who filled a prescription in trained PTs. PTs evaluated its content and structure as good and the paper material in DIN A3 format as feasible and clearly arranged. Time required for its application differed between the PTs (range: 15–30 minutes) and most managed it within one treatment unit. There were no additional personal resources needed. Overall, PTs completed physical assessment section of the guide fully, but used the performed assessments rather incomplete.
All PTs stated to have profited from the guide, especially due to the structured procedure, so that patients benefit from adequate treatment and efficient clinical reasoning.
“If I save time with the diagnostic process, he has more time for therapy at the 1st appointment. […] If I know in a more focused way where exactly the problem is, I can help even better, offer support. […] So, I think he simply benefits from the fact that you know much more focused (PT05, female, 33 years)
Overall, PTs rated the intervention as acceptable and feasible in daily practice, whereby practical exercise by repeated application of the guide leads to safety in use and thus to time savings.
PTs reported changes in their competence and behaviour and their self-efficacy has been strengthened by knowledge and skills.
PTs adhered well to the guide, so that all patients received VDB specific treatment and at least one target group-oriented flyer (92.3%). PTs evaluated these as targeted to patients needs and age.
“I always put a cross on the exercises that we have discussed or that they can or should do at home. And that simply makes it easier. There is the picture and the text, well explained. I find it very helpful.” (PT10, female, 52 years)
Most PTs reported that interdisciplinary interaction with GPs was scarce, whereas intra-professional exchange in practice team and with colleagues outside increased.
Utilization of the telephone helpline was scarce (1 call, call duration < 5 minutes). Reasons were only stated by one PT (forgot the option).
For further information and an overview of barriers and facilitators subdivided in all domains see Additional file 3.
Delivery to and response of individuals
Nearly all patients (90.9%) received the GPs’ intervention between June 2019 and January 2020 and they were mostly satisfied with their treatment. A total of 10 patients (45.5%) received a referral to at least one medical specialist (cardiologist, ophthalmologist, neurologist or ENT physician) and 63.6% (n = 14) to physical therapy. However, 13.6% (n = 3) received neither a PT prescription nor a referral to a medical specialist. Also, two patients declined a referral to PT due to lacking interest and focusing on other acute health issues. GPs reported patients’ characteristics (poor motivation, lacking awareness about effects of specific therapy) as potential barriers for further referral, but also organizational issues. 92.9% patients decided to filled it in practices with specially trained PTs and reported to be satisfied with therapy. Patients rated the leaflets for home exercises as easy to understand and feasible at home, whereas two persons received help from relatives in performance. Most reported to perform exercises regularly motivated by the hope of symptom relief, but few sporadically due to lacking time, focusing on other health issues or forgetting.
“I just realized it is getting better. […] Vertigo seems to be a vicious circle. That means when I have vertigo, I do less activity. Less activity means, especially in older people, that the muscles weaken and the problem becomes worse and worse. [...] So if I now try to at least do exercises and train these areas a little bit […] I hope that the strength, i.e. the intensity of the vertigo, is no longer the same as before.” (P09, male, 67 years)
85.7% (n = 12) of patients receiving physical therapy at least felt a slight improvement of symptoms and some reported a behavioural change due to the integration of exercises in everyday life.
“I have caught myself a few times when I go into town and see cobblestones that are markers for me, I try to walk straight along them.” (P12, male, 79 years)
Unintended consequences
Health professionals reported no unintended harmful consequences in application their intervention parts towards patients and themselves. No patients suffered harm, e.g. due to a fall event directly related to the intervention, which indicates its safety.