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Table 1 Overview of data sources and measuring points by target groups for process evaluation (quantitative/qualitative)

From: Implementation, mechanisms of change and contextual factors of a complex intervention to improve interprofessional collaboration and the quality of medical care for nursing home residents: study protocol of the process evaluation of the interprof ACT intervention package

Target population Data collection Measurement points Target population and recruitment strategies Sample size
T0a T0b First training (only in IG) Kick-off meeting (only in IG) Second training (only in IG) T1 T2
General practitioners (both study groups) Quantitative x
(Q)
   xa
(Q)
   x
(Q)
All GPs involved in the medical care for participating NHRs and interested in participation
For recruitment:
• GPs will be invited in written form to take part in the interprof ACT trial, including. the process evaluation
• All GPs will receive an expense allowance.
Data from a previous trial conducted in the German long-term care setting suggest a resident-to-physician ratio of approximately 3. A total number of about 210 GPs to be invited to participate in the process evaluation will be expected [8]. Based on previous data, a response rate of 45% is assumed, reducing the sample size to about 95 GPs [20,21,22].
Qualitative   x
(I, O)
  x
(O)
  x
(I, O)
x
(I, O)
GPs who participate in the main trial and agree to participate in the process evaluation.
For recruitment: GPs will be contacted in writing and/or via telephone by members of the research team.
On average, two GPs per NH per measurement point are expected.
Participation at each kick-off meeting (n = 5) of the subsample of the qualitative process evaluation will be expected.
Registered nurses (both study groups) Quantitative x
(Q)
   xa
(Q)
   x
(Q)
All RNs working in direct nursing and medical care for the NHRs throughout the day, evening, or night shifts at data collection days.
For recruitment: RNs will be contacted in writing and orally by study team members involved in data collection for main trial outcomes.
On average four RNs may be reached per cluster, representing approximately 30% of the target population [8].
Qualitative   x
(I, O)
  x
(O)
  x
(I, O)
x
(I, O)
RNs pre-selected by nursing or facility directors based on their involvement in interprofessional collaboration. RNs are included if they are available and willing to take part in the qualitative process evaluation.
For recruitment: RNs will be contacted in writing and/or via telephone by members of the research team.
On average, two RNs per NH per measurement point will be expected.
Participation at each kick-off meeting (n = 5) of the subsample of the qualitative process evaluation will be expected.
Nursing home residents (both study groups) Quantitative xb
(Q)
   xa
(Q)
   xb
(Q)
All NHRs participating in the interprof ACT trial, i.e., meeting following inclusion criteria [12]:
• Have experienced at least one GP contact in the last three months or two GP contacts in the last 6 months or were admitted to the nursing home during the preceding 6 months independently of the actual number of documented GP contacts
• Are aged 18 years or older
• Provide written informed consent for the study, either by themselves or through their legal guardian
Of these, only NHRs able to answer simple questions of satisfaction with medical care by themselves are to be included in the process evaluation.
For recruitment: Detailed recruitment strategies and methods to appraise NHRs’ ability to answer questions are described in the main trial protocol [12].
As estimated for the interprof ACT trial [12].
Qualitative     x
(O)
    NHRs who are co-subject of non-participating observations.
For recruitment: In these cases, NHRs will be informed about the observation in written and oral form before the observation takes place. NHRs or their legal guardian must provide informed consent.
Not applicable
Nursing/ facility directors (both study groups) Quantitative xc
(Q)
   xa
(Q)
   xc
(Q)
Nursing or facility directors of all nursing homes participating interprof ACT trial [12].
For recruitment: Detailed recruitment strategies are described in the main trial protocol [12]. All nursing homes will receive an expense allowance.
As estimated for the interprof ACT trial [12].
Qualitative     x
(O)
    Only nursing or facility directors who are co-subject of non-participating observations (during kick-off meetings).
No specific recruitment strategies are required.
Not applicable
IPAVs (only in IG) Quantitative    x
(Q)
xa
(Q)
x
(Q)
x
(Q)
x
(Q)
All designated IPAVs or their substitutes.
No specific recruitment strategies are required.
In each participating nursing home of the intervention group (n = 17), one IPAV and one substitute should be designated, resulting in an expected sample size of approximately n = 34.
Qualitative     x
(O)
    IPAVs who are:
• Involved in direct nursing care and interaction with GPs during non-participating observations, can also be subject of these observations and interviews.
• Co-subject of non-participating observations (during kick-off meetings).
No specific recruitment strategies are required.
Not applicable
Study team members (only in IG) Quantitative    x
(Q, M)
x
(Qa, M)
x
(Q, M)
xd
(Q, M)
xd
(Q, M)
Involved in the supervision and training of IPAVs
No specific recruitment strategies are required.
Approximately 2–4 study team members per study site, resulting in an expected sample size of approximately n = 6–12.
Qualitative     x
(O)
    Co-subject of non-participating observations during kick-off meetings Not applicable
Participants and moderators of the kick-off meetings Quantitative     xa
(Q)
    All relevant stakeholders, especially NHRs and their relatives, RNs, the nursing or facility director of the nursing home, the GPs associated with this nursing home, and the nursing home advisory board.
Kick-off meetings will be jointly moderated by the IPAV and one study team member
For recruitment: Target persons of the kick-off meetings will be invited orally and in writing by IPAVs of intervention nursing homes.
10 to 15 participants will be expected for each meeting, with one meeting conducted in each of the 17 intervention nursing homes.
Qualitative     x
(O)
   
  1. Abbreviations: GP general practitioner, I interview, IG intervention group, IPAV interprof ACT agent, M minutes, NHR nursing home resident, O observation, Q questionnaire, RN registered nurse, T0a baseline assessment (before randomized allocation), T0b shortly post randomization, T1 follow-up after 6 months, T2 follow-up after 12 months
  2. aPre-post questionnaire. bIn the form of face-to-face interview. cIntegrated in case report form of main study. dDuring supervision (questionnaire for baseline characteristics)