|Category of data||Method of data collection||Timing of collection||Items and instruments||Piloting|
|1) Characteristics of PPs & sites||i) Structured interview and site visit||Prior to observation period||
Setting and geographic location|
PPs profile: Age, gender, highest educational qualification, salary/band, full/part time status, job title/role;
Service Information: service description & patient profile, single or multi-professional team, other NMPs in team
Interview schedules were reviewed by research team and project advisory group. Main interviewer (JE) was buddied by experienced team member (KS) for first two interviews in order to provide guidance and clarify and address any issues with the interview schedule.|
Following this, minor revisions were made to improve the flow of questions.
|2) Patient characteristics||i) Patient questionnaire 1 & 2||Post consultation and 2 months following||Socio-demographics: age, gender, living arrangements; accommodation, employment; education; ethnicity||
Q1: Patients (n = 5) completed and commented on ease of comprehension, length and time. Based on comments no refinements were made.|
Q2: piloted concurrently at first site (case-site 3). After first 10 completed, ease of use, consistency and question completion rate were discussed with no amendments or changes required.
|3) Patient reported outcomes||
i) Patient questionnaire 1|
ii) Patient questionnaire1 and 2
Post- consultation and 2 months following consultation (excluding 1st
Patient satisfaction: with consultation, advice and medicines information comprised subscales from several validated tools (total 24 items):|
i) Consultation Satisfaction Questionnaire i.e. ‘professional care’, ‘perceived time’ and ‘overall satisfaction’ and ii) Medical Interview Satisfaction Survey (MISS) [53, 54] ‘compliance intent’ (10 items) & for patients who received medicines information or advice questions from PP iii) Satisfaction with Information about Medicines (SIMS) Scale  e.g. dose schedule, how medicine works, side-effects, and medicines adherence) [54,55,56,57] (14 items).
Service Satisfaction: was measured by 7 items on ease of access to services from the outpatients’ opinion of quality of hospital departments questionnaire –7 items.
Attitudes towards PP-IP [56, 59]–4 items.
6 point Likert scales (strongly disagree to strongly agree) used for all items
Quality of life validated EQ-5D-5L  comprising 5 dimensions, from independent – dependent, with 5 weighted levels affording a single index value score. (i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression)
Formal piloting was undertaken in January 2015 in a secondary care based rheumatology outpatient clinic (not designated as a site). Five completed questionnaires were returned with comments indicating that content, layout and design was comprehensive and completion time was of acceptable length, ranging from 9 to 15 min.|
Questionnaire 2 was implemented following data collection completion at the first four sites, and was piloted concurrently at the first site visited (site 3) after its approval. After the first 10 completed questionnaires, ease of use, consistency and question completion rate were discussed at team meetings; no amendments or changes were required.
|4) PPs activities||
i) Observation diary completed by researcher|
Real-time service delivery up to 5 working days (37 h)|
Real-time service delivery up to 5 working days (37 h)
Using a Microsoft Access© custom built electronic diary based on previous validated tools [61,62,63], a researcher recorded details of the model of service provision and MMA (including outcome and prescribing actions) during each observed consultation.|
Model of service provision: Consultation duration (in minutes); type of consultation (face to face, telephone, email) and appointment (initial, follow-up, emergency), service & referral source (e.g. NHS in/outpatient, community, GP, social enterprise, private). Other work activities in relation to care included referrals made (to whom and how), discussion with colleagues, time spent in discussions with colleagues and review arrangements.
MMA i) outcome: whether a new medication was required; decisions to alter, stop, or make no change to existing medications; or decision to repeat prescribe previous item(s);
ii) prescribing actions; decision to recommend OTC product; recommend to Dr., other prescriber or via hospital notes prescription is required; adjust dose/drug according to pre-agreed protocols; (i.e. PGD; PSD, exemptions); whether provided advice to patients about medicines (i.e. how it works, when to take and side-effects); medication details (i.e. name, dose, duration, formulation)
Questions were fixed option and/or free text.
All prescriptions issued by PP-IPs during observed consultations were collected and assessed based on previous work [64,65,66] and guidelines for prescription writing in the BNF  (i.e. accuracy, legibility, correct use of terminology, whether medicines were prescribed generically, preparation details, dose, dose frequency, length of treatment, and instructions regarding frequency, location and application of topical treatments).
Details of 8 observed consultations were recorded and downloaded into Microsoft Excel©. Data were found to be comprehensive, and the template layout/design revised following team discussion data.|
There was no piloting of the assessment tool as it had been used in previous studies [41, 68].
|5) Resource implications and costs||i) Interviews with PP||Prior to baseline data collection||Grade/ banding of each of the PPs in the study.||(as reported above)|
|ii) Observation diary completed by researcher||Real-time service delivery up to 5 working days (37 h)||
Six items related to consultations with individual patients were also examined for differences between PP-IPs and NP-PP-NPs|
-number and duration of consultations
- frequency & duration of discussions with colleague or other professional regarding patient’s medication
-frequency of new medications
-frequency of referrals and follow-up consultations
|(as reported above)|
|iv) Patient record audit||
Clinical records 2 months following consultation.|
A maximum of 15 patients per site were selected.
|Requested investigations, tests (e.g. BP, bloods, x-ray, MRI scan, CT, urine, sputum etc.) and referrals and services used relevant to the presenting complaint (i.e. case site PP, consultant specialist, clinical nurse specialist, GP, GP based nurse/ nurse practitioner, community nurse pharmacists, social services, other healthcare professionals) other hospital outpatients, hospital admissions, and number of in-patient days, A&E visits etc.||Audit tool: was piloted on 8 sets of medical records. Concerns were raised about quality of available data and that retrospective data collection could present difficulties with potential incomplete data. Following data collection at first four sites an amendment to the study protocol, as previously described was made.|
|iii) Patient questionnaire 2||2 months following consultation (excluding first 4 sites)||Self- report use of health services for PP related issues in the previous 2 months including: tests received, referrals, follow-up consultations, un-planned consultation; visits or contact with GPs, clinical nurse specialist, pharmacists, social services, other healthcare professionals, hospital outpatient clinics, A&E visits, hospital admissions, and number of inpatient days|