Intervention name |
CARE Plus: a primary-based whole system complex
intervention (CARE Plus) for patients with multimorbidity living in areas of
high socioeconomic deprivation. |
This paper describes the development and
optimisation of the intervention and the final iteration to be tested in a
phase 2 exploratory RCT. |
This work is part of a 4-year programme of research
called ‘Living Well with Multimorbidity’ funded by the Chief Scientis Office
of the Scottish Government NHS Applied Research Programme Award
(ARPG07/01). |
WHY (theory, background, essential elements) |
Likely key components drawn from literature, expert
opinion, and views of patients, representatives and health care staff. |
This papers outlines the background to the research
and how the key components of the CARE Plus intervention were identified and
developed. |
See Bamett et al.2 and O’Brien et al.,7,8 for details of the baseline
epidemiology and qualitative research that informed the intervention
development. |
WHAT (materials) |
Longer consultations using bespoke CARE Plus care
plan; practitioners training and support materials; patient self-management
support materials. |
The key components of the intervention are presented
in the paper and the final iteration is outlined under the ‘optimisation
section.’ In the pilot, a variety of CBT-based booklets were given to
different patients. Mindfulness-CDs were not available at the time of the
pilot. |
A final version of the CARE Plan will be developed
for the RCT. The final version of the materials given to practitioners in the
training days and to the patients in the RCT will be developed before the RCT
begins, informed by the current findings of this paper. The patient
self-management support pack requires further development before the RCT. |
WHO will provide intervention |
CARE Plus consultations Practitioner training and
support |
This paper identified the need for flexibility in
terms of who delivers the intervention (GP or PN) and that different practices
will be allowed to operationalise this differently. |
The practitioner training and support in the pilot
study was delivered by an academic GP (SWM) and a psychiatrist skilled in CBT
and mindfulness. This will also be the case in the exploratory trial. |
HOW (modes of delivery) |
Patient consultations will be face-to-face with GP
or PN Practitioner training will be group based. |
In the pilot study the CARE Plus consultations were
all held face-to-face. |
In the exploratory trial, practitioners will deliver
the consultations face-to-face for reasons of efficiency. |
WHERE (locations) |
Patients consultations Practitioner training and
support. |
In the pilot study almost all the consultations were
delivered in the practices. Practitioner training and support was only
delivered in one practice, and this took place in the practice. |
In the exploratory trial consultations will take
place in the practices. Group training and support will involve all GPs and
PNs in the intervention group meeting 3–4 times over 12 months in a single
location. |
WHEN and how much |
Number of CARE Plus consultations per patients.
Practitioner training and support meetings: maximum 4 meetings; 3 h per
meeting. Patient self-management support material. |
In the current paper, it was clear that the length
of the consultations required was contested in the development phase; however,
in the pilot in the 2 practices, it was agreed that the initial consultation
needs 30-40 min and the follow-up 20-30 min. The number of follow-up
consultations required was not established. In this paper, only 1 practice
took part in the training and support and had only 1 meeting of 3 h. |
In the exploratory trial we will recommend that
practitioners see the selected patients in the CARE Plus intervention at least
twice, and that the initial consultation will require 30–40 min and follow-up
20–30 min. Further follow-up consultations will be at GP/PNs discretion
depending on patients’ needs and progress, as in the pilot. Practitioner
training and support meetings: In the RCT we will aim for 3–4 meetings, 3 h
per meeting, over the 12 months of the trial. Patient self-management support
pack will be given to patients by the practitioners and used at the patients’
own discretion. |
Tailoring |
GPs/PNs allowed flexibility to tailor to patients’
needs but core components essential. |
As above, the core ingredients as described in the
paper are fixed but discretion is allowed as to who delivers, and how
often. |
As above |
Modifications |
To CARE Plus consultations, practitioner training
and support and/or patient self-management pack. |
Several modifications were made during the
development and optimization as outlined in this paper |
Further modifications required before exploratory
RCT as above. |