Trial
Participant eligibility
Patients were eligible for the trial if they:
were literate;
were aged 18–80 years old;
had never before received the intervention; and
in the family physician’s (FP’s) clinical judgement, were cognitively intact and had ≥3 chronic conditions.23,24
The upper age limit of 80 years was chosen to minimise loss to follow-up because the participant had been admitted to an institution. The threshold of ≥3 chronic conditions was chosen for two reasons:
this is likely to engender more burden for the patient and the FP than the other common definition of multimorbidity of ≥2 conditions; and
as the patients had more medical needs, the researchers felt they had the potential for a greater level of improvement in outcomes.
The number of chronic conditions was validated with the patient’s self-report in the baseline questionnaire.
| Patient-centred interventions for patients with multimorbidity have shown mixed results to date, so there is a need to help improve them. The present study indicated that the intervention implemented had a neutral impact on primary outcomes. Given the subgroup results in which the intervention showed improvements only for patients with an annual income of ≥C$50 000, the qualitative findings, and the fidelity assessment, policymakers and clinicians are encouraged to seek ways to enhance care for patients with annual incomes of <C$50 000, to optimise team composition based on an individual patient’s preferences and abilities, and to enhance and tailor follow-up care by ensuring the creation of a coherent plan with actionable steps. |
Design and setting
A pragmatic randomised trial was conducted with nine team-based family practices that were familiar with the intervention (along with solo practices and emergency departments affiliated with those teams) in Toronto, Ontario, Canada. The provincial policy context emphasised innovations for complex patients with high healthcare utilisation.25
Ethics approval was received and the protocol has been published.26 The trial was registered in Ontario, Canada (NCTO2742597), and the CONSORT guidelines for pragmatic trials were followed for reporting methods and results.27
Intervention development
A patient-centred, multi-provider case conference — the Telemedicine IMPACT Plus (TIP) programme — was developed by the providers, then chosen by the researchers from six programmes identified in a province-wide environmental scan. The intervention was chosen because of its lengthy development and preliminary evaluation. It was developed in a way that aligned with guidelines for complex interventions,28–30 covering theory, gaps, pre-trial evaluations, and adaptation over time, and contained two key theoretical underpinnings — namely a patient-centred process6 in the patient–provider interaction and an integrated version of the Chronic Care Model.31
Two evidence gaps from a scoping review32 that had been conducted by the team were lack of empowering patient-centred communication and lack of integrated care among multiple providers in the context of multimorbidity care. Pre-trial evaluations of early versions, which had a longer face-to-face component but less follow-up support, of the intervention revealed enablers of and barriers to patient and provider enthusiasm relating to:
time and scheduling of the multiple providers;33
patient need for support to implement recommendations;33
patient-centred agenda setting;34
the process of identifying and inviting patients;34 and
remuneration of providers.34
Over a period of 10 years, the intervention was shortened, provided a telemedicine (video) option in addition to the face-to-face option, and remuneration was negotiated.
The patient-centred invitation to patients to engage in the discussion, which was not explicit before, was made explicit and was honed: ‘What are your goals for this session?’ was asked in the context of improved agenda setting.
The TIP programme
A nurse, hired by the programme, met with each patient face to face for approximately 1 hour to understand what mattered to them, and then planned and coordinated a case conference of approximately six providers relevant to that patient from the following:
In preparation for the case conference, the nurse accessed the patient’s file from the FP and forwarded all relevant medical and social history to the intervention team. The providers met (face to face or by video) with the patient for 1–1.5 hours so all parties could, through mutual collaboration, focus on the patient’s goals and develop an agreed care plan. Follow-up was provided by the nurse to help execute the recommendations over the subsequent 4 months. A full description is shown in Supplementary Box S1 using the TIDieR Checklist.35
TIP and the literature
The literature describes three main intervention types: patient-oriented, organisational, and training interventions.8.36 Combining 47 trials from two reviews,8,36 the researchers found that patient-oriented interventions were tested in 36% of trials, organisational interventions were tested in 51% of trials (of which all also had a patient-oriented component), and training interventions were tested in 13% of trials; training was not an element of the intervention presented here. The focus on patient goals was a common thread in all the patient-oriented interventions; however, TIP’s multi-provider team was unique and not found in any of the 47 interventions — the closest thing being a team comprising the practice nurse, a psychologist, and a psychiatrist.37
Pilot evaluation of the TIP programme
A pragmatic randomised pilot study to determine the feasibility of suggested outcomes, to estimate recruitment, and to identify effect sizes for sample size calculation was conducted.38
Description of usual care
Patients in the control group received usual care in the office of their FP (typically a 15-minute visit) and a one-page list of community resources that patients with their conditions could contact if desired. The three-quarters of patients were referred by FPs who worked in an interprofessional team on site and a quarter were not. The three-quarters worked in Ontario’s model of team-based care, called the Family Health Team (FHT), which meant that a nurse practitioner and social worker would be readily available on site; the patients comprising a quarter of the control group were referred by FPs who were in a non-team practice but who could refer patients to medical specialists and health professionals off site.
Recruitment
Nine team-based practices and their affiliated practitioners referred eligible patients. There was a two-step recruitment process. Patient selection was based on clinical judgement and clinicians approached patients and requested consent to send their name to the researchers. The project coordinator received names and contact details of patients, and contacted them by telephone to explain the project in detail and obtain signed consent to participate.
Outcomes
Outcomes were assessed at baseline and at 4 months after the case conference, a period considered long enough for the nurse and patient to complete the plan and feasible for follow-up to the trial. Two primary outcome measures were chosen to represent patient education, empowerment, and agency:
There were four secondary outcome measures:
VR12 Health Status — Physical Component Score and Mental Component Score;41
EQ-5D quality of life;42
Kessler Psychological Distress Scale;43 and
Health Behaviour Survey.44
Psychometric properties are available in the protocol article for the project.26
Sample size
For the two primary outcome measures (heiQ and SEM), comparing mean scores to detect a medium effect size (0.5) with a two-sided α = 0.05 and 80% power resulted in 64 participants being needed in both the intervention group and the control group; this equated to a sample size of = 128.45 Allowing for a 15% drop-out, the researchers aimed to recruit 150 patients, with 75 in each group.
Randomisation
Individual patients were allocated using randomly sequenced envelopes. Supplementary Box S2 details the procedures using the CONSORT guidelines27 regarding assignment of the intervention, sequence generation, allocation concealment, implementation, blinding, and data collection.
Statistical methods
Outcome data were analysed using the mixed model for repeated measures (MMRM).46 This method is a simple form of mixed effect; it does not explicitly model the random effects but, rather, explicitly models correlations among measurements within a subject. An advantage is that it can effectively handle missing data without strong assumptions that missing data occurred randomly. It also controlled for the baseline outcome measure. Nonetheless, a sensitivity analysis, omitting the lost cases, was conducted.
Two exploratory, post-hoc, subgroup analyses were conducted, on:
<$50K annual income versus ≥$50K annual income (the sample’s median income); and
≥6 morbidities versus fewer (again, using MMRM).
In addition, the relationship between the fidelity of the intervention (involving a subset of 40 patients from the intervention group) and outcomes was analysed using analysis of covariance, controlling for baseline.
Qualitative study
Design
A thematic analysis47 was used to explore the patients’ experiences of context, process, and under what circumstances the intervention worked or failed to work. It was undertaken at the same time as the trial measures were being collected.
Participant recruitment and final sample
Participants were selected purposively from those in the trial intervention arm. A maximum-variation sample varied by age, sex, and practice.
Data collection
Participants were interviewed 4 months after their TIP case conference at a time and date organised by the study research coordinator. Interviewers had no prior relationship with participants. Before the interview, participants read the letter of information that outlined the reasons for the qualitative study and informed consent for the interview was obtained.
Semi-structured individual interviews (Supplementary Box S3) were conducted with each participant alone in their home or the FP’s office. These lasted 30–60 minutes, and were audio-recorded and transcribed verbatim. Four members of the research team trained in conducting qualitative interviews undertook the collection and analysis of the qualitative data; they were not involved in the collection of the trial data.
Data analysis
The data analysis was both iterative and interpretive. All transcripts were independently reviewed and coded by the four researchers to determine the key emerging concepts. They then met, shared, and created a consensus that informed the development of the coding template. This process continued until no new themes were identified; the data were input into NVivo 10. In the final step, the research team identified overarching themes and exemplar quotations for each theme.
Trustworthiness and credibility were ensured using audio-recordings, verbatim transcripts, independent as well as team analysis, and field notes following each interview. A commitment to reflexivity considered how the researchers’ professional backgrounds (for example, social work, epidemiology, family medicine), particularly during the coding and interpretation of the data, could influence the findings.
