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Table 4 Evaluation of the Health TAPESTRY in older adult RCT assessed according to the PRECIS domains

From: A protocol for a pragmatic randomized controlled trial using the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) platform approach to promote person-focused primary healthcare for older adults

PRECIS domain

Element

Assessment of the Health TAPESTRY older adult RCT

Research team rating on scale 1 to 5 (1 = least pragmatic to 5 = most pragmatic)

Participants

Participant eligibility criteria

Sample is quite healthy—intentionally left it open and not too targeted at people who are frail; included individuals along bus routes had to screen-out those people who volunteers could not physically access (i.e., long-term care facilities, hospices, along rural routes); had to screen-out individuals who could not speak English or did not have a caregiver who spoke English and willing to facilitate volunteer visits—this was outside the volunteer program’s capacity

4

Interventions and expertise

Experimental intervention-flexibility

TAP-reports reviewed and action plan is developed for that particular person based on their individual self-report information so action plans are all different. There is not a “one size fits all” approach to reports. No specific instructionsgiven to intake teams on process, allowed teams to develop own process and workflow for TAPESTRY; practice was allowed to be different between the two clinics. Never forced clients to use PHR to facilitate connection to healthcare team. At least one home visit by the volunteer was initiated, but no minimum or maximum follow-up visits were enforced in the trial

5

Experimental intervention-practitioner expertise

MFHT and intake teams made up of different people, intake teams changed throughout the trial, elements of care plan carried out by various MFHT members, regardless of level of expertise

5

Comparison intervention-flexibility

Control individuals allowed to receive any type of care from any healthcare professional at the clinic. Individuals in the control group do not receive volunteer visits, the TAP-App and are not discussed at the intake team meetings

5

Comparison intervention-practitioner expertise

Same MFHT members are involved in the care of individuals in the intervention and control groups

5

Follow-up and outcomes

Follow-up intensity

Formal follow-up to collect research outcomes (baseline, 6 and 12 months). No formal volunteer home visit follow-up schedule of clients, no instruction for MFHT of clinic follow-up

4

Primary trial outcome

Primary out is GAS score, which is subjective, person-centered care outcome and clinically meaningful to client

5

Compliance/adherence

Participant compliance with “prescribed” intervention

No formal strategy to encourage compliance; methods to encourage use of PHR, improve volunteer confidence in role

5

Practitioner adherence to study protocol

Only subtle strategies to encourage intervention to move forward have left for organic process, but no formal strategy to monitor adherence or encourage adherence; researchers sat in intake team meetings early on to track development of processes, however, have withdrawn researchers have intake teams to lessen influence of initiative

4

Analysis of primary outcome

Using intention to treat principle, intention to include all experiences in evaluation (good and bad), statistical analysis plan will work under “noise”

5

  1. The pragmatic-explanatory continuum indicator summary (PRECIS) was developed by an international group of interested trialists at two meetings in Toronto (2005 and 2008) and in the time between. The initiative grew from the Pragmatic Randomized Controlled Trials in Health Care (Practihc) project (www.practihc.org), an initiative funded by Canada and the European Union to promote pragmatic trials in low- and middle-income countries [81]. The PRECIS elements that are relatively less pragmatic include the eligibility criteria of participants, follow-up intensity, and practitioner adherence to study protocol, although ratings still represent a highly pragmatic trial. Program reasons for logistical purposes (i.e., excluding people living in areas not easily accessible by bus) and for the collection of process and outcome research measures (i.e., strictly timed follow-up measurement of research outcomes and researchers recording field notes in intake team meetings) have contributed to the lower pragmatic ratings of these elements