Increasing palliative care capacity in primary care: study protocol of a cluster randomized controlled trial of the CAPACITI training program

Study design

We are conducting a prospective cluster randomized controlled trial (cRCT) in which the clusters are primary care practices (teams) randomized to either a Facilitated or Self-Directed model of CAPACITI. This program consists of three distinct education modules, each which will be evaluated separately. The primary comparison will be between the trial arms upon completion of a module to compare effectiveness of the two approaches. Our study will also measure the change in outcomes within the same team, before and after completion of a module. The anticipated completion date of the cRCT is July 2023. Ethical approval for this study was obtained from the Hamilton Integrated Research Ethics Board (#13867) (see https://clinicaltrials.gov/ct2/show/NCT05120154 for approved operating protocol).

CAPACITI Intervention

The development of CAPACITI has been described previously [23]. This intervention originated from an extensive review of existing palliative care training programs and input from national and international experts. CAPACITI differs from other educational interventions in that it is intended to complement established programs that teach core palliative care skills by focusing on the application of these skills in practice by generalists using facilitated, case-based, virtual education. The current iteration of CAPACITI was revised based on the feedback of the pilot study, for example, additional case examples, more concise content, and shorter program duration. In this intervention, participants will enroll in three distinct modules, taken in order; each module is comprised of four sessions (1 h long).

Each module addresses a critical component of implementing a palliative approach to care into primary care practice: (1) Identify and Assess; (2) Enhance Communication Skills; (3) Coordinate for Ongoing Care (including involvement of family and specialists). Over bi-monthly sessions, each CAPACITI module integrates 3 components: clinical education in the form of expert advice and tips; evidence-based tools; and case studies to serve as practical examples. Between sessions, PCPs are to complete an activity to encourage them to apply the session content in practice. The session content of each module is presented in Table 1 and the learning components in Fig. 1. CAPACITI will be provided virtually to participants, hosted on an online learning management system (Moodle, https://moodle.org/). Emails will be sent from the learning management system to participants to notify /remind them of module /session dates, assignment completion, etc.

Table 1 Session content of CAPACITI education modulesFig. 1figure 1

CAPACITI virtual session components

Study groups

The control group will receive access to the online session slide decks, tools, “cheat sheets”, resources, and assignments. The intervention group will receive the same access to the online session materials but will also be invited to participate in facilitated virtual webinars, that includes a presentation of the session slide deck and open discussion of the content (Fig. 1).

Control group: Self-Directed – Access to online CAPACITI materials only (no live presented sessions)

Intervention group: Facilitated – Access to online CAPACITI materials plus each session is presented on a live interactive video conference, including group discussion of the material for adaptation to local context.

We hypothesize that the interactive sessions and opportunity for open discussion offered to the facilitated group in CAPACITI will better assist them to overcome challenges to knowledge translation and implementation, compared to the self-directed group.

Outcomes

Study outcomes and corresponding measures, summarized in Table 2, are as follows:

Table 2 Summary of study outcomes and measures by framework domainPrimary outcomes

1. Palliative care access and timing, measured based on self-reported: i) number of patients in caseload and number (calculated %) reported as Identified as requiring a palliative approach to care in last 3 months, ii) Typical timing of when PCP initiates a palliative approach to care for their cancer and non-cancer patients, respectively.

2. Palliative care competency, measured by scores on the End-of-life Professional Caregiver Survey (EPCS). The EPCS is a 28-item scale developed to assess palliative care-specific educational needs within an interprofessional team related to three main subdomains: Effective Care Delivery (ECD 8-items); Patient and Family-Centered Communication (PFCC 12-items); and Cultural and Ethical Values (CEV 8-items) [24]. Each item is scored on a 5-point Likert scale ranging from 1 (lowest level of skill) to 5 (greatest level of skill). Items represent care-provider comfort with a variety of situations related to palliative and end-of-life care. The EPCS covers all eight domains of the national palliative care guidelines and core lessons of physician-specific and nurse-specific end-of-life education curricula in the USA. The EPCS exhibits strong internal consistency (alpha = 0.96). For the purposes of this study, we will exclude the CEV sub-domain items from the EPCS.

3. Assignment completion and perceived change in practice, measured by number of module assignments attempted/completed (checklist) and reported change in thinking, behaviour, processes, and patient/family experience (Assignment Completion & Change Survey). 

This survey is a two-part, study-created questionnaire based on the CAPACITI module activities. Part A is unique to each module, asking participants to indicate the extent to which they were able to complete each of the session assignments for the module. Response options are: Have not started (1), Started but not completed (2), Completed (3). Part B contains four items assessing changes in thinking, behaviour, processes, and patient/family experience, respectively.

Secondary outcomes

1. CAPACITI confidence in palliative care, where primary care team member’s capacity is measured by scores on the CAPACITI Competency Survey [23]. The CAPACITI Competency Survey is a study created questionnaire based on the CanMEDS framework for improving patient care by enhancing physician training and the topics covered in the CAPACITI program. CanMEDS, developed by the Royal College of Physicians, delineates critical competencies to effectively meeting the health care needs of patients, including communication, expertise, collaboration, advocacy, and commitment [25] Each item on the Competency Survey is scored on a 7-point Likert scale ranging from 1 (lowest level of confidence) to 7 (greatest level of confidence). The survey was developed and tested in the CAPACITI pilot study, and exhibits strong internal consistency (alpha = 0.96) [23].

2. Team interprofessional collaboration, measured by scores on the Assessment of Interprofessional Team Collaboration Scale II (AITCS II) [26]. The AITCS is an instrument designed to measure interprofessional collaboration among team members. The AITCS consists of 23 items considered characteristic of interprofessional collaboration (how team works and acts). Scale items represent three elements considered to be key to collaborative practice. These subscales are: Partnership (8 items), Cooperation (8 items), and Coordination (7 items). Each item is scored on a 5-point Likert scale indicating the extent to which the team exhibits each, ranging from 1 (Never) to 5 (Always). Internal consistency estimates for reliability of each subscale range from 0.80 to 0.97, with an overall reliability of 0.98.

3. Satisfaction with CAPACITI program measured by team members’ Session evaluations (poll survey of 4 items).

4. Effectiveness and adaptations by local context, focus groups to assess teams’ perceptions of the program overall and impact on practice.

5. Program analytics, for each team member measured through the Learning Management System (module pages accessed, time spend on platform, quizzes completed, session attendance).

6. Effectiveness on above outcomes by co-variates, contextual factors impacting effectiveness of program outcomes, specifically across self-reported: i) Team/member characteristics (profession, role, palliative care training, years working with team, remuneration model, team size, location), ii) Individual’s level of readiness, measured by scores on the Organizational Readiness to Change Assessment survey (ORCA) [27], and iii) Individual’s preferred learning style (self-directed or group facilitated).

The ORCA measures organizational readiness to implement evidence-based practices in clinical settings. The survey was developed from the Promoting Action on Research Implementation in Health Services (PARIHS) framework, a theoretical model to guide implementation of evidence-based interventions, which contains 3 major domains of evidence, context, and facilitation [28]. The ORCA is intended to be modified to ensure applicability to the intervention being assessed – the modified version for our study contains a total of 31 items with 8 subscales [27].

Data collection

All survey data will be collected online, self-reported through the learning management system. Module surveys will be completed by PCP participants from all teams at five time points: before (T1) and after Module 1 (T2), after Module 2 (T3) and Module 3 (T4), and at 6 months following final module completion (T5). For Module 2 and Module 3, the post module survey from the immediately preceding module will serve as the baseline survey. Completion of the baseline measures will be a prerequisite to enrollment in CAPACITI. We will follow the Dillman Tailored Design Method to administer the questionnaire with up to five follow-up emails to non-responders [29].

We will conduct virtual focus groups (30 to 60 min in length) approximately three weeks post module completion with a purposive sample of teams from intervention and control groups: 6 to 10 teams in each arm per module (12 to 20 teams total, representing 60 to 100 team members total). The focus group discussion guide was developed and tested in the CAPACITI pilot [23]. In the focus group we will inquire if implementation was perceived as successful (If so, how? If not, why?) and what were the barriers and facilitators. These data will be supplemented by field notes maintained by staff during the study.

Statistical power /sample size

Sample size calculation is based on the assessment of the primary outcomes of Effective Care Delivery (ECD 8-items) subdomain on the End-of-life Professional Caregiver Survey (EPCS) and the palliative care identification variable (% of patients identified as requiring a palliative approach to care).

Previous work using the EPCS with nurses, physicians, and social workers identified a mean score of 3.6 for the ECD subdomain and a standard deviation (SD) of 1.0 (scale from 1 to 5) [24]. We assumed that a difference of 0.5 in SD (i.e., a delta of 0.5 or a half point on the scale) between treatment groups at T2 would be important to detect. Accounting for the cluster design, we estimate that the correlation between providers within teams was 0.15 and that each team would have a minimum of 4 members participate. Given a two-sided alpha of 0.05, a power of 80%, 192 providers from 48 teams would be required. This will also allow for detection of a 1-point difference increase of the % of patients identified as requiring a palliative approach to care (SD = 2).

We anticipate 100 PCP teams with an average of 4 members per team, in each module. The teams will be from across Canada and geographically diverse (e.g., rural, urban, and remote), which is critical to generating evidence on generalizability in diverse communities across the country.

Recruitment

Study participants will be members of PCP teams that enroll in CAPACITI (See Appendix for CAPACITI information sheet). Participants can also sign up as individuals or solo providers. Potential teams across Canada will be informed about CAPACITI through a promotional campaign, including direct solicitation and advertising by our partner stakeholders and organizations, including Pallium Canada, Hospice Palliative Care Ontario, Saint Elizabeth Health Care, Canadian Hospice Palliative Care Association, and provincial professional associations, e.g., Medical Association of Ontario. A team wishing to participate in the program will complete a registration form, indicating the team members that will be participating. Team members will then register individually on the Moodle learning management system to enrol in the program.

Eligibility

To be eligible the “team” or individual must be community-based and willing to provide palliative care to their patients, defined as managing symptoms, addressing psychosocial needs, educating patients and families, and coordinating care. Teams need to include at least one prescribing clinician (e.g., primary care physician, nurse practitioner). Participates in CAPACITI can include physicians, nurses, social workers, office assistants, patient coordinators, etc. The program will be offered free to teams, with the understanding that those participating will complete the educational and data collection components.

Participants will be strongly encouraged to complete an interprofessional, standardized, evidence-based, education program, namely Pallium Canada’s LEAP course (Learning Essential Approaches to Palliative care), prior to starting CAPACITI. LEAP is the most widely recognized palliative care education program for generalist health care providers in Canada [14, 15, 20]. Some topics include the palliative care philosophy and complex management for common symptoms such as pain, delirium, constipation, depression, grief, etc. The courses are taught in-person, or via fully online or hybrid delivery, by certified program facilitators [16]. Studies have shown that the LEAP courses provide primary health care teams with foundational skills that allow them to integrate primary palliative care in their clinics [18].

Randomization

The unit of randomization is the team: individuals clustered within teams or the individual themselves as their own team. Teams who register will be randomized to either the intervention or control arm using a permuted block design to ensure groups of equal sizes [30]. Randomization to either the intervention or control arm will occur independently for each module. That is, group allocation for a module does not predetermine that allocation for subsequent modules. Randomization will be stratified by team size (small or large) and location (west, central, or east) to ensure balanced sub-groups. Randomization is performed independently by using a computer-generated sequence. The randomization procedure will be centralized and managed by an independent statistician.

Data analysis

The unit of analysis will be the PCP team. Survey (quantitative) data will be used to compare treatment groups with respect to team and individual characteristics (potential covariates) by tabulation methods (means, standard deviations, frequencies). Both team level variables (e.g., region) and member level variables (e.g., palliative care training) will be tabulated. The primary analysis will be a between treatment comparison of intervention and control groups of the change in pre versus post module scores on the primary outcomes (EPCS and % identified for palliative care). Secondary analyses will include comparisons of all team outcomes. Mixed model ANOVA methods will be used, taking into account the increased variance due to cluster randomization, for the assessment of the primary outcomes [30]. Multilevel mixed models with two levels, cluster and repeated measures will be used to investigate the effect of the intervention over time (baseline, post module, 6 months post module).

Qualitative analysis (focus group data)

We will conduct a thematic analysis using a constant comparison method along a 4-stage process based on Pope’s Framework Approach [31], as we have done previously [32, 33]: 1) Focus groups will be audio taped and transcribed into a document, along with staff notes, for analysis. 2) The Focus group questions will be used to create a template for organizing each team’s data and emerging ideas. 3) Emerging ideas from each template construct will be coded and compared within and across teams, first independently by two analysts and then conjointly. Emerging themes will be compared and discussed until consensus is obtained between the analysts. 4) Common themes for each construct will be identified. We will maintain an audit trail that documents and justifies decisions in the analysis to promote consistency [34].

Evaluative framework

We will use the Kirkpatrick Model, a globally recognized training evaluation framework, to frame the various program evaluation components (Table 2). This model outlines 4 critical domains of an effective training program [35]:

Reaction: The participant’s reaction or satisfaction to the education program.

Learning: The participant’s acquired knowledge and skills from the education program.

Behaviour: The participant’s application of what they learned during the program to their practice.

Results: The direct outcomes, e.g., patient outcomes, that occur as a result of the education program.

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