Implementation fidelity of a nurse-led RCT-tested complex intervention, care coordination for health promotion and activities in Parkinson’s disease (CHAPS) in meeting challenges in care management

CHAPS Model components, listed in Table 1, were implemented as demonstrated by content, frequency, and duration results (column 3 of Table 1), achieving full implementation fidelity for all components except for partial fidelity to telephone encounter frequency. Adherence coverage, as defined by the Hasson model, was the proportion of a target group that received the intervention [21]. For CHAPS, this was defined post-hoc as, at minimum, receipt of the CHAPS Initial Assessment. Adherence coverage was 86% (n = 140 of the 162 intervention arm participants).

Potential moderators during the CHAPS implementation were identified (Table 2) for each of the six conceptional framework categories [21] (Fig. 1). First, concerning participant responsiveness, survey results at study end indicated engagement by all three stakeholder groups (i.e., patient/participants, CHAPS nurse care managers, and Parkinson’s disease specialists). Their feedback was overall positive [20]. CHAPS nurse care manager usability responses included facilitators for both the Siebens Domain Management Model and the Notebook and the three attributes: user-friendly, person/patient-centered, and organized. Second, comprehensiveness of policy (protocol) description consisted of already published data describing the study protocol [7] and details of the CHAPS implementation [14]. Third, strategies to facilitate implementation included educational materials, practice with CHAPS tools, and scheduled communications for decision support. Fourth, quality of delivery modes included multiple care management components for proactive holistic Parkinson’s care and nurse care managers’ attention to participants’ self-care actions [14]. Fifth, recruitment and maintaining participant involvement was effective [14]. Sixth, some aspects of the CHAPS implementation’s context provided support for the randomized controlled trial while other aspects were barriers to full implementation. For example, a hiring freeze resulted in CHAPS nurse care manager availability for only 68% median CHAPS nurse care manager days of coverage, interquartile range, 47–100% [17].

In examining implementation fidelity, Hasson recommended a description of the control group. In the CHAPS parent study, both intervention and control (usual care) groups had access to Veterans Affairs PADRECCs present at all five sites to provide medical, educational, and support services to patients with movement disorders [39]. All participants received a brief educational handout on Parkinson’s [40] and had similar numbers of patient/participant interactions by visit and provider types from baseline to 18 months [17].

The control group (usual care) received no CHAPS Initial Assessments. Of note, they were assessed significantly less frequently for excessive daytime sleepiness (14% vs 85%, p < 0.0001) and orthostatic hypotension (41% vs 86%, p < 0.0001), psychosis/hallucinations/delirium (60% vs 94%, p < 0.0001), cognition (70% vs 93%, p < 0.0001), depression (80% vs 94%, p = 0.0002), and falls (74% vs 96%, p < 0.0001) [17]. These participants did not receive the CHAPS self-care Notebook and they received significantly fewer telephone calls (0.11 SD 0.2 versus 3.02 SD 2.2).

Given the complexity of Parkinson’s care, a strength of CHAPS is the simplification of care delivery through discrete, defined, and transparent structured components for reproduceable dissemination. Quality of delivery was evidenced by meeting PD quality of care indicators and garnering positive stakeholder feedback.

The 4-domain Siebens Domain Management Model, as the Organizing Framework, applied in documentation, allows clinicians to find information about areas of greatest concern. For example, if pneumonia prevention is a concern for Parkinson’s disease specialists or primary care providers, they can review Domain I to learn about a patient’s swallowing status. If psychiatrists are concerned about hallucinations or delirium, they can focus on acute medical issues in Domain I that could be contributory to cognitive issues documented under Domain II. Any provider with concerns about function (Domain III) or the home situation (Domain IV) can quickly review these sections.

The CHAPS structured documentation by CHAPS nurse care managers may initially appear as a documentation burden, a known contributor to clinician burnout [38]; however, these nurse care managers obtained and documented information that both they and Parkinson’s disease specialists appreciated and found relevant [20]. For example, motor and non-motor signs and symptoms were assessed, and managed, significantly more frequently than in the usual care group [17]. The process of assessing Parkinson’s disease signs and symptoms - per the PD quality indicators - are not clinical or patient-reported outcomes [38], yet we believe they are necessary precursors to managing these problems if participants’ outcomes are to be improved.

CHAPS addresses nursing assessments, care coordination, and care management similar to published information on the Dutch nursing guidelines in ParkinsonNet [14, 42, 43] and the Integrated Parkinson’s Care Network [44, 45]. All three programs utilize nurses with specialized knowledge in Parkinson’s and address self-management support needs of individuals with Parkinson’s. All have a network approach. CHAPS was administered in one of 6 regional Veterans Affairs Centers of Excellence for Parkinson’s disease, called PADRECCs, in the United States with building blocks for networked care [46]. The PADRECCs expanded care of Parkinson’s through a national Veterans Affairs consortium of providers with movement disorder expertise.

ParkinsonNet proposes 1:370 full-time employee equivalent (FTEE) nurse to individual with Parkinson’s with additional help from a care coordinator, not necessarily a nurse [42]. CHAPS achieved a ratio of 1:125 FTEE nurse care manager to individuals with Parkinson’s without any coordinator assistance. CHAPS contact time and frequency [17] are like those proposed for ParkinsonNet nurses [43].

To the best of our knowledge, the proactive CHAPS intervention is the first to document improved Parkinson’s care quality through nurse care managers oriented to Parkinson’s using a set of specific tools. These tools included (1) a standardized CHAPS Assessment regardless of disease stage, with algorithms to trigger problems/topics and their severity for care management, (2) an evidence-based, interdisciplinary person/patient-centered Organizing Framework (the Siebens Domain Management Model), (3) 5-step problem/topic intervention protocols for decision support for nurse care managers, (4) a personalized self-care plan, “My Action Plan”, with coaching by the CHAPS nurse care managers, and (5) an individualized self-care Notebook with teaching in its use. The overall contact frequency approach was flexible with contacts every 6 months and more frequently if needed.

CHAPS, as a care management program, includes communication, collaboration, and coordination like other successful non-Parkinson’s care delivery studies. The Advanced Illness Coordinated Care Program [47] provided health counseling, education, and care coordination in a 6-session intervention focused on individuals’ disease status and long-term planning. This intervention was based on a 3-domain biopsychosocial model. However, CHAPS used the 4-domain Siebens Domain Management Model [19], including function, which is consistent with the biopsycho-ecological model. CHAPS nurse care managers assessed participants’ understanding of their Parkinson’s and planning for future needs (e.g., discussion about surrogate decision-maker, which occurred more frequently than in usual care group [17]). In collaborative care for patients with depression and chronic illness [48], nurses received decision-support from physicians, worked collaboratively with them, and followed guideline-based protocols, as occurred similarly in CHAPS. In the Medicare Coordinated Care Demonstration [49], six activities were identified across four programs that reduced hospitalizations in high-risk patients. These activities occurred in CHAPS through nurse care managers who: (1) were a single point of contact, (2) met regularly with Parkinson’s disease specialists, (3) delivered evidence-based education to patients, (4) provided tailored medication management, and (5) addressed transitional care (e.g., medication review, discharge instructions) via telephone. Finally, (6) in-person meetings to supplement telephone calls were used a few times in CHAPS (n = 23 (3.5%) of 656 notes) [14]. Given these care management components common to prior studies and CHAPS, health systems and providers may wish to examine their Parkinson’s care management delivery and determine if they can use the CHAPS Model, and its components, building on their current strengths.

The Care and Learn model for improving care quality in health care delivery highlights the importance of people involved (patients and clinicians) and a holistic approach to patients and their context. The model advocates for gaining evidence about the caring provided and on stakeholder learning including program acceptability [50]. CHAPS followed these considerations. The caring provided was described in detail using documentation review [14]. The focus on individuals is reflected in the CHAPS stakeholder feedback. Patients reported helpfulness of the CHAPS nurse care manager, acceptability of the CHAPS Initial Assessment, overall knowledge about Parkinson’s disease care, and Notebook benefits and features liked. CHAPS nurse care manager and Parkinson’s disease specialist surveys addressed knowledge/understanding, self-confidence, clinical appropriateness, participant’s self-management improvement, and program endorsement. Overall, these surveys provided positive feedback and some suggestions for refinements. Additionally, surveys on usability of new tools (i.e., Siebens Domain Management Model, CHAPS Assessment, and Siebens Health Care Notebook) provided evidence of their acceptability [20].

The literature supports providing Parkinson’s care remotely (telehealth via telephone and/or home video or clinical video telehealth) in both rural and urban areas. Telehealth is advantageous when access to specialists is limited, patients have trouble keeping appointments, specialists have inadequate time per patient, and coronavirus disease (COVID 19) precludes some in-person visits [51‐55]. These findings add support to CHAPS as a telephone-based program. In the future, CHAPS could be augmented with clinical video telehealth when clarity in assessment or face-to-face teaching are needed. Other telehealth applications could include zoom/virtual classes for individuals’ education and support (e.g., introductory class to the self-care Notebook tool) by CHAPS nurse care managers organized by support staff. Future digital technologies like wearable sensors (e.g., detection of sleep disturbances, on/off phenomena) and their data could also be integrated into proactive CHAPS care management [56].

Among the multiple dimensions of safety [57, 58], CHAPS addressed four directly: care integration, patient engagement, meaningful work for providers, and broader interdisciplinary approaches [59‐61]. First, care integration started with CHAPS nurse care managers proactively identifying participants’ safety risks through a structured CHAPS Assessment with embedded algorithms. Assessment Summary reports were shared through electronic medical record documentation, available to inpatient and outpatient Veterans Affairs providers, and through paper copies in participants’ personalized Notebooks. Structured team communications were designed for care integration through collaboration and coordination (e.g., clinical huddles, orderly documentation format/template using the Siebens Domain Management Model). The self-care Notebook served as a care integration tool, portable to any venue (inpatient, outpatient, residential), especially important for urgent care and emergencies [62]. Second, CHAPS fostered patient/participant engagement through nurse care manager coaching in specific actions and, at times, including the care partner (e.g., when to call Parkinson’s disease specialist, using electronic and/or hard copy self-care tools based on participants’ preferences [14, 20, 63, 64]). Third, the CHAPS Program facilitated meaningful work for the nurse care managers and Parkinson’s disease specialists (e.g., CHAPS Assessment provided information that would improve their patient care, their patients had a better understanding of how to manage their Parkinson’s). Furthermore, nurse care managers and Parkinson’s disease specialists endorsed CHAPS (81% would refer other patients to CHAPS) [20]. Fourth, broad interdisciplinary approaches occurred in CHAPS through referrals (n = 501) to providers, Veterans Affairs services, and community services. Warm hand-offs (n = 358) between nurse care managers and other health care professionals occurred frequently through live telephone discussions, concurrent co-signatures on specific notes, secure email, and face-to-face discussions [14].