Bernacki 2019.
| Study characteristics | ||
| Methods |
Aim: to assess the feasibility and acceptability of the Serious Illness Care Program Study design: cluster‐RCT; 3 arms original trial (intervention, usual care, secondary control group*). Data from 2 arms available (intervention, UC) Unit of randomisation: clinician (stratified by disease centre or satellite facility) Consumer involvement: project was informed by an advisory group which included clinicians from a range of specialties as well as patients. Feedback sought from DFCI Patient and Family Advisory Council on materials for use in the study through a series of meetings. The Council includes patients, family members, executive leaders and providers working in partnership to improve overall quality of care, policies and hospital programmes Focus groups (patient, family, clinician) were also held to inform choices of terminology, wording and format of materials Funding source: Branta Foundation; Charina Endowment Fund; Margaret T Morris Foundation; Richard A Canot Fund; Partners Healthcare; John A Hartford. Primary author supported by Health Resources Services Administration Grant (KO1HP2046); 2 authors declared conflicts of interest related to writing and editorial work; other authors declared no conflicts of interest |
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| Participants |
Participants: Patients: people aged > 18 years with advanced incurable cancer and life expectancy < 12 months and their identified surrogates (friend or family member identified by the patient; over 18 years, able to speak English and to provide informed consent) Clinicians: oncology physicians, nurse practitioners (NP’s), physician assistants (PA’s) caring for patients with advanced incurable cancer and life expectancy < 12 months Setting and geographic location: Boston, USA. Hospital: Dana‐Faber Cancer Institute and 2 affiliated satellite clinics (Dana‐Faber Milford regional Medical Center and Dana‐Faber South Shore hospital) Methods of recruitment: Recruitment at meetings in the clinic or by email or in person Clinicians seeing patients at least 1‐half day per week were eligible. Enrolled clinicians identified patients through review of patient lists and answering the surprise question; patients for whom clinicians answered no were eligible Selection criteria for participation in study: Inclusion:
Exclusion:
Diagnosis of person approaching EoL: advanced incurable cancer and life expectancy < 12 months Target of intervention: multicomponent structured communication intervention used with patient and surrogate (communication quality improvement intervention) Age: patients 61.8 years (range 58.2 to 66) intervention; 62.1 years (58.2 to 66) UC Gender: patients: 53.7% female intervention; 52.8% female UC Clinicians: 62.5% female intervention; 51.2% female UC Ethnicity/culture/language: 93.2% White intervention; 92.7% White UC Other PROGRESS aspects: people not speaking English were excluded. Participants were majority White and predominantly college or professional school educated (80% or higher both groups) Numbers of participants: see Additional Table 1 |
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| Interventions |
Intervention: Serious Illness Conversation Guide (SICG), a communication quality improvement intervention Aim of intervention:
Comparison: usual care Delivered by: clinicians (oncology physicians, NP’s, AP’s), who were triggered by research staff to have the SICG conversation (either by email day before scheduled visit or via packet of study materials on day of consultation) Social worker conducted bereavement telephone interview 2.5 hour training programme for intervention, small groups (6 to 10). Included didactic session on evidence base for ACP; demonstration and discussion of SICG use; individual practice using role‐plays with personalised feedback Aim of training: to teach clinicians how to orient patients to the conversation, ask permission to discuss future care desires, reassuring patients about continued treatment, starting support for patient/family, reiterating that no decisions have to be made during the initial discussion. Then summarise and confirm the conversation’s content; provide patients with Family Communication Guide All intervention clinicians received Clinician Reference Guide summarising the main training information, with guidance on challenging scenarios Tutorial completed on how to document conversations in EMR Feedback provided (individual) to clinicians after first SICG conversation. Additional support or coaching available to clinicians if desired Setting: at clinic on Dana‐Faber sites Materials, procedures, content: Development of the Serious Illness Conversation Guide (SICG) followed the following process:
Pre‐visit letter was sent (mailed) to patients to activate and prepare them for the conversation. The letter introduced SICG topics The Serious Illness Conversation Guide was used at the clinical visit. This contains 7 elements: illness understanding, decision‐making and information preferences; prognostic disclosure; patient goals and fears; views on acceptable function and trade‐offs; desires for family involvement Outcome documented by clinicians via structured format in EMR (reminds clinicians of key elements of discussion, eases burden of documentation, allows other clinicians easy access to the information in a consistent and structured way) Family guide provided at the time of consultation (suggesting an approach for discussing illness and care preferences with family) When and how much: Pre‐visit letter sent to patient to activate and prepare them for the conversation (introduces SICG topics) SICG used at consultation, and Family Guide provided to patients/carers (suggesting an approach for discussing illness and care preferences with family) Documentation of conversation via EMR Participants could receive the intervention more than once over the trial course. Data from authors indicate that of participants in the intervention group 3/76 (4%) had no intervention, 12/76 (16%) received the intervention once and 61/76 (80%) twice or more, compared with 18/85 (21%), 29/85 (34%) and 38/85 (45%) for 0, 1 or 2+ times the intervention was delivered in the usual care group Tailoring: unclear. Clinicians instructed that they were able to split the conversation across consultations but to continue to conduct the conversation until all questions in the EMR module were completed. (Time to fit in the conversation was identified as a significant issue discussed in training) Modified during study: modified after pilot study Co‐intervention(s): not reported Fidelity assessed: intervention clinicians readily used the intervention, and attended training and rated it as effective Theoretical base: not reported |
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| Outcomes |
Primary outcomes Enhanced goal‐consistent care (number of goals met) [Evaluation of the communication] Method: Life Priorities survey for patients, Family Perceptions survey for identified surrogates Timing: baseline and every 2 months Scale and scoring: scoring system 0, 1, 2, 3 corresponding to top 3 goals met at EoL. Scored by matching patient final Life Priorities survey (within 3 months of death) to that of Family Perceptions: "scored each of the patient’s 3 highest ranking goals as concordant if the caregiver indicated the goal had been achieved to a large extent, resulting in a score of 0, 1, 2, or 3 goals met" (page 753) Therapeutic alliance [Evaluation of the communication] Method: Human Connection Scale Timing: baseline, 14 and 24 weeks Scale and scoring: 7/16 of the original scale items used; total score range 7 (lower) to 28 (higher therapeutic alliance) i.e. therapeutic alliance = patients’ sense of mutual understanding, caring, trust with their physicians (higher = better) Perception of quality of communication [Evaluation of the communication] Method: Quality of Communication scale Timing: unclear Scale and scoring: unclear Conversation numbers (per patient) [Discussions of EoL care/EoL] Method: EMR review Timing: post‐death Scale and scoring: not applicable Conversation content/quality (domains) [Discussions of EoL care/EoL] Method: EMR review Timing: post‐death Scale and scoring: thematic coding by multidisciplinary team. Documented SIC domains per patient (scored 0 to 4 according to number of domains discussed and documented); also reported in subdomains: patients with at least 1 serious illness conversation documented prior to death; patients with documented discussion about values/goals; about prognosis/illness understanding; about EoL care planning; about life‐sustaining treatment preferences Timing of first documented SIC before death (median days, IQR) [Discussions of EoL care/EoL] Method: EMR review Timing: post‐death Scale and scoring: not applicable Primary outcomes ‐ adverse events None reported Secondary outcomes Peacefulness at EoL [Quality of EoL care] Method: PEACE scale. 2 subscales ‘Peaceful Acceptance of Illness’ and ‘Struggle with Illness’ Timing: baseline and every 2 months Scale and scoring: struggle with illness (feelings of upset, worry, anger, etc.), 7 questions total score 7 to 28 Peaceful acceptance (acceptance of diagnosis, inner calm, feelings of being well‐loved); 5 questions, total score 5 to 20 Quality of life and general physical health function [Quality of life] Method: SF‐12 V2 health survey Timing: unclear Scale and scoring: unclear |
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| Notes | Trial registered (NCT01786811) *Trial established as 3‐arm trial: intervention, usual care, and secondary control group. Main comparison is between the intervention and UC arms; secondary control arm is based on non‐participating physicians’ patients. Author response indicates that data have been collected but not yet available (public) for this secondary control arm All patients: assessments at baseline and every 2 months Intervention group: patients surveyed 1 week after SICG conversation to assess perception of the conversation and its acceptability Control group: parallel survey every 2 months around same time that intervention patients would have SIC conversation. These patients are asked about the number and content of ACP or EoL discussions with clinicians and family Cluster‐RCT; unit of randomisation: clinician, unit of analysis: patient "All comparisons across study arms accounted for clustering of patients within clinician teams" (page 753). Used Generalised Estimating Equations with Wald, t or Chi2 tests for analysis (depending on outcome). Seems likely that analyses were appropriately adjusted This trial also reported patient anxiety and depression, and survival. These were judged as clinical outcomes for the purpose of this review and data were not extracted and reported as results Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were reported by the trial and reported in this review as measures of intervention delivery (reported for the intervention group only; therefore not reported as comparative results). Duration was reported for the intervention arm only and therefore not collected for analysis for this review Data were not yet available for perceptions of quality of communication, or quality of life The study by Paladino 2020 on patient and clinician experiences of the Serious Illness Conversation Guide is included as a secondary reference for this trial. As data were reported for the intervention arm only these data were not extracted for inclusion in this review |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Clinician clusters were stratified by disease centre or satellite facility and randomised within strata. Half randomised to UC (n = 21) and half to intervention (n = 20) Author contact confirmed use of computer‐generated random number sequence |
| Allocation concealment (selection bias) | Low risk | Author response indicated clusters were identified prior to randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Clinicians were not blinded (author contact confirms that clinicians knew that they were being trained); patients were blinded to assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Social workers not involved in the study conducted telephone bereavement interviews and were blinded to the study arm |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Sample size calculated as 200 evaluable patients per arm for required power, assuming 6% dropout Patient participation rates and numbers analysable were low but comparable between arms. Authors note non‐participants and those not analysed were not significantly different from those who were analysed, and groups were still comparable (based on randomisation), although non‐participants were older, and less likely to have breast cancer than participants; and those patients with analysable data were more likely to be married and have higher incomes than those with non‐analysable data |
| Selective reporting (reporting bias) | Low risk | Outcomes described in the protocol were reported. Primary outcomes were reported Data are not available for all outcomes assessed but author contact confirms that these data are pending publication (for several secondary outcomes) |
| Other bias | Low risk | Selective recruitment of cluster participants: clusters were identified before randomisation, therefore this risk of bias seems low Baseline imbalances: authors state that randomisation was maintained despite low participation rates. There were no differences at baseline between clinician groups or patient groups at baseline |