Au 2012.
| Study characteristics | ||
| Methods |
Aim: to assess whether an intervention using patient‐specific feedback about preferences for EoL care would improve the occurrence and quality of communication between patients with COPD and their clinicians Study design: cluster‐RCT; 2 arms (intervention; usual care) Unit of randomisation: clinician (patients clustered per clinician) Consumer involvement: none explicitly stated Funding source: disclosures regarding funding support from industry are recorded. Authors state that the research was conducted independently of the research sponsor |
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| Participants |
Participants: clinicians and patients with COPD Clinicians were physicians and non‐physicians from primary care and chest clinics Setting and geographic location: USA. University of Washington provided institutional review board approval for the protocol Methods of recruitment: Outpatient clinic at 2 veteran affairs facilities (1 university‐affiliated tertiary referral medical centre; 1 primarily non‐teaching outpatient facility). Participants were approved for participation by a clinician Other details of recruitment were not reported "All participants provided informed consent" (page 727) (not otherwise described) Selection criteria for participation in study: Inclusion:
Exclusion:
Diagnosis of person approaching EoL: COPD as defined by the GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria 14 Target of intervention: Clinicians and patients Surrogates were also included as a recipient of the intervention (patient‐specific feedback form mailed to patients prior to clinical consultation in order to review and share with surrogates; self‐reported discussions with surrogates reported as outcomes; no further details of who surrogates were, their characteristics or their relationship to the patient) Age: patients: mean 69.4 years both study arms. Not recorded for clinicians Gender: patients: intervention 97.9% male, UC 96.2% male Clinicians: intervention 50% male, UC 44% male Ethnicity/culture/language: Patient ‐ White 85.3% (intervention); 87.0% (UC) Not recorded for clinicians Other PROGRESS aspects: Focus on patients with COPD in a veterans’ care facility; predominantly male, predominantly White. Those with cognitive, psychiatric or language barriers were not included Numbers of participants: see Additional Table 1 |
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| Interventions |
Intervention: 1 page patient‐specific feedback form based on patient’s self‐reported responses Aim of intervention: to improve the occurrence and quality of communication about preferences for EoL care between patients and their clinicians Comparison: usual care Neither clinician nor patients received patient‐specific feedback forms Further details not reported Delivered by: clinicians. No specific training is mentioned Setting: outpatient clinic Materials, procedures, content: Participants completed the following measures:
1‐page patient‐specific feedback form was generated automatically via computerised process. This selected the patient’s responses, including perspectives on whether their physician would know what type of care they would like, their desire for communication about ACP, patient‐specific barriers and facilitators to communication about EoL care, preferences for CPR and mechanical ventilation, severity of airflow limitation When and how much: intervention group were mailed their 1 page patient‐specific feedback form to the patient to review with surrogate prior to consultation with clinician On day of scheduled clinic visit the 1 page patient‐specific feedback form provided to clinicians and patients without endorsements to use during clinic visit Tailoring: patient‐specific feedback from provided Patient‐specific highest‐ranked barrier and facilitator to EoL communication, with introductory sentence that clinicians could use to lower the threshold to initiate conversations; patient’s 3 most important preferences for EoL experiences Modified during study: no Co‐intervention(s): not reported Fidelity assessed: not reported Theoretical base: social cognitive theory, with intervention designed to increase self‐efficacy of clinician and patient for discussing EoL |
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| Outcomes |
Primary outcomes Quality of communication [Evaluation of the communication] Method: questionnaire; completed with research assistants’ help Timing: prior to (baseline) and after clinic visit (2 weeks) Scale and scoring: Quality of Communication (QOC) questionnaire, (0 to 100, higher score is better) Results for the 7 subscales of this tool also reported Reported discussion of treatment preferences with clinician at last visit [Discussions of EoL/ EoL care] Method: questionnaire (self‐reported rates; not clear how this was assessed exactly) Timing: 2 weeks after clinic visit Scale and scoring: unclear Discussion with surrogate since last clinic visit [Discussions of EoL/EoL care] Method: questionnaire (self‐reported rates; not clear how this was assessed exactly) Timing: 2 weeks after clinic visit Scale and scoring: unclear Primary outcomes ‐ adverse events None reported Secondary outcomes None reported |
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| Notes | Protocol available from trial registry; approved by review board of University of Washington Cluster‐RCT; unit of allocation clinician, unit of analysis patient. All analyses adjusted for clustering (i.e. "All models accounted for the clustering of patients within clinician" page 729). Seems likely that results were appropriately adjusted The Preferences for Dying and Death Questionnaire, St George Respiratory Questionnaire, preferences for communication about EoL care and patient‐specific barriers and facilitators to this communication, and preferences for life‐sustaining treatments were given to patients and used to develop the 1‐page patient‐specific information sheet that formed the basis of the intervention Reported outcomes of 'Discussion of treatment preferences with clinician (ever)', 'Discussion with surrogate (ever)' were not reported by this review as 'ever' discussions could not be clearly linked to the effects of the intervention |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stratified random sampling. No further details provided |
| Allocation concealment (selection bias) | Low risk | Investigators and staff administering outcome measures were blinded to treatment assignment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not clear whether participants were blinded to allocation; unit of randomisation was clinician so this may be likely. Effect on self‐reported outcomes is not clear (patients) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Authors state that investigators and staff administering outcome measures were blinded to treatment assignment. Study staff members contacting patients (for survey 2 weeks post‐intervention) were blinded to treatment group assignment |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawal 15% to 22% respectively control and intervention arms Reasons for withdrawal/dropout were reasonably comparable except that more (15 versus 6) refused to continue participation in the intervention group Authors report no differences in baseline characteristics regarding whether patients completed the study or were lost to follow‐up ITT analysis was used; effect of imputed data on results was examined in analysis models with authors reporting similar results where imputed and non‐imputed data were used in analysis |
| Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes were reported as per protocol |
| Other bias | Unclear risk | Participants were mostly comparable at baseline although a few differences were noted between groups: greater proportion of control group reported at‐risk drinking; greater proportion intervention group reported hypertension Selective recruitment of cluster participants: details of randomisation and allocation are unclear |