Nelson 1991.
Methods | DETAILS OF STUDY AIM OF INTERVENTION: improve the appropriateness of the parents use of follow‐up care. AIM OF STUDY: To test the hypothesis that the appropriateness of parents' use of early follow‐up care after ED visits can be improved by post visit support from a nurse practitioner. We hypothesized that telephone support, given by pediatric nurse practitioners to parents within 1 day after their ED‐visit for their children's acute illness could improve the appropriateness of the parents use of follow‐up care. STUDY DESIGN: RCT. METHODS OF RECRUITMENT OF PARTICIPANTS: potential subjects were identified on arrival at the ED. Patients were told that they were conducting a survey to try to learn ways of improving pediatric ED care. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: child younger than 8 years accompanied by parent or usual caretaker, free of active chronic illness, presenting with a chief complaint suggesting an acute infectious or allergic condition/ parents speaking English, acces to telephone, primary care source is hospital's primary care center. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: requiring hospital admission. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: yes. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: adequate. EPOC‐ QUALITY CRITERIA 2002: B. moderate risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: use of a random number table and a balanced block‐randomization METHOD OF CONCEALMENT OF ALLOCATION: sealed envelopes given to the parents on leaving the ED. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: yes. INTENTION TO TREAT ANALYSIS: yes. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: chi‐square. CONSUMER INVOLVEMENT: not stated. |
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Participants | DESCRIPTION: ED patients / pediatric patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 190. RANDOMISED TO INTERVENTION: 95. RANDOMISED TO CONTROL: 95. INCLUDED IN ANALYSIS INTERVENTION GROUP: 91. INCLUDED IN ANALYSIS CONTROL GROUP: 93. AGE: RANGE OR MEAN (SD): 2 GENDER (% MALE) 48 ETHNICITY 77% black PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: ED‐visit with complaint of infectious or allergic condition OTHER HEALTH PROBLEM/S: unclear TREATMENT RECEIVED/RECEIVING: antibiotic in 46% OTHER SOCIAL/DEMOGRAPHIC DETAILS: parents 86% single and 74% unemployed |
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Interventions | DETAILS OF INTERVENTION: The intervention consisted of only a single telephone call; mostly the call required less than 5 minutes. The NP called each parent in 6 to 18 hours after discharge from the ED. She offered further explanation about the child's diagnosis and treatment, reinforced follow‐up instructions and offered around the clock access to herself or another NP by telephone if needed; the protocol allowed her to answer questions or offer clinical assistance over the phone if it seemed warranted. DETAILS OF CONTROL: usual care. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION Frequency: 1. First time at day 1 after discharge. Period: PROVIDERS: nurse. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear. |
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Outcomes | NUMBER OF OUTCOMES: 1 OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..): B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): Compliance (appropriate use of follow‐up care) / self‐developed / yes / hospital record/ telephone interview / 1 week after discharge D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..): |
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Notes | ·CHANGES IN TRIAL PROTOCOL ·CONTACT WITH AUTHOR ·POWER CALCULATION? ·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH. ·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |