Jones 1988.
Methods | DETAILS OF STUDY AIM OF INTERVENTION: To enhance compliance (based on health belief model)/ AIM OF STUDY: the purpose of the study was to test the effect of clinical and telephone intervention on compliance for ED‐patients. STUDY DESIGN: RCT. METHODS OF RECRUITMENT OF PARTICIPANTS: consecutive patients who met the sampling criteria were randomly assigned to one of 4 groups. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: Patients presenting at the ED with one of following problems (chest pain, hypertension, asthma, otitis media, diabetes, urinary tract infection, headache, urethritis, vaginitis, low back pain, rash)/ signed release of information/ able to respond to HBM intervention/ did not require hospital admission/ had a referral follow‐up recommendation/ telephone at home. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not specified. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? yes. FUNDING: yes. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: unclear. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: 2X2X11 factorial design/ blocked randomization within each presenting problem. METHOD OF CONCEALMENT OF ALLOCATION: not specified. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: no. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: not stated. STATISTICAL METHODS AND THEIR APPROPRIATENESS: chi‐square/logistic regression. CONSUMER INVOLVEMENT: not stated. |
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Participants | DESCRIPTION: ED patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 842. RANDOMISED TO INTERVENTION: 166. RANDOMISED TO CONTROL: 264 ‐ 251 ‐ 161. INCLUDED IN ANALYSIS INTERVENTION GROUP: 166. INCLUDED IN ANALYSIS CONTROL GROUP: 264 ‐ 251 ‐ 161. AGE: RANGE OR MEAN (SD): 0 to 60+ GENDER (% MALE): unclear. ETHNICITY: unclear. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: mixed (largest groups: chest pain, urinary tract infection and low back pain). OTHER HEALTH PROBLEM/S: unclear. TREATMENT RECEIVED/RECEIVING: unclear. OTHER SOCIAL/DEMOGRAPHIC DETAILS: 61% single. |
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Interventions | DETAILS OF INTERVENTION: Telephone call, which was a modified and shortened application of the Health Belief Model (HBM) clinical intervention, by a nurse 1 or 2 days after the ED‐visit/ DETAILS OF CONTROL: There are 3 control groups: group 1 received usual care, group 2 received a HBM clinical intervention during their ED‐visit, and group 3 received a HBM clinical intervention during their ED‐visit and a telephone HBM follow‐up. 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 / self‐developed / unclear / telephone interview to health agency where patient had referral / different across patients. 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. yes, Jones et al. published 5 manuscripts, in which they present results for several subgroups (eg. hypertension, low back pain, otitis media, urinary tract infection). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |