Weaver 2001.
| Methods | DETAILS OF STUDY AIM OF INTERVENTION: to reinforce education, answer questions, and support the patient and family in regard to the post‐operative recovery process. AIM OF STUDY: to evaluate the telephone follow‐up program; it was sought to compare 2 groups of cardiac surgery patients: those who received usual care and those who received usual care and telephone follow‐up calls for 1 month after discharge, with regard to satisfaction with continuity of care, depression, recidivism, and complications. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: all eligible cardiac surgery patients were invited to participate. The resulting convenience sample was then randomly divided to control and intervention group. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: 21 years and older/ discharged home 3 to 7 days after surgery, able to read, speak and understand English. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not specified. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? unclear. FUNDING: yes. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: unclear. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: not specified. 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: not stated. CONSUMER INVOLVEMENT: not stated. |
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| Participants | DESCRIPTION: cardiac patients / surgery patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 90. RANDOMISED TO INTERVENTION: 44. RANDOMISED TO CONTROL: 46. INCLUDED IN ANALYSIS INTERVENTION GROUP: 44. INCLUDED IN ANALYSIS CONTROL GROUP: 46. AGE: RANGE OR MEAN (SD): 63. GENDER (% MALE): 70. ETHNICITY: unclear. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: coronary artery disease. OTHER HEALTH PROBLEM/S: not specified. TREATMENT RECEIVED/RECEIVING: CABG or valve replacement. OTHER SOCIAL/DEMOGRAPHIC DETAILS: 20% living alone, 55% retired. |
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| Interventions | DETAILS OF INTERVENTION: within 2 days of discharge, a telephone call was made by a cardiovascular stepdown nurse. This nurse called once weekly for one month or more frequently if the needs or concerns of the patient or his family so required. The nurse was allowed to talk with either the patient or a family member. A standardized assessment sheet guided the calls. Areas of focus included respiratory, cardiac, and neurologic systems, fluid status, pain management, sleep, nutrition, elimination, activity, self‐care, psychosocial status, wound management and patient knowledge. DETAILS OF CONTROL: usual care. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION Frequency: 4‐? First time at day 2 after discharge. Period: 1 month. PROVIDERS: nurse. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: good. |
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| Outcomes | NUMBER OF OUTCOMES: 4 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, ..): Satisfaction / self‐developed / unclear / postal questionnaire / 1 month after discharge. Depression / geriatric depression scale / unclear / postal questionnaire / 1 month after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..): Readmission / self‐developed / no / hospital record / 1 month after discharge. ED‐visits / self‐developed / no / hospital record / 1 month after discharge. |
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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? | Unclear risk | B ‐ Unclear |
Cells containing blanks under a heading mean there was no information on that item in the trial report. No studies reported methods of follow‐up for non‐respondents, or adverse events. RCT: randomised controlled trial CCT: controlled clinical trial (quasi‐randomised)