Health-promoting Conversations and Open-heart Surgery- an Intervention Model for Families
Study Details
Study Description
Brief Summary
Elective open-heart surgery involves physical and psychological strain for the person undergoing surgery. Family plays a significant part in care before and after surgery, and the family has care needs of their own. Health services need to address the family-caregiver burden as an essential aspect of care. Different methods aiming at stress reduction and involvement of patients and family members in care exist. The evidence is conflicting concerning which way is the most effective. Health-promoting conversations are an intervention model promoting family well-being and alleviation of illness and illness-related suffering for the whole family.
Families´ in the intervention group in this trial will, before and after one family member's elective open-heart surgery, participate in Health-promoting conversations. Health-promoting conversation is an intervention model based on the Family Systems Nursing theory. The person undergoing surgery decides which family members should be asked to participate in 1-3 conversations whit a family nurse. Effects on postoperative recovery, health-related quality of life, stress, and patient and family involvement in care will be evaluated with patient- and family-reported outcome measures.
The aim is to evaluate Health-promoting conversation's effect on family wellbeing, functioning, and involvement in care. The cost-effectiveness of the intervention will also be evaluated.
The study will follow the ethical guidelines of the Declaration of Helsinki. The Swedish National Committee on Health Research Ethics reviewed and accepted the study in march 2020 (nr 2019-06315)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patient and family member of patient undergoing elective open heart surgery- Intervention Family randomized to the intervention group receiving Health-promoting conversation intervention |
Behavioral: Health promoting conversations
The Health-promoting conversations intervention is a conversation model between the patient, family members, and a trained nurse. Patients and families included in the study will, after submitting base-line-data, be randomized to
|
| No Intervention: Patient and family member of patient undergoing elective open heart surgery- Control Family of a patient undergoing elective open-heart surgery randomized to the intervention group receiving standard care |
Outcome Measures
Primary Outcome Measures
- Family-Sense Of Coherence (F-SOC) [A clinically significant change in F-SOC from baseline at three months after hospital discharge]
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
Secondary Outcome Measures
- RAND-36 [Baseline (before randomization)]
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
- Postoperative Recovery Profile (PRP) [Patients only: 2 weeks after hospital discharge]
Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions.
- Family Members Involvement Questionnaire (FMIQ) [Family members only: 2 weeks after hospital discharge]
Person-reported outcome measure, questionnaire measuring family members perceived involvement in care of the family member who is a patient. 21 items.
- Cost-Effectiveness of Heath promoting conversations [Baseline (before randomization)]
A questionnaire measuring care utilization and absence from work, 7 items.
- RAND-36 [2 weeks after hospital discharge]
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
- RAND-36 [3 month follow up]
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
- RAND-36 [12 month follow up]
Swedish version of Short Form-36 (SF-36) a questionnaire measuring health-related quality of life. 36 items, 8 dimensions.
- Family-Sense Of Coherence (F-SOC) [Baseline (before randomization)]
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
- Family-Sense Of Coherence (F-SOC) [2 weeks after hospital discharge]
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
- Family-Sense Of Coherence (F-SOC) [12 month follow up]
Person-reported outcome measure, questionnaire measuring sense of coherence at family level. 12 items.
- Postoperative Recovery Profile (PRP) [3 month follow up]
Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions.
- Postoperative Recovery Profile (PRP) [12 month follow up]
Person-reported outcome measure, questionnaire measuring self-reported postoperative recovery. 19 items, 5 dimensions.
- Cost-Effectiveness of Heath promoting conversations [6 month follow up]
A questionnaire measuring care utilization and absence from work, 7 items.
- Cost-Effectiveness of Heath promoting conversations [12 month follow up]
A questionnaire measuring care utilization and absence from work, 7 items.
Eligibility Criteria
Criteria
Inclusion Criteria
Patients:
-
Patients =/>18 years of age
-
undergoing elective, open-heart surgery
-
having a minimum of one family member willing to participate in Health-promoting conversations
Family members
-
Family member of a patient undergoing elective, open-heart surgery
-
willing to participate in Health-promoting conversations *=/> 15 years of age
Exclusion Criteria patient and family member:
-
Inability to speak or understand Swedish to the extent of giving informed consent
-
Cognitive and/or psychiatric disorder to the extent of not being able to give informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Örebro University, Sweden
Investigators
- Principal Investigator: Elisabeth Ericsson, Örebro University, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4.2-05418/2020