The ACTIVE Intervention to Improve Hospice Care
15 januari 2021 uppdaterad av: Debra Parker Oliver, Washington University School of Medicine
The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs.
The mixed methods evaluation of this randomized controlled trial (RCT) will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices.
Studieöversikt
Detaljerad beskrivning
The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs.
The mixed methods evaluation of this RCT will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices.
We will rigorously test the effectiveness of the ACTIVE intervention.
We will investigate whether the assessment of the informal caregivers perception of pain management will identify those who will benefit most and whether changes in the perceptions of informal caregivers will result in improvement of patient pain.
We will explore barriers and challenges in the implementation of this into every day practice within hospice
Studietyp
Interventionell
Inskrivning (Faktisk)
446
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Missouri
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Columbia, Missouri, Förenta staterna, 65203
- Hospice Compassus
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Saint Joseph, Missouri, Förenta staterna, 65203
- Hands of Hope Hospice
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria: Informal Caregiver Inclusion Criteria
- Informal caregiver of an enrolled hospice patient
- Age 18 or over and legally able to provide informed consent
- Involved in decisions related to pain medications
Access to at least one of the below:
- A standard land line telephone
- A high-speed Internet connection with operational computer
Without functional hearing loss or with a hearing aid that allows the participant to conduct phone or Internet conversations as assessed by the research staff (by questioning and observation
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Exclusion Criteria:Informal caregivers of hospice patients with a life expectancy less than 14 days as assessed by the hospice nurse with the palliative performance scale (PPS) (99)
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Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Usual Care
Usual hospice care- there is no intervention in this arm
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Experimentell: ACTIVE
Behavioral intervention using web conferencing
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Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Caregiver Perceptions of Pain Medicine Questionaire
Tidsram: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure
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This 16 question instrument measures the perceptions hospice caregivers have toward the administration of pain medications.
Scores on items vary from 1-5 with the lower scores indicating more problematic perceptions of pain management.
A Total score is computed between 16-80 Only the last available measure will be used to reflect the measure closest to time of death.
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Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Caregiver Quality of Life-Revised Subscale Emotional
Tidsram: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure
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This is one domain of a four domain instrument.
It involves one question with a range of 0-10.Only the last available measure will be used to reflect the measure closest to time of death.
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Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure
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Anxiety
Tidsram: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure
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This measure determines the level of anxiety experienced by a hospice caregiver.
Total scores range from 0-21 with higher scores representing more anxiety.
Only the last available measure will be used to reflect the measure closest to time of death.
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Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Debra Parker Oliver, PhD, University of Missouri-Columbia
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Washington KT, Demiris G, Pike KC, Kruse RL, Oliver DP. Anxiety among informal hospice caregivers: an exploratory study. Palliat Support Care. 2015 Jun;13(3):567-73. doi: 10.1017/S1478951513001193. Epub 2014 Feb 13.
- Demiris G, Parker Oliver D, Capurro D, Wittenberg-Lyles E. Implementation science: implications for intervention research in hospice and palliative care. Gerontologist. 2014 Apr;54(2):163-71. doi: 10.1093/geront/gnt022. Epub 2013 Apr 4.
- Parker Oliver D, Demiris G, Washington K, Kruse RL, Petroski G. Hospice Family Caregiver Involvement in Care Plan Meetings: A Mixed-Methods Randomized Controlled Trial. Am J Hosp Palliat Care. 2017 Nov;34(9):849-859. doi: 10.1177/1049909116661816. Epub 2016 Jul 27.
- Kruse RL, Parker Oliver D, Wittenberg-Lyles E, Demiris G. Conducting the ACTIVE randomized trial in hospice care: keys to success. Clin Trials. 2013 Feb;10(1):160-9. doi: 10.1177/1740774512461858. Epub 2012 Oct 25.
- Parker Oliver D, Albright DL, Washington K, Wittenberg-Lyles E, Gage A, Mooney M, Demiris G. Hospice caregiver depression: the evidence surrounding the greatest pain of all. J Soc Work End Life Palliat Care. 2013;9(4):256-71. doi: 10.1080/15524256.2013.846891.
- Albright DL, Kruse RL, Oliver DP, Washington K, Cagle J, Demiris G. Testing the factorial validity of scores from the caregiver pain medicine questionnaire. J Pain Symptom Manage. 2014 Jul;48(1):99-109. doi: 10.1016/j.jpainsymman.2013.08.014. Epub 2013 Nov 15.
- Wittenberg-Lyles E, Goldsmith J, Oliver DP, Demiris G, Kruse RL, Van Stee S. Using medical words with family caregivers. J Palliat Med. 2013 Sep;16(9):1135-9. doi: 10.1089/jpm.2013.0041. Epub 2013 Aug 12.
- Wittenberg-Lyles E, Goldsmith J, Oliver DP, Demiris G, Kruse RL, Van Stee S. Exploring oral literacy in communication with hospice caregivers. J Pain Symptom Manage. 2013 Nov;46(5):731-6. doi: 10.1016/j.jpainsymman.2012.11.006. Epub 2013 Mar 21.
- Baldwin PK, Wittenberg-Lyles E, Kruse RL, Demiris G, Parker Oliver D. Pain management and the African American hospice caregiver: a case report. Am J Hosp Palliat Care. 2013 Dec;30(8):795-8. doi: 10.1177/1049909112469274. Epub 2012 Dec 10. No abstract available.
- Washington KT, Wittenberg-Lyles E, Parker Oliver D, Demiris G, Shaunfield S, Crumb E. Application of the VALUE communication principles in ACTIVE hospice team meetings. J Palliat Med. 2013 Jan;16(1):60-6. doi: 10.1089/jpm.2012.0229. Epub 2012 Oct 4.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2010
Primärt slutförande (Faktisk)
1 april 2014
Avslutad studie (Faktisk)
1 juli 2015
Studieregistreringsdatum
Först inskickad
23 september 2010
Först inskickad som uppfyllde QC-kriterierna
28 september 2010
Första postat (Uppskatta)
29 september 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 februari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 januari 2021
Senast verifierad
1 april 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1160518
Plan för individuella deltagardata (IPD)
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NEJ
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